Trial Outcomes & Findings for HOPE Consortium Trial to Reduce Pain and Opioid Use in Hemodialysis (NCT NCT04571619)

Last Updated: 2025-01-13

Results Overview

Pain interference as measured by the Brief Pain Index (BPI) Interference Scale. This is typically scored as the mean of the seven items. Lowest score - 0; Highest score - 10. A higher score is worse.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

643 participants

Primary outcome timeframe

The primary outcome of pain interference will be ascertained at Week 12 coinciding with the end of the PCST weekly coaching sessions.

Results posted on

2025-01-13

Participant Flow

643 participants were randomized across 16 recruitment sites.

The original enrollment target was 640 participants. Permission to over-enroll was granted by the single IRB of record due to the nature of 16 recruitment sites enrolling simultaneously. The study teams did not want to have to exclude participants who had been consented and were in the screening process when the original target of 640 was reached. Therefore, 3 extra participants were enrolled as they had already been consented when the 640th participant was randomized.

Participant milestones

Participant milestones
Measure	Pain Coping Skills Training (PCST) PCST: Participants in the PCST arm will be provided with written educational material about chronic pain and opioid medications, and available resources for treatment. The PCST intervention aims to reduce pain interference and improve self-management skills. During Weeks 1-12 the PCST will be delivered by coaches via weekly video- or tele-conferencing sessions. During Weeks 13-24, Interactive Voice Response (IVR) will be delivered via daily telephone interactions, each lasting approximately 5 minutes. The IVR content is intended to enhance and sustain the effects of the coach-led session. Both components of the intervention will be available in English and Spanish. Buprenorphine: At Week 24, participants who meet the eligibility criteria for the buprenorphine intervention will be encouraged to switch from their full agonist opioid medication to the partial opioid agonist, buprenorphine. Participants who switch will be provided with individualized buprenorphine treatment recommendations made by a study physician based on current opioid use and other relevant factors. Participants who do not meet the Phase 2 eligibility criteria will not be offered buprenorphine. All participants will continue to be followed from Week 24 until Week 36 for ascertainment of pain, opioid use, and other outcomes to address durability of the effects of PCST, and, for those who switch to buprenorphine, to assess buprenorphine acceptability, tolerability, and efficacy as exploratory outcomes.	Usual Care Usual Care: Participants in the Usual Care arm will be provided with written educational material about chronic pain and opioid medications, and available resources for treatment. Buprenorphine: At Week 24, participants who meet the eligibility criteria for the buprenorphine intervention will be encouraged to switch from their current full agonist opioid medication to the partial opioid agonist, buprenorphine. Participants who switch to Buprenorphine will be provided with individualized buprenorphine treatment recommendations. Individualized buprenorphine treatment recommendations will be made by the study buprenorphine physician based on current opioid use and other relevant factors. Participants who do not meet the Phase 2 eligibility criteria will not be offered buprenorphine. All participants will continue to be followed from Week 24 until Week 36 for ascertainment of pain, opioid use, and other outcomes to address durability of the effects of PCST, and, for those who switch to buprenorphine, to assess buprenorphine acceptability, tolerability, and efficacy as exploratory outcomes.
Phase 1 STARTED	319	324
Phase 1 COMPLETED	290	304
Phase 1 NOT COMPLETED	29	20
Phase 2 STARTED	290	304
Phase 2 COMPLETED	271	284
Phase 2 NOT COMPLETED	19	20

Reasons for withdrawal

Reasons for withdrawal
Measure	Pain Coping Skills Training (PCST) PCST: Participants in the PCST arm will be provided with written educational material about chronic pain and opioid medications, and available resources for treatment. The PCST intervention aims to reduce pain interference and improve self-management skills. During Weeks 1-12 the PCST will be delivered by coaches via weekly video- or tele-conferencing sessions. During Weeks 13-24, Interactive Voice Response (IVR) will be delivered via daily telephone interactions, each lasting approximately 5 minutes. The IVR content is intended to enhance and sustain the effects of the coach-led session. Both components of the intervention will be available in English and Spanish. Buprenorphine: At Week 24, participants who meet the eligibility criteria for the buprenorphine intervention will be encouraged to switch from their full agonist opioid medication to the partial opioid agonist, buprenorphine. Participants who switch will be provided with individualized buprenorphine treatment recommendations made by a study physician based on current opioid use and other relevant factors. Participants who do not meet the Phase 2 eligibility criteria will not be offered buprenorphine. All participants will continue to be followed from Week 24 until Week 36 for ascertainment of pain, opioid use, and other outcomes to address durability of the effects of PCST, and, for those who switch to buprenorphine, to assess buprenorphine acceptability, tolerability, and efficacy as exploratory outcomes.	Usual Care Usual Care: Participants in the Usual Care arm will be provided with written educational material about chronic pain and opioid medications, and available resources for treatment. Buprenorphine: At Week 24, participants who meet the eligibility criteria for the buprenorphine intervention will be encouraged to switch from their current full agonist opioid medication to the partial opioid agonist, buprenorphine. Participants who switch to Buprenorphine will be provided with individualized buprenorphine treatment recommendations. Individualized buprenorphine treatment recommendations will be made by the study buprenorphine physician based on current opioid use and other relevant factors. Participants who do not meet the Phase 2 eligibility criteria will not be offered buprenorphine. All participants will continue to be followed from Week 24 until Week 36 for ascertainment of pain, opioid use, and other outcomes to address durability of the effects of PCST, and, for those who switch to buprenorphine, to assess buprenorphine acceptability, tolerability, and efficacy as exploratory outcomes.
Phase 1 Death	22	18
Phase 1 Withdrawal by Subject	7	2
Phase 2 Death	13	16
Phase 2 Withdrawal by Subject	6	4

Baseline Characteristics

HOPE Consortium Trial to Reduce Pain and Opioid Use in Hemodialysis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pain Coping Skills Training n=319 Participants Pain Coping Skills Training (PCST): The PCST intervention will focus primarily on reducing pain interference in daily activities and improving pain self-management skills. For participants with recent or current opioid use, the PCST intervention will include motivational interviewing aimed at reducing opioid use. During Weeks 1 - 12 the PCST will be delivered by coaches via telehealth (video). During Weeks 13 - 24, the Interactive Voice Response (IVR) will be delivered via telephone. The telehealth component will consist of weekly sessions, each lasting 45-50 minutes. The IVR content, intended to enhance and sustain the effects of the coach-led session, will be delivered with daily telephone interactions, each lasting approximately 5 minutes. Both components of the intervention will be available in English and Spanish.	Usual Care n=324 Participants Usual Care: Participants in the Usual Care arm will be provided with written educational material about chronic pain and opioid medications, and available resources for treatment.	Total n=643 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age, Categorical Between 18 and 65 years	193 Participants n=99 Participants	194 Participants n=107 Participants	387 Participants n=206 Participants
Age, Categorical >=65 years	126 Participants n=99 Participants	130 Participants n=107 Participants	256 Participants n=206 Participants
Age, Continuous	60.3 years STANDARD_DEVIATION 12.6 • n=99 Participants	60.4 years STANDARD_DEVIATION 12.5 • n=107 Participants	60.3 years STANDARD_DEVIATION 12.6 • n=206 Participants
Sex: Female, Male Female	155 Participants n=99 Participants	138 Participants n=107 Participants	293 Participants n=206 Participants
Sex: Female, Male Male	164 Participants n=99 Participants	186 Participants n=107 Participants	350 Participants n=206 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	62 Participants n=99 Participants	57 Participants n=107 Participants	119 Participants n=206 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	256 Participants n=99 Participants	261 Participants n=107 Participants	517 Participants n=206 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=99 Participants	6 Participants n=107 Participants	7 Participants n=206 Participants
Race (NIH/OMB) American Indian or Alaska Native	10 Participants n=99 Participants	12 Participants n=107 Participants	22 Participants n=206 Participants
Race (NIH/OMB) Asian	4 Participants n=99 Participants	2 Participants n=107 Participants	6 Participants n=206 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	2 Participants n=99 Participants	4 Participants n=107 Participants	6 Participants n=206 Participants
Race (NIH/OMB) Black or African American	160 Participants n=99 Participants	148 Participants n=107 Participants	308 Participants n=206 Participants
Race (NIH/OMB) White	99 Participants n=99 Participants	111 Participants n=107 Participants	210 Participants n=206 Participants
Race (NIH/OMB) More than one race	5 Participants n=99 Participants	6 Participants n=107 Participants	11 Participants n=206 Participants
Race (NIH/OMB) Unknown or Not Reported	39 Participants n=99 Participants	41 Participants n=107 Participants	80 Participants n=206 Participants
Region of Enrollment United States	319 participants n=99 Participants	324 participants n=107 Participants	643 participants n=206 Participants

PRIMARY outcome

Timeframe: The primary outcome of pain interference will be ascertained at Week 12 coinciding with the end of the PCST weekly coaching sessions.

Population: Participants withdrew at various points during the trial. Some participants were not able to complete the PRO assessments.

Pain interference as measured by the Brief Pain Index (BPI) Interference Scale. This is typically scored as the mean of the seven items. Lowest score - 0; Highest score - 10. A higher score is worse.

Outcome measures

Outcome measures
Measure	Pain Coping Skills Training n=318 Participants PCST: Participants in the PCST arm will be provided with written educational material about chronic pain and opioid medications, and available resources for treatment. The PCST intervention aims to reduce pain interference and improve self-management skills. During Weeks 1-12 the PCST will be delivered by coaches via weekly video- or tele-conferencing sessions. During Weeks 13-24, Interactive Voice Response (IVR) will be delivered via daily telephone interactions, each lasting approximately 5 minutes. The IVR content is intended to enhance and sustain the effects of the coach-led session. Both components of the intervention will be available in English and Spanish. Buprenorphine: At Week 24, participants who meet the eligibility criteria for the buprenorphine intervention will be encouraged to switch from their full agonist opioid medication to the partial opioid agonist, buprenorphine. Participants who switch will be provided with individualized buprenorphine treatment recommendations made by a study physician based on current opioid use and other relevant factors. Participants who do not meet the Phase 2 eligibility criteria will not be offered buprenorphine. All participants will continue to be followed from Week 24 until Week 36 for ascertainment of pain, opioid use, and other outcomes to address durability of the effects of PCST, and, for those who switch to buprenorphine, to assess buprenorphine acceptability, tolerability, and efficacy as exploratory outcomes.	Usual Care n=324 Participants Usual Care: Participants in the Usual Care arm will be provided with written educational material about chronic pain and opioid medications, and available resources for treatment. Buprenorphine: At Week 24, participants who meet the eligibility criteria for the buprenorphine intervention will be encouraged to switch from their current full agonist opioid medication to the partial opioid agonist, buprenorphine. Participants who switch to Buprenorphine will be provided with individualized buprenorphine treatment recommendations. Individualized buprenorphine treatment recommendations will be made by the study buprenorphine physician based on current opioid use and other relevant factors. Participants who do not meet the Phase 2 eligibility criteria will not be offered buprenorphine. All participants will continue to be followed from Week 24 until Week 36 for ascertainment of pain, opioid use, and other outcomes to address durability of the effects of PCST, and, for those who switch to buprenorphine, to assess buprenorphine acceptability, tolerability, and efficacy as exploratory outcomes.
Pain Interference Baseline	6.26 score on a scale Standard Deviation 2.02	6.45 score on a scale Standard Deviation 2.13
Pain Interference Week 12	5.09 score on a scale Standard Deviation 2.37	5.75 score on a scale Standard Deviation 2.55

SECONDARY outcome

Timeframe: Weeks 12, 24, and 36

Population: Participants withdrew at various points during the study. Some participants were not able to complete the PRO assessments.

Pain intensity as measured by the Brief Pain Index (BPI) Severity Scale. Lowest score - 0; Highest score - 40. A higher score is worse.

Outcome measures

Outcome measures
Measure	Pain Coping Skills Training n=319 Participants PCST: Participants in the PCST arm will be provided with written educational material about chronic pain and opioid medications, and available resources for treatment. The PCST intervention aims to reduce pain interference and improve self-management skills. During Weeks 1-12 the PCST will be delivered by coaches via weekly video- or tele-conferencing sessions. During Weeks 13-24, Interactive Voice Response (IVR) will be delivered via daily telephone interactions, each lasting approximately 5 minutes. The IVR content is intended to enhance and sustain the effects of the coach-led session. Both components of the intervention will be available in English and Spanish. Buprenorphine: At Week 24, participants who meet the eligibility criteria for the buprenorphine intervention will be encouraged to switch from their full agonist opioid medication to the partial opioid agonist, buprenorphine. Participants who switch will be provided with individualized buprenorphine treatment recommendations made by a study physician based on current opioid use and other relevant factors. Participants who do not meet the Phase 2 eligibility criteria will not be offered buprenorphine. All participants will continue to be followed from Week 24 until Week 36 for ascertainment of pain, opioid use, and other outcomes to address durability of the effects of PCST, and, for those who switch to buprenorphine, to assess buprenorphine acceptability, tolerability, and efficacy as exploratory outcomes.	Usual Care n=324 Participants Usual Care: Participants in the Usual Care arm will be provided with written educational material about chronic pain and opioid medications, and available resources for treatment. Buprenorphine: At Week 24, participants who meet the eligibility criteria for the buprenorphine intervention will be encouraged to switch from their current full agonist opioid medication to the partial opioid agonist, buprenorphine. Participants who switch to Buprenorphine will be provided with individualized buprenorphine treatment recommendations. Individualized buprenorphine treatment recommendations will be made by the study buprenorphine physician based on current opioid use and other relevant factors. Participants who do not meet the Phase 2 eligibility criteria will not be offered buprenorphine. All participants will continue to be followed from Week 24 until Week 36 for ascertainment of pain, opioid use, and other outcomes to address durability of the effects of PCST, and, for those who switch to buprenorphine, to assess buprenorphine acceptability, tolerability, and efficacy as exploratory outcomes.
Pain Intensity Baseline	5.83 score on a scale Standard Deviation 2.05	5.98 score on a scale Standard Deviation 2.13
Pain Intensity Week 12	4.95 score on a scale Standard Deviation 2.32	5.38 score on a scale Standard Deviation 2.24
Pain Intensity Week 24	4.64 score on a scale Standard Deviation 2.44	5.21 score on a scale Standard Deviation 2.31
Pain Intensity Week 36	4.74 score on a scale Standard Deviation 2.49	5.10 score on a scale Standard Deviation 2.46

SECONDARY outcome

Timeframe: Weeks 12, 24, and 36

Population: Participants withdrew at various points throughout the study, and some participants were unable to complete the PRO assessments.

Pain catastrophizing will be measured using the Pain Catastrophizing Scale (PCS) Short Form (SF) 6. Lowest score - 0; Highest score - 24. A higher score is worse.

Outcome measures

Outcome measures
Measure	Pain Coping Skills Training n=319 Participants PCST: Participants in the PCST arm will be provided with written educational material about chronic pain and opioid medications, and available resources for treatment. The PCST intervention aims to reduce pain interference and improve self-management skills. During Weeks 1-12 the PCST will be delivered by coaches via weekly video- or tele-conferencing sessions. During Weeks 13-24, Interactive Voice Response (IVR) will be delivered via daily telephone interactions, each lasting approximately 5 minutes. The IVR content is intended to enhance and sustain the effects of the coach-led session. Both components of the intervention will be available in English and Spanish. Buprenorphine: At Week 24, participants who meet the eligibility criteria for the buprenorphine intervention will be encouraged to switch from their full agonist opioid medication to the partial opioid agonist, buprenorphine. Participants who switch will be provided with individualized buprenorphine treatment recommendations made by a study physician based on current opioid use and other relevant factors. Participants who do not meet the Phase 2 eligibility criteria will not be offered buprenorphine. All participants will continue to be followed from Week 24 until Week 36 for ascertainment of pain, opioid use, and other outcomes to address durability of the effects of PCST, and, for those who switch to buprenorphine, to assess buprenorphine acceptability, tolerability, and efficacy as exploratory outcomes.	Usual Care n=324 Participants Usual Care: Participants in the Usual Care arm will be provided with written educational material about chronic pain and opioid medications, and available resources for treatment. Buprenorphine: At Week 24, participants who meet the eligibility criteria for the buprenorphine intervention will be encouraged to switch from their current full agonist opioid medication to the partial opioid agonist, buprenorphine. Participants who switch to Buprenorphine will be provided with individualized buprenorphine treatment recommendations. Individualized buprenorphine treatment recommendations will be made by the study buprenorphine physician based on current opioid use and other relevant factors. Participants who do not meet the Phase 2 eligibility criteria will not be offered buprenorphine. All participants will continue to be followed from Week 24 until Week 36 for ascertainment of pain, opioid use, and other outcomes to address durability of the effects of PCST, and, for those who switch to buprenorphine, to assess buprenorphine acceptability, tolerability, and efficacy as exploratory outcomes.
Pain Catastrophizing Baseline	15.5 score on a scale Standard Deviation 5.61	15.5 score on a scale Standard Deviation 5.68
Pain Catastrophizing Week 12	13.3 score on a scale Standard Deviation 6.14	14.3 score on a scale Standard Deviation 6.32
Pain Catastrophizing Week 24	12.8 score on a scale Standard Deviation 6.93	14.2 score on a scale Standard Deviation 6.37
Pain Catastrophizing Week 36	12.8 score on a scale Standard Deviation 6.68	13.7 score on a scale Standard Deviation 6.85

SECONDARY outcome

Timeframe: Weeks 12, 24, and 36

Population: Not all participants reported opioid use, as this was not an inclusion criterion but rather a subset of the study population. This outcome was assessed only for those participants reporting opioid use at the time of enrollment.

Morphine milligram equivalent per day (MME/day). A lower MME is better as this indicates less prescription opioid drug use. Lowest score: 0; Highest score: N/A

Outcome measures

Outcome measures
Measure	Pain Coping Skills Training n=53 Participants PCST: Participants in the PCST arm will be provided with written educational material about chronic pain and opioid medications, and available resources for treatment. The PCST intervention aims to reduce pain interference and improve self-management skills. During Weeks 1-12 the PCST will be delivered by coaches via weekly video- or tele-conferencing sessions. During Weeks 13-24, Interactive Voice Response (IVR) will be delivered via daily telephone interactions, each lasting approximately 5 minutes. The IVR content is intended to enhance and sustain the effects of the coach-led session. Both components of the intervention will be available in English and Spanish. Buprenorphine: At Week 24, participants who meet the eligibility criteria for the buprenorphine intervention will be encouraged to switch from their full agonist opioid medication to the partial opioid agonist, buprenorphine. Participants who switch will be provided with individualized buprenorphine treatment recommendations made by a study physician based on current opioid use and other relevant factors. Participants who do not meet the Phase 2 eligibility criteria will not be offered buprenorphine. All participants will continue to be followed from Week 24 until Week 36 for ascertainment of pain, opioid use, and other outcomes to address durability of the effects of PCST, and, for those who switch to buprenorphine, to assess buprenorphine acceptability, tolerability, and efficacy as exploratory outcomes.	Usual Care n=64 Participants Usual Care: Participants in the Usual Care arm will be provided with written educational material about chronic pain and opioid medications, and available resources for treatment. Buprenorphine: At Week 24, participants who meet the eligibility criteria for the buprenorphine intervention will be encouraged to switch from their current full agonist opioid medication to the partial opioid agonist, buprenorphine. Participants who switch to Buprenorphine will be provided with individualized buprenorphine treatment recommendations. Individualized buprenorphine treatment recommendations will be made by the study buprenorphine physician based on current opioid use and other relevant factors. Participants who do not meet the Phase 2 eligibility criteria will not be offered buprenorphine. All participants will continue to be followed from Week 24 until Week 36 for ascertainment of pain, opioid use, and other outcomes to address durability of the effects of PCST, and, for those who switch to buprenorphine, to assess buprenorphine acceptability, tolerability, and efficacy as exploratory outcomes.
Opioid Use Baseline	45 morphine milliequivalents Standard Deviation 148	24 morphine milliequivalents Standard Deviation 36
Opioid Use Week 12	47 morphine milliequivalents Standard Deviation 163	32 morphine milliequivalents Standard Deviation 53
Opioid Use Week 24	48 morphine milliequivalents Standard Deviation 165	29 morphine milliequivalents Standard Deviation 44
Opioid Use Week 36	49 morphine milliequivalents Standard Deviation 173	27 morphine milliequivalents Standard Deviation 43

SECONDARY outcome

Timeframe: Throughout the 36-week follow-up

Number of fall events per arm.

Outcome measures

Outcome measures
Measure	Pain Coping Skills Training n=319 Participants PCST: Participants in the PCST arm will be provided with written educational material about chronic pain and opioid medications, and available resources for treatment. The PCST intervention aims to reduce pain interference and improve self-management skills. During Weeks 1-12 the PCST will be delivered by coaches via weekly video- or tele-conferencing sessions. During Weeks 13-24, Interactive Voice Response (IVR) will be delivered via daily telephone interactions, each lasting approximately 5 minutes. The IVR content is intended to enhance and sustain the effects of the coach-led session. Both components of the intervention will be available in English and Spanish. Buprenorphine: At Week 24, participants who meet the eligibility criteria for the buprenorphine intervention will be encouraged to switch from their full agonist opioid medication to the partial opioid agonist, buprenorphine. Participants who switch will be provided with individualized buprenorphine treatment recommendations made by a study physician based on current opioid use and other relevant factors. Participants who do not meet the Phase 2 eligibility criteria will not be offered buprenorphine. All participants will continue to be followed from Week 24 until Week 36 for ascertainment of pain, opioid use, and other outcomes to address durability of the effects of PCST, and, for those who switch to buprenorphine, to assess buprenorphine acceptability, tolerability, and efficacy as exploratory outcomes.	Usual Care n=324 Participants Usual Care: Participants in the Usual Care arm will be provided with written educational material about chronic pain and opioid medications, and available resources for treatment. Buprenorphine: At Week 24, participants who meet the eligibility criteria for the buprenorphine intervention will be encouraged to switch from their current full agonist opioid medication to the partial opioid agonist, buprenorphine. Participants who switch to Buprenorphine will be provided with individualized buprenorphine treatment recommendations. Individualized buprenorphine treatment recommendations will be made by the study buprenorphine physician based on current opioid use and other relevant factors. Participants who do not meet the Phase 2 eligibility criteria will not be offered buprenorphine. All participants will continue to be followed from Week 24 until Week 36 for ascertainment of pain, opioid use, and other outcomes to address durability of the effects of PCST, and, for those who switch to buprenorphine, to assess buprenorphine acceptability, tolerability, and efficacy as exploratory outcomes.
Number of Falls	138 number of falls	155 number of falls

SECONDARY outcome

Timeframe: Though Week 36 follow-up

Event rate as calculated by number of falls/patient years

Outcome measures

Outcome measures
Measure	Pain Coping Skills Training n=319 Participants PCST: Participants in the PCST arm will be provided with written educational material about chronic pain and opioid medications, and available resources for treatment. The PCST intervention aims to reduce pain interference and improve self-management skills. During Weeks 1-12 the PCST will be delivered by coaches via weekly video- or tele-conferencing sessions. During Weeks 13-24, Interactive Voice Response (IVR) will be delivered via daily telephone interactions, each lasting approximately 5 minutes. The IVR content is intended to enhance and sustain the effects of the coach-led session. Both components of the intervention will be available in English and Spanish. Buprenorphine: At Week 24, participants who meet the eligibility criteria for the buprenorphine intervention will be encouraged to switch from their full agonist opioid medication to the partial opioid agonist, buprenorphine. Participants who switch will be provided with individualized buprenorphine treatment recommendations made by a study physician based on current opioid use and other relevant factors. Participants who do not meet the Phase 2 eligibility criteria will not be offered buprenorphine. All participants will continue to be followed from Week 24 until Week 36 for ascertainment of pain, opioid use, and other outcomes to address durability of the effects of PCST, and, for those who switch to buprenorphine, to assess buprenorphine acceptability, tolerability, and efficacy as exploratory outcomes.	Usual Care n=324 Participants Usual Care: Participants in the Usual Care arm will be provided with written educational material about chronic pain and opioid medications, and available resources for treatment. Buprenorphine: At Week 24, participants who meet the eligibility criteria for the buprenorphine intervention will be encouraged to switch from their current full agonist opioid medication to the partial opioid agonist, buprenorphine. Participants who switch to Buprenorphine will be provided with individualized buprenorphine treatment recommendations. Individualized buprenorphine treatment recommendations will be made by the study buprenorphine physician based on current opioid use and other relevant factors. Participants who do not meet the Phase 2 eligibility criteria will not be offered buprenorphine. All participants will continue to be followed from Week 24 until Week 36 for ascertainment of pain, opioid use, and other outcomes to address durability of the effects of PCST, and, for those who switch to buprenorphine, to assess buprenorphine acceptability, tolerability, and efficacy as exploratory outcomes.
Rate of Falls	0.66 falls/patient year	0.70 falls/patient year

SECONDARY outcome

Timeframe: Through 36-week follow-up

Number of hospitalizations per arm.

Outcome measures

Outcome measures
Measure	Pain Coping Skills Training n=319 Participants PCST: Participants in the PCST arm will be provided with written educational material about chronic pain and opioid medications, and available resources for treatment. The PCST intervention aims to reduce pain interference and improve self-management skills. During Weeks 1-12 the PCST will be delivered by coaches via weekly video- or tele-conferencing sessions. During Weeks 13-24, Interactive Voice Response (IVR) will be delivered via daily telephone interactions, each lasting approximately 5 minutes. The IVR content is intended to enhance and sustain the effects of the coach-led session. Both components of the intervention will be available in English and Spanish. Buprenorphine: At Week 24, participants who meet the eligibility criteria for the buprenorphine intervention will be encouraged to switch from their full agonist opioid medication to the partial opioid agonist, buprenorphine. Participants who switch will be provided with individualized buprenorphine treatment recommendations made by a study physician based on current opioid use and other relevant factors. Participants who do not meet the Phase 2 eligibility criteria will not be offered buprenorphine. All participants will continue to be followed from Week 24 until Week 36 for ascertainment of pain, opioid use, and other outcomes to address durability of the effects of PCST, and, for those who switch to buprenorphine, to assess buprenorphine acceptability, tolerability, and efficacy as exploratory outcomes.	Usual Care n=324 Participants Usual Care: Participants in the Usual Care arm will be provided with written educational material about chronic pain and opioid medications, and available resources for treatment. Buprenorphine: At Week 24, participants who meet the eligibility criteria for the buprenorphine intervention will be encouraged to switch from their current full agonist opioid medication to the partial opioid agonist, buprenorphine. Participants who switch to Buprenorphine will be provided with individualized buprenorphine treatment recommendations. Individualized buprenorphine treatment recommendations will be made by the study buprenorphine physician based on current opioid use and other relevant factors. Participants who do not meet the Phase 2 eligibility criteria will not be offered buprenorphine. All participants will continue to be followed from Week 24 until Week 36 for ascertainment of pain, opioid use, and other outcomes to address durability of the effects of PCST, and, for those who switch to buprenorphine, to assess buprenorphine acceptability, tolerability, and efficacy as exploratory outcomes.
Number of Hospitalizations	349 hospitalizations	313 hospitalizations

SECONDARY outcome

Timeframe: Through Week 36 follow-up

Event rate as calculated by number of hospitalizations/patient years

Outcome measures

Outcome measures
Measure	Pain Coping Skills Training n=319 Participants PCST: Participants in the PCST arm will be provided with written educational material about chronic pain and opioid medications, and available resources for treatment. The PCST intervention aims to reduce pain interference and improve self-management skills. During Weeks 1-12 the PCST will be delivered by coaches via weekly video- or tele-conferencing sessions. During Weeks 13-24, Interactive Voice Response (IVR) will be delivered via daily telephone interactions, each lasting approximately 5 minutes. The IVR content is intended to enhance and sustain the effects of the coach-led session. Both components of the intervention will be available in English and Spanish. Buprenorphine: At Week 24, participants who meet the eligibility criteria for the buprenorphine intervention will be encouraged to switch from their full agonist opioid medication to the partial opioid agonist, buprenorphine. Participants who switch will be provided with individualized buprenorphine treatment recommendations made by a study physician based on current opioid use and other relevant factors. Participants who do not meet the Phase 2 eligibility criteria will not be offered buprenorphine. All participants will continue to be followed from Week 24 until Week 36 for ascertainment of pain, opioid use, and other outcomes to address durability of the effects of PCST, and, for those who switch to buprenorphine, to assess buprenorphine acceptability, tolerability, and efficacy as exploratory outcomes.	Usual Care n=324 Participants Usual Care: Participants in the Usual Care arm will be provided with written educational material about chronic pain and opioid medications, and available resources for treatment. Buprenorphine: At Week 24, participants who meet the eligibility criteria for the buprenorphine intervention will be encouraged to switch from their current full agonist opioid medication to the partial opioid agonist, buprenorphine. Participants who switch to Buprenorphine will be provided with individualized buprenorphine treatment recommendations. Individualized buprenorphine treatment recommendations will be made by the study buprenorphine physician based on current opioid use and other relevant factors. Participants who do not meet the Phase 2 eligibility criteria will not be offered buprenorphine. All participants will continue to be followed from Week 24 until Week 36 for ascertainment of pain, opioid use, and other outcomes to address durability of the effects of PCST, and, for those who switch to buprenorphine, to assess buprenorphine acceptability, tolerability, and efficacy as exploratory outcomes.
Rate of Hospitalizations	1.67 hospitalizations/patient year	1.42 hospitalizations/patient year

SECONDARY outcome

Timeframe: Through the 36-week follow-up

The number of deaths per arms.

Outcome measures

Outcome measures
Measure	Pain Coping Skills Training n=319 Participants PCST: Participants in the PCST arm will be provided with written educational material about chronic pain and opioid medications, and available resources for treatment. The PCST intervention aims to reduce pain interference and improve self-management skills. During Weeks 1-12 the PCST will be delivered by coaches via weekly video- or tele-conferencing sessions. During Weeks 13-24, Interactive Voice Response (IVR) will be delivered via daily telephone interactions, each lasting approximately 5 minutes. The IVR content is intended to enhance and sustain the effects of the coach-led session. Both components of the intervention will be available in English and Spanish. Buprenorphine: At Week 24, participants who meet the eligibility criteria for the buprenorphine intervention will be encouraged to switch from their full agonist opioid medication to the partial opioid agonist, buprenorphine. Participants who switch will be provided with individualized buprenorphine treatment recommendations made by a study physician based on current opioid use and other relevant factors. Participants who do not meet the Phase 2 eligibility criteria will not be offered buprenorphine. All participants will continue to be followed from Week 24 until Week 36 for ascertainment of pain, opioid use, and other outcomes to address durability of the effects of PCST, and, for those who switch to buprenorphine, to assess buprenorphine acceptability, tolerability, and efficacy as exploratory outcomes.	Usual Care n=324 Participants Usual Care: Participants in the Usual Care arm will be provided with written educational material about chronic pain and opioid medications, and available resources for treatment. Buprenorphine: At Week 24, participants who meet the eligibility criteria for the buprenorphine intervention will be encouraged to switch from their current full agonist opioid medication to the partial opioid agonist, buprenorphine. Participants who switch to Buprenorphine will be provided with individualized buprenorphine treatment recommendations. Individualized buprenorphine treatment recommendations will be made by the study buprenorphine physician based on current opioid use and other relevant factors. Participants who do not meet the Phase 2 eligibility criteria will not be offered buprenorphine. All participants will continue to be followed from Week 24 until Week 36 for ascertainment of pain, opioid use, and other outcomes to address durability of the effects of PCST, and, for those who switch to buprenorphine, to assess buprenorphine acceptability, tolerability, and efficacy as exploratory outcomes.
Number of Deaths	35 deaths	34 deaths

SECONDARY outcome

Timeframe: Through Week 36 follow-up

Rate of deaths as calculated by number of events/patient years

Outcome measures

Outcome measures
Measure	Pain Coping Skills Training n=319 Participants PCST: Participants in the PCST arm will be provided with written educational material about chronic pain and opioid medications, and available resources for treatment. The PCST intervention aims to reduce pain interference and improve self-management skills. During Weeks 1-12 the PCST will be delivered by coaches via weekly video- or tele-conferencing sessions. During Weeks 13-24, Interactive Voice Response (IVR) will be delivered via daily telephone interactions, each lasting approximately 5 minutes. The IVR content is intended to enhance and sustain the effects of the coach-led session. Both components of the intervention will be available in English and Spanish. Buprenorphine: At Week 24, participants who meet the eligibility criteria for the buprenorphine intervention will be encouraged to switch from their full agonist opioid medication to the partial opioid agonist, buprenorphine. Participants who switch will be provided with individualized buprenorphine treatment recommendations made by a study physician based on current opioid use and other relevant factors. Participants who do not meet the Phase 2 eligibility criteria will not be offered buprenorphine. All participants will continue to be followed from Week 24 until Week 36 for ascertainment of pain, opioid use, and other outcomes to address durability of the effects of PCST, and, for those who switch to buprenorphine, to assess buprenorphine acceptability, tolerability, and efficacy as exploratory outcomes.	Usual Care n=324 Participants Usual Care: Participants in the Usual Care arm will be provided with written educational material about chronic pain and opioid medications, and available resources for treatment. Buprenorphine: At Week 24, participants who meet the eligibility criteria for the buprenorphine intervention will be encouraged to switch from their current full agonist opioid medication to the partial opioid agonist, buprenorphine. Participants who switch to Buprenorphine will be provided with individualized buprenorphine treatment recommendations. Individualized buprenorphine treatment recommendations will be made by the study buprenorphine physician based on current opioid use and other relevant factors. Participants who do not meet the Phase 2 eligibility criteria will not be offered buprenorphine. All participants will continue to be followed from Week 24 until Week 36 for ascertainment of pain, opioid use, and other outcomes to address durability of the effects of PCST, and, for those who switch to buprenorphine, to assess buprenorphine acceptability, tolerability, and efficacy as exploratory outcomes.
Rate of Deaths	0.17 deaths/patient year	0.15 deaths/patient year

SECONDARY outcome

Timeframe: Through Week 36

The proportion of participants who initiate buprenorphine from among those offered buprenorphine.

Outcome measures

Outcome measures
Measure	Pain Coping Skills Training n=319 Participants PCST: Participants in the PCST arm will be provided with written educational material about chronic pain and opioid medications, and available resources for treatment. The PCST intervention aims to reduce pain interference and improve self-management skills. During Weeks 1-12 the PCST will be delivered by coaches via weekly video- or tele-conferencing sessions. During Weeks 13-24, Interactive Voice Response (IVR) will be delivered via daily telephone interactions, each lasting approximately 5 minutes. The IVR content is intended to enhance and sustain the effects of the coach-led session. Both components of the intervention will be available in English and Spanish. Buprenorphine: At Week 24, participants who meet the eligibility criteria for the buprenorphine intervention will be encouraged to switch from their full agonist opioid medication to the partial opioid agonist, buprenorphine. Participants who switch will be provided with individualized buprenorphine treatment recommendations made by a study physician based on current opioid use and other relevant factors. Participants who do not meet the Phase 2 eligibility criteria will not be offered buprenorphine. All participants will continue to be followed from Week 24 until Week 36 for ascertainment of pain, opioid use, and other outcomes to address durability of the effects of PCST, and, for those who switch to buprenorphine, to assess buprenorphine acceptability, tolerability, and efficacy as exploratory outcomes.	Usual Care n=324 Participants Usual Care: Participants in the Usual Care arm will be provided with written educational material about chronic pain and opioid medications, and available resources for treatment. Buprenorphine: At Week 24, participants who meet the eligibility criteria for the buprenorphine intervention will be encouraged to switch from their current full agonist opioid medication to the partial opioid agonist, buprenorphine. Participants who switch to Buprenorphine will be provided with individualized buprenorphine treatment recommendations. Individualized buprenorphine treatment recommendations will be made by the study buprenorphine physician based on current opioid use and other relevant factors. Participants who do not meet the Phase 2 eligibility criteria will not be offered buprenorphine. All participants will continue to be followed from Week 24 until Week 36 for ascertainment of pain, opioid use, and other outcomes to address durability of the effects of PCST, and, for those who switch to buprenorphine, to assess buprenorphine acceptability, tolerability, and efficacy as exploratory outcomes.
Buprenorphine Acceptability	.27 proportion of participants	.50 proportion of participants

SECONDARY outcome

Timeframe: Through Week 36

The proportion of patients who started buprenorphine and did not discontinue buprenorphine due to adverse effects or intolerance.

Outcome measures

Outcome measures
Measure	Pain Coping Skills Training n=319 Participants PCST: Participants in the PCST arm will be provided with written educational material about chronic pain and opioid medications, and available resources for treatment. The PCST intervention aims to reduce pain interference and improve self-management skills. During Weeks 1-12 the PCST will be delivered by coaches via weekly video- or tele-conferencing sessions. During Weeks 13-24, Interactive Voice Response (IVR) will be delivered via daily telephone interactions, each lasting approximately 5 minutes. The IVR content is intended to enhance and sustain the effects of the coach-led session. Both components of the intervention will be available in English and Spanish. Buprenorphine: At Week 24, participants who meet the eligibility criteria for the buprenorphine intervention will be encouraged to switch from their full agonist opioid medication to the partial opioid agonist, buprenorphine. Participants who switch will be provided with individualized buprenorphine treatment recommendations made by a study physician based on current opioid use and other relevant factors. Participants who do not meet the Phase 2 eligibility criteria will not be offered buprenorphine. All participants will continue to be followed from Week 24 until Week 36 for ascertainment of pain, opioid use, and other outcomes to address durability of the effects of PCST, and, for those who switch to buprenorphine, to assess buprenorphine acceptability, tolerability, and efficacy as exploratory outcomes.	Usual Care n=324 Participants Usual Care: Participants in the Usual Care arm will be provided with written educational material about chronic pain and opioid medications, and available resources for treatment. Buprenorphine: At Week 24, participants who meet the eligibility criteria for the buprenorphine intervention will be encouraged to switch from their current full agonist opioid medication to the partial opioid agonist, buprenorphine. Participants who switch to Buprenorphine will be provided with individualized buprenorphine treatment recommendations. Individualized buprenorphine treatment recommendations will be made by the study buprenorphine physician based on current opioid use and other relevant factors. Participants who do not meet the Phase 2 eligibility criteria will not be offered buprenorphine. All participants will continue to be followed from Week 24 until Week 36 for ascertainment of pain, opioid use, and other outcomes to address durability of the effects of PCST, and, for those who switch to buprenorphine, to assess buprenorphine acceptability, tolerability, and efficacy as exploratory outcomes.
Buprenorphine Tolerability	1.00 proportion of participants	.33 proportion of participants

SECONDARY outcome

Timeframe: Weeks 12, 24, and 36

Population: Participants withdrew at various points throughout the study, and some participants were unable to complete the PRO assessments.

Quality of life will be measured using the Single-Item Quality of Life (QOL) Scale (SIS) from McGill Quality of Life (MQOL) questionnaire. Lowest score - 0; highest score - 10; Higher score equals better outcome.

Outcome measures

Outcome measures
Measure	Pain Coping Skills Training n=319 Participants PCST: Participants in the PCST arm will be provided with written educational material about chronic pain and opioid medications, and available resources for treatment. The PCST intervention aims to reduce pain interference and improve self-management skills. During Weeks 1-12 the PCST will be delivered by coaches via weekly video- or tele-conferencing sessions. During Weeks 13-24, Interactive Voice Response (IVR) will be delivered via daily telephone interactions, each lasting approximately 5 minutes. The IVR content is intended to enhance and sustain the effects of the coach-led session. Both components of the intervention will be available in English and Spanish. Buprenorphine: At Week 24, participants who meet the eligibility criteria for the buprenorphine intervention will be encouraged to switch from their full agonist opioid medication to the partial opioid agonist, buprenorphine. Participants who switch will be provided with individualized buprenorphine treatment recommendations made by a study physician based on current opioid use and other relevant factors. Participants who do not meet the Phase 2 eligibility criteria will not be offered buprenorphine. All participants will continue to be followed from Week 24 until Week 36 for ascertainment of pain, opioid use, and other outcomes to address durability of the effects of PCST, and, for those who switch to buprenorphine, to assess buprenorphine acceptability, tolerability, and efficacy as exploratory outcomes.	Usual Care n=324 Participants Usual Care: Participants in the Usual Care arm will be provided with written educational material about chronic pain and opioid medications, and available resources for treatment. Buprenorphine: At Week 24, participants who meet the eligibility criteria for the buprenorphine intervention will be encouraged to switch from their current full agonist opioid medication to the partial opioid agonist, buprenorphine. Participants who switch to Buprenorphine will be provided with individualized buprenorphine treatment recommendations. Individualized buprenorphine treatment recommendations will be made by the study buprenorphine physician based on current opioid use and other relevant factors. Participants who do not meet the Phase 2 eligibility criteria will not be offered buprenorphine. All participants will continue to be followed from Week 24 until Week 36 for ascertainment of pain, opioid use, and other outcomes to address durability of the effects of PCST, and, for those who switch to buprenorphine, to assess buprenorphine acceptability, tolerability, and efficacy as exploratory outcomes.
Overall Sense of Quality of Life Baseline	6.08 score on a scale Standard Deviation 2.61	5.82 score on a scale Standard Deviation 2.68
Overall Sense of Quality of Life Week 12	6.66 score on a scale Standard Deviation 2.53	5.88 score on a scale Standard Deviation 2.54
Overall Sense of Quality of Life Week 24	6.70 score on a scale Standard Deviation 2.43	6.09 score on a scale Standard Deviation 2.46
Overall Sense of Quality of Life Week 36	6.27 score on a scale Standard Deviation 2.70	6.19 score on a scale Standard Deviation 2.52

SECONDARY outcome

Timeframe: Weeks 12, 24, and 36

Population: Participants withdrew at various points during the study, and some participants were unable to complete the PRO assessments.

Physical functioning will be measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Functioning Short Form (SF)-6b questionnaire. Normalized score reported as t-values. The full range of possible scores is 21-59. 50 indicates the population mean with a standard deviation of 10. A higher score represents a better outcome.

Outcome measures

Outcome measures
Measure	Pain Coping Skills Training n=319 Participants PCST: Participants in the PCST arm will be provided with written educational material about chronic pain and opioid medications, and available resources for treatment. The PCST intervention aims to reduce pain interference and improve self-management skills. During Weeks 1-12 the PCST will be delivered by coaches via weekly video- or tele-conferencing sessions. During Weeks 13-24, Interactive Voice Response (IVR) will be delivered via daily telephone interactions, each lasting approximately 5 minutes. The IVR content is intended to enhance and sustain the effects of the coach-led session. Both components of the intervention will be available in English and Spanish. Buprenorphine: At Week 24, participants who meet the eligibility criteria for the buprenorphine intervention will be encouraged to switch from their full agonist opioid medication to the partial opioid agonist, buprenorphine. Participants who switch will be provided with individualized buprenorphine treatment recommendations made by a study physician based on current opioid use and other relevant factors. Participants who do not meet the Phase 2 eligibility criteria will not be offered buprenorphine. All participants will continue to be followed from Week 24 until Week 36 for ascertainment of pain, opioid use, and other outcomes to address durability of the effects of PCST, and, for those who switch to buprenorphine, to assess buprenorphine acceptability, tolerability, and efficacy as exploratory outcomes.	Usual Care n=324 Participants Usual Care: Participants in the Usual Care arm will be provided with written educational material about chronic pain and opioid medications, and available resources for treatment. Buprenorphine: At Week 24, participants who meet the eligibility criteria for the buprenorphine intervention will be encouraged to switch from their current full agonist opioid medication to the partial opioid agonist, buprenorphine. Participants who switch to Buprenorphine will be provided with individualized buprenorphine treatment recommendations. Individualized buprenorphine treatment recommendations will be made by the study buprenorphine physician based on current opioid use and other relevant factors. Participants who do not meet the Phase 2 eligibility criteria will not be offered buprenorphine. All participants will continue to be followed from Week 24 until Week 36 for ascertainment of pain, opioid use, and other outcomes to address durability of the effects of PCST, and, for those who switch to buprenorphine, to assess buprenorphine acceptability, tolerability, and efficacy as exploratory outcomes.
Physical Functioning Baseline	33.5 T-score Standard Deviation 7.60	33.3 T-score Standard Deviation 7.68
Physical Functioning Week 12	35.5 T-score Standard Deviation 8.08	33.9 T-score Standard Deviation 7.59
Physical Functioning Week 24	35.0 T-score Standard Deviation 8.40	34.2 T-score Standard Deviation 8.09
Physical Functioning Week 36	34.9 T-score Standard Deviation 7.89	34.5 T-score Standard Deviation 8.47

SECONDARY outcome

Timeframe: Weeks 12, 24, and 36

Population: Participants withdrew at various points during the study, and some participants were unable to complete the PRO assessments.

Depression will be measured using the Patient Health Questionnaire (PHQ)-9. Lowest score - 0; Highest score - 27; Lower score equals better outcome.

Outcome measures

Outcome measures
Measure	Pain Coping Skills Training n=319 Participants PCST: Participants in the PCST arm will be provided with written educational material about chronic pain and opioid medications, and available resources for treatment. The PCST intervention aims to reduce pain interference and improve self-management skills. During Weeks 1-12 the PCST will be delivered by coaches via weekly video- or tele-conferencing sessions. During Weeks 13-24, Interactive Voice Response (IVR) will be delivered via daily telephone interactions, each lasting approximately 5 minutes. The IVR content is intended to enhance and sustain the effects of the coach-led session. Both components of the intervention will be available in English and Spanish. Buprenorphine: At Week 24, participants who meet the eligibility criteria for the buprenorphine intervention will be encouraged to switch from their full agonist opioid medication to the partial opioid agonist, buprenorphine. Participants who switch will be provided with individualized buprenorphine treatment recommendations made by a study physician based on current opioid use and other relevant factors. Participants who do not meet the Phase 2 eligibility criteria will not be offered buprenorphine. All participants will continue to be followed from Week 24 until Week 36 for ascertainment of pain, opioid use, and other outcomes to address durability of the effects of PCST, and, for those who switch to buprenorphine, to assess buprenorphine acceptability, tolerability, and efficacy as exploratory outcomes.	Usual Care n=324 Participants Usual Care: Participants in the Usual Care arm will be provided with written educational material about chronic pain and opioid medications, and available resources for treatment. Buprenorphine: At Week 24, participants who meet the eligibility criteria for the buprenorphine intervention will be encouraged to switch from their current full agonist opioid medication to the partial opioid agonist, buprenorphine. Participants who switch to Buprenorphine will be provided with individualized buprenorphine treatment recommendations. Individualized buprenorphine treatment recommendations will be made by the study buprenorphine physician based on current opioid use and other relevant factors. Participants who do not meet the Phase 2 eligibility criteria will not be offered buprenorphine. All participants will continue to be followed from Week 24 until Week 36 for ascertainment of pain, opioid use, and other outcomes to address durability of the effects of PCST, and, for those who switch to buprenorphine, to assess buprenorphine acceptability, tolerability, and efficacy as exploratory outcomes.
Depression Baseline	8.78 score on a scale Standard Deviation 5.77	9.51 score on a scale Standard Deviation 6.11
Depression Week 12	7.29 score on a scale Standard Deviation 5.22	8.92 score on a scale Standard Deviation 5.83
Depression Week 24	7.47 score on a scale Standard Deviation 5.90	8.96 score on a scale Standard Deviation 5.72
Depression Week 36	8.29 score on a scale Standard Deviation 6.04	8.75 score on a scale Standard Deviation 6.09

SECONDARY outcome

Timeframe: Weeks 12, 24, and 36

Population: Participants withdrew at various points throughout the trial, and some participants were unable to complete the PRO assessments.

Anxiety will be measured using the Generalized Anxiety Disorder (GAD)-7 questionnaire. Lowest score - 0; Highest score - 21; Lower score equals better outcome.

Outcome measures

Outcome measures
Measure	Pain Coping Skills Training n=319 Participants PCST: Participants in the PCST arm will be provided with written educational material about chronic pain and opioid medications, and available resources for treatment. The PCST intervention aims to reduce pain interference and improve self-management skills. During Weeks 1-12 the PCST will be delivered by coaches via weekly video- or tele-conferencing sessions. During Weeks 13-24, Interactive Voice Response (IVR) will be delivered via daily telephone interactions, each lasting approximately 5 minutes. The IVR content is intended to enhance and sustain the effects of the coach-led session. Both components of the intervention will be available in English and Spanish. Buprenorphine: At Week 24, participants who meet the eligibility criteria for the buprenorphine intervention will be encouraged to switch from their full agonist opioid medication to the partial opioid agonist, buprenorphine. Participants who switch will be provided with individualized buprenorphine treatment recommendations made by a study physician based on current opioid use and other relevant factors. Participants who do not meet the Phase 2 eligibility criteria will not be offered buprenorphine. All participants will continue to be followed from Week 24 until Week 36 for ascertainment of pain, opioid use, and other outcomes to address durability of the effects of PCST, and, for those who switch to buprenorphine, to assess buprenorphine acceptability, tolerability, and efficacy as exploratory outcomes.	Usual Care n=324 Participants Usual Care: Participants in the Usual Care arm will be provided with written educational material about chronic pain and opioid medications, and available resources for treatment. Buprenorphine: At Week 24, participants who meet the eligibility criteria for the buprenorphine intervention will be encouraged to switch from their current full agonist opioid medication to the partial opioid agonist, buprenorphine. Participants who switch to Buprenorphine will be provided with individualized buprenorphine treatment recommendations. Individualized buprenorphine treatment recommendations will be made by the study buprenorphine physician based on current opioid use and other relevant factors. Participants who do not meet the Phase 2 eligibility criteria will not be offered buprenorphine. All participants will continue to be followed from Week 24 until Week 36 for ascertainment of pain, opioid use, and other outcomes to address durability of the effects of PCST, and, for those who switch to buprenorphine, to assess buprenorphine acceptability, tolerability, and efficacy as exploratory outcomes.
Anxiety Baseline	6.76 score on a scale Standard Deviation 5.84	7.38 score on a scale Standard Deviation 6.14
Anxiety Week 12	5.63 score on a scale Standard Deviation 5.48	7.04 score on a scale Standard Deviation 6.03
Anxiety Week 24	6.18 score on a scale Standard Deviation 5.83	7.48 score on a scale Standard Deviation 5.89
Anxiety Week 36	6.22 score on a scale Standard Deviation 5.75	6.96 score on a scale Standard Deviation 6.09

SECONDARY outcome

Timeframe: Weeks 12, 24, and 36

Population: Participants withdrew at various points throughout the trial, and some participants were unable to complete the PRO assessments.

Coping will be measured using the 1-Item Coping Strategies Questionnaire (CSQ). Lowest score - 0; Highest score - 6; Lower score equals better outcome.

Outcome measures

Outcome measures
Measure	Pain Coping Skills Training n=319 Participants PCST: Participants in the PCST arm will be provided with written educational material about chronic pain and opioid medications, and available resources for treatment. The PCST intervention aims to reduce pain interference and improve self-management skills. During Weeks 1-12 the PCST will be delivered by coaches via weekly video- or tele-conferencing sessions. During Weeks 13-24, Interactive Voice Response (IVR) will be delivered via daily telephone interactions, each lasting approximately 5 minutes. The IVR content is intended to enhance and sustain the effects of the coach-led session. Both components of the intervention will be available in English and Spanish. Buprenorphine: At Week 24, participants who meet the eligibility criteria for the buprenorphine intervention will be encouraged to switch from their full agonist opioid medication to the partial opioid agonist, buprenorphine. Participants who switch will be provided with individualized buprenorphine treatment recommendations made by a study physician based on current opioid use and other relevant factors. Participants who do not meet the Phase 2 eligibility criteria will not be offered buprenorphine. All participants will continue to be followed from Week 24 until Week 36 for ascertainment of pain, opioid use, and other outcomes to address durability of the effects of PCST, and, for those who switch to buprenorphine, to assess buprenorphine acceptability, tolerability, and efficacy as exploratory outcomes.	Usual Care n=324 Participants Usual Care: Participants in the Usual Care arm will be provided with written educational material about chronic pain and opioid medications, and available resources for treatment. Buprenorphine: At Week 24, participants who meet the eligibility criteria for the buprenorphine intervention will be encouraged to switch from their current full agonist opioid medication to the partial opioid agonist, buprenorphine. Participants who switch to Buprenorphine will be provided with individualized buprenorphine treatment recommendations. Individualized buprenorphine treatment recommendations will be made by the study buprenorphine physician based on current opioid use and other relevant factors. Participants who do not meet the Phase 2 eligibility criteria will not be offered buprenorphine. All participants will continue to be followed from Week 24 until Week 36 for ascertainment of pain, opioid use, and other outcomes to address durability of the effects of PCST, and, for those who switch to buprenorphine, to assess buprenorphine acceptability, tolerability, and efficacy as exploratory outcomes.
Coping Baseline	3.19 score on a scale Standard Deviation 2.19	3.50 score on a scale Standard Deviation 2.29
Coping Week 12	2.56 score on a scale Standard Deviation 2.07	2.90 score on a scale Standard Deviation 2.11
Coping Week 24	2.50 score on a scale Standard Deviation 2.16	2.86 score on a scale Standard Deviation 2.11
Coping Week 36	2.41 score on a scale Standard Deviation 2.15	2.62 score on a scale Standard Deviation 2.06

SECONDARY outcome

Timeframe: Weeks 12, 24, and 36

Population: Participants withdrew at various times during the study, and some participants were unable to complete the PRO assessments.

Sleep quality will be measure using the PROMIS Sleep Disturbance Short Form (SF) 6a. Normalized score reported as t-values. The full range of possible scores is 31.7 - 76.1. 50 indicates the population mean with a standard deviation of 10. A lower score represents a better outcome.

Outcome measures

Outcome measures
Measure	Pain Coping Skills Training n=319 Participants PCST: Participants in the PCST arm will be provided with written educational material about chronic pain and opioid medications, and available resources for treatment. The PCST intervention aims to reduce pain interference and improve self-management skills. During Weeks 1-12 the PCST will be delivered by coaches via weekly video- or tele-conferencing sessions. During Weeks 13-24, Interactive Voice Response (IVR) will be delivered via daily telephone interactions, each lasting approximately 5 minutes. The IVR content is intended to enhance and sustain the effects of the coach-led session. Both components of the intervention will be available in English and Spanish. Buprenorphine: At Week 24, participants who meet the eligibility criteria for the buprenorphine intervention will be encouraged to switch from their full agonist opioid medication to the partial opioid agonist, buprenorphine. Participants who switch will be provided with individualized buprenorphine treatment recommendations made by a study physician based on current opioid use and other relevant factors. Participants who do not meet the Phase 2 eligibility criteria will not be offered buprenorphine. All participants will continue to be followed from Week 24 until Week 36 for ascertainment of pain, opioid use, and other outcomes to address durability of the effects of PCST, and, for those who switch to buprenorphine, to assess buprenorphine acceptability, tolerability, and efficacy as exploratory outcomes.	Usual Care n=324 Participants Usual Care: Participants in the Usual Care arm will be provided with written educational material about chronic pain and opioid medications, and available resources for treatment. Buprenorphine: At Week 24, participants who meet the eligibility criteria for the buprenorphine intervention will be encouraged to switch from their current full agonist opioid medication to the partial opioid agonist, buprenorphine. Participants who switch to Buprenorphine will be provided with individualized buprenorphine treatment recommendations. Individualized buprenorphine treatment recommendations will be made by the study buprenorphine physician based on current opioid use and other relevant factors. Participants who do not meet the Phase 2 eligibility criteria will not be offered buprenorphine. All participants will continue to be followed from Week 24 until Week 36 for ascertainment of pain, opioid use, and other outcomes to address durability of the effects of PCST, and, for those who switch to buprenorphine, to assess buprenorphine acceptability, tolerability, and efficacy as exploratory outcomes.
Sleep Quality Baseline	57.3 t-score Standard Deviation 9.95	58.2 t-score Standard Deviation 10.3
Sleep Quality Week 12	54.3 t-score Standard Deviation 11.5	57.4 t-score Standard Deviation 9.94
Sleep Quality Week 24	54.2 t-score Standard Deviation 10.9	56.8 t-score Standard Deviation 10.3
Sleep Quality Week 36	54.3 t-score Standard Deviation 11.2	55.9 t-score Standard Deviation 11.1

SECONDARY outcome

Timeframe: Weeks 12, 24, and 36

Population: Participants withdrew at various times during the study, and some participants were unable to complete the PRO assessments.

Fatigue will be measured using the PROMIS Fatigue Short Form (SF) 6a. Normalized score reported as t-values. The full range of possible scores is 26.2 - 65.6. 50 indicates the population mean with a standard deviation of 10. A lower score represents a better outcome.

Outcome measures

Outcome measures
Measure	Pain Coping Skills Training n=319 Participants PCST: Participants in the PCST arm will be provided with written educational material about chronic pain and opioid medications, and available resources for treatment. The PCST intervention aims to reduce pain interference and improve self-management skills. During Weeks 1-12 the PCST will be delivered by coaches via weekly video- or tele-conferencing sessions. During Weeks 13-24, Interactive Voice Response (IVR) will be delivered via daily telephone interactions, each lasting approximately 5 minutes. The IVR content is intended to enhance and sustain the effects of the coach-led session. Both components of the intervention will be available in English and Spanish. Buprenorphine: At Week 24, participants who meet the eligibility criteria for the buprenorphine intervention will be encouraged to switch from their full agonist opioid medication to the partial opioid agonist, buprenorphine. Participants who switch will be provided with individualized buprenorphine treatment recommendations made by a study physician based on current opioid use and other relevant factors. Participants who do not meet the Phase 2 eligibility criteria will not be offered buprenorphine. All participants will continue to be followed from Week 24 until Week 36 for ascertainment of pain, opioid use, and other outcomes to address durability of the effects of PCST, and, for those who switch to buprenorphine, to assess buprenorphine acceptability, tolerability, and efficacy as exploratory outcomes.	Usual Care n=324 Participants Usual Care: Participants in the Usual Care arm will be provided with written educational material about chronic pain and opioid medications, and available resources for treatment. Buprenorphine: At Week 24, participants who meet the eligibility criteria for the buprenorphine intervention will be encouraged to switch from their current full agonist opioid medication to the partial opioid agonist, buprenorphine. Participants who switch to Buprenorphine will be provided with individualized buprenorphine treatment recommendations. Individualized buprenorphine treatment recommendations will be made by the study buprenorphine physician based on current opioid use and other relevant factors. Participants who do not meet the Phase 2 eligibility criteria will not be offered buprenorphine. All participants will continue to be followed from Week 24 until Week 36 for ascertainment of pain, opioid use, and other outcomes to address durability of the effects of PCST, and, for those who switch to buprenorphine, to assess buprenorphine acceptability, tolerability, and efficacy as exploratory outcomes.
Fatigue Baseline	59.0 t-score Standard Deviation 10.0	59.4 t-score Standard Deviation 9.82
Fatigue Week 12	56.2 t-score Standard Deviation 11.4	58.4 t-score Standard Deviation 10.7
Fatigue Week 24	56.6 t-score Standard Deviation 12.0	58.4 t-score Standard Deviation 10.7
Fatigue Week 36	57.0 t-score Standard Deviation 11.1	57.5 t-score Standard Deviation 10.8

SECONDARY outcome

Timeframe: Weeks 12, 24, and 36

Population: Participants withdrew at various times throughout the trial, and some participants were unable to complete the PRO assessments.

Satisfaction will be measured using the Patient Global Impression of Change (PGIC). Lowest score - 1; Highest score - 7; Lower score equals better outcome.

Outcome measures

Outcome measures
Measure	Pain Coping Skills Training n=319 Participants PCST: Participants in the PCST arm will be provided with written educational material about chronic pain and opioid medications, and available resources for treatment. The PCST intervention aims to reduce pain interference and improve self-management skills. During Weeks 1-12 the PCST will be delivered by coaches via weekly video- or tele-conferencing sessions. During Weeks 13-24, Interactive Voice Response (IVR) will be delivered via daily telephone interactions, each lasting approximately 5 minutes. The IVR content is intended to enhance and sustain the effects of the coach-led session. Both components of the intervention will be available in English and Spanish. Buprenorphine: At Week 24, participants who meet the eligibility criteria for the buprenorphine intervention will be encouraged to switch from their full agonist opioid medication to the partial opioid agonist, buprenorphine. Participants who switch will be provided with individualized buprenorphine treatment recommendations made by a study physician based on current opioid use and other relevant factors. Participants who do not meet the Phase 2 eligibility criteria will not be offered buprenorphine. All participants will continue to be followed from Week 24 until Week 36 for ascertainment of pain, opioid use, and other outcomes to address durability of the effects of PCST, and, for those who switch to buprenorphine, to assess buprenorphine acceptability, tolerability, and efficacy as exploratory outcomes.	Usual Care n=324 Participants Usual Care: Participants in the Usual Care arm will be provided with written educational material about chronic pain and opioid medications, and available resources for treatment. Buprenorphine: At Week 24, participants who meet the eligibility criteria for the buprenorphine intervention will be encouraged to switch from their current full agonist opioid medication to the partial opioid agonist, buprenorphine. Participants who switch to Buprenorphine will be provided with individualized buprenorphine treatment recommendations. Individualized buprenorphine treatment recommendations will be made by the study buprenorphine physician based on current opioid use and other relevant factors. Participants who do not meet the Phase 2 eligibility criteria will not be offered buprenorphine. All participants will continue to be followed from Week 24 until Week 36 for ascertainment of pain, opioid use, and other outcomes to address durability of the effects of PCST, and, for those who switch to buprenorphine, to assess buprenorphine acceptability, tolerability, and efficacy as exploratory outcomes.
Satisfaction With Treatment Week 12	3.10 score on a scale Standard Deviation 1.28	4.02 score on a scale Standard Deviation 1.37
Satisfaction With Treatment Week 24	3.16 score on a scale Standard Deviation 1.42	3.69 score on a scale Standard Deviation 1.36
Satisfaction With Treatment Week 36	3.16 score on a scale Standard Deviation 1.38	3.63 score on a scale Standard Deviation 1.47

SECONDARY outcome

Timeframe: Weeks 12, 24, and 36

Population: Participants withdrew at various points during the study, and some participants were unable to complete the PRO assessments.

Social support will be measured using the Multidimensional Scale of Perceived Social Support (MSPSS). Lowest score - 1; Highest score - 7; Higher score is better and equals more support. Total score reported.

Outcome measures

Outcome measures
Measure	Pain Coping Skills Training n=319 Participants PCST: Participants in the PCST arm will be provided with written educational material about chronic pain and opioid medications, and available resources for treatment. The PCST intervention aims to reduce pain interference and improve self-management skills. During Weeks 1-12 the PCST will be delivered by coaches via weekly video- or tele-conferencing sessions. During Weeks 13-24, Interactive Voice Response (IVR) will be delivered via daily telephone interactions, each lasting approximately 5 minutes. The IVR content is intended to enhance and sustain the effects of the coach-led session. Both components of the intervention will be available in English and Spanish. Buprenorphine: At Week 24, participants who meet the eligibility criteria for the buprenorphine intervention will be encouraged to switch from their full agonist opioid medication to the partial opioid agonist, buprenorphine. Participants who switch will be provided with individualized buprenorphine treatment recommendations made by a study physician based on current opioid use and other relevant factors. Participants who do not meet the Phase 2 eligibility criteria will not be offered buprenorphine. All participants will continue to be followed from Week 24 until Week 36 for ascertainment of pain, opioid use, and other outcomes to address durability of the effects of PCST, and, for those who switch to buprenorphine, to assess buprenorphine acceptability, tolerability, and efficacy as exploratory outcomes.	Usual Care n=324 Participants Usual Care: Participants in the Usual Care arm will be provided with written educational material about chronic pain and opioid medications, and available resources for treatment. Buprenorphine: At Week 24, participants who meet the eligibility criteria for the buprenorphine intervention will be encouraged to switch from their current full agonist opioid medication to the partial opioid agonist, buprenorphine. Participants who switch to Buprenorphine will be provided with individualized buprenorphine treatment recommendations. Individualized buprenorphine treatment recommendations will be made by the study buprenorphine physician based on current opioid use and other relevant factors. Participants who do not meet the Phase 2 eligibility criteria will not be offered buprenorphine. All participants will continue to be followed from Week 24 until Week 36 for ascertainment of pain, opioid use, and other outcomes to address durability of the effects of PCST, and, for those who switch to buprenorphine, to assess buprenorphine acceptability, tolerability, and efficacy as exploratory outcomes.
Social Support Baseline	5.29 score on a scale Standard Deviation 1.46	5.02 score on a scale Standard Deviation 1.54
Social Support Week 12	5.37 score on a scale Standard Deviation 1.41	5.18 score on a scale Standard Deviation 1.42
Social Support Week 24	5.43 score on a scale Standard Deviation 1.33	5.26 score on a scale Standard Deviation 1.28
Social Support Week 36	5.38 score on a scale Standard Deviation 1.35	5.20 score on a scale Standard Deviation 1.39

SECONDARY outcome

Timeframe: Weeks 12, 24, and 36

Population: Participants withdrew at various times during the study. Some participants were unable to complete the PRO assessments.

Family intrusion will be measured using the PROMIS Satisfaction with Social Roles and Activities. Normalized score reported as t-values. The full range of possible scores is 26.2 - 65.6. 50 indicates the population mean with a standard deviation of 10. A higher score represents a better outcome.

Outcome measures

Outcome measures
Measure	Pain Coping Skills Training n=319 Participants PCST: Participants in the PCST arm will be provided with written educational material about chronic pain and opioid medications, and available resources for treatment. The PCST intervention aims to reduce pain interference and improve self-management skills. During Weeks 1-12 the PCST will be delivered by coaches via weekly video- or tele-conferencing sessions. During Weeks 13-24, Interactive Voice Response (IVR) will be delivered via daily telephone interactions, each lasting approximately 5 minutes. The IVR content is intended to enhance and sustain the effects of the coach-led session. Both components of the intervention will be available in English and Spanish. Buprenorphine: At Week 24, participants who meet the eligibility criteria for the buprenorphine intervention will be encouraged to switch from their full agonist opioid medication to the partial opioid agonist, buprenorphine. Participants who switch will be provided with individualized buprenorphine treatment recommendations made by a study physician based on current opioid use and other relevant factors. Participants who do not meet the Phase 2 eligibility criteria will not be offered buprenorphine. All participants will continue to be followed from Week 24 until Week 36 for ascertainment of pain, opioid use, and other outcomes to address durability of the effects of PCST, and, for those who switch to buprenorphine, to assess buprenorphine acceptability, tolerability, and efficacy as exploratory outcomes.	Usual Care n=324 Participants Usual Care: Participants in the Usual Care arm will be provided with written educational material about chronic pain and opioid medications, and available resources for treatment. Buprenorphine: At Week 24, participants who meet the eligibility criteria for the buprenorphine intervention will be encouraged to switch from their current full agonist opioid medication to the partial opioid agonist, buprenorphine. Participants who switch to Buprenorphine will be provided with individualized buprenorphine treatment recommendations. Individualized buprenorphine treatment recommendations will be made by the study buprenorphine physician based on current opioid use and other relevant factors. Participants who do not meet the Phase 2 eligibility criteria will not be offered buprenorphine. All participants will continue to be followed from Week 24 until Week 36 for ascertainment of pain, opioid use, and other outcomes to address durability of the effects of PCST, and, for those who switch to buprenorphine, to assess buprenorphine acceptability, tolerability, and efficacy as exploratory outcomes.
Family Intrusion Baseline	42.8 T-score Standard Deviation 9.29	43.3 T-score Standard Deviation 9.57
Family Intrusion Week 12	44.4 T-score Standard Deviation 9.71	43.8 T-score Standard Deviation 9.22
Family Intrusion Week 24	45.1 T-score Standard Deviation 9.67	43.9 T-score Standard Deviation 9.27
Family Intrusion Week 36	44.5 T-score Standard Deviation 10.3	42.9 T-score Standard Deviation 9.77

SECONDARY outcome

Timeframe: Weeks 12, 24, and 36

Population: Participants withdrew at various times during the study. Some participants were unable to complete the PRO assessments.

Self-efficacy will be measured using the PROMIS Self-Efficacy for Managing Chronic Conditions - Managing Symptoms - Short Form 8A and the Single item targeting self-efficacy for pain. PROMIS Self-Efficacy for Managing Chronic Conditions - Managing Symptoms - Short Form 8A: Lowest score - 8; Highest score - 40; Higher score equals better outcome. Normalized score reported. Single item targeting self-efficacy for pain: Lowest score - 0; Highest score - 100; Higher score equals better outcome.

Outcome measures

Outcome measures
Measure	Pain Coping Skills Training n=319 Participants PCST: Participants in the PCST arm will be provided with written educational material about chronic pain and opioid medications, and available resources for treatment. The PCST intervention aims to reduce pain interference and improve self-management skills. During Weeks 1-12 the PCST will be delivered by coaches via weekly video- or tele-conferencing sessions. During Weeks 13-24, Interactive Voice Response (IVR) will be delivered via daily telephone interactions, each lasting approximately 5 minutes. The IVR content is intended to enhance and sustain the effects of the coach-led session. Both components of the intervention will be available in English and Spanish. Buprenorphine: At Week 24, participants who meet the eligibility criteria for the buprenorphine intervention will be encouraged to switch from their full agonist opioid medication to the partial opioid agonist, buprenorphine. Participants who switch will be provided with individualized buprenorphine treatment recommendations made by a study physician based on current opioid use and other relevant factors. Participants who do not meet the Phase 2 eligibility criteria will not be offered buprenorphine. All participants will continue to be followed from Week 24 until Week 36 for ascertainment of pain, opioid use, and other outcomes to address durability of the effects of PCST, and, for those who switch to buprenorphine, to assess buprenorphine acceptability, tolerability, and efficacy as exploratory outcomes.	Usual Care n=324 Participants Usual Care: Participants in the Usual Care arm will be provided with written educational material about chronic pain and opioid medications, and available resources for treatment. Buprenorphine: At Week 24, participants who meet the eligibility criteria for the buprenorphine intervention will be encouraged to switch from their current full agonist opioid medication to the partial opioid agonist, buprenorphine. Participants who switch to Buprenorphine will be provided with individualized buprenorphine treatment recommendations. Individualized buprenorphine treatment recommendations will be made by the study buprenorphine physician based on current opioid use and other relevant factors. Participants who do not meet the Phase 2 eligibility criteria will not be offered buprenorphine. All participants will continue to be followed from Week 24 until Week 36 for ascertainment of pain, opioid use, and other outcomes to address durability of the effects of PCST, and, for those who switch to buprenorphine, to assess buprenorphine acceptability, tolerability, and efficacy as exploratory outcomes.
Self-Efficacy Baseline	45.4 score on a scale Standard Deviation 8.11	45.1 score on a scale Standard Deviation 8.32
Self-Efficacy Week 12	48.1 score on a scale Standard Deviation 8.75	46.2 score on a scale Standard Deviation 7.55
Self-Efficacy Week 24	48.3 score on a scale Standard Deviation 9.17	46.6 score on a scale Standard Deviation 8.79
Self-Efficacy Week 36	48.1 score on a scale Standard Deviation 9.10	47.2 score on a scale Standard Deviation 8.75

SECONDARY outcome

Timeframe: Weeks 12, 24, and 36

Population: Participants withdrew at various points during the study. Not all participants were able to complete the PRO assessments.

Presence of symptoms will be measured using the Dialysis Symptom Index (DSI) Symptom Subscale. Lowest score - 0; Highest score - 30; Lower score equals better outcome.

Outcome measures

Outcome measures
Measure	Pain Coping Skills Training n=319 Participants PCST: Participants in the PCST arm will be provided with written educational material about chronic pain and opioid medications, and available resources for treatment. The PCST intervention aims to reduce pain interference and improve self-management skills. During Weeks 1-12 the PCST will be delivered by coaches via weekly video- or tele-conferencing sessions. During Weeks 13-24, Interactive Voice Response (IVR) will be delivered via daily telephone interactions, each lasting approximately 5 minutes. The IVR content is intended to enhance and sustain the effects of the coach-led session. Both components of the intervention will be available in English and Spanish. Buprenorphine: At Week 24, participants who meet the eligibility criteria for the buprenorphine intervention will be encouraged to switch from their full agonist opioid medication to the partial opioid agonist, buprenorphine. Participants who switch will be provided with individualized buprenorphine treatment recommendations made by a study physician based on current opioid use and other relevant factors. Participants who do not meet the Phase 2 eligibility criteria will not be offered buprenorphine. All participants will continue to be followed from Week 24 until Week 36 for ascertainment of pain, opioid use, and other outcomes to address durability of the effects of PCST, and, for those who switch to buprenorphine, to assess buprenorphine acceptability, tolerability, and efficacy as exploratory outcomes.	Usual Care n=324 Participants Usual Care: Participants in the Usual Care arm will be provided with written educational material about chronic pain and opioid medications, and available resources for treatment. Buprenorphine: At Week 24, participants who meet the eligibility criteria for the buprenorphine intervention will be encouraged to switch from their current full agonist opioid medication to the partial opioid agonist, buprenorphine. Participants who switch to Buprenorphine will be provided with individualized buprenorphine treatment recommendations. Individualized buprenorphine treatment recommendations will be made by the study buprenorphine physician based on current opioid use and other relevant factors. Participants who do not meet the Phase 2 eligibility criteria will not be offered buprenorphine. All participants will continue to be followed from Week 24 until Week 36 for ascertainment of pain, opioid use, and other outcomes to address durability of the effects of PCST, and, for those who switch to buprenorphine, to assess buprenorphine acceptability, tolerability, and efficacy as exploratory outcomes.
Presence of Other Symptoms Baseline	15.8 score on a scale Standard Deviation 6.39	16.5 score on a scale Standard Deviation 6.45
Presence of Other Symptoms Week 12	14.3 score on a scale Standard Deviation 6.80	15.8 score on a scale Standard Deviation 6.38
Presence of Other Symptoms Week 24	14.2 score on a scale Standard Deviation 6.80	15.8 score on a scale Standard Deviation 6.68
Presence of Other Symptoms Week 36	14.3 score on a scale Standard Deviation 7.03	15.0 score on a scale Standard Deviation 7.01

SECONDARY outcome

Timeframe: Week 12, 24, 36

Population: Participants withdrew at various times during the trial. Not all participants were able to complete the PRO assessments.

Severity of symptoms will be measured using the Dialysis Symptom Index (DSI) Symptom Subscale. Lowest score - 0; Highest score - 150; Lower score equals better outcome.

Outcome measures

Outcome measures
Measure	Pain Coping Skills Training n=319 Participants PCST: Participants in the PCST arm will be provided with written educational material about chronic pain and opioid medications, and available resources for treatment. The PCST intervention aims to reduce pain interference and improve self-management skills. During Weeks 1-12 the PCST will be delivered by coaches via weekly video- or tele-conferencing sessions. During Weeks 13-24, Interactive Voice Response (IVR) will be delivered via daily telephone interactions, each lasting approximately 5 minutes. The IVR content is intended to enhance and sustain the effects of the coach-led session. Both components of the intervention will be available in English and Spanish. Buprenorphine: At Week 24, participants who meet the eligibility criteria for the buprenorphine intervention will be encouraged to switch from their full agonist opioid medication to the partial opioid agonist, buprenorphine. Participants who switch will be provided with individualized buprenorphine treatment recommendations made by a study physician based on current opioid use and other relevant factors. Participants who do not meet the Phase 2 eligibility criteria will not be offered buprenorphine. All participants will continue to be followed from Week 24 until Week 36 for ascertainment of pain, opioid use, and other outcomes to address durability of the effects of PCST, and, for those who switch to buprenorphine, to assess buprenorphine acceptability, tolerability, and efficacy as exploratory outcomes.	Usual Care n=324 Participants Usual Care: Participants in the Usual Care arm will be provided with written educational material about chronic pain and opioid medications, and available resources for treatment. Buprenorphine: At Week 24, participants who meet the eligibility criteria for the buprenorphine intervention will be encouraged to switch from their current full agonist opioid medication to the partial opioid agonist, buprenorphine. Participants who switch to Buprenorphine will be provided with individualized buprenorphine treatment recommendations. Individualized buprenorphine treatment recommendations will be made by the study buprenorphine physician based on current opioid use and other relevant factors. Participants who do not meet the Phase 2 eligibility criteria will not be offered buprenorphine. All participants will continue to be followed from Week 24 until Week 36 for ascertainment of pain, opioid use, and other outcomes to address durability of the effects of PCST, and, for those who switch to buprenorphine, to assess buprenorphine acceptability, tolerability, and efficacy as exploratory outcomes.
Severity of Other Symptoms Baseline	55.2 score on a scale Standard Deviation 27.5	58.2 score on a scale Standard Deviation 27.3
Severity of Other Symptoms Week 12	48.4 score on a scale Standard Deviation 28.3	55.9 score on a scale Standard Deviation 28.7
Severity of Other Symptoms Week 24	48.9 score on a scale Standard Deviation 28.9	54.8 score on a scale Standard Deviation 28.0
Severity of Other Symptoms Week 36	48.7 score on a scale Standard Deviation 28.0	51.9 score on a scale Standard Deviation 29.1

SECONDARY outcome

Timeframe: Baseline, Week 36

Population: Participants withdrew at various times during the study. Some participants were unable to complete the PRO assessments.

Discrimination will be measured using the Everyday Discrimination Scale Short Version (EDS-S). Lowest score - 0; Highest score - 5; Lower score equals better outcome.

Outcome measures

Outcome measures
Measure	Pain Coping Skills Training n=319 Participants PCST: Participants in the PCST arm will be provided with written educational material about chronic pain and opioid medications, and available resources for treatment. The PCST intervention aims to reduce pain interference and improve self-management skills. During Weeks 1-12 the PCST will be delivered by coaches via weekly video- or tele-conferencing sessions. During Weeks 13-24, Interactive Voice Response (IVR) will be delivered via daily telephone interactions, each lasting approximately 5 minutes. The IVR content is intended to enhance and sustain the effects of the coach-led session. Both components of the intervention will be available in English and Spanish. Buprenorphine: At Week 24, participants who meet the eligibility criteria for the buprenorphine intervention will be encouraged to switch from their full agonist opioid medication to the partial opioid agonist, buprenorphine. Participants who switch will be provided with individualized buprenorphine treatment recommendations made by a study physician based on current opioid use and other relevant factors. Participants who do not meet the Phase 2 eligibility criteria will not be offered buprenorphine. All participants will continue to be followed from Week 24 until Week 36 for ascertainment of pain, opioid use, and other outcomes to address durability of the effects of PCST, and, for those who switch to buprenorphine, to assess buprenorphine acceptability, tolerability, and efficacy as exploratory outcomes.	Usual Care n=324 Participants Usual Care: Participants in the Usual Care arm will be provided with written educational material about chronic pain and opioid medications, and available resources for treatment. Buprenorphine: At Week 24, participants who meet the eligibility criteria for the buprenorphine intervention will be encouraged to switch from their current full agonist opioid medication to the partial opioid agonist, buprenorphine. Participants who switch to Buprenorphine will be provided with individualized buprenorphine treatment recommendations. Individualized buprenorphine treatment recommendations will be made by the study buprenorphine physician based on current opioid use and other relevant factors. Participants who do not meet the Phase 2 eligibility criteria will not be offered buprenorphine. All participants will continue to be followed from Week 24 until Week 36 for ascertainment of pain, opioid use, and other outcomes to address durability of the effects of PCST, and, for those who switch to buprenorphine, to assess buprenorphine acceptability, tolerability, and efficacy as exploratory outcomes.
Discrimination Baseline	4.75 score on a scale Standard Error 4.70	4.76 score on a scale Standard Error 4.95
Discrimination Week 36	3.86 score on a scale Standard Error 4.70	4.18 score on a scale Standard Error 5.23

Adverse Events

Pain Coping Skills Training

Serious events: 169 serious events

Other events: 102 other events

Deaths: 35 deaths

Usual Care

Serious events: 167 serious events

Other events: 115 other events

Deaths: 34 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Pain Coping Skills Training n=319 participants at risk PCST: Participants in the PCST arm will be provided with written educational material about chronic pain and opioid medications, and available resources for treatment. The PCST intervention aims to reduce pain interference and improve self-management skills. During Weeks 1-12 the PCST will be delivered by coaches via weekly video- or tele-conferencing sessions. During Weeks 13-24, Interactive Voice Response (IVR) will be delivered via daily telephone interactions, each lasting approximately 5 minutes. The IVR content is intended to enhance and sustain the effects of the coach-led session. Both components of the intervention will be available in English and Spanish. Buprenorphine: At Week 24, participants who meet the eligibility criteria for the buprenorphine intervention will be encouraged to switch from their full agonist opioid medication to the partial opioid agonist, buprenorphine. Participants who switch will be provided with individualized buprenorphine treatment recommendations made by a study physician based on current opioid use and other relevant factors. Participants who do not meet the Phase 2 eligibility criteria will not be offered buprenorphine. All participants will continue to be followed from Week 24 until Week 36 for ascertainment of pain, opioid use, and other outcomes to address durability of the effects of PCST, and, for those who switch to buprenorphine, to assess buprenorphine acceptability, tolerability, and efficacy as exploratory outcomes.	Usual Care n=324 participants at risk Usual Care: Participants in the Usual Care arm will be provided with written educational material about chronic pain and opioid medications, and available resources for treatment. Buprenorphine: At Week 24, participants who meet the eligibility criteria for the buprenorphine intervention will be encouraged to switch from their current full agonist opioid medication to the partial opioid agonist, buprenorphine. Participants who switch to Buprenorphine will be provided with individualized buprenorphine treatment recommendations. Individualized buprenorphine treatment recommendations will be made by the study buprenorphine physician based on current opioid use and other relevant factors. Participants who do not meet the Phase 2 eligibility criteria will not be offered buprenorphine. All participants will continue to be followed from Week 24 until Week 36 for ascertainment of pain, opioid use, and other outcomes to address durability of the effects of PCST, and, for those who switch to buprenorphine, to assess buprenorphine acceptability, tolerability, and efficacy as exploratory outcomes.
General disorders Withdrawal symptoms	0.31% 1/319 • Adverse event data was collected over the course of 36 Weeks, beginning after consent.	1.5% 5/324 • Adverse event data was collected over the course of 36 Weeks, beginning after consent.
Psychiatric disorders Suicidal ideation	3.4% 11/319 • Adverse event data was collected over the course of 36 Weeks, beginning after consent.	5.9% 19/324 • Adverse event data was collected over the course of 36 Weeks, beginning after consent.
General disorders Adverse effect from a medication starting to treat pain, depression or anxiety	3.4% 11/319 • Adverse event data was collected over the course of 36 Weeks, beginning after consent.	2.8% 9/324 • Adverse event data was collected over the course of 36 Weeks, beginning after consent.
Injury, poisoning and procedural complications Fall	26.3% 84/319 • Adverse event data was collected over the course of 36 Weeks, beginning after consent.	29.0% 94/324 • Adverse event data was collected over the course of 36 Weeks, beginning after consent.
Psychiatric disorders Opioid use disorder	0.00% 0/319 • Adverse event data was collected over the course of 36 Weeks, beginning after consent.	0.00% 0/324 • Adverse event data was collected over the course of 36 Weeks, beginning after consent.
Psychiatric disorders Substance use disorder	0.00% 0/319 • Adverse event data was collected over the course of 36 Weeks, beginning after consent.	0.00% 0/324 • Adverse event data was collected over the course of 36 Weeks, beginning after consent.

Additional Information

Natalie Kuzla

University of Pennsylvania

Phone: 2155732935

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place