Trial Outcomes & Findings for Project STAMINA (Syringe Service Telemedicine Access for Medication-assisted Intervention Through NAvigation) (NCT NCT04575324)
NCT ID: NCT04575324
Last Updated: 2024-07-09
Results Overview
Whether the participant attends 1 in-person MOUD treatment appointment
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
275 participants
Primary outcome timeframe
Within 14 days of enrollment
Results posted on
2024-07-09
Participant Flow
Participant milestones
| Measure |
Intervention Arm
Participants will receive the telemedicine linkage intervention.
Telemedicine Linkage Intervention: Participants will be immediately linked to telemedicine care provided by an FQHC provider waivered to prescribe buprenorphine and naltrexone or able to refer patients to methadone treatment. Participants will have their vitals checked and be virtually connected to the provider. The research assistant will share the vitals with the provider, and the provider will provide personalized care during which they discuss treatment options with the participant. If a medication for opioid use disorder is prescribed or if a methadone referral is made, transportation assistance will be provided to the participant as part of the intervention. Transportation to pick up the prescription or complete the first appointment will be provided via a HIPAA compliant ride-share company, and a bus pass will be provided to the participant for the return trip.
|
Control Arm
Participants will receive a standard referral to an in-person MOUD treatment appointment, which typically occurs within 24-72 hours. They also receive a bus pass to cover transportation (both directions), as well as an appointment reminder card.
|
|---|---|---|
|
Overall Study
STARTED
|
138
|
137
|
|
Overall Study
COMPLETED
|
108
|
109
|
|
Overall Study
NOT COMPLETED
|
30
|
28
|
Reasons for withdrawal
| Measure |
Intervention Arm
Participants will receive the telemedicine linkage intervention.
Telemedicine Linkage Intervention: Participants will be immediately linked to telemedicine care provided by an FQHC provider waivered to prescribe buprenorphine and naltrexone or able to refer patients to methadone treatment. Participants will have their vitals checked and be virtually connected to the provider. The research assistant will share the vitals with the provider, and the provider will provide personalized care during which they discuss treatment options with the participant. If a medication for opioid use disorder is prescribed or if a methadone referral is made, transportation assistance will be provided to the participant as part of the intervention. Transportation to pick up the prescription or complete the first appointment will be provided via a HIPAA compliant ride-share company, and a bus pass will be provided to the participant for the return trip.
|
Control Arm
Participants will receive a standard referral to an in-person MOUD treatment appointment, which typically occurs within 24-72 hours. They also receive a bus pass to cover transportation (both directions), as well as an appointment reminder card.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
29
|
25
|
|
Overall Study
Death
|
1
|
2
|
|
Overall Study
Withdrawn: Did not meet eligibility criteria
|
0
|
1
|
Baseline Characteristics
Block randomization was added to the study protocol after 3 participants had been previously enrolled; thus, only 271 participants are included in this analysis population.
Baseline characteristics by cohort
| Measure |
Intervention Arm
n=138 Participants
Participants will receive the telemedicine linkage intervention.
Telemedicine Linkage Intervention: Participants will be immediately linked to telemedicine care provided by an FQHC provider waivered to prescribe buprenorphine and naltrexone or able to refer patients to methadone treatment. Participants will have their vitals checked and be virtually connected to the provider. The research assistant will share the vitals with the provider, and the provider will provide personalized care during which they discuss treatment options with the participant. If a medication for opioid use disorder is prescribed or if a methadone referral is made, transportation assistance will be provided to the participant as part of the intervention. Transportation to pick up the prescription or complete the first appointment will be provided via a HIPAA compliant ride-share company, and a bus pass will be provided to the participant for the return trip.
|
Control Arm
n=136 Participants
Participants will receive a standard referral to an in-person MOUD treatment appointment, which typically occurs within 24-72 hours. They also receive a bus pass to cover transportation (both directions), as well as an appointment reminder card.
|
Total
n=274 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
47.59 years
STANDARD_DEVIATION 10.15 • n=138 Participants
|
48.92 years
STANDARD_DEVIATION 10.58 • n=136 Participants
|
48.24 years
STANDARD_DEVIATION 10.37 • n=274 Participants
|
|
Sex/Gender, Customized
Male
|
106 Participants
n=138 Participants
|
107 Participants
n=136 Participants
|
213 Participants
n=274 Participants
|
|
Sex/Gender, Customized
Female
|
32 Participants
n=138 Participants
|
28 Participants
n=136 Participants
|
60 Participants
n=274 Participants
|
|
Sex/Gender, Customized
Transgender
|
0 Participants
n=138 Participants
|
1 Participants
n=136 Participants
|
1 Participants
n=274 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
29 Participants
n=138 Participants
|
31 Participants
n=136 Participants
|
60 Participants
n=274 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
109 Participants
n=138 Participants
|
105 Participants
n=136 Participants
|
214 Participants
n=274 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=138 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=274 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=138 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=274 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=138 Participants
|
0 Participants
n=136 Participants
|
1 Participants
n=274 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=138 Participants
|
0 Participants
n=136 Participants
|
1 Participants
n=274 Participants
|
|
Race (NIH/OMB)
Black or African American
|
83 Participants
n=138 Participants
|
82 Participants
n=136 Participants
|
165 Participants
n=274 Participants
|
|
Race (NIH/OMB)
White
|
47 Participants
n=138 Participants
|
44 Participants
n=136 Participants
|
91 Participants
n=274 Participants
|
|
Race (NIH/OMB)
More than one race
|
6 Participants
n=138 Participants
|
9 Participants
n=136 Participants
|
15 Participants
n=274 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=138 Participants
|
1 Participants
n=136 Participants
|
1 Participants
n=274 Participants
|
|
Region of Enrollment
United States
|
138 Participants
n=138 Participants
|
136 Participants
n=136 Participants
|
274 Participants
n=274 Participants
|
|
Employment Status
Unemployed
|
107 Participants
n=138 Participants
|
97 Participants
n=136 Participants
|
204 Participants
n=274 Participants
|
|
Employment Status
Other
|
31 Participants
n=138 Participants
|
39 Participants
n=136 Participants
|
70 Participants
n=274 Participants
|
|
Housing Status
Stable
|
76 Participants
n=138 Participants
|
75 Participants
n=136 Participants
|
151 Participants
n=274 Participants
|
|
Housing Status
Unstable
|
62 Participants
n=138 Participants
|
61 Participants
n=136 Participants
|
123 Participants
n=274 Participants
|
|
Insurance Status
Uninsured
|
18 Participants
n=138 Participants
|
18 Participants
n=136 Participants
|
36 Participants
n=274 Participants
|
|
Insurance Status
Insured
|
115 Participants
n=138 Participants
|
113 Participants
n=136 Participants
|
228 Participants
n=274 Participants
|
|
Insurance Status
Unknown
|
5 Participants
n=138 Participants
|
5 Participants
n=136 Participants
|
10 Participants
n=274 Participants
|
|
Syringe Exchange Client Status
No
|
92 Participants
n=138 Participants
|
90 Participants
n=136 Participants
|
182 Participants
n=274 Participants
|
|
Syringe Exchange Client Status
Yes
|
46 Participants
n=138 Participants
|
46 Participants
n=136 Participants
|
92 Participants
n=274 Participants
|
|
Prior Lifetime Overdose(s)
|
4.85 overdoses
STANDARD_DEVIATION 10.86 • n=138 Participants
|
3.80 overdoses
STANDARD_DEVIATION 9.21 • n=136 Participants
|
4.33 overdoses
STANDARD_DEVIATION 10.07 • n=274 Participants
|
|
Opioid Use Severity
|
10.48 units on a scale
STANDARD_DEVIATION 1.19 • n=138 Participants
|
10.40 units on a scale
STANDARD_DEVIATION 1.05 • n=136 Participants
|
10.44 units on a scale
STANDARD_DEVIATION 1.12 • n=274 Participants
|
|
Withdrawal Severity
|
5.00 units on a scale
STANDARD_DEVIATION 5.16 • n=138 Participants
|
4.00 units on a scale
STANDARD_DEVIATION 3.74 • n=136 Participants
|
4.50 units on a scale
STANDARD_DEVIATION 4.53 • n=274 Participants
|
|
Block Randomization
MOUD open
|
64 Participants
n=136 Participants • Block randomization was added to the study protocol after 3 participants had been previously enrolled; thus, only 271 participants are included in this analysis population.
|
60 Participants
n=135 Participants • Block randomization was added to the study protocol after 3 participants had been previously enrolled; thus, only 271 participants are included in this analysis population.
|
124 Participants
n=271 Participants • Block randomization was added to the study protocol after 3 participants had been previously enrolled; thus, only 271 participants are included in this analysis population.
|
|
Block Randomization
Methadone only
|
72 Participants
n=136 Participants • Block randomization was added to the study protocol after 3 participants had been previously enrolled; thus, only 271 participants are included in this analysis population.
|
75 Participants
n=135 Participants • Block randomization was added to the study protocol after 3 participants had been previously enrolled; thus, only 271 participants are included in this analysis population.
|
147 Participants
n=271 Participants • Block randomization was added to the study protocol after 3 participants had been previously enrolled; thus, only 271 participants are included in this analysis population.
|
PRIMARY outcome
Timeframe: Within 14 days of enrollmentPopulation: The analysis population is N=274. This includes all 138/138 enrolled in the intervention arm and 136/137 enrolled in the control arm; one control arm participant was removed from the outcome analysis population as they were withdrawn from the study for not meeting eligibility criteria. Electronic health record data were obtained for all 274 participants.
Whether the participant attends 1 in-person MOUD treatment appointment
Outcome measures
| Measure |
Intervention Arm
n=138 Participants
Participants will receive the telemedicine linkage intervention.
Telemedicine Linkage Intervention: Participants will be immediately linked to telemedicine care provided by an FQHC provider waivered to prescribe buprenorphine and naltrexone or able to refer patients to methadone treatment. Participants will have their vitals checked and be virtually connected to the provider. The research assistant will share the vitals with the provider, and the provider will provide personalized care during which they discuss treatment options with the participant. If a medication for opioid use disorder is prescribed or if a methadone referral is made, transportation assistance will be provided to the participant as part of the intervention. Transportation to pick up the prescription or complete the first appointment will be provided via a HIPAA compliant ride-share company, and a bus pass will be provided to the participant for the return trip.
|
Control Arm
n=136 Participants
Participants will receive a standard referral to an in-person MOUD treatment appointment, which typically occurs within 24-72 hours. They also receive a bus pass to cover transportation (both directions), as well as an appointment reminder card.
|
|---|---|---|
|
Linkage to Medication for Opioid Use Disorder (MOUD)
Yes
|
25 Participants
|
47 Participants
|
|
Linkage to Medication for Opioid Use Disorder (MOUD)
No
|
113 Participants
|
89 Participants
|
SECONDARY outcome
Timeframe: Within 34 days of enrollmentPopulation: The analysis population is N=274. This includes all 138/138 enrolled in the intervention arm and 136/137 enrolled in the control arm; one control arm participant was removed from the outcome analysis population as they were withdrawn from the study for not meeting eligibility criteria. Electronic health record data and prescription drug monitoring program data were obtained for all 274 participants.
Whether the participant attends 2 in-person treatment appointments
Outcome measures
| Measure |
Intervention Arm
n=138 Participants
Participants will receive the telemedicine linkage intervention.
Telemedicine Linkage Intervention: Participants will be immediately linked to telemedicine care provided by an FQHC provider waivered to prescribe buprenorphine and naltrexone or able to refer patients to methadone treatment. Participants will have their vitals checked and be virtually connected to the provider. The research assistant will share the vitals with the provider, and the provider will provide personalized care during which they discuss treatment options with the participant. If a medication for opioid use disorder is prescribed or if a methadone referral is made, transportation assistance will be provided to the participant as part of the intervention. Transportation to pick up the prescription or complete the first appointment will be provided via a HIPAA compliant ride-share company, and a bus pass will be provided to the participant for the return trip.
|
Control Arm
n=136 Participants
Participants will receive a standard referral to an in-person MOUD treatment appointment, which typically occurs within 24-72 hours. They also receive a bus pass to cover transportation (both directions), as well as an appointment reminder card.
|
|---|---|---|
|
Medication for Opioid Use Disorder (MOUD) Treatment Engagement
Yes
|
19 Participants
|
29 Participants
|
|
Medication for Opioid Use Disorder (MOUD) Treatment Engagement
No
|
119 Participants
|
107 Participants
|
SECONDARY outcome
Timeframe: 3 month study periodPopulation: The analysis population is N=274. This includes all 138/138 enrolled in the intervention arm and 136/137 enrolled in the control arm; one control arm participant was removed from the outcome analysis population as they were withdrawn from the study for not meeting eligibility criteria. Electronic health record data and prescription drug monitoring program data were obtained for all 274 participants.
Whether the participant is actively engaged in treatment (i.e. participant goes no more than 14 days without medication for opioid use disorder (MOUD) or being discharged from care)
Outcome measures
| Measure |
Intervention Arm
n=138 Participants
Participants will receive the telemedicine linkage intervention.
Telemedicine Linkage Intervention: Participants will be immediately linked to telemedicine care provided by an FQHC provider waivered to prescribe buprenorphine and naltrexone or able to refer patients to methadone treatment. Participants will have their vitals checked and be virtually connected to the provider. The research assistant will share the vitals with the provider, and the provider will provide personalized care during which they discuss treatment options with the participant. If a medication for opioid use disorder is prescribed or if a methadone referral is made, transportation assistance will be provided to the participant as part of the intervention. Transportation to pick up the prescription or complete the first appointment will be provided via a HIPAA compliant ride-share company, and a bus pass will be provided to the participant for the return trip.
|
Control Arm
n=136 Participants
Participants will receive a standard referral to an in-person MOUD treatment appointment, which typically occurs within 24-72 hours. They also receive a bus pass to cover transportation (both directions), as well as an appointment reminder card.
|
|---|---|---|
|
Medication for Opioid Use Disorder (MOUD) Treatment Retention
No
|
126 Participants
|
122 Participants
|
|
Medication for Opioid Use Disorder (MOUD) Treatment Retention
Yes
|
12 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: 3 month study periodPopulation: The analysis population is N=219. This includes only participants that completed a 3-month follow-up interview.
Self reported days of non-prescribed opioid use in the past 30 days using questions from the National Survey on Drug Use and Health, which was modified to ask about separate known use of heroin, fentanyl/carfentanyl, and prescription pain killers
Outcome measures
| Measure |
Intervention Arm
n=110 Participants
Participants will receive the telemedicine linkage intervention.
Telemedicine Linkage Intervention: Participants will be immediately linked to telemedicine care provided by an FQHC provider waivered to prescribe buprenorphine and naltrexone or able to refer patients to methadone treatment. Participants will have their vitals checked and be virtually connected to the provider. The research assistant will share the vitals with the provider, and the provider will provide personalized care during which they discuss treatment options with the participant. If a medication for opioid use disorder is prescribed or if a methadone referral is made, transportation assistance will be provided to the participant as part of the intervention. Transportation to pick up the prescription or complete the first appointment will be provided via a HIPAA compliant ride-share company, and a bus pass will be provided to the participant for the return trip.
|
Control Arm
n=109 Participants
Participants will receive a standard referral to an in-person MOUD treatment appointment, which typically occurs within 24-72 hours. They also receive a bus pass to cover transportation (both directions), as well as an appointment reminder card.
|
|---|---|---|
|
Self-report Non-medication for Opioid Use Disorder (MOUD) Opioid Use
|
19.09 Days
Standard Deviation 12.72
|
19.92 Days
Standard Deviation 12.08
|
SECONDARY outcome
Timeframe: 3 month study periodPopulation: The analysis population is N=149. This includes only participants that submitted a urine drug screen at the 3-month follow-up interview.
Whether illicit opioids were detected through urine tests administered at 3 months.
Outcome measures
| Measure |
Intervention Arm
n=73 Participants
Participants will receive the telemedicine linkage intervention.
Telemedicine Linkage Intervention: Participants will be immediately linked to telemedicine care provided by an FQHC provider waivered to prescribe buprenorphine and naltrexone or able to refer patients to methadone treatment. Participants will have their vitals checked and be virtually connected to the provider. The research assistant will share the vitals with the provider, and the provider will provide personalized care during which they discuss treatment options with the participant. If a medication for opioid use disorder is prescribed or if a methadone referral is made, transportation assistance will be provided to the participant as part of the intervention. Transportation to pick up the prescription or complete the first appointment will be provided via a HIPAA compliant ride-share company, and a bus pass will be provided to the participant for the return trip.
|
Control Arm
n=76 Participants
Participants will receive a standard referral to an in-person MOUD treatment appointment, which typically occurs within 24-72 hours. They also receive a bus pass to cover transportation (both directions), as well as an appointment reminder card.
|
|---|---|---|
|
Detected Non-prescribed Opioids
Yes
|
52 Participants
|
56 Participants
|
|
Detected Non-prescribed Opioids
No
|
21 Participants
|
20 Participants
|
Adverse Events
Intervention Arm
Serious events: 34 serious events
Other events: 50 other events
Deaths: 2 deaths
Control Arm
Serious events: 22 serious events
Other events: 41 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Intervention Arm
n=108 participants at risk
Participants will receive the telemedicine linkage intervention.
Telemedicine Linkage Intervention: Participants will be immediately linked to telemedicine care provided by an FQHC provider waivered to prescribe buprenorphine and naltrexone or able to refer patients to methadone treatment. Participants will have their vitals checked and be virtually connected to the provider. The research assistant will share the vitals with the provider, and the provider will provide personalized care during which they discuss treatment options with the participant. If a medication for opioid use disorder is prescribed or if a methadone referral is made, transportation assistance will be provided to the participant as part of the intervention. Transportation to pick up the prescription or complete the first appointment will be provided via a HIPAA compliant ride-share company, and a bus pass will be provided to the participant for the return trip.
|
Control Arm
n=109 participants at risk
Participants will receive a standard referral to an in-person MOUD treatment appointment, which typically occurs within 24-72 hours. They also receive a bus pass to cover transportation (both directions), as well as an appointment reminder card.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Drug Overdose
|
17.6%
19/108 • All-cause mortality data were collected for a duration of 6 months post-enrollment via the County's Medical Examiner records. All other adverse event and serious adverse event data were collected 3 months post-enrollment via follow-up interviews with participants.
The total number of participants at risk for all-cause mortality is N=274. This includes 138/138 enrolled in the intervention arm and 136/137 enrolled in the control arm; one control participant was withdrawn for not meeting eligibility criteria and removed from monitoring. Medical Examiner records were searched for all 274 participants. The total number of participants at risk for all other adverse events is N=217. This includes only participants that completed a 3-month follow-up interview.
|
17.4%
19/109 • All-cause mortality data were collected for a duration of 6 months post-enrollment via the County's Medical Examiner records. All other adverse event and serious adverse event data were collected 3 months post-enrollment via follow-up interviews with participants.
The total number of participants at risk for all-cause mortality is N=274. This includes 138/138 enrolled in the intervention arm and 136/137 enrolled in the control arm; one control participant was withdrawn for not meeting eligibility criteria and removed from monitoring. Medical Examiner records were searched for all 274 participants. The total number of participants at risk for all other adverse events is N=217. This includes only participants that completed a 3-month follow-up interview.
|
|
Psychiatric disorders
Suicide Attempt
|
6.5%
7/108 • All-cause mortality data were collected for a duration of 6 months post-enrollment via the County's Medical Examiner records. All other adverse event and serious adverse event data were collected 3 months post-enrollment via follow-up interviews with participants.
The total number of participants at risk for all-cause mortality is N=274. This includes 138/138 enrolled in the intervention arm and 136/137 enrolled in the control arm; one control participant was withdrawn for not meeting eligibility criteria and removed from monitoring. Medical Examiner records were searched for all 274 participants. The total number of participants at risk for all other adverse events is N=217. This includes only participants that completed a 3-month follow-up interview.
|
1.8%
2/109 • All-cause mortality data were collected for a duration of 6 months post-enrollment via the County's Medical Examiner records. All other adverse event and serious adverse event data were collected 3 months post-enrollment via follow-up interviews with participants.
The total number of participants at risk for all-cause mortality is N=274. This includes 138/138 enrolled in the intervention arm and 136/137 enrolled in the control arm; one control participant was withdrawn for not meeting eligibility criteria and removed from monitoring. Medical Examiner records were searched for all 274 participants. The total number of participants at risk for all other adverse events is N=217. This includes only participants that completed a 3-month follow-up interview.
|
|
Injury, poisoning and procedural complications
Drug Overdose-Related Emergency Room Visit
|
13.0%
14/108 • All-cause mortality data were collected for a duration of 6 months post-enrollment via the County's Medical Examiner records. All other adverse event and serious adverse event data were collected 3 months post-enrollment via follow-up interviews with participants.
The total number of participants at risk for all-cause mortality is N=274. This includes 138/138 enrolled in the intervention arm and 136/137 enrolled in the control arm; one control participant was withdrawn for not meeting eligibility criteria and removed from monitoring. Medical Examiner records were searched for all 274 participants. The total number of participants at risk for all other adverse events is N=217. This includes only participants that completed a 3-month follow-up interview.
|
12.8%
14/109 • All-cause mortality data were collected for a duration of 6 months post-enrollment via the County's Medical Examiner records. All other adverse event and serious adverse event data were collected 3 months post-enrollment via follow-up interviews with participants.
The total number of participants at risk for all-cause mortality is N=274. This includes 138/138 enrolled in the intervention arm and 136/137 enrolled in the control arm; one control participant was withdrawn for not meeting eligibility criteria and removed from monitoring. Medical Examiner records were searched for all 274 participants. The total number of participants at risk for all other adverse events is N=217. This includes only participants that completed a 3-month follow-up interview.
|
|
Injury, poisoning and procedural complications
Drug Overdose-Related Hospitalization
|
2.8%
3/108 • All-cause mortality data were collected for a duration of 6 months post-enrollment via the County's Medical Examiner records. All other adverse event and serious adverse event data were collected 3 months post-enrollment via follow-up interviews with participants.
The total number of participants at risk for all-cause mortality is N=274. This includes 138/138 enrolled in the intervention arm and 136/137 enrolled in the control arm; one control participant was withdrawn for not meeting eligibility criteria and removed from monitoring. Medical Examiner records were searched for all 274 participants. The total number of participants at risk for all other adverse events is N=217. This includes only participants that completed a 3-month follow-up interview.
|
2.8%
3/109 • All-cause mortality data were collected for a duration of 6 months post-enrollment via the County's Medical Examiner records. All other adverse event and serious adverse event data were collected 3 months post-enrollment via follow-up interviews with participants.
The total number of participants at risk for all-cause mortality is N=274. This includes 138/138 enrolled in the intervention arm and 136/137 enrolled in the control arm; one control participant was withdrawn for not meeting eligibility criteria and removed from monitoring. Medical Examiner records were searched for all 274 participants. The total number of participants at risk for all other adverse events is N=217. This includes only participants that completed a 3-month follow-up interview.
|
|
Psychiatric disorders
Mental Health-Related Hospitalization
|
11.1%
12/108 • All-cause mortality data were collected for a duration of 6 months post-enrollment via the County's Medical Examiner records. All other adverse event and serious adverse event data were collected 3 months post-enrollment via follow-up interviews with participants.
The total number of participants at risk for all-cause mortality is N=274. This includes 138/138 enrolled in the intervention arm and 136/137 enrolled in the control arm; one control participant was withdrawn for not meeting eligibility criteria and removed from monitoring. Medical Examiner records were searched for all 274 participants. The total number of participants at risk for all other adverse events is N=217. This includes only participants that completed a 3-month follow-up interview.
|
3.7%
4/109 • All-cause mortality data were collected for a duration of 6 months post-enrollment via the County's Medical Examiner records. All other adverse event and serious adverse event data were collected 3 months post-enrollment via follow-up interviews with participants.
The total number of participants at risk for all-cause mortality is N=274. This includes 138/138 enrolled in the intervention arm and 136/137 enrolled in the control arm; one control participant was withdrawn for not meeting eligibility criteria and removed from monitoring. Medical Examiner records were searched for all 274 participants. The total number of participants at risk for all other adverse events is N=217. This includes only participants that completed a 3-month follow-up interview.
|
Other adverse events
| Measure |
Intervention Arm
n=108 participants at risk
Participants will receive the telemedicine linkage intervention.
Telemedicine Linkage Intervention: Participants will be immediately linked to telemedicine care provided by an FQHC provider waivered to prescribe buprenorphine and naltrexone or able to refer patients to methadone treatment. Participants will have their vitals checked and be virtually connected to the provider. The research assistant will share the vitals with the provider, and the provider will provide personalized care during which they discuss treatment options with the participant. If a medication for opioid use disorder is prescribed or if a methadone referral is made, transportation assistance will be provided to the participant as part of the intervention. Transportation to pick up the prescription or complete the first appointment will be provided via a HIPAA compliant ride-share company, and a bus pass will be provided to the participant for the return trip.
|
Control Arm
n=109 participants at risk
Participants will receive a standard referral to an in-person MOUD treatment appointment, which typically occurs within 24-72 hours. They also receive a bus pass to cover transportation (both directions), as well as an appointment reminder card.
|
|---|---|---|
|
General disorders
New Chronic Health Condition
|
30.6%
33/108 • All-cause mortality data were collected for a duration of 6 months post-enrollment via the County's Medical Examiner records. All other adverse event and serious adverse event data were collected 3 months post-enrollment via follow-up interviews with participants.
The total number of participants at risk for all-cause mortality is N=274. This includes 138/138 enrolled in the intervention arm and 136/137 enrolled in the control arm; one control participant was withdrawn for not meeting eligibility criteria and removed from monitoring. Medical Examiner records were searched for all 274 participants. The total number of participants at risk for all other adverse events is N=217. This includes only participants that completed a 3-month follow-up interview.
|
26.6%
29/109 • All-cause mortality data were collected for a duration of 6 months post-enrollment via the County's Medical Examiner records. All other adverse event and serious adverse event data were collected 3 months post-enrollment via follow-up interviews with participants.
The total number of participants at risk for all-cause mortality is N=274. This includes 138/138 enrolled in the intervention arm and 136/137 enrolled in the control arm; one control participant was withdrawn for not meeting eligibility criteria and removed from monitoring. Medical Examiner records were searched for all 274 participants. The total number of participants at risk for all other adverse events is N=217. This includes only participants that completed a 3-month follow-up interview.
|
|
Psychiatric disorders
Mental Health-Related Outpatient Treatment
|
13.0%
14/108 • All-cause mortality data were collected for a duration of 6 months post-enrollment via the County's Medical Examiner records. All other adverse event and serious adverse event data were collected 3 months post-enrollment via follow-up interviews with participants.
The total number of participants at risk for all-cause mortality is N=274. This includes 138/138 enrolled in the intervention arm and 136/137 enrolled in the control arm; one control participant was withdrawn for not meeting eligibility criteria and removed from monitoring. Medical Examiner records were searched for all 274 participants. The total number of participants at risk for all other adverse events is N=217. This includes only participants that completed a 3-month follow-up interview.
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8.3%
9/109 • All-cause mortality data were collected for a duration of 6 months post-enrollment via the County's Medical Examiner records. All other adverse event and serious adverse event data were collected 3 months post-enrollment via follow-up interviews with participants.
The total number of participants at risk for all-cause mortality is N=274. This includes 138/138 enrolled in the intervention arm and 136/137 enrolled in the control arm; one control participant was withdrawn for not meeting eligibility criteria and removed from monitoring. Medical Examiner records were searched for all 274 participants. The total number of participants at risk for all other adverse events is N=217. This includes only participants that completed a 3-month follow-up interview.
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Social circumstances
Criminal Arrests, Bookings, Charges
|
11.1%
12/108 • All-cause mortality data were collected for a duration of 6 months post-enrollment via the County's Medical Examiner records. All other adverse event and serious adverse event data were collected 3 months post-enrollment via follow-up interviews with participants.
The total number of participants at risk for all-cause mortality is N=274. This includes 138/138 enrolled in the intervention arm and 136/137 enrolled in the control arm; one control participant was withdrawn for not meeting eligibility criteria and removed from monitoring. Medical Examiner records were searched for all 274 participants. The total number of participants at risk for all other adverse events is N=217. This includes only participants that completed a 3-month follow-up interview.
|
6.4%
7/109 • All-cause mortality data were collected for a duration of 6 months post-enrollment via the County's Medical Examiner records. All other adverse event and serious adverse event data were collected 3 months post-enrollment via follow-up interviews with participants.
The total number of participants at risk for all-cause mortality is N=274. This includes 138/138 enrolled in the intervention arm and 136/137 enrolled in the control arm; one control participant was withdrawn for not meeting eligibility criteria and removed from monitoring. Medical Examiner records were searched for all 274 participants. The total number of participants at risk for all other adverse events is N=217. This includes only participants that completed a 3-month follow-up interview.
|
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Social circumstances
Criminal Detainment or Imprisonment
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11.1%
12/108 • All-cause mortality data were collected for a duration of 6 months post-enrollment via the County's Medical Examiner records. All other adverse event and serious adverse event data were collected 3 months post-enrollment via follow-up interviews with participants.
The total number of participants at risk for all-cause mortality is N=274. This includes 138/138 enrolled in the intervention arm and 136/137 enrolled in the control arm; one control participant was withdrawn for not meeting eligibility criteria and removed from monitoring. Medical Examiner records were searched for all 274 participants. The total number of participants at risk for all other adverse events is N=217. This includes only participants that completed a 3-month follow-up interview.
|
3.7%
4/109 • All-cause mortality data were collected for a duration of 6 months post-enrollment via the County's Medical Examiner records. All other adverse event and serious adverse event data were collected 3 months post-enrollment via follow-up interviews with participants.
The total number of participants at risk for all-cause mortality is N=274. This includes 138/138 enrolled in the intervention arm and 136/137 enrolled in the control arm; one control participant was withdrawn for not meeting eligibility criteria and removed from monitoring. Medical Examiner records were searched for all 274 participants. The total number of participants at risk for all other adverse events is N=217. This includes only participants that completed a 3-month follow-up interview.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place