Trial Outcomes & Findings for Guiding Aging Long-Term Opioid Therapy Users Into Safer Use Patterns (NCT NCT05808127)
NCT ID: NCT05808127
Last Updated: 2026-04-13
Results Overview
Count of referrals to non-opioid care during the timeframe of 8/9/2023-5/8/2024. Referrals to non-opioid care include mental and behavioral health care, physical therapy, and/or sleep medicine referrals
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
286 participants
Primary outcome timeframe
9 months
Results posted on
2026-04-13
Participant Flow
Clinician participants treating Chronic Opioid Use Registry patients that meet the inclusion criteria will be assigned to one of two conditions involving patient surveys: 1) Current Opioid Misuse Measure \[COMM\] \[standard clinical care\] or 2) COMM + PainTracker.
Participant milestones
| Measure |
Current Opioid Misuse Measure (COMM)
On a monthly basis, patients of clinicians randomized to COMM will receive the abbreviated Current Opioid Misuse Measure (COMM), a 6-item self-report screener to identify and monitor the risk of aberrant opioid-related behavior in chronic pain patients on opioid therapy. The COMM asks patients to report their behaviors over the past 30 days using a five-point Likert-type rating scale.
Current Opioid Misuse Measure: The abbreviated Current Opioid Misuse Measure (COMM) is a 6-item self-report screener to identify and monitor the risk of aberrant opioid-related behavior in chronic pain patients on opioid therapy. The COMM asks patients to report their behaviors over the past 30 days using a five-point Likert-type rating scale.
|
Current Opioid Misuse Measure (COMM) + PainTracker
On a monthly basis, patients of clinicians randomized to COMM+PainTracker will receive both the abbreviated Current Opioid Misuse Measure (COMM) and PainTracker. PainTracker tracks multiple outcomes relevant to the treatment of chronic pain: pain severity, general activity interference, enjoyment of life interference, sleep (initiating and maintaining), depression, and anxiety.
PainTracker: The PainTracker tool reframes the patient visit around improving functional status and obtaining functional goals, understanding psychological concerns that may exacerbate pain such as traumatic stress, anxiety, and depression. This approach may promote an increase in referrals for physical therapy, mental health counseling, and psychiatric follow-up.
Current Opioid Misuse Measure: The abbreviated Current Opioid Misuse Measure (COMM) is a 6-item self-report screener to identify and monitor the risk of aberrant opioid-related behavior in chronic pain patients on opioid therapy. The COMM asks patients to report their behaviors over the past 30 days using a five-point Likert-type rating scale.
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|---|---|---|
|
Overall Study
STARTED
|
143
|
143
|
|
Overall Study
COMPLETED
|
136
|
128
|
|
Overall Study
NOT COMPLETED
|
7
|
15
|
Reasons for withdrawal
| Measure |
Current Opioid Misuse Measure (COMM)
On a monthly basis, patients of clinicians randomized to COMM will receive the abbreviated Current Opioid Misuse Measure (COMM), a 6-item self-report screener to identify and monitor the risk of aberrant opioid-related behavior in chronic pain patients on opioid therapy. The COMM asks patients to report their behaviors over the past 30 days using a five-point Likert-type rating scale.
Current Opioid Misuse Measure: The abbreviated Current Opioid Misuse Measure (COMM) is a 6-item self-report screener to identify and monitor the risk of aberrant opioid-related behavior in chronic pain patients on opioid therapy. The COMM asks patients to report their behaviors over the past 30 days using a five-point Likert-type rating scale.
|
Current Opioid Misuse Measure (COMM) + PainTracker
On a monthly basis, patients of clinicians randomized to COMM+PainTracker will receive both the abbreviated Current Opioid Misuse Measure (COMM) and PainTracker. PainTracker tracks multiple outcomes relevant to the treatment of chronic pain: pain severity, general activity interference, enjoyment of life interference, sleep (initiating and maintaining), depression, and anxiety.
PainTracker: The PainTracker tool reframes the patient visit around improving functional status and obtaining functional goals, understanding psychological concerns that may exacerbate pain such as traumatic stress, anxiety, and depression. This approach may promote an increase in referrals for physical therapy, mental health counseling, and psychiatric follow-up.
Current Opioid Misuse Measure: The abbreviated Current Opioid Misuse Measure (COMM) is a 6-item self-report screener to identify and monitor the risk of aberrant opioid-related behavior in chronic pain patients on opioid therapy. The COMM asks patients to report their behaviors over the past 30 days using a five-point Likert-type rating scale.
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|---|---|---|
|
Overall Study
Clinicians did not have any valid prescriptions and were excluded from the analysis
|
7
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15
|
Baseline Characteristics
Age data were not collected for clinicians and are not available in the Northwestern Medicine EHR.
Baseline characteristics by cohort
| Measure |
Current Opioid Misuse Measure (COMM)
n=143 Participants
On a monthly basis, patients of clinicians randomized to COMM condition will receive the abbreviated Current Opioid Misuse Measure (COMM), a 6-item self-report screener to identify and monitor the risk of aberrant opioid-related behavior in chronic pain patients on opioid therapy. The COMM asks patients to report their behaviors over the past 30 days using a five-point Likert-type rating scale.
Current Opioid Misuse Measure: The abbreviated Current Opioid Misuse Measure (COMM) is a 6-item self-report screener to identify and monitor the risk of aberrant opioid-related behavior in chronic pain patients on opioid therapy. The COMM asks patients to report their behaviors over the past 30 days using a five-point Likert-type rating scale.
|
Current Opioid Misuse Measure (COMM) + PainTracker
n=143 Participants
On a monthly basis, patients of clinicians randomized to COMM + PainTracker will receive both the abbreviated Current Opioid Misuse Measure (COMM) and PainTracker. PainTracker tracks multiple outcomes relevant to the treatment of chronic pain: pain severity, general activity interference, enjoyment of life interference, sleep (initiating and maintaining), depression, and anxiety.
PainTracker: The PainTracker tool reframes the patient visit around improving functional status and obtaining functional goals, understanding psychological concerns that may exacerbate pain such as traumatic stress, anxiety, and depression. This approach may promote an increase in referrals for physical therapy, mental health counseling, and psychiatric follow-up.
Current Opioid Misuse Measure: The abbreviated Current Opioid Misuse Measure (COMM) is a 6-item self-report screener to identify and monitor the risk of aberrant opioid-related behavior in chronic pain patients on opioid therapy. The COMM asks patients to report their behaviors over the past 30 days using a five-point Likert-type rating scale.
|
Total
n=286 Participants
Total of all reporting groups
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|---|---|---|---|
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Age, Customized
Age
|
—
|
—
|
0 Participants
Age data were not collected for clinicians and are not available in the Northwestern Medicine EHR.
|
|
Sex: Female, Male
Female
|
90 Participants
n=143 Participants
|
78 Participants
n=143 Participants
|
168 Participants
n=286 Participants
|
|
Sex: Female, Male
Male
|
53 Participants
n=143 Participants
|
65 Participants
n=143 Participants
|
118 Participants
n=286 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
143 participants
n=143 Participants
|
143 participants
n=143 Participants
|
286 participants
n=286 Participants
|
PRIMARY outcome
Timeframe: 9 monthsCount of referrals to non-opioid care during the timeframe of 8/9/2023-5/8/2024. Referrals to non-opioid care include mental and behavioral health care, physical therapy, and/or sleep medicine referrals
Outcome measures
| Measure |
Current Opioid Misuse Measure (COMM)
n=136 Participants
On a monthly basis, patients will receive the abbreviated Current Opioid Misuse Measure (COMM), a 6-item self-report screener to identify and monitor the risk of aberrant opioid-related behavior in chronic pain patients on opioid therapy. The COMM asks patients to report their behaviors over the past 30 days using a five-point Likert-type rating scale.
Current Opioid Misuse Measure: The abbreviated Current Opioid Misuse Measure (COMM) is a 6-item self-report screener to identify and monitor the risk of aberrant opioid-related behavior in chronic pain patients on opioid therapy. The COMM asks patients to report their behaviors over the past 30 days using a five-point Likert-type rating scale.
|
Current Opioid Misuse Measure (COMM) + PainTracker
n=128 Participants
On a monthly basis, patients will receive both the abbreviated Current Opioid Misuse Measure (COMM) and PainTracker. PainTracker tracks multiple outcomes relevant to the treatment of chronic pain: pain severity, general activity interference, enjoyment of life interference, sleep (initiating and maintaining), depression, and anxiety.
PainTracker: The PainTracker tool reframes the patient visit around improving functional status and obtaining functional goals, understanding psychological concerns that may exacerbate pain such as traumatic stress, anxiety, and depression. This approach may promote an increase in referrals for physical therapy, mental health counseling, and psychiatric follow-up.
Current Opioid Misuse Measure: The abbreviated Current Opioid Misuse Measure (COMM) is a 6-item self-report screener to identify and monitor the risk of aberrant opioid-related behavior in chronic pain patients on opioid therapy. The COMM asks patients to report their behaviors over the past 30 days using a five-point Likert-type rating scale.
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|---|---|---|
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Count of Referrals to Non-opioid Care
|
3.075 Count of referrals
Interval 0.95 to 5.513
|
3.61 Count of referrals
Interval 0.65 to 8.624
|
PRIMARY outcome
Timeframe: 9 monthsCount of orders for antidepressant medications during the timeframe of 8/9/2023-5/8/2024.
Outcome measures
| Measure |
Current Opioid Misuse Measure (COMM)
n=136 Participants
On a monthly basis, patients will receive the abbreviated Current Opioid Misuse Measure (COMM), a 6-item self-report screener to identify and monitor the risk of aberrant opioid-related behavior in chronic pain patients on opioid therapy. The COMM asks patients to report their behaviors over the past 30 days using a five-point Likert-type rating scale.
Current Opioid Misuse Measure: The abbreviated Current Opioid Misuse Measure (COMM) is a 6-item self-report screener to identify and monitor the risk of aberrant opioid-related behavior in chronic pain patients on opioid therapy. The COMM asks patients to report their behaviors over the past 30 days using a five-point Likert-type rating scale.
|
Current Opioid Misuse Measure (COMM) + PainTracker
n=128 Participants
On a monthly basis, patients will receive both the abbreviated Current Opioid Misuse Measure (COMM) and PainTracker. PainTracker tracks multiple outcomes relevant to the treatment of chronic pain: pain severity, general activity interference, enjoyment of life interference, sleep (initiating and maintaining), depression, and anxiety.
PainTracker: The PainTracker tool reframes the patient visit around improving functional status and obtaining functional goals, understanding psychological concerns that may exacerbate pain such as traumatic stress, anxiety, and depression. This approach may promote an increase in referrals for physical therapy, mental health counseling, and psychiatric follow-up.
Current Opioid Misuse Measure: The abbreviated Current Opioid Misuse Measure (COMM) is a 6-item self-report screener to identify and monitor the risk of aberrant opioid-related behavior in chronic pain patients on opioid therapy. The COMM asks patients to report their behaviors over the past 30 days using a five-point Likert-type rating scale.
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|---|---|---|
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Count of Antidepressant Orders
|
3.45 Count of antidepressant medications
Interval 1.21 to 5.94
|
3.43 Count of antidepressant medications
Interval 0.38 to 7.76
|
SECONDARY outcome
Timeframe: 9 monthsThe statistic reported represents the interaction of differences between the pre and post periods. Using data from the electronic health record, we estimated total monthly milligram morphine equivalent for each clinician summing the total number of daily morphine equivalents written within a monthly observation period. That outcome is observed repeatedly over time. The monthly values are not separate outcomes; they are repeated measurements of the same quantity. The scientific question is whether the intervention changes the linear trajectory of the outcome relative to control. The analysis summarizes this change into a single, prespecified effect rather than comparing months one by one. MME standardizes the potency of different opioid medications into a single value based on morphine, providing a comparable measure for which to evaluate intervention impact.
Outcome measures
| Measure |
Current Opioid Misuse Measure (COMM)
n=136 Participants
On a monthly basis, patients will receive the abbreviated Current Opioid Misuse Measure (COMM), a 6-item self-report screener to identify and monitor the risk of aberrant opioid-related behavior in chronic pain patients on opioid therapy. The COMM asks patients to report their behaviors over the past 30 days using a five-point Likert-type rating scale.
Current Opioid Misuse Measure: The abbreviated Current Opioid Misuse Measure (COMM) is a 6-item self-report screener to identify and monitor the risk of aberrant opioid-related behavior in chronic pain patients on opioid therapy. The COMM asks patients to report their behaviors over the past 30 days using a five-point Likert-type rating scale.
|
Current Opioid Misuse Measure (COMM) + PainTracker
n=128 Participants
On a monthly basis, patients will receive both the abbreviated Current Opioid Misuse Measure (COMM) and PainTracker. PainTracker tracks multiple outcomes relevant to the treatment of chronic pain: pain severity, general activity interference, enjoyment of life interference, sleep (initiating and maintaining), depression, and anxiety.
PainTracker: The PainTracker tool reframes the patient visit around improving functional status and obtaining functional goals, understanding psychological concerns that may exacerbate pain such as traumatic stress, anxiety, and depression. This approach may promote an increase in referrals for physical therapy, mental health counseling, and psychiatric follow-up.
Current Opioid Misuse Measure: The abbreviated Current Opioid Misuse Measure (COMM) is a 6-item self-report screener to identify and monitor the risk of aberrant opioid-related behavior in chronic pain patients on opioid therapy. The COMM asks patients to report their behaviors over the past 30 days using a five-point Likert-type rating scale.
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|---|---|---|
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Clinician Monthly Milligram Morphine Equivalent (MME)
|
81.86 MME/monthly
Interval 81.42 to 82.3
|
82.14 MME/monthly
Interval 82.06 to 82.23
|
SECONDARY outcome
Timeframe: 9 monthsThe statistic reported represents the interaction of differences between the pre and post periods. Using data from the electronic health record, we estimated total monthly milligram valium equivalent for each clinician summing the total number of daily valium equivalents written within a monthly observation period. That outcome is observed repeatedly over time. The monthly values are not separate outcomes; they are repeated measurements of the same quantity. The scientific question is whether the intervention changes the linear trajectory of the outcome relative to control. The analysis summarizes this change into a single, prespecified effect rather than comparing months one by one. VE standardizes the potency of different benzodiazepine medications into a single value based on valium, providing a comparable measure for which to evaluate intervention impact.
Outcome measures
| Measure |
Current Opioid Misuse Measure (COMM)
n=136 Participants
On a monthly basis, patients will receive the abbreviated Current Opioid Misuse Measure (COMM), a 6-item self-report screener to identify and monitor the risk of aberrant opioid-related behavior in chronic pain patients on opioid therapy. The COMM asks patients to report their behaviors over the past 30 days using a five-point Likert-type rating scale.
Current Opioid Misuse Measure: The abbreviated Current Opioid Misuse Measure (COMM) is a 6-item self-report screener to identify and monitor the risk of aberrant opioid-related behavior in chronic pain patients on opioid therapy. The COMM asks patients to report their behaviors over the past 30 days using a five-point Likert-type rating scale.
|
Current Opioid Misuse Measure (COMM) + PainTracker
n=128 Participants
On a monthly basis, patients will receive both the abbreviated Current Opioid Misuse Measure (COMM) and PainTracker. PainTracker tracks multiple outcomes relevant to the treatment of chronic pain: pain severity, general activity interference, enjoyment of life interference, sleep (initiating and maintaining), depression, and anxiety.
PainTracker: The PainTracker tool reframes the patient visit around improving functional status and obtaining functional goals, understanding psychological concerns that may exacerbate pain such as traumatic stress, anxiety, and depression. This approach may promote an increase in referrals for physical therapy, mental health counseling, and psychiatric follow-up.
Current Opioid Misuse Measure: The abbreviated Current Opioid Misuse Measure (COMM) is a 6-item self-report screener to identify and monitor the risk of aberrant opioid-related behavior in chronic pain patients on opioid therapy. The COMM asks patients to report their behaviors over the past 30 days using a five-point Likert-type rating scale.
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|---|---|---|
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Benzodiazepine Prescribing
|
7.32 VE/monthly
Interval 7.07 to 7.58
|
5.78 VE/monthly
Interval 5.61 to 5.95
|
Adverse Events
Current Opioid Misuse Measure (COMM)
Serious events: 2 serious events
Other events: 0 other events
Deaths: 27 deaths
Current Opioid Misuse Measure (COMM) + PainTracker
Serious events: 1 serious events
Other events: 0 other events
Deaths: 39 deaths
Serious adverse events
| Measure |
Current Opioid Misuse Measure (COMM)
n=686 participants at risk
On a monthly basis, patients will receive the abbreviated Current Opioid Misuse Measure (COMM), a 6-item self-report screener to identify and monitor the risk of aberrant opioid-related behavior in chronic pain patients on opioid therapy. The COMM asks patients to report their behaviors over the past 30 days using a five-point Likert-type rating scale.
Current Opioid Misuse Measure: The abbreviated Current Opioid Misuse Measure (COMM) is a 6-item self-report screener to identify and monitor the risk of aberrant opioid-related behavior in chronic pain patients on opioid therapy. The COMM asks patients to report their behaviors over the past 30 days using a five-point Likert-type rating scale.
|
Current Opioid Misuse Measure (COMM) + PainTracker
n=765 participants at risk
On a monthly basis, patients will receive both the abbreviated Current Opioid Misuse Measure (COMM) and PainTracker. PainTracker tracks multiple outcomes relevant to the treatment of chronic pain: pain severity, general activity interference, enjoyment of life interference, sleep (initiating and maintaining), depression, and anxiety.
PainTracker: The PainTracker tool reframes the patient visit around improving functional status and obtaining functional goals, understanding psychological concerns that may exacerbate pain such as traumatic stress, anxiety, and depression. This approach may promote an increase in referrals for physical therapy, mental health counseling, and psychiatric follow-up.
Current Opioid Misuse Measure: The abbreviated Current Opioid Misuse Measure (COMM) is a 6-item self-report screener to identify and monitor the risk of aberrant opioid-related behavior in chronic pain patients on opioid therapy. The COMM asks patients to report their behaviors over the past 30 days using a five-point Likert-type rating scale.
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|---|---|---|
|
Nervous system disorders
Emergency Department or Hospitalization for Opioid Withdrawal
|
0.29%
2/686 • Number of events 2 • 9 months
ED Visit/Hospitalization for Opioid Withdrawal and All Cause Mortality in patients of randomized clinicians: n= 686 patients for COMM and n=765 patients in COMM+PainTracker. Because these AEs are related to patients of clinicians (and not the clinicians themselves), the denominator is different than the participant flow section (which reflects clinicians). We did not collect AEs for the clinicians themselves as indicated in our Data and Safety Monitoring Plan, which was approved by the DSMB.
|
0.13%
1/765 • Number of events 1 • 9 months
ED Visit/Hospitalization for Opioid Withdrawal and All Cause Mortality in patients of randomized clinicians: n= 686 patients for COMM and n=765 patients in COMM+PainTracker. Because these AEs are related to patients of clinicians (and not the clinicians themselves), the denominator is different than the participant flow section (which reflects clinicians). We did not collect AEs for the clinicians themselves as indicated in our Data and Safety Monitoring Plan, which was approved by the DSMB.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place