An interventional study of PainTracker and Current Opioid Misuse Measure in Pain and Opioid Use, sponsored by University of Southern California. Completed at 1 site in United States. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2026-04-13.
Sponsored by University of Southern California · Not applicable, Interventional, and Health services research
Patients on long-term opioid therapy are aging and now face magnified risk of harm with continued high-dose opioid use. These increased risks are due to age-related changes in drug metabolism, multi-morbidity, and polypharmacy. The dominant approach to mitigate these risks is to screen for aberrant patient opioid behaviors so that clinicians can pre-empt misuse early through review of contractual opioid agreements or by lowering patient dosages. By focusing on opioid misuse alone, this strategy encourages forced opioid tapering that is associated with opioid overdose and mental health crisis. Directing clinician attention to the comorbid conditions associated with opioid misuse may promote safer and more effective care.
The objective of this study is to assess the comparative effectiveness of PainTracker, a set of questions that targets a broad range of problems associated with pain, in a randomized controlled trial involving 286 Northwestern Medicine clinicians treating Chronic Opioid Use Registry patients (n=1451).
Using the electronic health record, patient portal, and patient-reported outcome capabilities, the investigators will develop programming logic for a randomized experimentation platform wherein two or more versions of pain surveys may be delivered to patients. This system will be used to evaluate PainTracker, delivered to half of the patient sample. Clinicians 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. Surveys will be delivered monthly and patients will be prompted 3 times to complete the survey; once completed, patients will receive a score also delivered to their physician's inbox in Epic.
2,219 studies on the registry are indexed under Pain; 917 are open to participants now.
This study's enrollment of 286 is above the median of 70 across 1,904 interventional studies indexed under Pain.
Browse Pain studies →University of Southern California is the lead sponsor of 773 studies on the registry; 135 are open to participants now.
Of its 68 completed or terminated interventional studies of FDA-regulated products, 32 (47%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion criteria:
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.
Behavioral: Current Opioid Misuse Measure
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.
Behavioral: PainTracker · Behavioral: Current Opioid Misuse Measure
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.
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.
Count of Referrals to Non-opioid Care
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
Time frame: 9 months
Count of Antidepressant Orders
Count of orders for antidepressant medications during the timeframe of 8/9/2023-5/8/2024.
Time frame: 9 months
Clinician Monthly Milligram Morphine Equivalent (MME)
The 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.
Time frame: 9 months
Benzodiazepine Prescribing
The 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.
Time frame: 9 months
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.
| Milestone | Current Opioid Misuse Measure (COMM) | Current Opioid Misuse Measure (COMM) + PainTracker |
|---|---|---|
| Started | 143 | 143 |
| Completed | 136 | 128 |
| Not completed | 7 | 15 |
| Withdrew: Clinicians did not have any valid prescriptions and were excluded from the analysis | 7 | 15 |
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
| Count of referrals | Current Opioid Misuse Measure (COMM) | Current Opioid Misuse Measure (COMM) + PainTracker |
|---|---|---|
| Count of Referrals to Non-opioid Care | 3.075 (0.95 to 5.513) | 3.61 (0.65 to 8.624) |
Count of orders for antidepressant medications during the timeframe of 8/9/2023-5/8/2024.
| Count of antidepressant medications | Current Opioid Misuse Measure (COMM) | Current Opioid Misuse Measure (COMM) + PainTracker |
|---|---|---|
| Count of Antidepressant Orders | 3.45 (1.21 to 5.94) | 3.43 (0.38 to 7.76) |
The 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.
| MME/monthly | Current Opioid Misuse Measure (COMM) | Current Opioid Misuse Measure (COMM) + PainTracker |
|---|---|---|
| Clinician Monthly Milligram Morphine Equivalent (MME) | 81.86 (81.42 to 82.30) | 82.14 (82.06 to 82.23) |
The 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.
| VE/monthly | Current Opioid Misuse Measure (COMM) | Current Opioid Misuse Measure (COMM) + PainTracker |
|---|---|---|
| Benzodiazepine Prescribing | 7.32 (7.07 to 7.58) | 5.78 (5.61 to 5.95) |
Collected over 9 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Current Opioid Misuse Measure (COMM) | 27/686 (3.9%) | 2/686 (0.3%) | 0/686 (0%) |
| Current Opioid Misuse Measure (COMM) + PainTracker | 39/765 (5.1%) | 1/765 (0.1%) | 0/765 (0%) |
| Event | Current Opioid Misuse Measure (COMM) | Current Opioid Misuse Measure (COMM) + PainTracker |
|---|---|---|
| Emergency Department or Hospitalization for Opioid WithdrawalNervous system disorders | 2/686 | 1/765 |
The baseline analysis population includes Northwestern Medicine (NM) clinicians randomized to COMM or COMM + PainTracker. We can only report on clinician sex as neither age nor race/ethnicity are available in the NM electronic health record data. Patients were not enrolled in this study and outcomes pertain to clinician orders only. Adverse events were assessed for patients per Data and Safety Monitoring Board request to ensure that the clinician interventions were not compromising patient care.
| Age, Customized(Participants) | Current Opioid Misuse Measure (COMM) | Current Opioid Misuse Measure (COMM) + PainTracker | Total |
|---|---|---|---|
| Age | — | — | 0 |
| Sex: Female, Male(Participants) | Current Opioid Misuse Measure (COMM) | Current Opioid Misuse Measure (COMM) + PainTracker | Total |
|---|---|---|---|
| Female | 90 | 78 | 168 |
| Male | 53 | 65 | 118 |
| Race and Ethnicity Not Collected(Participants) | Current Opioid Misuse Measure (COMM) | Current Opioid Misuse Measure (COMM) + PainTracker | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | Current Opioid Misuse Measure (COMM) | Current Opioid Misuse Measure (COMM) + PainTracker | Total |
|---|---|---|---|
| United States | 143 | 143 | 286 |
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University of Southern California