Opioid Use, Pain
Conditions
Brief summary
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).
Detailed description
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.
Interventions
BEHAVIORALPainTracker
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.
BEHAVIORALCurrent 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.
Sponsors
University of Southern California
Northwestern University
National Institute on Aging (NIA)
University of Washington
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Clinicians treating Chronic Opioid Use Registry patients will be randomized to one of two conditions involving surveys completed by the patients: (1) Current Opioid Misuse Measure \[COMM\] \[standard clinical care\] or (2) COMM + PainTracker
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• Patients age 65 or older on long-term opioid therapy within the Northwestern Medicine Chronic Opioid Use registry system with at least one primary care encounter in the past 12 months.
Exclusion criteria
• Patient visits with active cancer diagnoses
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Count of Referrals to Non-opioid Care | 9 months | 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 Antidepressant Orders | 9 months | Count of orders for antidepressant medications during the timeframe of 8/9/2023-5/8/2024. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinician Monthly Milligram Morphine Equivalent (MME) | 9 months | 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. |
| Benzodiazepine Prescribing | 9 months | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJason Doctor, PhD
University of Southern California
Participant flow
Recruitment details
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.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Customized Age | 0 Participants |
| Race and Ethnicity Not Collected | 0 Participants |
| Region of Enrollment United States | 143 participants |
| Sex: Female, Male Female | 168 Participants |
| Sex: Female, Male Male | 53 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 27 / 686 | 39 / 765 |
| other Total, other adverse events | 0 / 686 | 0 / 765 |
| serious Total, serious adverse events | 2 / 686 | 1 / 765 |
Outcome results
None listed