Guiding Aging Long-Term Opioid Therapy Users Into Safer Use Patterns

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).

Study Overview

• Status: Completed
• Conditions: Pain; Opioid Use
• Intervention / Treatment: Behavioral: PainTracker; Behavioral: Current Opioid Misuse Measure

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.

• Study Type: Interventional
• Enrollment (Actual): 286
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Current Opioid Misuse Measure (COMM) + PainTracker; 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; 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.; Behavioral: 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.
Active Comparator: Current Opioid Misuse Measure (COMM); 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	9 months
Count of Antidepressant Orders	Count of orders for antidepressant medications during the timeframe of 8/9/2023-5/8/2024.	9 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	9 months

Collaborators and Investigators

• Sponsor: University of Southern California
• Collaborators: Northwestern University; National Institute on Aging (NIA); University of Washington
• Investigators: Principal Investigator: Jason Doctor, PhD, University of Southern California

Study record dates

Study Major Dates

• Study Start (Actual): August 9, 2023
• Primary Completion (Actual): May 9, 2024
• Study Completion (Actual): May 9, 2024

Study Registration Dates

• First Submitted: March 29, 2023
• First Submitted That Met QC Criteria: March 29, 2023
• First Posted (Actual): April 11, 2023

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: March 24, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain
• Other Study ID Numbers: HS-22-00517; 3P30AG024968-20S1 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No