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Completed

NCT Number: NCT05808127

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).

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Key information

Conditions

Pain Neurologic Manifestations Opioid Use Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northwestern Medicine

Chicago, Illinois, 60611, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PainTracker

Behavioral

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

Behavioral

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.

Primary outcomes

  1. Count of Referrals to Non-opioid Care

    Time frame: 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

  2. Count of Antidepressant Orders

    Time frame: 9 months

    Count of orders for antidepressant medications during the timeframe of 8/9/2023-5/8/2024.

Secondary outcomes

  1. Clinician Monthly Milligram Morphine Equivalent (MME)

    Time frame: 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.

  2. Benzodiazepine Prescribing

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Southern California

Other

Collaborators

  • National Institute on Aging (NIA)
  • Northwestern University
  • University of Washington

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Apr 11, 2023
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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