NCT05808127

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 286 (actual)
• Sponsor: University of Southern California · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pain
• Opioid Use

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-08-09
• Primary completion: 2024-05-09
• Completion: 2024-05-09
• First posted: 2023-04-11
• Last updated: 2026-04-13
• Results posted: 2026-04-13

Locations

1 site across 1 country: United States