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

NCT05808127 | Completed Results DMC

• 2 other identifiers: HS-22-005173P30AG024968-20S1
• Study Type: interventional
• Target: 286
• Locations: 1 country
• Sites: 1

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).

Conditions

Pain; Opioid Use

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Clinician Monthly Milligram Morphine Equivalent (MME)

  9 months

• Benzodiazepine Prescribing

  9 months

Study Arms (2)

Current Opioid Misuse Measure (COMM)

ACTIVE COMPARATOR

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

Current Opioid Misuse Measure (COMM) + PainTracker

EXPERIMENTAL

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

Interventions

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 (COMM) + PainTracker

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.

Current Opioid Misuse Measure (COMM); Current Opioid Misuse Measure (COMM) + PainTracker

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patient visits with active cancer diagnoses

Sponsors & Collaborators

• National Institute on Aging (NIA): collaborator
• University of Washington: collaborator
• University of Southern California: lead
• Northwestern University: collaborator

Study Sites (1)

Northwestern Medicine

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Jason Doctor
• Organization: University of Southern California

jdoctor@usc.edu

213.821.1842

Study Officials

• Jason Doctor, PhD

  University of Southern California

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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

Study Record Dates

• First Submitted: March 29, 2023
• First Posted: April 11, 2023
• Study Start: August 9, 2023
• Primary Completion: May 9, 2024
• Study Completion: May 9, 2024
• Last Updated: April 13, 2026
• Results First Posted: April 13, 2026

Record last verified: 2026-03

Locations

US (1)