Clinical trial NCT05808127: Guiding Aging Long-Term Opioid Therapy Users Into Safer Use Patterns
Official title: Guiding Aging Long-Term Opioid Therapy Users Into Safer Use Patterns
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Opioid Use
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: Northwestern University
name: National Institute on Aging (NIA)
name: University of Washington
First posted: 2023-04-11
Enrollment: 286
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: HEALTH_SERVICES_RESEARCH

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 300 Northwestern Medicine clinicians treating Chronic Opioid Use Registry patients (n=5159).

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 sample (approximately 2,579 patients). 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.

Eligibility criteria: 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

Primary outcomes:
measure: Referral rate to non-opioid care
timeFrame: 9 months
measure: Antidepressant orders
timeFrame: 9 months
Secondary outcomes:
measure: Clinician monthly milligram morphine equivalent (MME)
timeFrame: 9 months
measure: Benzodiazepine prescribing
timeFrame: 9 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern Medicine
state: Illinois
Study officials:
affiliation: University of Southern California
name: Jason Doctor, PhD
role: PRINCIPAL_INVESTIGATOR
References: