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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05808127
• Other study ID #: HS-22-00517
• Secondary ID: 3P30AG024968-20S
• Status: Completed
• Phase: N/A
• Start date: August 9, 2023
• Est. completion date: May 9, 2024

Study information

• Verified date: May 2024
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 286
• Est. completion date: May 9, 2024
• Est. primary completion date: May 9, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Opioid Use
• Pain

Intervention

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.

Locations

Country	Name	City	State
United States	Northwestern Medicine	Chicago	Illinois

Sponsors (4)

Lead Sponsor	Collaborator
University of Southern California	National Institute on Aging (NIA), Northwestern University, University of Washington

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Referral rate to non-opioid care	Patient referral rate to non-opioid care that includes mental and behavioral health care, physical therapy, or sleep medicine referrals	9 months
Primary	Antidepressant orders	Rate of orders for antidepressant medications	9 months
Secondary	Clinician monthly milligram morphine equivalent (MME)	Clinician aggregate monthly milligram (mg) morphine equivalent (ME) for >50 mg ME daily dose visits	9 months
Secondary	Benzodiazepine prescribing	Clinician aggregate monthly milligram (mg) valium equivalent (VE) for >50 mg VE daily dose visits	9 months