Consensus-based Algorithms to Address Opioid Misuse Behaviors Among Individuals Prescribed Long-term Opioid Therapy

NCT05182606 | Completed Results

• 2 other identifiers: STUDY20030189R34DA050004
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

The NIH Helping to End Addiction Long-term (HEAL) initiative has identified a critical next step to addressing the opioid crisis: improving treatments for opioid misuse behaviors (e.g., using more opioids than prescribed, illicit substance use) in patients prescribed long-term opioid therapy for chronic pain. In previous work, the investigators have developed innovative consensus-based algorithms to manage these behaviors. By developing implementation strategies for these algorithms, this project is directly responsive to the HEAL initiative and promises to reduce opioid misuse-related harms.

Conditions

Chronic Pain; Opioid Misuse

Keywords

Long-Term Opioid Therapy; Algorithms; Opioid Misuse; Chronic Pain

Outcome Measures

Primary Outcomes (2)

• Feasibility of Algorithms

  The number of algorithms used by physicians was assessed via a survey administered at the end of the 6- or 9-month implementation period, measuring self-reported toolkit utilization during the study. Our primary feasibility benchmark will be that 80% of physicians report using at least one algorithm during the study period.

  At the end of the 6- or 9-month implementation period

• Acceptability of Algorithms

  Acceptability of the algorithms was assessed via a self-report survey administered at the end of the 6- or 9-month implementation period, measuring physicians' awareness of the algorithms and self-reported toolkit use within six months of implementation. Our primary acceptability benchmark is that at least 80% of physicians report awareness of the algorithm implementation and at least 50% report using the algorithms during the study period. Additionally, qualitative interviews with physicians and staff provided further insights, which were analyzed using thematic analysis.

  At the end of the 6- or 9-month implementation period

Secondary Outcomes (4)

• Preliminary Effectiveness of Algorithms - MME Reduction ≥10%

  Pre-implementation (12 months), implementation (6 to 9 months), post-implementation (12 months)

• Preliminary Effectiveness - Average MME Within Last 90 Days

  Pre-implementation (12 months), implementation (6 or 9 months), post-implementation (12 months)

• Preliminary Effectiveness of Algorithms - Opioid Discontinuation

  Pre-implementation (12 months), implementation (6 to 9 months), post-implementation (12 months)

• Preliminary Effectiveness of the Algorithms - New OUD Diagnoses

  Pre-implementation (12 months), implementation (6 to 9 months), post-implementation (12 months)

Study Arms (1)

Implementation Bundle

EXPERIMENTAL

The 'Implementation Bundle' was integrated into all three participating clinics over six to nine months.

Behavioral: Pilot study of algorithms implementation package

Interventions

Pilot study of algorithms implementation package BEHAVIORAL

The algorithm implementation package includes a link to the algorithms in the Electronic Health Record, Smartphrases, audited feedback, and instructions.

Implementation Bundle

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinicians practicing at UPMC community primary care clinics.

You may not qualify if:

• Clinicians not practicing at UPMC community primary care clinics.

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15231, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders; Chronic Pain

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

The study's findings are limited by its pilot nature, focusing on a small number of clinics and clinicians. Results may not be generalizable to other settings or populations. Additionally, qualitative data were collected from a subset of participants, which may not fully represent all perspectives. The limited follow-up time may also restrict the interpretation of longer-term outcomes or broader feasibility.

Results Point of Contact

• Title: Dr. Jessica Merlin
• Organization: University of Pittsburgh

merlinjs@upmc.edu

(412) 383-0617

Study Officials

• Jessica Merlin

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Investigators will conduct a pilot trial to assess the feasibility, acceptability, and preliminary effectiveness of the Algorithm Implementation Package across three University of Pittsburgh Medical Center (UPMC) primary care practices. The intervention will be implemented using a staggered rollout across the three clinics - General Internal Medicine Oakland will receive the intervention first, followed by Northern Medical Associates Hampton and Wexford. All clinics will receive the same intervention. Feasibility and acceptability will be assessed once only after the 6- or 9-month implementation period through clinician surveys and qualitative interviews. Preliminary effectiveness will be evaluated using electronic health record (EHR) data assessing reductions in concerning opioid-related behaviors and increases in the diagnosis and treatment of Opioid Use Disorder.

Study Record Dates

• First Submitted: November 28, 2021
• First Posted: January 10, 2022
• Study Start: March 1, 2022
• Primary Completion: September 30, 2023
• Study Completion: September 30, 2024
• Last Updated: January 8, 2026
• Results First Posted: June 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)