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

NCT ID: NCT05182606

Last Updated: 2026-01-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-01
• Study Completion Date: 2024-09-30

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.

Detailed Description

Despite a growing understanding of the risks of long-term opioid therapy (LTOT), it continues to be frequently prescribed and remains a mainstay of treatment for chronic pain. The Centers for Disease and Control (CDC) Guideline for Prescribing Opioids for Chronic Pain is geared toward primary care providers and has been adopted as the standard of care by many healthcare organizations and insurers. Importantly, it encourages monitoring of patients on LTOT for opioid-related harms. By implementing monitoring, primary care providers may uncover various concerning behaviors, sometimes called aberrant drug-related behaviors or opioid misuse behaviors, that arise among individuals prescribed LTOT for chronic pain. These behaviors (e.g., missed appointments, using more opioid medication than prescribed, asking for an increase in opioid dose, aggressive behavior, and alcohol and other substance use) are common, concerning, and may represent unsafe use of LTOT or a developing opioid use disorder (OUD). However, the CDC Guideline and other existing evidence do not provide specific, detailed guidance about how to address concerning behaviors when they occur. Therefore, there is a critical need to understand how to best respond to these behaviors. The long-term goal of our program of research is to reduce LTOT-related harms, particularly from opioid misuse, and diminish their impact on the U.S. opioid epidemic. As a first step toward accomplishing this goal, the investigators conducted a Delphi study to rigorously establish consensus-based approaches to managing common and challenging concerning behaviors, from which algorithms were created. Identifying and operationalizing implementation strategies using an evidence-based framework are the critical next steps that must occur before any testing of the algorithms.

The investigators successfully uncovered optimal implementation strategies through primary care provider experiences with Standardized Patients (SPs) followed by Consolidated Framework for Implementation Research (CFIR)- and Expert Recommendations for Implementing Change (ERIC)-guided individual interviews. Using our prior expertise developing clinic-wide opioid risk reduction strategies and a Patient-Provider advisory board, the investigators developed a comprehensive "implementation package" that can be delivered to primary care practices.

The investigators now aim to conduct a pilot trial to test the algorithm implementation package. Guided by the CFIR-based implementation plan and using the implementation package that the investigators developed, pilot trial will be conducted to investigate feasibility, acceptability, and preliminary effectiveness of the algorithm implementation package.

Conditions

Opioid Misuse; Chronic Pain

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Implementation Bundle

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

Group Type: EXPERIMENTAL

Pilot study of algorithms implementation package

Intervention Type: BEHAVIORAL

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

Interventions

Pilot study of algorithms implementation package

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Clinicians practicing at UPMC community primary care clinics.

Exclusion Criteria

• Clinicians not practicing at UPMC community primary care clinics.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

University of Pittsburgh

OTHER

Sponsor Role: lead

Responsible Party

Jessica Merlin

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jessica Merlin

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

R34DA050004

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY20030189

Identifier Type: -

Identifier Source: org_study_id