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

Not Applicable

Completed

Conditions: Opioid Misuse
Chronic Pain

Registration Number: NCT05182606

Lead Sponsor: University of Pittsburgh

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 49

Inclusion Criteria

Clinicians practicing at UPMC community primary care clinics.

Exclusion Criteria

Clinicians not practicing at UPMC community primary care clinics.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Feasibility of Algorithms	At the end of the 6- or 9-month implementation period	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.
Acceptability of Algorithms	At the end of the 6- or 9-month implementation period	Acceptability of the algorithms was assessed in part via a 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 thematically rather than numerically.

Secondary Outcome Measures

Name	Time	Method
Preliminary Effectiveness of Algorithms	Pre-implementation (12 months), implementation (6 or 9 months), post-implementation (12 months)	Change in opioid misuse behaviors in relation to clinicians' use of the algorithm implementation package, assessed using Electronic Health Record retrospective data collected over the 12-month pre-implementation period, the 6- or 9-month implementation periods, and over the 12-month post-implementation period, and natural language processing methods.

Trial Locations

Locations (1): University of Pittsburgh
🇺🇸
Pittsburgh, Pennsylvania, United States
University of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States