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Completed

NCT Number: NCT05182606

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15231, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Clinicians practicing at UPMC community primary care clinics.

Exclusion criteria

  • Clinicians not practicing at UPMC community primary care clinics.

Treatment and study plan

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.

Primary outcomes

  1. Feasibility of Algorithms

    Time frame: 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.

  2. Acceptability of Algorithms

    Time frame: At the end of the 6- or 9-month implementation period

    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.

Secondary outcomes

  1. Preliminary Effectiveness of Algorithms - MME Reduction ≥10%

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

    Number of long-term opioid therapy (LTOT) patients whose 90-day average Morphine Milligram Equivalents (MME) decreased at or above a margin of 10% from the start of the reporting period to the end of the reporting period.

  2. Preliminary Effectiveness - Average MME Within Last 90 Days

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

    Average morphine milligram equivalents (MME) among long-term opioid therapy (LTOT) patients during the last 90 days of each period.

  3. Preliminary Effectiveness of Algorithms - Opioid Discontinuation

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

    Number of long-term opioid therapy (LTOT) patients whose 90-day average Morphine Milligram Equivalents (MME) at the start of this reporting period was 0.

  4. Preliminary Effectiveness of the Algorithms - New OUD Diagnoses in LTOT Patients

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

    New opioid use disorder (OUD) diagnoses documented in the electronic health record (EHR) among all LTOT patients seen by participating physicians, by period. No new OUD diagnoses were documented in any period in LTOT patients.

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

Consensus-based Algorithms to Address Opioid Misuse Behaviors Among Individuals Prescribed Long-term Opioid Therapy: Developing Implementation Strategies and Pilot Testing

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Jan 10, 2022
Registry last updated
Jun 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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