Consensus-based Algorithms to Address Opioid Misuse Behaviors Among Individuals Prescribed LTOT

Sponsor
University of Pittsburgh (Other)
Overall Status
Recruiting
CT.gov ID
NCT05182606
Collaborator
National Institute on Drug Abuse (NIDA) (NIH)
80
1
1
12
6.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Pilot study of algorithms implementation package
N/A

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 CFIR- and 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Investigators will conduct a pilot trial to investigate the feasibility, acceptability, and preliminary effectiveness of the algorithm Implementation Package. The investigators will conduct the pilot in 3 University of Pittsburgh Medical Center (UPMC) practices. the investigators will randomize by site and use a waitlist control. Feasibility and acceptability will be assessed qualitatively and via a clinician survey. Preliminary effectiveness outcomes will include reduction in concerning behaviors and increased diagnosis/treatment of Opioid Use Disorder (OUD). The investigators will also pilot Electronic Health Record-based outcomes assessment.Investigators will conduct a pilot trial to investigate the feasibility, acceptability, and preliminary effectiveness of the algorithm Implementation Package. The investigators will conduct the pilot in 3 University of Pittsburgh Medical Center (UPMC) practices. the investigators will randomize by site and use a waitlist control. Feasibility and acceptability will be assessed qualitatively and via a clinician survey. Preliminary effectiveness outcomes will include reduction in concerning behaviors and increased diagnosis/treatment of Opioid Use Disorder (OUD). The investigators will also pilot Electronic Health Record-based outcomes assessment.
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
Consensus-based Algorithms to Address Opioid Misuse Behaviors Among Individuals Prescribed Long-term Opioid Therapy: Developing Implementation Strategies and Pilot Testing
Actual Study Start Date :
Mar 1, 2022
Anticipated Primary Completion Date :
Mar 1, 2023
Anticipated Study Completion Date :
Mar 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Implementation bundle

Participating clinics will experience integration of the "Implementation Bundle" into their practices.

Behavioral: Pilot study of algorithms implementation package
The "Implementation Bundle" will include a link to algorithms in the Electronic Health Record, Smartphrases, audited feedback, and instructions.

Outcome Measures

Primary Outcome Measures

  1. Feasibility of algorithms [1 year]

    Number of algorithms used by Primary Care Physicians (PCPs) during the study period, measured by surveys administered to the PCPs at the end of the study period.

  2. Acceptability of algorithms [1 year]

    Level of acceptability of the algorithms will be measured via qualitative interviews with clinicians and staff at each of the clinics.

Secondary Outcome Measures

  1. Preliminary Effectiveness of algorithms [1 year]

    Change in opioid misuse behaviors as assessed using the Electronic Health Record and natural language processing methods.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • UPMC community primary care practices
Exclusion Criteria:
  • non-UPMC practices

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Pittsburgh Pittsburgh Pennsylvania United States 15231

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: Jessica Merlin, University of Pittsburgh

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jessica Merlin, Associate Professor, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT05182606
Other Study ID Numbers:
  • STUDY20030189
  • R34DA050004
First Posted:
Jan 10, 2022
Last Update Posted:
Apr 7, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Jessica Merlin, Associate Professor, University of Pittsburgh
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 7, 2022