Clinical Decision Support for Opioid Use Disorders in Medical Settings (COMPUTE 2.0)

NCT04198428 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10891

Last updated 2025-10-02

Study results available
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Summary

Through CTN-0076-Ot (Clinical Decision Support for Opioid Use Disorders in Medical Settings: Pilot Usability Testing in an EMR (COMPUTE)), our team has iteratively developed and piloted a web-based and electronic health record (EHR)-integrated Opioid Use Disorder (OUD) Clinical Decision Support (CDS) system to offer expert guidance to primary care providers (PCPs) on the diagnosis and management of OUD. The OUD-CDS has been implemented within the EPIC EHR of one large care system and was piloted with 55 providers to ensure content validity and provider satisfaction. The team will now implement this OUD-CDS in a large multi-site clinic-randomized controlled trial to evaluate its impact on practice process measures and patient outcomes. The investigators also aim to prepare for scalability (i.e., integration into usual primary care practice after the study is complete) and dissemination by evaluating facilitators and barriers to implementation, determining the costs of implementation and maintenance, and assessing the short-term cost impacts of the OUD-CDS.

The study will include three large diverse care systems and randomize a minimum of 30 clinics to receive the OUD-CDS intervention or usual care (UC). In intervention clinics, the OUD-CDS will identify patients who are at high risk for OUD or diagnosed with OUD; use data stored in the EHR for each eligible patient to assemble treatment recommendations tailored to each patient's current needs; display these recommendations to PCPs via the OUD-CDS user interface; and store analytic data from all targeted visits. In UC clinics, the OUD-CDS will run invisibly in the background to identify high-risk or OUD patients, assemble treatment recommendations tailored to each eligible patient's needs, and store analytic data from all targeted visits.

Conditions

  • Opioid-use Disorder

Interventions

OTHER

Opioid Wizard

The Opioid Wizard is an OUD clinical decision support tool for primary care providers to help assess, diagnose, and treat OUD in primary care (where appropriate).

Sponsors & Collaborators

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH
  • The Emmes Company, LLC

    collaborator INDUSTRY
  • Hennepin Healthcare Research Institute

    collaborator OTHER
  • Geisinger Clinic

    collaborator OTHER
  • Essentia Health

    collaborator OTHER
  • HealthPartners Institute

    lead OTHER

Principal Investigators

  • Gavin Bart, MD PhD FACP DFASAM · Hennepin Healthcare

  • Rebecca Rossom, MD, MSCR · HealthPartners Institute

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-12
Primary Completion
2023-12-31
Completion
2023-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04198428 on ClinicalTrials.gov