Clinical Decision Support for Opioid Use Disorders in Medical Settings: Usability Testing in an EMR (COMPUTE)

March 9, 2020 updated by: HealthPartners Institute

Clinical Decision Support for Opioid Use Disorders in Medical Settings: Pilot Usability Testing in an EMR

The primary objective of this pilot study is to program an opioid use disorder (OUD) clinical decision support (CDS) tool for use in an electronic medical record (EMR) and obtain high primary care physician (PCP) usability and acceptability. The OUD-CDS is based on the NIDA-Blending Initiative white paper, "Clinical Decision Support for Opioid Use Disorders: Working Group Report," which itself is based on national evidence-based guidelines (American Society of Addiction Medicine (ASAM 2015), VA (VA 2015). As such, this pilot study aims to help PCPs achieve accepted standards of care in OUD treatment. The secondary objectives of this pilot study are to evaluate the usefulness of the tool by comparing OUD case-finding, medication-assisted therapy (MAT) and referral patterns pre- and post-CDS deployment for PCPs with and without CDS access.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

55

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Bloomington, Minnesota, United States, 55425
        • HealthPartners

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Be an MD, Doctor of Osteopathy, Nurse Practitioner or Physician's Assistant engaged in independent primary care of adults at HealthPartners or Park Nicollet
  • Have at least schedule 3 DEA prescribing privileges
  • Voluntarily provide written informed consent to participate in this study

Exclusion Criteria:

  • Less than half-time clinical primary care responsibilities

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Waivered Providers Receive the Opioid Wizard
All providers who have a buprenorphine waiver will receive the OUD clinical decision support tool (Opioid Wizard).
Other: Opioid Wizard
The Opioid Wizard is an OUD clinical decision support tool for primary care providers.
No Intervention: Does not Receive the Opioid Wizard
All non-buprenorphine waivered providers will be randomized to receive or not receive the Opioid Wizard. This arm of providers will continue to treat their patients as usual.
Experimental: Non-Waivered Providers who receive Opioid Wizard
All non-buprenorphine waivered providers will be randomized to receive or not receive the Opioid. This arm of providers will receive the OUD clinical decision support tool (Opioid Wizard).
Other: Opioid Wizard
The Opioid Wizard is an OUD clinical decision support tool for primary care providers.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intervention PCP Confidence in Assessing and Treating OUD
Time Frame: This outcome measure was calculated at approximately month 10 of the pilot study
# of intervention PCPs who report feeling "moderately" or "very" confident in assessing and treating OUD.
This outcome measure was calculated at approximately month 10 of the pilot study
Intervention PCP Likeliness to Recommend Use of the OUD-CDS
Time Frame: This was calculated after PCP surveys were completed, approximately month 10
# of PCPs with CDS access who rate the OUD-CDS >4 on a 5-point Likert scale of likeliness to recommend use of the tool to their colleagues. The scale ranges from 1-"not at all likely" to 5-"very likely," with higher values representing a higher likelihood of recommending the OUD-CDS to other colleagues.
This was calculated after PCP surveys were completed, approximately month 10

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compare Pre- and Post-intervention Rates of OUD Diagnosis in High-risk Patients.
Time Frame: This was calculated at the end of the pilot study (month 8).
Calculate and compare the number of patients diagnosed with OUD pre- and post-intervention. This will be presented as rate of OUD diagnoses per patient year.
This was calculated at the end of the pilot study (month 8).
Compare Pre- and Post-intervention Rates of Medication-assisted Therapy (MAT) Use.
Time Frame: This was calculated at the end of the pilot study (month 8).
Calculate and compare the rate of MAT use among patients with OUD pre- and post-intervention. This is presented as a pre/post ratio of MAT rx per patient year.
This was calculated at the end of the pilot study (month 8).
Compare Post-intervention Referral Patterns Between Intervention and Control Groups
Time Frame: This was calculated at the end of the pilot study (month 8).
Calculate and compare how often patients diagnosed with OUD are referred to specialty care or inpatient treatment post-intervention. Compare these rates between intervention and control groups.
This was calculated at the end of the pilot study (month 8).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

HealthPartners Institute

Collaborators

National Institute on Drug Abuse (NIDA)
Hennepin Healthcare Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 30, 2018

Primary Completion (Actual)

February 14, 2019

Study Completion (Actual)

February 14, 2019

Study Registration Dates

First Submitted

May 9, 2018

First Submitted That Met QC Criteria

June 5, 2018

First Posted (Actual)

June 18, 2018

Study Record Updates

Last Update Posted (Actual)

March 17, 2020

Last Update Submitted That Met QC Criteria

March 9, 2020

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0076-ot
  • 3UG1DA040316-03S1 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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