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

Primary Purpose

Opioid-use Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Opioid Wizard
Sponsored by
HealthPartners Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Opioid-use Disorder focused on measuring CDS, Medication Assisted Therapy

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • HealthPartners

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

Experimental

Arm Label

Waivered Providers Receive the Opioid Wizard

Does not Receive the Opioid Wizard

Non-Waivered Providers who receive Opioid Wizard

Arm Description

All providers who have a buprenorphine waiver will receive the OUD clinical decision support tool (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.

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).

Outcomes

Primary Outcome Measures

Intervention PCP Confidence in Assessing and Treating OUD
# of intervention PCPs who report feeling "moderately" or "very" confident in assessing and treating OUD.
Intervention PCP Likeliness to Recommend Use of the OUD-CDS
# 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.

Secondary Outcome Measures

Compare Pre- and Post-intervention Rates of OUD Diagnosis in High-risk Patients.
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.
Compare Pre- and Post-intervention Rates of Medication-assisted Therapy (MAT) Use.
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.
Compare Post-intervention Referral Patterns Between Intervention and Control Groups
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.

Full Information

First Posted
May 9, 2018
Last Updated
March 9, 2020
Sponsor
HealthPartners Institute
Collaborators
National Institute on Drug Abuse (NIDA), Hennepin Healthcare Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT03559179
Brief Title
Clinical Decision Support for Opioid Use Disorders in Medical Settings: Usability Testing in an EMR
Acronym
COMPUTE
Official Title
Clinical Decision Support for Opioid Use Disorders in Medical Settings: Pilot Usability Testing in an EMR
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
April 30, 2018 (Actual)
Primary Completion Date
February 14, 2019 (Actual)
Study Completion Date
February 14, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
HealthPartners Institute
Collaborators
National Institute on Drug Abuse (NIDA), Hennepin Healthcare Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid-use Disorder
Keywords
CDS, Medication Assisted Therapy

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
55 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Waivered Providers Receive the Opioid Wizard
Arm Type
Experimental
Arm Description
All providers who have a buprenorphine waiver will receive the OUD clinical decision support tool (Opioid Wizard).
Arm Title
Does not Receive the Opioid Wizard
Arm Type
No Intervention
Arm Description
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.
Arm Title
Non-Waivered Providers who receive Opioid Wizard
Arm Type
Experimental
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
Opioid Wizard
Intervention Description
The Opioid Wizard is an OUD clinical decision support tool for primary care providers.
Primary Outcome Measure Information:
Title
Intervention PCP Confidence in Assessing and Treating OUD
Description
# of intervention PCPs who report feeling "moderately" or "very" confident in assessing and treating OUD.
Time Frame
This outcome measure was calculated at approximately month 10 of the pilot study
Title
Intervention PCP Likeliness to Recommend Use of the OUD-CDS
Description
# 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.
Time Frame
This was calculated after PCP surveys were completed, approximately month 10
Secondary Outcome Measure Information:
Title
Compare Pre- and Post-intervention Rates of OUD Diagnosis in High-risk Patients.
Description
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.
Time Frame
This was calculated at the end of the pilot study (month 8).
Title
Compare Pre- and Post-intervention Rates of Medication-assisted Therapy (MAT) Use.
Description
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.
Time Frame
This was calculated at the end of the pilot study (month 8).
Title
Compare Post-intervention Referral Patterns Between Intervention and Control Groups
Description
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.
Time Frame
This was calculated at the end of the pilot study (month 8).

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
HealthPartners
City
Bloomington
State/Province
Minnesota
ZIP/Postal Code
55425
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
34130758
Citation
Rossom RC, Sperl-Hillen JM, O'Connor PJ, Crain AL, Nightingale L, Pylkas A, Huntley KV, Bart G. A pilot study of the functionality and clinician acceptance of a clinical decision support tool to improve primary care of opioid use disorder. Addict Sci Clin Pract. 2021 Jun 15;16(1):37. doi: 10.1186/s13722-021-00245-7.
Results Reference
derived

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

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