NCT03559179

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 30, 2018

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

May 9, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 18, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 14, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 14, 2019

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

March 10, 2020

Completed
Last Updated

March 17, 2020

Status Verified

February 1, 2019

Enrollment Period

10 months

First QC Date

May 9, 2018

Results QC Date

January 29, 2020

Last Update Submit

March 9, 2020

Conditions

Keywords

CDSMedication Assisted Therapy

Outcome Measures

Primary Outcomes (2)

  • Intervention PCP Confidence in Assessing and Treating OUD

    \# 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

    \# 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 Outcomes (3)

  • Compare Pre- and Post-intervention Rates of OUD Diagnosis in High-risk Patients.

    This was calculated at the end of the pilot study (month 8).

  • Compare Pre- and Post-intervention Rates of Medication-assisted Therapy (MAT) Use.

    This was calculated at the end of the pilot study (month 8).

  • Compare Post-intervention Referral Patterns Between Intervention and Control Groups

    This was calculated at the end of the pilot study (month 8).

Study Arms (3)

Waivered Providers Receive the Opioid Wizard

EXPERIMENTAL

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

Other: Opioid Wizard

Does not Receive the Opioid Wizard

NO INTERVENTION

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.

Non-Waivered Providers who receive Opioid Wizard

EXPERIMENTAL

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

Interventions

The Opioid Wizard is an OUD clinical decision support tool for primary care providers.

Non-Waivered Providers who receive Opioid WizardWaivered Providers Receive the Opioid Wizard

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Less than half-time clinical primary care responsibilities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HealthPartners

Bloomington, Minnesota, 55425, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Results Point of Contact

Title
Dr. Rebecca C Rossom
Organization
HealthPartners Institute

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 9, 2018

First Posted

June 18, 2018

Study Start

April 30, 2018

Primary Completion

February 14, 2019

Study Completion

February 14, 2019

Last Updated

March 17, 2020

Results First Posted

March 10, 2020

Record last verified: 2019-02

Locations