NCT04867382

Brief Summary

The prevalence of opioid use disorder (OUD) and opioid-related deaths has risen dramatically in recent years. Effective treatments, including medications for opioid use disorder (MOUDs; e.g., buprenorphine-naloxone and methadone) are under-utilized. There are few evidence-based interventions for changing attitudes toward Opioid Use Disorder (OUD) in the general public and especially among healthcare clinicians. This study proposed an innovative intervention to change attitudes of Primary Care Clinicians (PCCs) toward persons with OUD. Study participants were stratified into one of two online learning courses: the intervention training was compared with an attention-control training.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
88

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2021

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 9, 2021

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

April 27, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 30, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 10, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2021

Completed
1 year until next milestone

Results Posted

Study results publicly available

December 15, 2022

Completed
Last Updated

December 15, 2022

Status Verified

August 1, 2021

Enrollment Period

5 months

First QC Date

April 27, 2021

Results QC Date

August 19, 2022

Last Update Submit

November 18, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Difference, Disdain, and Blame Scales

    Attitudes toward people with OUD were measured using the Difference, Disdain, and Blame scales, which measure attitudes toward people with mental illness and substance use disorders (SUDs). Difference, Disdain, and Blame scales measured stigma toward people with OUD, with three questions in each domain. Items are scored on a 9-point agreement scale. The range is 1-9; some items are reverse-scored. Items are averaged to obtain a score, with higher scores reflecting more stigma (range = 1-9). Evidence suggests that the scales demonstrate good internal consistency and are positively associated.

    Immediately after completing online training.

Secondary Outcomes (3)

  • Intentions to Get Waivered to Prescribe Buprenorphine.

    Immediately after completing online training

  • Intentions to Prescribe Buprenorphine Should a Waiver no Longer be Required.

    Immediately after completing online training

  • Opioid Wizard Use

    Six months following online training.

Study Arms (2)

Intervention

EXPERIMENTAL

This arm received a case-based training on how to use the Opioid Wizard tool, including patient narratives and videos and person-first language.

Behavioral: Online training

Comparison training

PLACEBO COMPARATOR

This arm received a case-based training on how to use the Opioid Wizard tool.

Behavioral: Online training

Interventions

Online trainingBEHAVIORAL

This intervention consisted of two different interactive online trainings delivered through an online learning platform at HealthPartners.

Comparison trainingIntervention

Eligibility Criteria

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

You may qualify if:

  • Primary Care Clinician: Had to be a family physician, general internist, adult-care non-obstetric nurse practitioner, or a physician assistant
  • Had to practice at a study-eligible primary care clinic already involved in the main study intervention arm

You may not qualify if:

  • PCCs were ineligible to participate if they had fewer than 5 eligible patient encounters between Sep 2020 and Feb 2021.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HealthPartners

Bloomington, Minnesota, 55425-4516, United States

Location

Related Publications (1)

  • Hooker SA, Crain AL, LaFrance AB, Kane S, Fokuo JK, Bart G, Rossom RC. A randomized controlled trial of an intervention to reduce stigma toward people with opioid use disorder among primary care clinicians. Addict Sci Clin Pract. 2023 Feb 11;18(1):10. doi: 10.1186/s13722-023-00366-1.

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Limitations and Caveats

The online training meant there was no way for the research team to control for PCC engagement with content. The training, at 25-35 minutes, may not have been intensive enough to have substantial impact. The comparison training, which lasted the same amount of time and covered some of the same topics, may have had an effect on PCCs. The study did not include a baseline training to avoid signaling the primary outcome was stigma, so there is no way to measure pre-training attitudes.

Results Point of Contact

Title
Stephanie Hooker, PhD, MPH, MS, Principal Investigator
Organization
HealthPartners Institute

Study Officials

  • Stephanie Hooker, PhD, MPH, MS

    HealthPartners Institute

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Methods for concealment of allocation. PCCs were blind to their randomized MyLearning training assignment. The study statistician generated the randomization assignment, and a study team member submitted that list to HealthPartners (HP) MyLearning staff. Study team members collecting outcome data from surveys, Opioid Wizard, and Epic (including use rates, buprenorphine prescriptions) also were blinded to treatment assignment.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: This study used a randomized controlled trial (RCT) design embedded in a larger, multisite trial of a clinical decision support (CDS) tool to help PCCs identify, diagnose, and treat patients with OUD. PCCs in clinics randomized to Opioid Wizard were randomized 1:1 to the intervention or comparison training and stratified by clinic.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 27, 2021

First Posted

April 30, 2021

Study Start

April 9, 2021

Primary Completion

September 10, 2021

Study Completion

November 30, 2021

Last Updated

December 15, 2022

Results First Posted

December 15, 2022

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will share

As part of the HEAL initiative, the main study results, as described in the initial publication, will be shared on the HEAL Data Platform.

Time Frame
Pending
Access Criteria
You will not need to log in in order to: browse the study metadata on the Discovery Page or read the pre-made tutorial notebooks in the "Example Analysis" tab. You will need to log in and obtain authorization (access) in order to: register your own study; access studies with controlled data perform analyses in workspaces; and download data files and file manifests. run interactive tutorial notebooks in workspaces
More information

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