- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04867382
Comparing Two Training Methods for Opioid Wizard
Reducing Stigma Toward People With Opioid Use Disorder Among Primary Care Clinicians
Study Overview
Status
Intervention / Treatment
Detailed Description
Primary care offers an ideal setting in which to treat OUD; however, few clinicians are waivered to prescribe buprenorphine and of those who are waivered, less than one-third do prescribe. One potential barrier to increasing access to MOUDs are primary care clinician (PCC) attitudes towards people with OUD.
This study used a randomized controlled trial design to examine a novel intervention to change attitudes towards people with OUD among PCCs. PCCs in clinics randomized to the intervention in COMPUTE 2.0 (PCCs in 15 of the 30 clinics randomized in the parent study) were randomized 1:1 to the intervention or comparison training, stratified by clinic and waiver status. Training was conducted via MyLearning, an online learning software. All PCCs were asked to complete a brief training (25-35 minutes for both trainings) on the shared decision-making tool (SDM) called the Opioid Wizard, which alerts PCCs to screen, diagnose, and treat people with OUD. PCCs in the intervention arm heard patient narratives designed to shift attitudes about patients with OUD. PCCs in the comparison training had training on using the SDM tool. The PCCs were asked to complete a survey of attitudes and intentions to get waivered to prescribe buprenorphine immediately following the online training. Use of the CDS was monitored in both groups for 6 months.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Minnesota
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Bloomington, Minnesota, United States, 55425-4516
- HealthPartners
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
PCCs were ineligible to participate if they had fewer than 5 eligible patient encounters between Sep 2020 and Feb 2021.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Intervention
This arm received a case-based training on how to use the Opioid Wizard tool, including patient narratives and videos and person-first language.
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This intervention consisted of two different interactive online trainings delivered through an online learning platform at HealthPartners.
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Placebo Comparator: Comparison training
This arm received a case-based training on how to use the Opioid Wizard tool.
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This intervention consisted of two different interactive online trainings delivered through an online learning platform at HealthPartners.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Difference, Disdain, and Blame Scales
Time Frame: Immediately after completing online training.
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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.
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Immediately after completing online training.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Intentions to Get Waivered to Prescribe Buprenorphine.
Time Frame: Immediately after completing online training
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Non-waivered PCCs rated one question on their intention to get waivered to prescribe buprenorphine ("How likely are you to get waivered to prescribe buprenorphine in the next year?") on a five-point Likert-type scale ranging from 1 (I definitely will not) to 5 (I definitely will).
Higher scores correspond to greater intention to get waivered.
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Immediately after completing online training
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Intentions to Prescribe Buprenorphine Should a Waiver no Longer be Required.
Time Frame: Immediately after completing online training
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Non-waivered PCCs rated one question on their intentions to prescribe buprenorphine if a waiver were no longer required ("If your patient with OUD requested buprenorphine in the next year and a waiver were no longer required, would you prescribe buprenorphine?") on a five-point Likert-type scale ranging from 1 (I definitely would not) to 5 (I definitely would).
Higher numbers indicate greater likelihood to prescribe buprenorphine.
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Immediately after completing online training
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Opioid Wizard Use
Time Frame: Six months following online training.
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PCC Opioid Wizard use was defined as clicking within the tool, such as screening for OUD, making a diagnosis, providing a referral, prescribing a medication, printing patient education materials, or prescribing naloxone.
This variable was dichotomized as whether the PCC ever clicked in the tool (1=yes; 0=no) in the 6 months following the training.
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Six months following online training.
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Stephanie Hooker, PhD, MPH, MS, HealthPartners Institute
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- A20-156
- 3UG1DA040316-06S4 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing 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
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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