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Comparing Two Training Methods for Opioid Wizard

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ClinicalTrials.gov Identifier: NCT04867382
Recruitment Status : Completed
First Posted : April 30, 2021
Last Update Posted : January 6, 2022
Sponsor:
Collaborators:
Hennepin Healthcare Research Institute
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
HealthPartners Institute

Study Description
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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 proposes an innovative intervention to change attitudes of Primary Care Clinicians (PCCs) toward persons with OUD. Study participants will be stratified into one of two online learning courses: the intervention training will be compared with an attention-control training.

Condition or disease Intervention/treatment Phase
Opioid-use Disorder Opioid Dependence Attitude of Health Personnel Behavioral: Online training Not Applicable

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 will use a randomized controlled trial design to examine a novel intervention to change attitudes towards people with OUD among PCCs. PCCs in clinics randomized in COMPUTE 2.0 to the intervention (in 15 of the 30 clinics randomized in the parent study) will be randomized 1:1 to the intervention or comparison training, stratified by clinic and waiver status. Training will be conducted via MyLearning, an online learning software. PCCs will be asked to complete a brief training on the clinical decision support (CDS) tool, Opioid Wizard. PCCs in the intervention arm will hear patient narratives designed to shift attitudes about patients with OUD. PCCs in the comparison training will have training on using the clinical decision support tool. Immediately following the training, the PCCs will complete a survey of attitudes and intentions to get waivered to prescribe buprenorphine. Use of the CDS will be monitored in both groups for 6 months.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This study will use 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.
Masking: Single (Participant)
Masking Description: Methods for concealment of allocation. PCCs will be blind to their randomized MyLearning training assignment. The study statistician will generate the randomization assignment, and a study team member will submit that list to HealthPartners (HP) MyLearning staff. Study team members capturing outcome data from surveys, Opioid Wizard, and Epic (including use rates, buprenorphine prescriptions) will also be blind to treatment assignment.
Primary Purpose: Health Services Research
Official Title: Comparing Two Training Methods for Opioid Wizard
Actual Study Start Date : April 9, 2021
Actual Primary Completion Date : September 10, 2021
Actual Study Completion Date : November 30, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Intervention
PCCs in clinics randomized to Opioid Wizard will be randomized 1:1 to the intervention or comparison training, stratified by clinic and waiver status. Both arms will receive a case-based training on how to use the Opioid Wizard tool. The intervention arm will receive an online training that includes patient narratives and videos and person-first language.
 Behavioral: Online training
This intervention consists of two different interactive online trainings that are delivered through an online learning platform at HealthPartners.
Placebo Comparator: Comparison training
PCCs in clinics randomized to Opioid Wizard will be randomized 1:1 to the intervention or comparison training, stratified by clinic and waiver status. Both arms will receive a case-based training on how to use the Opioid Wizard tool.
 Behavioral: Online training
This intervention consists of two different interactive online trainings that are delivered through an online learning platform at HealthPartners.


Outcome Measures
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Primary Outcome Measures :
  1. OUD Attitudes [ Time Frame: Immediately after completing online training and three-month follow-up. ]
    Attitudes toward people with OUD will be measured using the Difference and Disdain scales, which measure attitudes toward people with mental illness and substance use disorders (SUDs).


Secondary Outcome Measures :
  1. Intentions to get waivered to prescribe buprenorphine. [ Time Frame: Immediately after completing online training and three-month follow-up. ]
    Non-waivered PCCs will be asked to rate one question on their intentions to get waivered to prescribe buprenorphine.

  2. Intentions to prescribe buprenorphine should a waiver no longer be required. [ Time Frame: Immediately after completing online training and three-month follow-up. ]
    Non-waivered PCCs will be asked to rate one question on their intentions to prescribe buprenorphine.

  3. Opioid Wizard Use [ Time Frame: Six months following online training. ]
    The use rates for each PCC for the follow-up period (6 months) will be calculated as the proportion of eligible visits in which Opioid Wizard was used.


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

None

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04867382


Locations
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United States, Minnesota
HealthPartners
Bloomington, Minnesota, United States, 55425-4516
Sponsors and Collaborators
HealthPartners Institute
Hennepin Healthcare Research Institute
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Stephanie Hooker, PhD HealthPartners Institute
  Study Documents (Full-Text)

Documents provided by HealthPartners Institute:
Study Protocol, Statistical Analysis Plan, and Informed Consent Form  [PDF] May 7, 2021

More Information
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Responsible Party: HealthPartners Institute
ClinicalTrials.gov Identifier: NCT04867382    
Other Study ID Numbers: A20-156
3UG1DA040316-06S4 ( U.S. NIH Grant/Contract )
First Posted: April 30, 2021    Key Record Dates
Last Update Posted: January 6, 2022
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Opioid-Related Disorders
Narcotic-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders