search
Back to results

Comparing Two Training Methods for Opioid Wizard

Primary Purpose

Opioid-use Disorder, Opioid Dependence, Attitude of Health Personnel

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

About this trial

This is an interventional health services research trial for Opioid-use Disorder

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • HealthPartners

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Intervention

Comparison training

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Intentions to Get Waivered to Prescribe Buprenorphine.
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.
Intentions to Prescribe Buprenorphine Should a Waiver no Longer be Required.
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.
Opioid Wizard Use
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.

Full Information

First Posted
April 27, 2021
Last Updated
November 18, 2022
Sponsor
HealthPartners Institute
Collaborators
Hennepin Healthcare Research Institute, National Institute on Drug Abuse (NIDA)
search

1. Study Identification

Unique Protocol Identification Number
NCT04867382
Brief Title
Comparing Two Training Methods for Opioid Wizard
Official Title
Reducing Stigma Toward People With Opioid Use Disorder Among Primary Care Clinicians
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
April 9, 2021 (Actual)
Primary Completion Date
September 10, 2021 (Actual)
Study Completion Date
November 30, 2021 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

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

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid-use Disorder, Opioid Dependence, Attitude of Health Personnel

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
Participant
Masking Description
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.
Allocation
Randomized
Enrollment
88 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
This arm received a case-based training on how to use the Opioid Wizard tool, including patient narratives and videos and person-first language.
Arm Title
Comparison training
Arm Type
Placebo Comparator
Arm Description
This arm received a case-based training on how to use the Opioid Wizard tool.
Intervention Type
Behavioral
Intervention Name(s)
Online training
Intervention Description
This intervention consisted of two different interactive online trainings delivered through an online learning platform at HealthPartners.
Primary Outcome Measure Information:
Title
Difference, Disdain, and Blame Scales
Description
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.
Time Frame
Immediately after completing online training.
Secondary Outcome Measure Information:
Title
Intentions to Get Waivered to Prescribe Buprenorphine.
Description
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.
Time Frame
Immediately after completing online training
Title
Intentions to Prescribe Buprenorphine Should a Waiver no Longer be Required.
Description
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.
Time Frame
Immediately after completing online training
Title
Opioid Wizard Use
Description
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.
Time Frame
Six months following online training.

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephanie Hooker, PhD, MPH, MS
Organizational Affiliation
HealthPartners Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
HealthPartners
City
Bloomington
State/Province
Minnesota
ZIP/Postal Code
55425-4516
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
As part of the HEAL initiative, the main study results, as described in the initial publication, will be shared on the HEAL Data Platform.
IPD Sharing Time Frame
Pending
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
IPD Sharing URL
https://healdata.org/portal/discovery/3UG1DA040316-06S4/

Learn more about this trial

Comparing Two Training Methods for Opioid Wizard

We'll reach out to this number within 24 hrs