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Comparing Two Training Methods for Opioid Wizard

Reducing Stigma Toward People With Opioid Use Disorder Among Primary Care Clinicians

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04867382
Enrollment
88
Registered
2021-04-30
Start date
2021-04-09
Completion date
2021-11-30
Last updated
2022-12-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

BEHAVIORALOnline training

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

Sponsors

Hennepin Healthcare Research Institute
CollaboratorOTHER
National Institute on Drug Abuse (NIDA)
CollaboratorNIH
HealthPartners Institute
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Subject)

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.

Intervention 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.

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Difference, Disdain, and Blame ScalesImmediately after completing online training.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

MeasureTime frameDescription
Intentions to Get Waivered to Prescribe Buprenorphine.Immediately after completing online trainingNon-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.Immediately after completing online trainingNon-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 UseSix months following online training.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.

Countries

United States

Participant flow

Recruitment details

Eligible participants for this study were primary care providers (PCCs) who practice at HealthPartners Clinics that were previously randomized into the intervention arm of the parent study (NCT04198428). Family physician, general internist or adult-care non-obstetric nurse practitioner or physician assistant were the titles included. PCCs were eligible to participate regardless of whether they were waivered to prescribe buprenorphine. 162 PCCs were invited by email to participate in this study.

Pre-assignment details

A total of 411 Primary Care Clinicians (PCCs) actively practicing at clinics within the parent study were screened for eligibility. They were ineligible to participate if: * They had fewer than 5 eligible patient encounters between Sep 2020 and Feb 2021 (N=50); * They practiced in a non-intervention clinic (n=199)

Participants by arm

ArmCount
Intervention
The intervention arm received an online training in the use of the SDM tool that included patient narratives and videos and person-first language.
48
Comparison Training
The comparison training arm received an online training in the use of the SDM tool.
40
Total88

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyDid not complete the survey21

Baseline characteristics

CharacteristicInterventionComparison TrainingTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
6 Participants5 Participants11 Participants
Age, Categorical
Between 18 and 65 years
40 Participants34 Participants74 Participants
Age, Continuous47.76 years
STANDARD_DEVIATION 11.85
47.00 years
STANDARD_DEVIATION 11.31
47.4 years
STANDARD_DEVIATION 11.6
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
6 Participants2 Participants8 Participants
Race (NIH/OMB)
Black or African American
3 Participants3 Participants6 Participants
Race (NIH/OMB)
More than one race
1 Participants1 Participants2 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
7 Participants5 Participants12 Participants
Race (NIH/OMB)
White
29 Participants28 Participants57 Participants
Region of Enrollment
United States
48 participants40 participants88 participants
Sex/Gender, Customized
Female
27 Participants22 Participants49 Participants
Sex/Gender, Customized
Male
17 Participants14 Participants31 Participants
Sex/Gender, Customized
Not Listed
1 Participants0 Participants1 Participants
Sex/Gender, Customized
Prefer not to answer
1 Participants3 Participants4 Participants
Type of provider degree
Doctor of Medicine/Doctor of Osteopathic Medicine MD/DO
30 Participants25 Participants55 Participants
Type of provider degree
Physician Assistant/Nurse Practitioner PA/NP
16 Participants14 Participants30 Participants
Waivered to prescribe buprenorphine3 Participants5 Participants8 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 00 / 0
other
Total, other adverse events
0 / 00 / 0
serious
Total, serious adverse events
0 / 00 / 0

Outcome results

Primary

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.

Time frame: Immediately after completing online training.

ArmMeasureValue (MEAN)Dispersion
InterventionDifference, Disdain, and Blame Scales4.1 score on a scaleStandard Deviation 1.3
Comparison TrainingDifference, Disdain, and Blame Scales4.3 score on a scaleStandard Deviation 1.2
p-value: 0.63t-test, 2 sided
Secondary

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.

Time frame: Immediately after completing online training

ArmMeasureValue (MEAN)Dispersion
InterventionIntentions to Get Waivered to Prescribe Buprenorphine.2.3 score on a scaleStandard Deviation 0.7
Comparison TrainingIntentions to Get Waivered to Prescribe Buprenorphine.2.1 score on a scaleStandard Deviation 0.8
p-value: 0.27t-test, 2 sided
Secondary

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.

Time frame: Immediately after completing online training

ArmMeasureValue (MEAN)Dispersion
InterventionIntentions to Prescribe Buprenorphine Should a Waiver no Longer be Required.3.2 score on a scaleStandard Deviation 1
Comparison TrainingIntentions to Prescribe Buprenorphine Should a Waiver no Longer be Required.3.0 score on a scaleStandard Deviation 0.9
p-value: 0.37t-test, 2 sided
Secondary

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.

Time frame: Six months following online training.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
InterventionOpioid Wizard Use3 Participants
Comparison TrainingOpioid Wizard Use4 Participants
p-value: 0.1295% CI: [0.86, 3.57]Regression, Logistic

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026