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| ID | Type | Description | Link |
|---|---|---|---|
| 3UG1DA040316-06S4 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Hennepin Healthcare Research Institute | OTHER |
| National Institute on Drug Abuse (NIDA) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Comparison training | Placebo Comparator | This arm received a case-based training on how to use the Opioid Wizard tool. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Online training | Behavioral | This intervention consisted of two different interactive online trainings delivered through an online learning platform at HealthPartners. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
PCCs were ineligible to participate if they had fewer than 5 eligible patient encounters between Sep 2020 and Feb 2021.
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| Name | Affiliation | Role |
|---|---|---|
| Stephanie Hooker, PhD, MPH, MS | HealthPartners Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HealthPartners | Bloomington | Minnesota | 55425-4516 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36774521 | Derived | 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. |
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As part of the HEAL initiative, the main study results, as described in the initial publication, will be shared on the HEAL Data Platform.
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Pending
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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:
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention | The intervention arm received an online training in the use of the SDM tool that includes patient narratives and videos and person-first language. |
| FG001 | Comparison Training | The comparison training arm received an online training in the use of the SDM tool. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Comparison Training |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Three participants completed the training but not the survey and we lack any demographic data on them. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | score on a scale | Immediately after completing online training. |
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Adverse events were not monitored because this was a minimal-risk study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention | The intervention arm received an online training in the use of the SDM tool that includes patient narratives and videos and person-first language. |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Stephanie Hooker, PhD, MPH, MS, Principal Investigator | HealthPartners Institute | (952) 967-5056 | Stephanie.A.HookerShowalter@HealthPartners.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Nov 23, 2021 | Oct 18, 2022 | Prot_SAP_ICF_001.pdf |
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| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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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.
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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.
| Immediately after completing online training |
| 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. | Immediately after completing online training |
| 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. | Six months following online training. |
The comparison training arm received an online training in the use of the SDM tool.
| BG002 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
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| Age, Continuous | Three participants completed the training but not the survey and we lack any demographic data on them. | Mean | Standard Deviation | years |
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| Sex/Gender, Customized | Three participants completed the training but not the survey and we lack any demographic data on them. | Count of Participants | Participants |
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| Race (NIH/OMB) | Three participants completed the training but not the survey and we lack any demographic data on them. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Waivered to prescribe buprenorphine | Count of Participants | Participants |
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| Type of provider degree | Three participants completed the training but not the survey and we lack any demographic data on them. | Count of Participants | Participants |
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| OG001 | Comparison Training | The comparison training arm received an online training in the use of the SDM tool. |
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| 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. | Posted | Mean | Standard Deviation | score on a scale | Immediately after completing online training |
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| 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. | Posted | Mean | Standard Deviation | score on a scale | Immediately after completing online training |
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| 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. | Posted | Count of Participants | Participants | Six months following online training. |
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| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Comparison Training | The comparison training arm received an online training in the use of the SDM tool. | 0 | 0 | 0 | 0 | 0 | 0 |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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