Developing a Tailored Stigma Reduction Intervention to Increase Buprenorphine Prescribing
Primary Purpose
Opioid-Related Disorders, Buprenorphine, Social Stigma
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Stigma-reduction training
Placebo
Sponsored by
About this trial
This is an interventional health services research trial for Opioid-Related Disorders
Eligibility Criteria
Inclusion Criteria:
- physician, nurse practitioner, or physician assistant
- eligible to prescribe buprenorphine under federal law
- currently practices in primary care setting
- currently practices in rural-designated county
- at least 18 years of age
Exclusion Criteria:
- currently prescribing buprenorphine at full capacity
Sites / Locations
- Berkeley FranzRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Intervention
Control
Arm Description
Outcomes
Primary Outcome Measures
Feasibility Intervention Measure
Feasibility refers to the ease in which a new intervention can be used within a specific setting. It will be measured using the 4-item Feasibility Intervention Measure (FIM). Scale values range from 1 to 5 with higher values indicating a better outcome.
Acceptability
Acceptability refers to HCP attitudes about whether the brief training intervention is agreeable or satisfactory. It is measured with the 4-item Acceptability of Intervention Measure (AIM) in HCP participants. Scale values range from 1 to 5 with higher values indicating a better outcome.
Appropriateness
Appropriateness refers to the perceived alignment of the intervention within a particular practice setting and will be measured by the 4-item Intervention Appropriateness Measure (IAM). Scale values range from 1 to 5 with higher values indicating a better outcome.
Adoption
Adoption refers to intentions or actions to adopt an EBI. Adoption will be measured as whether a HCP initiates buprenorphine prescribing for the first time or increases their patient panel (yes/no) and as the total number of patients receiving buprenorphine for each HCP.
Secondary Outcome Measures
Full Information
NCT ID
NCT05505227
First Posted
August 12, 2022
Last Updated
March 2, 2023
Sponsor
Ohio University
Collaborators
Ohio State University, Rutgers University, University of North Carolina
1. Study Identification
Unique Protocol Identification Number
NCT05505227
Brief Title
Developing a Tailored Stigma Reduction Intervention to Increase Buprenorphine Prescribing
Official Title
Developing a Tailored Stigma Reduction Intervention to Increase Buprenorphine Prescribing Among Rural Primary Care Providers in Ohio
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2022 (Actual)
Primary Completion Date
December 30, 2024 (Anticipated)
Study Completion Date
June 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ohio University
Collaborators
Ohio State University, Rutgers University, University of North Carolina
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Buprenorphine is an evidence-based treatment for opioid use disorder that also has strong potential to reduce HIV transmission in people who use drugs. Rural health care professionals are eligible and critically needed to provide these medications, but stigma currently limits provider willingness to prescribe buprenorphine, especially in regions where mortality and HIV transmission secondary to opioid use are high. In this developmental trial, the investigators will adapt, refine, and test the feasibility of a prototype brief stigma-reduction training intervention aimed at increasing buprenorphine prescribing in the rural primary care setting.
Detailed Description
Rural counties, particularly in Appalachia, are battling fast-growing outbreaks of HIV and have been labeled by the CDC as vulnerable to growing transmission rates due to widespread injection drug use. One of the most promising mechanisms for reducing HIV transmission in these communities is the use of buprenorphine, which treats opioid use disorder and also reduces behaviors that increase HIV risk. Despite the potential benefit of buprenorphine, health care professionals (HCPs) in rural areas of the United States are much less likely to have received the training and federal waiver necessary to prescribe this medication. Stigma toward patients who use drugs is an accepted barrier to substance use treatment, but it also impacts health care professionals, especially rural primary care prescribers such as physicians, nurse practitioners, and physicians assistants who are on the front lines of the opioid crisis. The investigators have shown in previous studies that stigma is a primary reason why fewer rural health care professionals are willing to work with patients with OUD. Stigma and negative attitudes toward patients with OUD, fortunately, are modifiable but require training interventions that are both effective and feasible to implement in rural practice settings. Previous interventions have been used with health care professionals successfully to reduce stigma, but they have not been tailored for medications for opioid use, such as buprenorphine, or for the rural primary care setting. The study team proposes to adapt an existing brief stigma-reduction training intervention to the rural primary care setting to increase buprenorphine prescribing and implement a randomized, pilot study to assess feasibility and acceptability among rural primary care providers. Our specific aims are to: 1) Examine HCP knowledge and attitudes about OUD to understand their reluctance to prescribe MOUD and manage patients with OUD. 2) Develop a prototype narrative-based stigma reduction intervention and tailor it to the rural primary care setting using HCP feedback and 3) Assess the feasibility and acceptability of a stigma-reduction intervention in a pilot study in a diverse group of rural HCPs across 6 primary care clinics. The primary pilot trial outcomes are feasibility, acceptability, appropriateness, and adoption, measured among a cohort of HCPs who do not currently prescribe buprenorphine at full capacity. The investigators will also measure additional stigma outcomes such as attitudes towards patients with OUD and harm reduction. The invesstigators will use in-depth interviews to further assess perceptions of the intervention and finalize it for use in a follow-up cluster randomized controlled trial. This developmental trial will produce a brief stigma reduction training intervention that is acceptable and feasible to implement in rural primary care clinics. The long-term goal is to establish a brief stigma-reduction training intervention that is modifiable for different practice settings and effective at increasing buprenorphine prescribing in underserved communities.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid-Related Disorders, Buprenorphine, Social Stigma, Rural Health Services
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
400 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Active Comparator
Arm Title
Control
Arm Type
Placebo Comparator
Intervention Type
Behavioral
Intervention Name(s)
Stigma-reduction training
Intervention Description
While the details will be finalized by the intervention working group after the key modifiable features of OUD-stigma among rural HCPs are isolated in Aim 1, our intervention will include several new elements that distinguish it from existing stigma-reduction interventions. The prototype intervention includes several modules aimed at decreasing stigma, increasing knowledge about medications for OUD, and increasing willingness to prescribe buprenorphine (see Table 3) among rural HCPs currently in practice.
Intervention Type
Behavioral
Intervention Name(s)
Placebo
Intervention Description
HCPs affiliated with clinics in the control arm will receive no training but will be provided with a link to the SAMHSA website where prescribers can learn more about buprenorphine prescribing and apply to receive an X-waiver.
Primary Outcome Measure Information:
Title
Feasibility Intervention Measure
Description
Feasibility refers to the ease in which a new intervention can be used within a specific setting. It will be measured using the 4-item Feasibility Intervention Measure (FIM). Scale values range from 1 to 5 with higher values indicating a better outcome.
Time Frame
Up to 6 months
Title
Acceptability
Description
Acceptability refers to HCP attitudes about whether the brief training intervention is agreeable or satisfactory. It is measured with the 4-item Acceptability of Intervention Measure (AIM) in HCP participants. Scale values range from 1 to 5 with higher values indicating a better outcome.
Time Frame
Up to 6 months
Title
Appropriateness
Description
Appropriateness refers to the perceived alignment of the intervention within a particular practice setting and will be measured by the 4-item Intervention Appropriateness Measure (IAM). Scale values range from 1 to 5 with higher values indicating a better outcome.
Time Frame
Up to 6 months
Title
Adoption
Description
Adoption refers to intentions or actions to adopt an EBI. Adoption will be measured as whether a HCP initiates buprenorphine prescribing for the first time or increases their patient panel (yes/no) and as the total number of patients receiving buprenorphine for each HCP.
Time Frame
Up to 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
physician, nurse practitioner, or physician assistant
eligible to prescribe buprenorphine under federal law
currently practices in primary care setting
currently practices in rural-designated county
at least 18 years of age
Exclusion Criteria:
currently prescribing buprenorphine at full capacity
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Berkeley Franz, Ph.D.
Phone
3176262218
Email
franzb@ohio.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Lindsay Dhanani, Ph.D.
Phone
321-662-7083
Email
ld733@smlr.rutgers.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Berkeley Franz, Ph.D.
Organizational Affiliation
Ohio University Heritage College of Osteopathic Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Berkeley Franz
City
Athens
State/Province
Ohio
ZIP/Postal Code
45701
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Berkeley Franz
Phone
317-626-2218
Email
franzb@ohio.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Developing a Tailored Stigma Reduction Intervention to Increase Buprenorphine Prescribing
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