Clinical trial NCT05505227: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Opioid-Related Disorders
Buprenorphine
Social Stigma
Rural Health Services
Lead sponsor: Ohio University
Sponsor class: OTHER
Collaborators: name: Ohio State University
name: Rutgers University
name: University of North Carolina
First posted: 2022-08-17
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Feasibility Intervention Measure
timeFrame: Up to 6 months
measure: Acceptability
timeFrame: Up to 6 months
measure: Appropriateness
timeFrame: Up to 6 months
measure: Adoption
timeFrame: Up to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Athens
country: United States
facility: Berkeley Franz
state: Ohio
Study officials:
affiliation: Ohio University Heritage College of Osteopathic Medicine
name: Berkeley Franz, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: