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Clinical Trials/NCT05352412
NCT05352412
Completed
Not Applicable

Piloting a Shared Decision-Making Aid for Reducing Stigma in Drug Use and HIV Harm Reduction in a Rural Setting

Washington University School of Medicine1 site in 1 country62 target enrollmentApril 7, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Opioid Use Disorder
Sponsor
Washington University School of Medicine
Enrollment
62
Locations
1
Primary Endpoint
Patient Internalized Stigma Towards Medicaid for Opioid Use Disorder (MOUDs) Over the Course of the Project
Status
Completed
Last Updated
10 months ago

Overview

Brief Summary

A major barrier for the uptake of evidence-based interventions to address the ongoing opioid epidemic in the US, especially in rural regions, is stigma, which occurs at many levels, including that of the patient and provider. A shared decision making aid is an evidence-based method for increasing engagement and knowledge of both patients and providers, potentially democratizing treatment decisions, especially in stigmatized conditions. The investigators propose to adapt and pilot a decision aid for opioid use disorder (OUD) treatment and harm reduction in two hospitals in rural Missouri to evaluate whether this reduces stigma in both patients and providers.

Detailed Description

In the past decade, the US opioid crisis has emerged as a leading cause of death among adults. It has also led to an increase in invasive bacterial and fungal infections; and HIV and hepatitis C virus (HCV) outbreaks in multiple regions. Rural communities have had an especially disproportionate burden from the impact of opioid use disorder (OUD). Treatment of OUD with pharmacotherapy is one of the most effective strategies for reducing OUD-related mortality and morbidity. But while there has been increasing will for expanding pharmacotherapy, stigma - from community, providers and patients-remains a significant barrier to uptake pharmacotherapy and harm reduction. The approach to substance use has historically favored abstinence strategies that are often without evidence, influenced by punitive, stigmatizing framework. This stigma may be even more prevalent in rural communities. To date there have been very few effective interventions to address inter- and intrapersonal stigma, and none with sustained effectiveness. The investigators propose adapting and piloting a shared decision-making aid for patients presenting to the emergency department or are being admitted at two hospitals in rural Missouri, where there is a high prevalence of OUD and its complications. The decision-aid is an evidence-based intervention show to increase knowledge, engagement and decision-making concordant with patient values in a variety of medical conditions. It is feasible that by democratizing treatment and standardizing decision-making counseling, the decision aid can mediate attitudes and reduce stigma. The investigators hypothesize by delivering standardized, high-quality knowledge to both provider and patient, that stigma can be reduced in both parties. In Aim 1 the investigators will adapt an existing decision aid for OUD treatment to the specific context of rural hospital care. This decision aid will be a part of an existing bundled care program for OUD and related infections that the investigators have implemented in these hospitals. In Aim 2 the investigators will conduct a randomized pilot comparing the decision aid intervention with counseling as usual without decision aid to assess feasibility, acceptability and preliminary effectiveness for reducing stigma in substance use, HIV, OUD pharmacotherapy and harm reduction. The investigators will measure these around the time of the intervention and in longitudinal follow up. The findings could potentially identify a novel intervention and methodology for treatment expansion and stigma reduction that has not been previously explored, especially in the rural context, where need is high. Following the successful completion of this pilot trial, the investigators will develop an expanded multi-site comparative effectiveness trial of the decision aid, implementation studies, and cost-effectiveness analysis.

Registry
clinicaltrials.gov
Start Date
April 7, 2022
End Date
March 31, 2024
Last Updated
10 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Patients from a rural community currently admitted or recently admitted to Barnes-Jewish Hospital
  • Admission must be for an infection associated with intravenous drug use
  • Patient must be willing to speak with healthcare provider about medications for opioid use disorder (MOUDs)
  • patient must be over 18 years old
  • must be able to complete electronic survey written in English

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Patient Internalized Stigma Towards Medicaid for Opioid Use Disorder (MOUDs) Over the Course of the Project

Time Frame: 3 months

Sum of 6 5-point Likert scale questions that determines self-reported stigma on taking MOUDs. This was compromised of 6 separate questions with a scale of 1-5 with 1 having the lowest stigma and 5 having the highest stigma. The range is thus 6 - 30.

Secondary Outcomes

  • Patient Anticipated MOUD Stigma(3 months)
  • Patient Satisfaction With Clarity of Shared Decision Aid(Immediate post-baseline survey)
  • Patient Satisfaction With Helpfulness of Shared Decision Aid(Immediate post-baseline survey)
  • Overall Patient Satisfaction With the Shared Decision Aid(Immediate post-baseline survey)
  • Provider Willingness To Work With Patients With Opioid Use Disorder(Immediately post-intervention)
  • Hospital Policy Stigma Towards Patients With Opioid Use Disorder(Immediate)
  • Provider Comfort Treating Patients With Opioid Use Disorder(Immediate post-intervention)
  • Provider Stigma Towards Patients With Opioid Use Order(Immediate)

Study Sites (1)

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