Stigma and a Shared Decision Aid

Opioid Use Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05352412
• Other study ID #: 202107155
• Status: Completed
• Phase: N/A
• Start date: April 7, 2022
• Est. completion date: March 31, 2024

Study information

• Verified date: April 2024
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 OUD treatment and harm reduction in two hospitals in rural Missouri to evaluate whether this reduces stigma in both patients and providers.

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 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 ED 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: March 31, 2024
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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 MOUDs

• patient must be over 18 years old

• must be able to complete electronic survey written in English

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Opioid Use Disorder
• Opioid-Related Disorders

Intervention

Behavioral:
• Shared Decision Making Aid
Patients will be randomized to the shared decision making aid intervention.
• Baseline Counseling As usual
Patients will be randomized to the baseline counseling as usual.

Locations

Country	Name	City	State
United States	Barnes Jewish Hospital	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of recruiting	Percent eligible participants recruited	12 months
Primary	Feasibility of retaining	Percent recruited participants retained at 3 months	3 months
Primary	Fidelity of intervention - Survey Completion	Participant responsiveness will be measured by survey completion. Patients will be contacted a total of 4 times over the course of 3 months to complete the surveys. These will take place at baseline visit, immediately after randomization, 2 weeks post-discharge, and 3 months post-discharge.	3 months
Primary	Acceptability of the intervention to patients	Percent providers reporting acceptability and barriers to acceptability (interviews)	3 months
Primary	Acceptability of recruitment/randomization	Percent participants reporting acceptability and barriers to acceptability (interviews)	3 months
Primary	Contamination of arms for patients	Percent participants in both arms who reporting access to shared decision aid (the intervention)	3 months