Stigma and a Shared Decision Aid

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Opioid Use Disorder

Intervention / Treatment
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* Behavioral: Shared Decision Making Aid
* Behavioral: Baseline Counseling As usual


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Baseline Counseling As Usual<br>Patients randomized to the baseline counseling as usual arm will receive provision of one of 3 MAT options, prescription and referral to community providers; overdose prevention education and access to naloxone kits; harm reduction counseling (e.g safe injection practices, referral to PrEP); lab testing for HIV, HBV, HCV infection, and routine vaccinations (e.g. Hepatitis A). That includes wrap-around services modeled on the Ryan White Program, with access to social worker, case manager, and mental health counselor who follow up with patients, enroll them in insurance as eligible, and provide ongoing support. This will be a 10-minute tablet- or web-based intervention administered by one of our wraparound care service team members in-person or via telehealth (or possibly in person depending on pandemic procedures). IT will be a 10-minute procedure with summary of decision considerations and patient value assessment. | Behavioral: Baseline Counseling As usual<br>* Patients will be randomized to the baseline counseling as usual.<br>|
| Active Comparator: Shared Decision Making Aid<br>Patients randomized to the decision aid arm will receive all of the above as well as a shared decision making aid. This will be a 10-minute tablet- or web-based intervention administered by one of our wraparound care service team members in-person or via telehealth (or possibly in person depending on pandemic procedures). IT will be a 10-minute procedure with summary of decision considerations and patient value assessment.The provider will have access to then have access to this summary in making final care decisions with the patient. | Behavioral: Shared Decision Making Aid<br>* Patients will be randomized to the shared decision making aid intervention.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of recruiting | Percent eligible participants recruited | 12 months | 
| Feasibility of retaining | Percent recruited participants retained at 3 months | 3 months | 
| Fidelity of intervention - Participant Responsiveness | Participant responsiveness refers to the manner in which participants react to or engage in a program. Aspects of participant responsiveness can include participants' level of interest in the program; perceptions about the relevance and usefulness of a program; and their level of engagement, enthusiasm, and willingness to engage in discussion or activities which will be measured by survey responses a total of 4 times over the course of 3 months. These will take place at baseline visit, immediately after randomization, 2 weeks post-discharge, and 3 months post-discharge. | 3 months | 
| Acceptability of the intervention to patients | Percent providers reporting acceptability and barriers to acceptability (interviews) | 3 months | 
| Acceptability of recruitment/randomization | Percent participants reporting acceptability and barriers to acceptability (interviews) | 3 months | 
| Contamination of arms for patients | Percent participants in both arms reporting access to decision aid (CAU) or CAU (intervention) or discussing content w/ other individuals. | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stigma, Decision Aid