Stigma and a Shared Decision Aid

NCT05352412 | Completed Results

• 1 other identifier: 202107155
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Opioid Use Disorder

Keywords

Stigma; Decision Aid

Outcome Measures

Primary Outcomes (1)

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

  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.

  3 months

Secondary Outcomes (8)

• 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

Study Arms (4)

Baseline Counseling As Usual - Patient

NO INTERVENTION

Patients randomized to the baseline counseling from their healthcare provider regarding medications for opioid use disorder.

Shared Decision Making Aid - Patient

ACTIVE COMPARATOR

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 survey that takes into account their priorities and preferences around medications for opioid use disorder.

Behavioral: Shared Decision Making Aid - Patients

Baseline Counseling As Usual - Provider

NO INTERVENTION

Providers of patients randomized to the baseline counseling as usual arm will will be asked to participate in a survey to assess their stigma in regards to taking care of patients with opioid use disorder.

Shared Decision Making Aid - Provider

ACTIVE COMPARATOR

Providers of patients randomized to the decision aid arm will will be asked to participate in a survey to assess their stigma in regards to taking care of patients with opioid use disorder.

Behavioral: Shared Decision Making Aid - Providers

Interventions

Shared Decision Making Aid - Patients BEHAVIORAL

Patients will be randomized to the shared decision making aid intervention.

Shared Decision Making Aid - Patient

Shared Decision Making Aid - Providers BEHAVIORAL

Providers of patients randomized o the shared decision making aid intervention.

Shared Decision Making Aid - Provider

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• None

Sponsors & Collaborators

• Washington University School of Medicine: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Barnes Jewish Hospital

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders; Social Stigma

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Social Behavior; Behavior

Limitations and Caveats

Our preliminary findings included patients who were hospitalized. Anecdotally ,our team needed time to screen, recruit, and consent participants. On average, this ended up taking about 2 days. Our findings were biased more towards individuals who were hospitalized for a prolonged period of time and for individuals with a long history of opioid use disorder. If or how this would work in outpatient settings needs to be evaluated. The shared decision aid was somewhat time consuming to complete.

Results Point of Contact

• Title: Dr. Michael J. Durkin, Principal Investigator
• Organization: Washington University School of Medicine

mdurkin@wustl.edu

314-454-8225

Study Officials

• Michael J. Durkin, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2022
• First Posted: April 28, 2022
• Study Start: April 7, 2022
• Primary Completion: March 31, 2024
• Study Completion: March 31, 2024
• Last Updated: June 24, 2025
• Results First Posted: June 24, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)