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Opioid Use DisorderNCT05352412

Stigma and a Shared Decision Aid

A study testing Shared Decision Making Aid - Patients and Shared Decision Making Aid - Providers in people with Opioid Use Disorder, run by Washington University School of Medicine at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 100 years
Conditions the study is for
Opioid Use Disorder
What is being tested?
Shared Decision Making Aid - Patients and Shared Decision Making Aid - Providers
Could I receive a placebo?
No, everyone receives an active treatment
How many people
62 participants
Where
1 siteUnited States
Study dates
7 Apr 2022to 31 Mar 2024
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • None

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Barnes Jewish Hospital

    St Louis, Missouri, 63110

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
Shared Decision Making Aid - Patients, Shared Decision Making Aid - Providers
Keywords
Stigma, Decision Aid
Medical subject headings
Opioid-Related Disorders, Social Stigma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Shared Decision Making Aid - PatientsBehavioural

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

  • Shared Decision Making Aid - ProvidersBehavioural

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

Study groups in NCT05352412
Study groupRoleWhat they receive
Baseline Counseling As Usual - PatientNo interventionPatients randomized to the baseline counseling from their healthcare provider regarding medications for opioid use disorder.
Shared Decision Making Aid - PatientActive comparatorPatients 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.
Receives: Behavioral: Shared Decision Making Aid - Patients
Baseline Counseling As Usual - ProviderNo interventionProviders 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 - ProviderActive comparatorProviders 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.
Receives: Behavioral: Shared Decision Making Aid - Providers

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 3 months

Secondary outcomes (8)
  1. Patient Anticipated MOUD Stigma

    This 5-point Likert scale was compromised of 7 questions of a range of 7-35. The lower score denotes the lower stigma and the higher score denotes the higher stigma.

    Measured: 3 months

  2. Patient Satisfaction With Clarity of Shared Decision Aid

    Likert scale from 1-4 with 1 being the best and 4 being the worst. There is no statistical analysis for this secondary outcome as patients who did not receive the decision aid cannot provide satisfaction regarding clarity of shared decision aid.

    Measured: Immediate post-baseline survey

  3. Patient Satisfaction With Helpfulness of Shared Decision Aid

    Likert scale from 1-4 with 1 being the best and 4 being the worst

    Measured: Immediate post-baseline survey

  4. Overall Patient Satisfaction With the Shared Decision Aid

    "I like the decision aid", "The decision aid is appealing", "The decision aid is easy to use", and "The decision aid is doable". The scale range is 1 to 2 with a score of 1 being a better outcome.

    Measured: Immediate post-baseline survey

  5. Provider Willingness To Work With Patients With Opioid Use Disorder

    5-point Likert scale where score of 1 is the most stigma and 5 is the least stigma. The overall number is a sum of 4 questions with a theoretical range of 4 - 20.

    Measured: Immediately post-intervention

  6. Hospital Policy Stigma Towards Patients With Opioid Use Disorder

    5-point Likert scale where score of 1 least stigma towards patients with opioid use disorder and 5 is the highest stigma towards patients with opioid use disorder. The overall number is a sum of 4 questions with a theoretical range of 4 - 20.

    Measured: Immediate

  7. Provider Comfort Treating Patients With Opioid Use Disorder

    A 6 question 5-point Likert scale with a scale of 1= least stigma and 5=most stigma. A total of 6 questions were asked. Thus the range is 6 - 30.

    Measured: Immediate post-intervention

  8. Provider Stigma Towards Patients With Opioid Use Order

    A 6 question 5-point Likert scale with a scale of 1= least stigma and 5=most stigma. A total of 6 questions were asked. Thus the range is 6 - 30.

    Measured: Immediate

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Apr 2022
  2. Study start7 Apr 2022
  3. Primary completion31 Mar 2024
  4. Study completion31 Mar 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
62 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05352412
Sponsor's protocol ID
202107155
Status last verified
Jun 2025
First submitted
18 Apr 2022
Last updated
24 Jun 2025
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Shared Decision Making Aid - Patients and Shared Decision Making Aid - Providers in people with Opioid Use Disorder, run by Washington University School of Medicine at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patient Internalized Stigma Towards Medicaid for Opioid Use Disorder (MOUDs) Over the Course of the Project (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2025.

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