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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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.
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.
- Conditions
- Opioid Use Disorder
- 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Shared Decision Making Aid - Providers |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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
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
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
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
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
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
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
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.
- First posted28 Apr 2022
- Study start7 Apr 2022
- Primary completion31 Mar 2024
- Study completion31 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Opioid Use DisorderStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Michael J. Durkin, MD, Principal investigator, Washington University School of Medicine
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
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Piloting a Shared Decision-Making Aid for Reducing Stigma in Drug Use and HIV Harm Reduction in a Rural Setting
- ClinicalTrials.gov ID
- NCT05352412
- Acronym / sponsor ID
- 202107155
- Conditions
- Opioid Use Disorder
- Keywords
- Stigma, Decision Aid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 7 Apr 2022 (actual)
- Primary completion
- 31 Mar 2024 (actual)
- Study completion
- 31 Mar 2024 (actual)
- First posted
- 28 Apr 2022 (actual)
- Results
- Posted 24 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Shared Decision Making Aid - PatientsPatients 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. |
| 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 | Behavioral: Shared Decision Making Aid - ProvidersProviders 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Shared Decision Making Aid - PatientsPatients will be randomized to the shared decision making aid intervention. | Behavioural | Shared Decision Making Aid - Patient |
| Shared Decision Making Aid - ProvidersProviders of patients randomized o the shared decision making aid intervention. | Behavioural | Shared Decision Making Aid - Provider |
Primary outcome
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.
8 secondary outcomes
Patient Anticipated MOUD Stigma
Time frame: 3 months
Patient Satisfaction With Clarity of Shared Decision Aid
Time frame: Immediate post-baseline survey
Patient Satisfaction With Helpfulness of Shared Decision Aid
Time frame: Immediate post-baseline survey
Overall Patient Satisfaction With the Shared Decision Aid
Time frame: Immediate post-baseline survey
Provider Willingness To Work With Patients With Opioid Use Disorder
Time frame: Immediately post-intervention
Hospital Policy Stigma Towards Patients With Opioid Use Disorder
Time frame: Immediate
Provider Comfort Treating Patients With Opioid Use Disorder
Time frame: Immediate post-intervention
Provider Stigma Towards Patients With Opioid Use Order
Time frame: Immediate
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael J. Durkin, MD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
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.