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Stigma and a Shared Decision Aid

Primary Purpose

Opioid Use Disorder

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Shared Decision Making Aid
Baseline Counseling As usual
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Opioid Use Disorder focused on measuring Stigma, Decision Aid

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Barnes Jewish HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Baseline Counseling As Usual

Shared Decision Making Aid

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Feasibility of recruiting
Percent eligible participants recruited
Feasibility of retaining
Percent recruited participants retained at 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.
Acceptability of the intervention to patients
Percent providers reporting acceptability and barriers to acceptability (interviews)
Acceptability of recruitment/randomization
Percent participants reporting acceptability and barriers to acceptability (interviews)
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.

Secondary Outcome Measures

Full Information

First Posted
April 18, 2022
Last Updated
April 26, 2022
Sponsor
Washington University School of Medicine
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT05352412
Brief Title
Stigma and a Shared Decision Aid
Official Title
Piloting a Shared Decision-Making Aid for Reducing Stigma in Drug Use and HIV Harm Reduction in a Rural Setting
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 7, 2022 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid Use Disorder
Keywords
Stigma, Decision Aid

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Baseline Counseling As Usual
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Shared Decision Making Aid
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Shared Decision Making Aid
Intervention Description
Patients will be randomized to the shared decision making aid intervention.
Intervention Type
Behavioral
Intervention Name(s)
Baseline Counseling As usual
Intervention Description
Patients will be randomized to the baseline counseling as usual.
Primary Outcome Measure Information:
Title
Feasibility of recruiting
Description
Percent eligible participants recruited
Time Frame
12 months
Title
Feasibility of retaining
Description
Percent recruited participants retained at 3 months
Time Frame
3 months
Title
Fidelity of intervention - Participant Responsiveness
Description
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.
Time Frame
3 months
Title
Acceptability of the intervention to patients
Description
Percent providers reporting acceptability and barriers to acceptability (interviews)
Time Frame
3 months
Title
Acceptability of recruitment/randomization
Description
Percent participants reporting acceptability and barriers to acceptability (interviews)
Time Frame
3 months
Title
Contamination of arms for patients
Description
Percent participants in both arms reporting access to decision aid (CAU) or CAU (intervention) or discussing content w/ other individuals.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michelle Jenkerson
Phone
314-362-5626
Email
jenkerson_m@wustl.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael J. Durkin, MD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Barnes Jewish Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michelle Jenkerson
Email
jenkerson_m@wsutl.edu
First Name & Middle Initial & Last Name & Degree
Michael J. Durkin,, MD, MPH

12. IPD Sharing Statement

Plan to Share IPD
No

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