Overcoming Stigma and Improving Outcomes for SUDs Through Education, Engagement, and Empowerment

NCT ID: NCT06266572

Last Updated: 2024-03-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-30
• Study Completion Date: 2023-09-29

Brief Summary

C4 Innovations (C4) and partners at Yale University (Yale) and the West Haven VA Medical Center (WHVA) proposed to develop and test OASIS (Overcoming and Addressing Stigma in Substance Use Disorders), a web-based educational platform for primary care clinicians and individuals with Opioid Use Disorder. The major aims of the study were to:

1. Develop a prototype of OASIS for patients with Opioid Use Disorder (OUD) and primary care clinicians; conduct usability testing.

2. Pilot OASIS with a small sample of individuals with untreated OUD and their clinicians to determine feasibility, acceptability, and preliminary product effectiveness for a Phase II effectiveness trial.

After development of the prototype, the C4-Yale-WHVA team planned to test OASIS with patients (N = 30) and clinicians (N = 5) using validated measures and qualitative interviews to assess usability, satisfaction, knowledge, empowerment, and stigma.

Conditions

Opioid Use Disorder

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Pre-Intervention

Research participants will receive access to a web-based platform designed to provide information about Opioid Use Disorder. Prior to receiving access to this application, research participants will complete online, self-reported surveys assessing stigma, empowerment, and knowledge of opioids.

Group Type: EXPERIMENTAL

Overcoming and Addressing Stigma in Substance Use Disorders (OASIS)

Intervention Type: BEHAVIORAL

Web-based educational platform for clinicians and individuals with OUD that will decrease barriers to care and enhance treatment outcomes

Post-Intervention

Research participants will have access to the web-based platform for 7 to 14 days prior to receiving a second, identical series of self-report surveys assessing stigma, empowerment, and knowledge of opioids. Additionally, after using the platform, research participants will complete a measure of system usability.

Group Type: EXPERIMENTAL

Overcoming and Addressing Stigma in Substance Use Disorders (OASIS)

Intervention Type: BEHAVIORAL

Web-based educational platform for clinicians and individuals with OUD that will decrease barriers to care and enhance treatment outcomes

Interventions

Overcoming and Addressing Stigma in Substance Use Disorders (OASIS)

Web-based educational platform for clinicians and individuals with OUD that will decrease barriers to care and enhance treatment outcomes

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

For providers:

• Clinically active and seeing patients;
• Having a device with Internet access to use the OASIS prototype
• English speaking
• Willing and able to complete data collection activities.

For patients:

• Diagnosed OUD
• Unmet substance use treatment need
• Has an upcoming primary care visit scheduled for the intervention period (1-2 months)
• English speaking
• Has access to a device with Internet access to use the OASIS prototype
• Willing and able to complete data collection activities

Exclusion Criteria

Patient participants will be excluded from this study if they:

1) Currently receiving or have received medication for opioid dependence.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Center for Social Innovation, Massachusetts

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

West Haven VA Medical Center

West Haven, Connecticut, United States

Countries

United States

Other Identifiers

1R43DA055182-01

Identifier Type: NIH

Identifier Source: org_study_id

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