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

NCT06266572 | Completed Phase 1

• 1 other identifier: 1R43DA055182-01
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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. 1.Develop a prototype of OASIS for patients with Opioid Use Disorder (OUD) and primary care clinicians; conduct usability testing.
2. 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.

Conditions

Opioid Use Disorder

Outcome Measures

Primary Outcomes (8)

• Open Minds Scale for Health Care Providers

  Description: A 20-item scale assessing stigma in health care providers, rated on a 5 point likert scale from Strongly Disagree (1) to Strongly Agree (5).

  Assessed at both timepoints: prior to accessing the online platform and after using the platform for at least one week.

• Brief Opioid Stigma Scale

  An 8-item scale assessing perceptions of stigma and endorsed stigma toward individuals using opioids. Rated on a 5 point likert scale from Strongly Disagree (1) to Strongly Agree (5). Providers in this study did not complete the items on the Harm subscale, items 9-12.

  Assessed at both timepoints: prior to accessing the online platform and after using the platform for at least one week.

• Perceived Stigma of Addiction Scale

  An 8-item scale assessing perceptions of stigma towards individuals with substance use disorders. Rated on a 7 point likert scale from Very Strongly Disagree (1) to Very Strongly Agree (7).

  Assessed at both timepoints: prior to accessing the online platform and after using the platform for at least one week.

• Knowledge Check

  A 10-item assessment developed by the research team to assess knowledge of opioids and opioid use disorder

  Assessed at both timepoints: prior to accessing the online platform and after using the platform for at least one week

• System Usability Scale

  A 10-item measure assessing the overall usability of the online platform. Rated on a 5 point likert scale from Strongly Disagree (1) to Strongly Agree (5).

  Assess only at the post-assessment, after using the platform for at least one week.

• Internalized Stigma of Mental Illness Scale

  A 29-item measure assessing the participant's own stigma relating to mental illness. Rated on a 4 point likert scale from Strongly Disagree (1) to Strongly Agree (4).

  Assessed at both timepoints: prior to accessing the online platform and after using the platform for at least one week.

• Recovery Empowerment Scale

  A 20-item scale assessing a participant's levels of empowerment, rated on a 7 point likert scale from Almost Never (1) to Almost Always (7).

  Assessed at both timepoints: prior to accessing the online platform and after using the platform for at least one week.

• Mental Health Seeking Attitudes Scale

  A 9-item scale assessing the individuals rating between two dichotomous choices and how accurately they describe their perceptions of help-seeking. Participants are asked to choose one of two words on a scale (e.g., useless vs. useful) and are asked to rate how strongly they feel this word describes their thoughts on a scale from Undecided (0) to Extremely (3).

  Assessed at both timepoints: prior to accessing the online platform and after using the platform for at least one week.

Study Arms (2)

Pre-Intervention

EXPERIMENTAL

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.

Behavioral: Overcoming and Addressing Stigma in Substance Use Disorders (OASIS)

Post-Intervention

EXPERIMENTAL

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.

Behavioral: Overcoming and Addressing Stigma in Substance Use Disorders (OASIS)

Interventions

Overcoming and Addressing Stigma in Substance Use Disorders (OASIS) BEHAVIORAL

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

Post-Intervention; Pre-Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patient participants will be excluded from this study if they:
• \) Currently receiving or have received medication for opioid dependence.

Sponsors & Collaborators

• Center for Social Innovation, Massachusetts: lead

Study Sites (1)

West Haven VA Medical Center

West Haven, Connecticut, 06516, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2024
• First Posted: February 20, 2024
• Study Start: September 30, 2021
• Primary Completion: September 29, 2023
• Study Completion: September 29, 2023
• Last Updated: March 1, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)