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

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

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.

Study Overview

• Status: Completed
• Conditions: Opioid Use Disorder
• Intervention / Treatment: Behavioral: Overcoming and Addressing Stigma in Substance Use Disorders (OASIS)

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • West Haven, Connecticut, United States, 06516
      • West Haven VA Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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
Experimental: 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.	Behavioral: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Center for Social Innovation, Massachusetts
• Collaborators: West Haven VA

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2021
• Primary Completion (Actual): September 29, 2023
• Study Completion (Actual): September 29, 2023

Study Registration Dates

• First Submitted: January 31, 2024
• First Submitted That Met QC Criteria: February 13, 2024
• First Posted (Actual): February 20, 2024

Study Record Updates

• Last Update Posted (Estimated): March 1, 2024
• Last Update Submitted That Met QC Criteria: February 29, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Narcotic-Related Disorders; Opioid-Related Disorders
• Other Study ID Numbers: 1R43DA055182-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No