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

Opioid Use Disorder Clinical Trial

— OASIS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06266572
• Other study ID #: 1R43DA055182-01
• Status: Completed
• Phase: Phase 1
• Start date: September 30, 2021
• Est. completion date: September 29, 2023

Study information

• Verified date: February 2024
• Source: Center for Social Innovation, Massachusetts
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: September 29, 2023
• Est. primary completion date: September 29, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Opioid Use Disorder
• Opioid-Related Disorders

Intervention

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

Locations

Country	Name	City	State
United States	West Haven VA Medical Center	West Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Center for Social Innovation, Massachusetts

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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
Primary	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.
Primary	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.
Primary	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.
Primary	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.