Clinical trial NCT06266572: Overcoming Stigma and Improving Outcomes for SUDs Through Education, Engagement, and Empowerment
Official title: Overcoming Stigma and Improving Outcomes for SUDs Through Education, Engagement,
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Opioid Use Disorder
Lead sponsor: Center for Social Innovation, Massachusetts
Sponsor class: OTHER
First posted: 2024-02-20
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


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.

Primary outcomes:
measure: Open Minds Scale for Health Care Providers
timeFrame: Assessed at both timepoints: prior to accessing the online platform and after using the platform for at least one week.
measure: Brief Opioid Stigma Scale
timeFrame: Assessed at both timepoints: prior to accessing the online platform and after using the platform for at least one week.
measure: Perceived Stigma of Addiction Scale
timeFrame: Assessed at both timepoints: prior to accessing the online platform and after using the platform for at least one week.
measure: Knowledge Check
timeFrame: Assessed at both timepoints: prior to accessing the online platform and after using the platform for at least one week
measure: System Usability Scale
timeFrame: Assess only at the post-assessment, after using the platform for at least one week.
measure: Internalized Stigma of Mental Illness Scale
timeFrame: Assessed at both timepoints: prior to accessing the online platform and after using the platform for at least one week.
measure: Recovery Empowerment Scale
timeFrame: Assessed at both timepoints: prior to accessing the online platform and after using the platform for at least one week.
measure: Mental Health Seeking Attitudes Scale
timeFrame: Assessed at both timepoints: prior to accessing the online platform and after using the platform for at least one week.
Secondary outcomes:
Other outcomes:
Locations:
city: West Haven
country: United States
facility: West Haven VA Medical Center
state: Connecticut
Study officials:
References: