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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06266572
Other study ID # 1R43DA055182-01
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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.
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