Overcoming Stigma and Improving Outcomes for SUDs Through Education, Engagement,
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Knowledge Check
研究概览
简要总结
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:
- Develop a prototype of OASIS for patients with Opioid Use Disorder (OUD) and primary care clinicians; conduct usability testing.
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •Patient participants will be excluded from this study if they:
- •1) Currently receiving or have received medication for opioid dependence.
研究组 & 干预措施
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.
干预措施: Overcoming and Addressing Stigma in Substance Use Disorders (OASIS) (Behavioral)
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.
干预措施: Overcoming and Addressing Stigma in Substance Use Disorders (OASIS) (Behavioral)
结局指标
主要结局
Knowledge Check
时间窗: Assessed at both timepoints: prior to accessing the online platform and after using the platform for at least one week
A 10-item assessment developed by the research team to assess knowledge of opioids and opioid use disorder
Internalized Stigma of Mental Illness Scale
时间窗: Assessed at both timepoints: prior to accessing the online platform and after using the platform for at least one week.
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).
Recovery Empowerment Scale
时间窗: Assessed at both timepoints: prior to accessing the online platform and after using the platform for at least one week.
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).
Perceived Stigma of Addiction Scale
时间窗: Assessed at both timepoints: prior to accessing the online platform and after using the platform for at least one week.
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).
System Usability Scale
时间窗: Assess only at the post-assessment, after using the platform for at least one week.
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).
Mental Health Seeking Attitudes Scale
时间窗: Assessed at both timepoints: prior to accessing the online platform and after using the platform for at least one week.
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).
Open Minds Scale for Health Care Providers
时间窗: Assessed at both timepoints: prior to accessing the online platform and after using the platform for at least one week.
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).
Brief Opioid Stigma Scale
时间窗: Assessed at both timepoints: prior to accessing the online platform and after using the platform for at least one week.
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.
次要结局
未报告次要终点