EMBRACE - Empowering Monterey Bay Residents for Activated, Collaborative, and Equitable Care
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 138
- 试验地点
- 1
研究概览
简要总结
The purpose of the EMBRACE Study is to evaluate whether a facilitated intervention improves shared decision-making (SDM) and patient activation among low-income and minority individuals more than usual care only. The ultimate goal is to enhance SDM and patient activation in care.
详细描述
This study will assess if an intervention that is delivered by a Stanford trained Research Assistant (RA) will help people better engage in their care with their clinicians.
A total of n=138 patients will be recruited for this study using flyers that will be distributed to our community partner organizations. Approximately 69 patients will be randomized into each study group.
Participants will receive either usual care or will be assigned into the intervention (EMBRACE). Participants assigned to the intervention will receive education provided by a trained RA who will meet with participants by phone for 30 minutes once a month for 6 months to: 1) discuss the importance of shared decision-making, advance care planning, and goal concordant care, and 2) encourage to engage in SDM with their clinicians.
All participants in the study will receive 4 surveys: at baseline (at time of enrollment), 1, 3, and 6 months after study enrollment by telephone, mail, or through a secure REDCap online link delivered to participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must be receiving clinical care by a primary care physician in the Monterey area
- •Participants must be 18 years or older.
- •Participants must speak either English or Spanish.
- •Participants must be able to consent verbally in English or Spanish to all study procedures.
- •Participants must self-identify as a racial/ethnic minorities OR identify as having low-income status OR have public health insurance
排除标准
- •- Patients unable to respond to survey questions in either English or Spanish.
研究组 & 干预措施
Usual Care
This arm is the control group. They will receive usual care from their regular provider and care team with no change in their care plans as a result of the intervention. Outcomes will be assessed at each of the following times: baseline, 3-months, and 6-months post-enrollment.
EMBRACE plus usual care
Participants assigned to the intervention will receive education provided by a trained RA who will meet with participants by phone for 30 minutes once a month for 6 months to: 1) discuss shared decision-making and 2) encourage to engage in SDM with their clinicians. Outcomes will be assessed at each of the following times: baseline, 3-months, and 6-months.
干预措施: Research Assistant Support (Behavioral)
结局指标
主要结局
未指定
次要结局
- Quality of shared decision-making using the "Shared Decision Making" questionnaire(3-months post-enrollment)
- Quality of shared decision-making using the "Shared Decision Making" questionnaire(6-months post-enrollment)
- Patient Quality of Life Using the "Functional Assessment of Cancer Therapy - General Survey"(3-months post-enrollment)
- Patient Quality of Life Using the "Functional Assessment of Cancer Therapy - General Survey"(6-months post-enrollment)
- Feeling Heart and Understood Using the "Ambulatory Palliative Care Patients' Experience of Feeling Heard and Understood"(3-months post-enrollment)
- Feeling Heart and Understood Using the "Ambulatory Palliative Care Patients' Experience of Feeling Heard and Understood"(6-months post-enrollment)
- Preference-Concordant Care using the "Preference Concordant Care" Survey(3-months post-enrollment)
- Preference-Concordant Care using the "Preference Concordant Care" Survey(6-months post-enrollment)
研究者
Manali Indravadan Patel
Principal Investigator
Stanford University