Empowering Monterey Bay Residents for Activated, Collaborative, and Equitable Care (EMBRACE)
2026年8月26日 更新者：Manali Indravadan Patel、Stanford University
EMBRACE - Empowering Monterey Bay Residents for Activated, Collaborative, and Equitable Care
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.
研究概览
详细说明
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.
研究类型
介入性
注册 (估计的)
138
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Manali I Patel, MD, MPH, MS
- 电话号码：(650) 736-2768
- 邮箱：manalip@stanford.edu
学习地点
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California
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Palo Alto、California、美国、94304
- 招聘中
- Stanford University
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接触：
- Manali I. Patel, MD, MPH, MS
- 邮箱：manalip@stanford.edu
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- Patients unable to respond to survey questions in either English or Spanish.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：卫生服务研究
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
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无干预：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.
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实验性的：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.
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For those in the experimental group, a Research Assistant will provide health education and support as described in the Intervention arm.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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使用“患者激活措施”调查激活患者
大体时间：入学后 3 个月
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每位患者将在入组时和研究入组后 3 个月接受使用“患者激活措施”进行验证的患者激活调查。
这是 Insignia Health 的一项经过验证的措施。
回答是：强烈不同意、不同意、同意、强烈同意，较高的激活与同意和强烈同意的反应相关。
每个项目都采用 4 分制评分（1 分非常不同意，4 分非常同意，还有额外的“不适用”选项）。
分数越高表明患者激活程度越高。
对于 PAM-10，最低分数为 0（如果全部不适用），最高分数为 40。
原始分数根据 Insignia Health 的评分指南转换为激活级别：1 级脱离和不知所措，2 级开始意识到但仍在挣扎，3 级采取行动并获得控制，4 级保持“行为并进一步推动。
每组的分数将在研究注册后 3 个月时取平均值。
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入学后 3 个月
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使用“患者激活措施”调查激活患者
大体时间：入学后 6 个月
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每位患者将在入组时和研究入组后 6 个月接受使用“患者激活措施”进行验证的患者激活调查。
这是 Insignia Health 的一项经过验证的措施。
回答是：强烈不同意、不同意、同意、强烈同意，较高的激活与同意和强烈同意的反应相关。
每个项目都采用 4 分制评分（1 分非常不同意，4 分非常同意，还有额外的“不适用”选项）。
分数越高表明患者激活程度越高。
对于 PAM-10，最低分数为 0（如果全部不适用），最高分数为 40。
原始分数根据 Insignia Health 的评分指南转换为激活级别：1 级脱离和不知所措，2 级开始意识到但仍在挣扎，3 级采取行动并获得控制，4 级保持“行为并进一步推动。
每组的分数将在研究注册后 6 个月时取平均值。
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入学后 6 个月
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Quality of shared decision-making using the "Shared Decision Making" questionnaire
大体时间：3-months post-enrollment
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The SDM-Q-9, a questionnaire assessing patient involvement in shared decision-making (SDM), is scored by summing the responses to its nine items, each on a 6-point Likert scale (0 completely disagree to 5 completely agree).
The raw scores range from 0 to 45, with higher scores indicating greater perceived SDM.
The change in shared-decision making from baseline to 3 months will be measured.
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3-months post-enrollment
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Quality of shared decision-making using the "Shared Decision Making" questionnaire
大体时间：6-months post-enrollment
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The SDM-Q-9, a questionnaire assessing patient involvement in shared decision-making (SDM), is scored by summing the responses to its nine items, each on a 6-point Likert scale (0 completely disagree to 5 completely agree).
The raw scores range from 0 to 45, with higher scores indicating greater perceived SDM.
The change in shared-decision making at baseline to 6 months will be measured.
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6-months post-enrollment
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Patient Quality of Life Using the "Functional Assessment of Cancer Therapy - General Survey"
大体时间：3-months post-enrollment
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Each patient will the validated "Functional Assessment of Cancer Therapy - General Survey (FACT-G)," which is a 27-item survey with response options including: not at all, a little bit, somewhat, quite a bit, or very much.
Five items also allow for a response of 'prefer not to answer.' Scoring for the FACT-G will be done in accordance with the FACT-G Scoring Guidelines (Version 4), available here: https://www.facit.org/measures-scoring-downloads/fact-g-scoring-downloads.
In summary, scoring is for four subscales included within the survey, including (1) Physical Well-Being (score range: 0-28), (2) Social Family Well-Being (score range: 0-28), (3) Emotional Well-Being (score range: 0-24), and (4) Functional Well-Being (score range: 0-28).
A total score is created from the sum of the subscale scores and has a minimum of zero and maximum of 108, where a higher score indicates greater quality of life.
The change in quality of life at baseline to 3 months will be measured.
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3-months post-enrollment
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Patient Quality of Life Using the "Functional Assessment of Cancer Therapy - General Survey"
大体时间：6-months post-enrollment
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Each patient will the validated "Functional Assessment of Cancer Therapy - General Survey (FACT-G)," which is a 27-item survey with response options including: not at all, a little bit, somewhat, quite a bit, or very much.
Five items also allow for a response of 'prefer not to answer.' Scoring for the FACT-G will be done in accordance with the FACT-G Scoring Guidelines (Version 4), available here: https://www.facit.org/measures-scoring-downloads/fact-g-scoring-downloads.
In summary, scoring is for four subscales included within the survey, including (1) Physical Well-Being (score range: 0-28), (2) Social Family Well-Being (score range: 0-28), (3) Emotional Well-Being (score range: 0-24), and (4) Functional Well-Being (score range: 0-28).
A total score is created from the sum of the subscale scores and has a minimum of zero and maximum of 108, where a higher score indicates greater quality of life.
The change in quality of life at baseline to 6 months will be measured.
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6-months post-enrollment
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Feeling Heart and Understood Using the "Ambulatory Palliative Care Patients' Experience of Feeling Heard and Understood"
大体时间：3-months post-enrollment
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The "Feeling Heard and Understood" Survey is a self-report instrument designed to assess participants' subjective experiences of being listened to and understood in clinical care settings.
The survey consists of Likert-scale items that capture the quality and emotional impact of these experiences.
Participants rate statements on a 5-point scale ranging from "Strongly Disagree" to "Strongly Agree."
Composite scores are calculated by averaging item responses, with higher scores indicating a greater perceived sense of being heard and understood.
The change in feeling heard and understood at baseline to 3 months will be measured.
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3-months post-enrollment
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Feeling Heart and Understood Using the "Ambulatory Palliative Care Patients' Experience of Feeling Heard and Understood"
大体时间：6-months post-enrollment
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The "Feeling Heard and Understood" Survey is a self-report instrument designed to assess participants' subjective experiences of being listened to and understood in clinical care settings.
The survey consists of Likert-scale items that capture the quality and emotional impact of these experiences.
Participants rate statements on a 5-point scale ranging from "Strongly Disagree" to "Strongly Agree."
Composite scores are calculated by averaging item responses, with higher scores indicating a greater perceived sense of being heard and understood.
The change in feeling heard and understood at baseline to 6 months will be measured.
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6-months post-enrollment
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Preference-Concordant Care using the "Preference Concordant Care" Survey
大体时间：3-months post-enrollment
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The Preference Concordant Care survey is a patient-reported instrument designed to assess the extent to which healthcare delivery aligns with a patient's individual preferences, values, and goals of care.
The tool utilized Likert-style questions to evaluate six key domains: understanding of preferences, alignment of care, communication, provider advocacy, outcome satisfaction, and responsiveness to changes in patient values over time.
Higher scores across domains indicate stronger alignment of care with the patient's stated preferences.
The change in preference-concordant care at baseline to 3 months will be measured.
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3-months post-enrollment
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Preference-Concordant Care using the "Preference Concordant Care" Survey
大体时间：6-months post-enrollment
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The Preference Concordant Care survey is a patient-reported instrument designed to assess the extent to which healthcare delivery aligns with a patient's individual preferences, values, and goals of care.
The tool utilized Likert-style questions to evaluate six key domains: understanding of preferences, alignment of care, communication, provider advocacy, outcome satisfaction, and responsiveness to changes in patient values over time.
Higher scores across domains indicate stronger alignment of care with the patient's stated preferences.
The change in preference-concordant care at baseline to 6 months will be measured.
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6-months post-enrollment
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
合作者
调查人员
- 首席研究员：Manali I Patel, MD, MPH, MS、Stanford University
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2026年8月26日
初级完成 (估计的)
2029年7月14日
研究完成 (估计的)
2030年1月14日
研究注册日期
首次提交
2026年6月10日
首先提交符合 QC 标准的
2026年6月10日
首次发布 (实际的)
2026年6月17日
研究记录更新
最后更新发布 (实际的)
2026年8月27日
上次提交的符合 QC 标准的更新
2026年8月26日
最后验证
2026年8月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.