Creating a Zone of Openness to Increase Patient-Centered Care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 300
- 主要终点
- Patients' Feeling of Respect by Their Doctor
研究概览
简要总结
This study implements a simple evidence-based patient activation intervention - "Ask 3 Questions"- augmented by a novel theory-based intervention - "Open Communication" - aimed at activating patients and healthcare providers. The goal of this project is to increase patient and physician's preparedness for more having more questions, expressing differing opinions, and working collaboratively in making medical decisions that are both informed and responsive to patients' needs and preferences.
详细描述
Conduct a pilot randomized controlled trial (RCT) to compare two interventions, "Ask 3 Questions," "Open Communication," a combination of both "Ask 3 Questions" and "Open Communication," to a usual care control condition. These data will inform a potential future large scale evaluation of the interventions in clinical practice. Consistent with a patient-centered approach, outcome measures are selected in collaboration with a group of patient stakeholders and will include measures of patient satisfaction. The study aims to collect 75 post-visit surveys and 10 appointment audio-recordings from patients at each of 4 participating sites (a total of 300 post-visit surveys and 40 audio-recordings).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Health Services Research
- 盲法
- Single (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
- 是
入选标准
- •Any patient with a scheduled appointment with the participating family medicine and internal medicine physicians during the study period.
排除标准
- •Non-English speakers
- •Patients younger than 18
研究组 & 干预措施
Usual Care
Standard clinical care in primary care offices
Ask 3 Questions
Patients using 3 questions to their physicians when making medical decisions during the office visit.
干预措施: Ask 3 Questions (Behavioral)
Open Communication
This arm has three components: (1) Patients, physicians, and medical assistants watching a video aimed at encouraging open communication; (2) Patients fill out a Visit Companion Booklet about what are the most important issues they want to discuss with their physicians, record their next steps, and teach back on their next steps; (3) physicians receiving communication coaching from a Standardized Patient Instructor on patient-centered communication.
干预措施: Open Communication (Behavioral)
Ask 3 Questions + Open Communication
A combination of both the Ask 3 and Open Communication arms.
干预措施: Ask 3 Questions (Behavioral)
Ask 3 Questions + Open Communication
A combination of both the Ask 3 and Open Communication arms.
干预措施: Open Communication (Behavioral)
结局指标
主要结局
Patients' Feeling of Respect by Their Doctor
时间窗: Day 1 (outcomes measures were assessed once for each participant)
Patient responses to one statement modified from Consumer Assessment of Healthcare Providers and Systems (CAHPS) regarding the respect they felt from their doctor. Patients rated the statement "My doctor showed respect for what I had to say," on a scale of 1 ("definitely disagree") to 4 ("definitely agree"). The outcome measure was the percentage of patients that gave the top score of 4 on this statement.
Patient Rating of Shared Decision Making
时间窗: Day 1 (outcomes measures were assessed once for each participant)
Responses from CollaboRATE, a 3-question validated patient reported measure of shared decision making. Patients answered questions on a scale of 0 ("definitely disagree") to 9 ("definitely agree"). The CollaboRATE questions are as follows: 1) How much effort was made to help you understand your health issues? 2) How much effort was made to listen to the things that matter most to you about your health issues?, 3) How much effort was made to include what matters most to you in choosing what to do next? The outcome measure was the percent of patients who gave the top score of 9 on all three questions.
Doctor Facilitation Subscale of the Perceived Involvement in Care Scale
时间窗: Day 1 (outcomes measures were assessed once for each participant)
"Responses from this patient reported measure regarding their attitudes of doctor facilitation of patient involvement for their illness management. Patients rated 5 statements on a scale of 0 (""definitely disagree"") to 9 (""definitely agree""). The statements are as follows: 1) My doctor encouraged me to talk about personal concerns related to my medical symptoms, 2) My doctor asked me what I believe is causing my medical symptoms, 3) My doctor gave me a complete explanation for my medical symptoms or treatment, 4) My doctor encouraged me to give my opinion about my medical treatment, 5) My doctor asked me whether I agree with his/her decisions. The outcome measure was the percent of patients who gave the top score of 9 on all five statements.
Patient Responses to Stakeholder Generated Questions
时间窗: Day 1 (outcomes measures were assessed once for each participant)
Patient responses to statements that were generated by the study's patient and physicians stakeholders regarding how they felt during their appointment. Patients rated 5 statements, described below, on a scale of 0 (definitely disagree) to 9 (definitely agree). The outcome measure is the percent of patients that responded with a top score of "9." Statement 1: My doctor and I accomplished my most important goals today. Statement 2: I feel cared for. Statement 3: I feel comfortable being open with my doctor. Statement 4: I felt my doctor was open with me. Statement 5: I know what my next steps are.
次要结局
- Option 5 Shared Decision Making Score(Day 1 (outcomes measures were assessed once for each participant based on analysis of the audio recording of their visits))
研究者
Ming Tai-Seale, Phd, MPH
Senior Scientist
Palo Alto Medical Foundation