Improving Patient-Centered Communication in Primary Care: A Cluster Randomized Controlled Trial of the Comparative Effectiveness of Three Interventions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5,565
- 试验地点
- 6
- 主要终点
- Patient reported experience with care: CollaboRATE
研究概览
简要总结
This large scale multi-center cluster randomized controlled trial (RCT) is designed to assess the comparative effectiveness of three interventions in diverse ambulatory care settings and patient populations. Findings will help healthcare systems decide which approach to adopt to empower patients and enable providers to engage in patient centered communication. The specific aims are to:
- Engage with patients and healthcare providers who have used the tools in the pilot study (ClinicalTrials.gov Identifier NCT02522286) at the Sutter Health Palo Alto Medical Foundation (PAMF), as well as new stakeholders at University of California San Diego Health System and Meyers Primary Care Institute at University of Massachusetts and Reliant Medical Group, to further refine and adapt these patient-centered interventions to be integrated into real world primary care clinics.
- Conduct a large scale cluster RCT with three arms, to evaluate the comparative effectiveness of three interventions: OPEN with in-person SPI training (High Touch), OPEN with online SPI training (High Tech), and ASK. Primary outcomes will include patient perceptions of how well their PCPs have engaged them in patient centered communication. The investigators will also measure patients' confidence in managing their health, intention to follow through with care plans, and downstream behaviors in following through with care plans, use of services such as phone calls, secure messaging, and additional visits.
- Identify the strategy that has the most potential for sustained impact and replication within and across healthcare systems. The investigators will analyze the fidelity to the intervention protocols, including consistency of delivery as intended and the time/effort involved in implementing the interventions. The investigators will also assess the extent to which the programs become institutionalized.
The investigators anticipate that this multi-level healthcare system intervention will result in significant improvement in: patient satisfaction with how PCP has engaged them in the visit, confidence in selfcare; patients' intention to adhere to care plan, and clinical indicators. Furthermore, more effective communication would lower health service utilization after the visit. The investigators further expect that the intervention will affect physicians', medical assistants' and nurses' experience as well as healthcare system leaders' intention to implement in routine practice.
详细描述
This is a three-arm, multi-site, cluster-randomized controlled trial, comparing three approaches to improve communication between patients and their doctors. Three health systems will participate in the study: UCSD Health, Reliant Medical Group, and Sutter Health.
The study will be carried out in 2 phases.
Phase 1: Phase 1 includes intervention and survey development work to take place prior to the RCT.
OPEN High Touch intervention - The High Touch intervention will be modeled after the Open Communication intervention developed in the pilot (ClinicalTrials.gov Identifier NCT02522286) which contained three components: (a) a one question pre-visit survey delivered through the patient portal of the EHR, asking patients what they most want to discuss with their physician in the upcoming visit; (b) an animated video for patients providing coaching on how to best prepare for their upcoming visits and get the most from the visits; and (c) Standardized Patient Instructor (SPI) providing communication coaching for physicians on how to incorporate what matter most to patients in the visit, with empathy, and clarity.
OPEN High Tech intervention - For the High Tech arm, the patient components of the intervention will be identical to the patient components of the High Touch arm (i.e., the pre-visit survey and patient coaching video). The difference will be in the PCP training: we will replace the in-person SPI with a mobile app with embedded audio and video vignettes demonstrating the communication challenges (e.g., patient with a big list of issues, patients who resist physician recommendations, and patients who disagree with physician) and recommended strategies. A mobile app offers several advantages, including being accessible at a convenient time for busy providers, being easily disseminated, and easily updated. The app will be interactive, posing questions to learners in association with video vignettes and asking learners to answer how they would handle the situation. We will start with the idea of building a set of short mobile modules that mirror the High Touch approach, honing skills on acknowledging patient's agenda, negotiate a joint agenda, invite patient to teachback and incorporate it in the After Visit Summary in the EHR.
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
- 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 patient participants:
- •Adults 18 years and older,
- •Have an activated account to the patient portal of the electronic health record
- •Able to read/write in English or Spanish
- •Have an appointment with their PCP, who has volunteered to be participate in the study, during the data collection period
- •Willing and able to provide informed consent and complete brief questionnaires online.
- •For health care team (primary care providers, nurse and medical assistants) participants:
- •Employed at one of the participating study clinics
- •Willing and able to provide informed consent and complete brief questionnaires online.
排除标准
- •For patient participants:
- •People who don't speak English or Spanish
- •People who do not have an active My Chart/My Health Online account.
- •Younger than 18 years old.
结局指标
主要结局
Patient reported experience with care: CollaboRATE
时间窗: Within 7 days of a regularly scheduled appointment (the indexed visit) and 3 months after the indexed visit.
Responses from CollaboRATE, a validated 3-item, patient-reported measure of shared decision making compared between baseline and intervention patients; immediately after the indexed visit and 3 months after the indexed visit with their PCP for intervention patients; and across interventions for variations. The 3 questions, which will be answered on a scale of o "No effort was made" to 9 "Every effort was made" are: 1. How much effort was made to help you understand your health issue? 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?
Patient reported experience with care: Doctor Facilitation subscale of the Perceived Involvement in Care Scale
时间窗: Within 7 days of a regularly scheduled appointment (the indexed visit) and 3 months after the indexed visit.
Responses from this validated 5-item, patient reported measure of their perceptions of how well their physician facilitated their involvement in decision making are compared between baseline and intervention patients; immediately after the indexed visit with their PCP and 3 months after the indexed visit for intervention patients; and across interventions for variations. The 5 questions, which will answered on a scale of 0 "Definitely Disagree" to 9 "Definitely Agree" are: 1. My doctor asked me whether I agree with his/her decisions 2. My doctor gave me a complete explanation for my medical symptoms or treatment 3. My doctor asked me what I believe is causing my medical symptoms 4. My doctor encouraged me to talk about personal concerns related to my medical symptoms 5. My doctor encouraged me to give my opinion about my medical treatment.
次要结局
- Patient-initiated calls(12 months after indexed visits for intervention patients.)
- Action Plan(This will be measured within 7 days of the indexed appointment for intervention patients.)
- Patient reported confidence to adhere to action plan(This will be measured within 7 days and again 3 months after the indexed visits for intervention patients.)
- LDL(12 months after indexed visits for intervention patients.)
- The Veterans RAND 12-item health survey (VR12)(This will be measured within 7 days and again 3 months after the indexed visits for intervention patients.)
- Office visits(12 months after indexed visits for intervention patients.)
- Patient reported intention to adhere to action plan(This will be measured within 7 days and again 3 months after the indexed visits for intervention patients.)
- Adherence to action plans(This will be measured within 7 days and again 3 months after the indexed visits for intervention patients.)
- Blood pressure(12 months after indexed visits for intervention patients.)
- A1c(12 months after indexed visits for intervention patients.)
- E-messages(12 months after indexed visits for intervention patients.)
研究者
Ming Tai-Seale, PhD, MPH
Professor of Family Medicine and Public Health, and Director of Outcomes Analytics
University of California, San Diego