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| Improving patient-centered communication in primary care: a cluster randomized controlled trial of the comparative effectiveness of three interventions | |
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| Investigator (PI): | Tai-Seale, Ming Past Investigator: Frosch, Dominick; Chan, Albert; Yu, Ed; Stults, Cheryl; Dillon, Ellis; Uhbrock, Ellen |
| Performing Organization (PO): |
(Current): University of California, San Diego, Herbert Wertheim School of Public Health and Human Longevity Science, Division of Health Policy / (858) 534-7596 (Past): Palo Alto Medical Foundation, Research Institute / (650) 326-8120 |
| Supporting Agency (SA): | Patient-Centered Outcomes Research Institute (PCORI) |
| Initial Year: | 2017 |
| Final Year: | 2022 |
| Record Source/Award ID: | PCORI/IHS-1608-35689-IC |
| Funding: | Total Award Amount: $5,664,527 |
| Award Type: | Contract |
| Award Information: | PCORI: More information and project results (when completed) |
| Abstract: | This research project is in progress. PCORI will post the research findings on the PCORI website within 90 days after the results are final. What is the research about? Patients who can speak openly with their doctors are more likely to get care that addresses what matters most to them. But research shows that patients often hesitate to talk openly with their doctors because they fear being labeled as difficult. Doctors also may not be prepared to answer all the questions a patient may have. Many approaches can help doctors improve communication with patients, but studies have not compared these approaches. This study compares three approaches, one of which improved communication between patients and doctors in earlier studies. Who can this research help? Doctors and leaders at health care organizations can use findings from the study to improve communication with patients. Findings from the study can help patients get more out of visits with doctors. What is the research team doing? This research is building on a previous study of an approach called Open Communication. The previous study showed that patients and doctors who used Open Communication had better communication than did patients who had usual care. In the current study, the research team is comparing three approaches to improve how patients and their doctors interact. Two approaches--Open High Touch and Open High Tech--are new and build on the initial Open Communication approach. The research team is also comparing a third approach called Ask, Share, Know, or ASK. The team wants to learn whether one of the three approaches works better than the others. The team also wants to know if one approach is easier than the others for health care organizations to put into practice. The research team includes researchers at three large health care organizations in two states. Twenty-one clinics and 105 primary care doctors are taking part in the study. The team is testing each of the three approaches with 5,250 patients. The team is assigning clinics, by chance, to use one of three communication approaches: (1) Open High Touch--Patients use an electronic system, called a patient portal, to prepare for office visits and communicate with their doctors. Before an office visit, patients are using the portal to answer questions about what they want to discuss with the doctor. Patients also watch a video about how to prepare for the upcoming appointment and get the most from the visit. Doctors are receiving in-person training on how to discuss what matters most to patients. (2) Open High Tech--Patients use the patient portal in the same manner as the patients in the Open High Tech group. Doctors receive training via a mobile app instead of in person. (3) ASK--Clinics that use this approach place posters in exam rooms that encourage patients to ask their doctors the following questions: What are my options? What are the possible risks and benefits of each option? How likely are the benefits of each option to occur to me? Patients, a patient advocacy group, doctors, clinic staff, and leaders in two large health care organizations meet regularly with the research team to guide the study's progress. Research methods. Design: The study design is a randomized controlled trial. Population: The study populations are adults 18 years and older who read and write English or Spanish, have an appointment with their primary care provider during the study period, and are willing to complete online questionnaires; and primary care providers, nurses, and medical assistants who work at clinics participating in the study and who are willing to complete online questionnaires. Interventions/comparators are Open High Touch, Open High Tech, and ASK. Outcomes: Outcomes are (a) primary: patient-reported experience with care and (b) secondary: written instructions provided to the patient after a visit with the provider. The timeframe is 3-month follow-up for primary outcome. |
| Abstract Archived: |
Patients' encounters with their providers are at the center of their health care. It has been well documented that patients often hesitate in being completely open about their concerns and preferences during clinical encounters out of fear of being labeled "difficult." Furthermore, when patients do ask questions and are more engaged in their visits, some are met with dismissive reactions from unprepared clinicians. Numerous efforts have been extended to improve patient-provider communication. Rarely has there been a head-to-head comparison of multiple efforts, however, that aims at assessing the comparative effectiveness of these efforts. In the wake of the Affordable Care Act, health systems are looking for efficient and scalable approaches that empower patients to speak up and that enable physicians to respond effectively when they do. The proposed study builds on a successfully concluded PCORI-funded pilot study that created an intervention (called "Open Communication") that resulted in better patient-provider communication compared with usual care. We have assembled an outstanding team of researchers within two large health care organizations in two states, with excellent patient stakeholders and systems leaders, to take achievements from the pilot to the next step: more rigorous study that answers the question of which approach is more effective and more scalable in promoting patient-centered communication. It is a head-to-head comparison of three different interventions: Open Communication High Touch, Open Communication High Tech, and ASK (a preexisting simple intervention). With our stakeholder group of patients, clinicians, and health system advisors, the proposed study will use the electronic health record (EHR) patient portal to nudge patients to be better prepared for their visits, to inform clinicians about what matters most to them, and to "teach back" in order to ensure accurate understanding of their care plan. We will enable clinicians to acknowledge what issues are most important to patients, jointly set visit agendas, and clearly document care plans in the EHR's After Visit Summary so that patients can review them via the patient portal. We will work with our information technology leaders to implement the EHR modifications. The study will have three arms: seven clinics, 35 primary care physicians, and 875 patients per arm. We will be advised by seven patients, one patient advocate organization, four clinicians, five clinic staff members, and 11 leaders in two large systems. We will meet with them regularly so that they can help adapt and finalize the interventions and guide the progress of the study. Our goal is to transform health care systems so that they empower patients and enable clinicians to engage in patient-centered communication, through innovative technologies and service design, to optimize the quality and outcomes of care for patients. Some of the tools were developed during an earlier PCORI- funded pilot study known as the Open Communication study. The communication tools that the current study will assess include (1) a booklet that patients use to write down priorities for their office visits. Patients also use the booklet to keep track of next steps recommended during the appointment. In addition, a trained patient-physician communication coach helps prepare the doctor for questions or concerns that may come from patients; (2) a questionnaire that patients receive through My Health Online, a digital portal that lets Sutter Health patients manage their health online. Patients list their priorities for the appointment via My Health Online; doctors then review the list to be better prepared for the visit; and (3) a poster that reminds the patients and doctors to discuss three questions about options, benefits and risks of options, and the likelihood that they would occur. The four-year study will involve over 2,600 patients at PAMF and Sutter East Bay Medical Foundation clinics. Patients and doctors with Reliant Medical Group in Massachusetts also will be part of the study as well as researchers from the University of Massachusetts Medical School at Amherst. Each approach to communication will be assessed by multiple outcome measures. Patients will fill out surveys on how well doctors engaged with them; investigators will review a patient's action plan and gauge the patient's intention to adhere to recommendations and treatments; and investigators also will look at clinical indicators and the patient's quality of life immediately after a primary care session, and again three months and 12 months later. |
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| Country: | United States || United States |
| State: | California || California |
| Zip Code: | 92093 / 94301 |
| UI: | 20173026 |
| CTgovId: | NCT03385512 |
| Project Status: | Ongoing |
| Record History: | ('2018: Project extended to 2022 and made all PIs except Ming Tai-Seale inactive.',) ('2019: PO changed',) ('2020: Archived abstract to Abstract Archived 1 field and added new abstract. Alternate Title: Comparing three approaches to improve communication between patients and their doctors',) |