PCORI funded the Pilot Projects to explore how to conduct and use patient-centered outcomes research in ways that can better serve patients and the healthcare community. Learn more.

Background

When patients and doctors communicate well and work together to make decisions about care, patients often have better health outcomes and a better experience with their health care. Some research studies have found that patients may be nervous about asking their doctor too many questions or disagreeing with their doctor’s recommendations. Patients worry they might not get the best care if the doctor thinks they are difficult.

Project Purpose

Researchers created a program to help patients and doctors make decisions together. They called the program Open Communication, and it consisted of video and print materials for patients and in-person training for doctors. They tested the program to find out whether patients who used it felt more satisfied with their doctor’s visit compared to those who used an existing program called Ask, Share, Know (ASK).

Methods

The research team worked with patients and doctors to create Open Communication. The program has three parts:

• A two-minute video to help patients prepare for a doctor visit
• A four-page booklet patients can bring to their doctor visit, including space to write down what they want to discuss during the visit and what they need to do after their visit
• A training session for doctors on good communication strategies, such as setting an agenda for the visit or discussing next steps

The ASK program provided patients and doctors with a handout with three questions to guide their conversations:

• What are my options?
• What are the possible benefits and harms of each option?
• How likely is it that any of those benefits and harms will happen to me?

The researchers worked with four primary care clinics in California. Each clinic was assigned at random to use one of four approaches:

• Open Communication
• ASK
• Open Communication and ASK
• No program (usual care)

A total of 300 patients, 26 doctors, and 54 medical assistants participated in the study. Patients were age 18 or older, spoke English, and had an appointment with a doctor at one of the four clinics.

The patients filled out a survey right after a visit with their doctor. Using the survey responses, the research team looked at how involved patients felt in making decisions about their care and whether they thought their doctor was doing a good job communicating.

The research team also selected 10 patients from each clinic by chance and audio recorded their visits. The research team listened to the recordings and scored how much shared decision making happened between the patient and the doctor.

The research team then compared patient responses from the clinic using the Open Communication program with responses from the clinics using the three other approaches.

Findings

Patients who participated in the Open Communication program by itself felt more involved in their care than patients who went to clinics that used the other three approaches. Patients from the clinics that used either Open Communication or ASK believed that doctors helped them feel involved in making a decision more than patients at the clinics that used usual care or a combination of the two programs together.

By listening to the audio recordings, the researchers found that doctors and patients using either Open Communication or ASK participated in more shared decision making than doctors and patients who used the other two approaches. Visits with patients who did not have a college education contained less shared decision making than visits with patients who did have a college education.

Limitations

This study looked at only four clinics. The researchers can’t be sure whether the differences in the results were because of the care program each clinic used or because of other differences among the clinics.

People who want to have better doctor-patient communication may have been more likely to join the study than other people. That could have affected the results by making the program appear more effective than it would be in real life.

Doctors also used the programs in different ways than the researchers expected. For example, some doctors only used the program with patients they had seen before, not new ones. The results might be different if all the doctors and patients at a clinic used the care program the same way.

Conclusions

Programs that help both patients and doctors have better conversations about healthcare decisions may improve the patient experience.

Sharing the Results

The research team

• Shared their findings with conferences, schools, healthcare systems, and government officials
• Published articles in professional research journals
• Held a webinar to present the study findings
• Created a video about the care program and shared it online

PCORI funded the Pilot Projects to explore how to conduct and use patient-centered outcomes research in ways that can better serve patients and the healthcare community. Learn more.

Background

Patient–provider communication and shared medical decision making (SMDM) are essential components of primary care delivery and vital contributors to patient experiences and health outcomes. Earlier studies found that patients were apprehensive about asking too many questions or disagreeing with a provider’s recommendation, believing they might be viewed as “difficult” and consequently receive lower quality care. This research aimed to determine whether involving stakeholders in the co-design of an intervention could produce an effective approach that would improve patient experiences with primary care.

Project Purpose

The objectives of this study were to (1) design a novel intervention with patient and healthcare team stakeholders that targeted both patients and providers to enhance patient–provider communication, and (2) conduct a cluster randomized controlled trial (RCT) of the new intervention comparing it to an existing patient intervention called Ask Share Know (ASK) to obtain data to guide the design of a large-scale comparative effectiveness study.

Study Design

After multiple brainstorming sessions with patient and provider stakeholders and user experience design consultants and several rounds of user tests, the researchers arrived at a multidimensional intervention called Open Communication (OpenComm). This intervention focused on changing patient and primary care provider (PCP) behaviors so that encounters might unfold purposefully and openly. Researchers compared (1) OpenComm) (2) ASK; (3) OpenComm and ASK; and (4) usual care, in a fully crossed 2x2 factorial design. Four primary care clinics were randomized, one to each arm.

Participants, Interventions, Settings, and Outcomes

All adult English-speaking patients with scheduled appointments with a participating PCP were eligible to join. The study included 300 patients, 26 providers, and 54 medical assistants.

OpenComm included (1) a two-minute animated video; (2) a Visit Companion Booklet for patients to record important issues that they wanted to discuss during the visit, as well as the next steps after the visit; and (3) individually tailored communication coaching for PCPs provided by a standardized patient instructor. For the ASK intervention, patient participants were given a handout with three questions:

• What are my options?
• What are the possible risks and benefits of each option?
• How likely are the benefits and risks of each option to occur?

PCPs were shown the handout as well.

The setting was four participating family and/or internal medicine clinics that are part of a large nonprofit delivery organization in California.

Patient-reported outcome measures included: patient ratings of SMDM using the CollaboRATE instrument, a three-item validated instrument on patient engagement in SMDM; patient responses to the doctor facilitation subscale of the Perceived Involvement in Care scale; and patients’ feelings of respect for their PCP from the Consumer Assessment of Healthcare Providers and Systems (CAHPS®) survey. The Observer OPTION5 instrument was also used to rate SMDM within a sample of 40 audio-recorded appointments.

Data Sources

Patient surveys collected by researchers immediately after patient–PCP visits. Researchers recorded 40 randomly selected visits.

Data Analysis

Quantitative: Descriptive analyses and generalized estimating equations (GEE) binary logistic regression were used to examine the association between the intervention groups and the probability of patients providing the highest possible CollaboRATE score and the highest possible doctor facilitation score. Because this was a pilot study, the researchers reported estimations and 75% confidence intervals to infer the size and direction of intervention effects.

Qualitative: Analysis of the audio-recorded visits focused on identifying agenda setting, discussion of next steps, teach-back, and using ASK prompts. Raters used the Observer OPTION5 instrument to assess shared decision making occurring across all clinical decision topics discussed during visits. Descriptive statistics and GEE were used to analyze the scores.

Quality of Data and Analysis

Quantitative: Survey responses were double-entered to ensure reliability. Sensitivity analyses were conducted using a structural equations method employing patients’ actual response scores. The results were robust.

Qualitative: Observer OPTION5: After reaching consensus on scoring the first 50 of 200 topics, raters scored topics individually with periodic checks to maintain inter-rater reliability.

Findings

Quantitative: CollaboRATE scores were significantly higher in the OpenComm intervention clinic compared to the usual care clinic. The odds ratio (OR) of patients giving the highest CollaboRATE score were 1.523 (75% confidence interval: 1.026, 2.259) relative to usual care. Researchers also found higher odds of patients giving the highest scores to doctor facilitation of patient involvement in the OpenComm clinic (OR: 1.548, 75% confidence interval: 1.104, 2.169) and ASK clinic (OR: 1.647, 75% confidence interval: 1.178, 2.304) compared to usual care.

Qualitative: In 40 recorded visits, the mean overall OPTION5 score was 26.5 out of 100 (SD = 15.2). OpenComm had higher mean item scores (out of 20) for eliciting (mean = 5.1, SD = 3.8) and integrating patient preferences (mean = 5.0, SD = 3.8). ASK had higher scores for presenting options (mean = 7.7, SD = 3.2) and discussing pros/cons (mean = 7.2, SD = 4.3). Lower patient education attainment was associated with lower scores in all analyses. Improving SMDM for patients with less education is crucial and higher scores for OpenComm visits suggest that targeting patient and physician behaviors effectively promotes SMDM.

Limitations

Due to the small number of clinics (n = 4) involved in this study, the researchers cannot rule out the impact of clinic-level variations on the results. Participation bias was also possible for patients and PCPs. There was also unexpected variation in the types of patient appointments included depending on individual PCP preference (e.g., new patients were sometimes excluded).

Conclusions

Carefully designed interventions targeting the behavior of both patients and PCPs enhance SMDM. Findings illustrate how a new intervention may improve patient experiences.