Creating a Zone of Openness to Increase Patient-Centered Care

Not Applicable

Completed

Conditions: Physician-Patient Relationship
Physician's Role
Patient Engagement

Interventions: Behavioral: Ask 3 Questions
Behavioral: Open Communication

Registration Number: NCT02522286

Lead Sponsor: Palo Alto Medical Foundation

Brief Summary: 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.

Detailed Description: 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).

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 300

Inclusion Criteria

Any patient with a scheduled appointment with the participating family medicine and internal medicine physicians during the study period.

Exclusion Criteria

Non-English speakers
Patients younger than 18

Study & Design

Study Type: INTERVENTIONAL

Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Ask 3 Questions	Ask 3 Questions	Patients using 3 questions to their physicians when making medical decisions during the office visit.
Open Communication	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.
Ask 3 Questions + Open Communication	Ask 3 Questions	A combination of both the Ask 3 and Open Communication arms.
Ask 3 Questions + Open Communication	Open Communication	A combination of both the Ask 3 and Open Communication arms.

Primary Outcome Measures

Name	Time	Method
Patients' Feeling of Respect by Their Doctor	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	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	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	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.

Secondary Outcome Measures

Name	Time	Method
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)	Researchers measured the shared decision making process that occurs between patients and physicians during the appointment using a method called OPTION5. Researchers listened to audio-recorded patient appointments, identified any topic, defined as "a health issue where alternate treatment or management option exist/where the need for a decision exists," and then measured each topic for each of the OPTION5 items on a scale of 0 ("no effort: nothing observed or heard") to 20 (exemplary effort: excellent, careful attention to communication around the ideas and issues, with checks on understanding," for each of the 5 items described below. The total score is a sum of the scores from each of the 5 items at the clinic. Item 1: presenting options Item 2: establishing a partnership with the patient Item 3: describing pros and cons of options Item 4: eliciting patient preferences Item 5: integrating patient preferences into the decision