Creating a Zone of Openness to Increase Patient-Centered Care

Patient Engagement Clinical Trial

Official title:

Creating a Zone of Openness to Increase Patient-Centered Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02522286
• Other study ID #: 37930708
• Secondary ID: PCORI-1IP2PI0000
• Status: Completed
• Phase: N/A
• Start date: June 2014
• Est. completion date: May 2015

Study information

• Verified date: September 2017
• Source: Palo Alto Medical Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: May 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Patient Engagement
• Physician's Role
• Physician-Patient Relationship

Intervention

Behavioral:
• Ask 3 Questions
Participants were asked to bring an "Ask 3" questions flyer into their appointment to use if they needed to make a choice about their health care during their appointment. These 3 questions have been shown to help patients make more informed decisions about their healthcare.
• Open Communication
Open Communication includes a combination of interventions. 1) Participants used a Visit Companion Booklet to write out issues they would like to discuss with their physician during their appointment before showing up. They were also asked to write out any next steps decided on during their appointment and to repeat back to their doctor what they wrote before leaving. 2) Patients watched a short, informational cartoon video to better understand the Visit Companion Booklet. 3) Participating physicians received a training through the use of a Standardized Patient Instructor as a means of providing convenient, individualized training on communication techniques. Dyads (physicians and their medical assistants) were trained on how to incorporate the Visit Companion Booklet into workflow.

Locations

Country	Name	City	State
n/a

Sponsors (6)

Lead Sponsor	Collaborator
Palo Alto Medical Foundation	Dartmouth College, Gordon and Betty Moore Foundation, Ideo, PRN Consulting, University of Rochester

References & Publications (4)

Barr PJ, Thompson R, Walsh T, Grande SW, Ozanne EM, Elwyn G. The psychometric properties of CollaboRATE: a fast and frugal patient-reported measure of the shared decision-making process. J Med Internet Res. 2014 Jan 3;16(1):e2. doi: 10.2196/jmir.3085. Erratum in: J Med Internet Res. 2015;17(2):e32. J Med Internet Res. 2015;17(2):e32. — View Citation

Elwyn G, Hutchings H, Edwards A, Rapport F, Wensing M, Cheung WY, Grol R. The OPTION scale: measuring the extent that clinicians involve patients in decision-making tasks. Health Expect. 2005 Mar;8(1):34-42. — View Citation

Lerman CE, Brody DS, Caputo GC, Smith DG, Lazaro CG, Wolfson HG. Patients' Perceived Involvement in Care Scale: relationship to attitudes about illness and medical care. J Gen Intern Med. 1990 Jan-Feb;5(1):29-33. — View Citation

Tai-Seale M, Elwyn G, Wilson CJ, Stults C, Dillon EC, Li M, Chuang J, Meehan A, Frosch DL. Enhancing Shared Decision Making Through Carefully Designed Interventions That Target Patient And Provider Behavior. Health Aff (Millwood). 2016 Apr;35(4):605-12. d — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Rating of Shared Decision Making	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.	Day 1 (outcomes measures were assessed once for each participant)
Primary	Doctor Facilitation Subscale of the Perceived Involvement in Care Scale	"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.	Day 1 (outcomes measures were assessed once for each participant)
Primary	Patient Responses to Stakeholder Generated Questions	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.	Day 1 (outcomes measures were assessed once for each participant)
Primary	Patients' Feeling of Respect by Their Doctor	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.	Day 1 (outcomes measures were assessed once for each participant)
Secondary	Option 5 Shared Decision Making Score	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	Day 1 (outcomes measures were assessed once for each participant based on analysis of the audio recording of their visits)

External Links

•   Open Communication Video