Trial Outcomes & Findings for Creating a Zone of Openness to Increase Patient-Centered Care (NCT NCT02522286)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

300 participants

Primary outcome timeframe

Day 1 (outcomes measures were assessed once for each participant)

Results posted on

2018-07-20

Participant Flow

From May 2014 to April 2015, 75 patients were screened and enrolled for each of the 4 participating family or internal medicine clinics. Researchers met with interested patients who had a regularly scheduled appointment in order to consent and advise on how to use the study materials. After their visit, they completed a post-visit survey.

New patients and patients with physical exams or osteopathic evaluations were initially excluded though later allowed for recruitment for some physicians at one of the participating clinics. There were 6 patients who consented to participate but did not complete the final survey when exiting their appointment.

Participant milestones

Participant milestones
Measure	Usual Care Standard clinical care in primary care offices	Ask 3 Questions Patients using 3 questions to their physicians when making medical decisions during the office visit. 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.	Ask 3 Questions + Open Communication A combination of both the Ask 3 and Open Communication arms.
Overall Study STARTED	78	75	75	78
Overall Study COMPLETED	75	75	75	75
Overall Study NOT COMPLETED	3	0	0	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Usual Care Standard clinical care in primary care offices	Ask 3 Questions Patients using 3 questions to their physicians when making medical decisions during the office visit. 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.	Ask 3 Questions + Open Communication A combination of both the Ask 3 and Open Communication arms.
Overall Study Withdrawal by Subject	3	0	0	3

Baseline Characteristics

Creating a Zone of Openness to Increase Patient-Centered Care

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Usual Care n=75 Participants Standard clinical care in primary care offices	Ask 3 Questions n=75 Participants Patients using 3 questions to their physicians when making medical decisions during the office visit. 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 n=75 Participants 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.	Ask 3 Questions + Open Communication n=75 Participants A combination of both the Ask 3 and Open Communication arms.	Total n=300 Participants Total of all reporting groups
Age, Continuous	54.7 years STANDARD_DEVIATION 16.2 • n=5 Participants	50.7 years STANDARD_DEVIATION 15.6 • n=7 Participants	49.0 years STANDARD_DEVIATION 15.0 • n=5 Participants	61.4 years STANDARD_DEVIATION 15.3 • n=4 Participants	54.0 years STANDARD_DEVIATION 16.2 • n=21 Participants
Sex: Female, Male Female	50 Participants n=5 Participants	34 Participants n=7 Participants	44 Participants n=5 Participants	54 Participants n=4 Participants	182 Participants n=21 Participants
Sex: Female, Male Male	25 Participants n=5 Participants	41 Participants n=7 Participants	31 Participants n=5 Participants	21 Participants n=4 Participants	118 Participants n=21 Participants
Race/Ethnicity, Customized Caucasian	45 participants n=5 Participants	38 participants n=7 Participants	44 participants n=5 Participants	63 participants n=4 Participants	190 participants n=21 Participants
Race/Ethnicity, Customized Asian or Pacific Islander	15 participants n=5 Participants	24 participants n=7 Participants	20 participants n=5 Participants	3 participants n=4 Participants	62 participants n=21 Participants
Race/Ethnicity, Customized Other	15 participants n=5 Participants	13 participants n=7 Participants	11 participants n=5 Participants	9 participants n=4 Participants	48 participants n=21 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Usual Care n=75 Participants Standard clinical care in primary care offices	Ask 3 Questions n=75 Participants Patients using 3 questions to their physicians when making medical decisions during the office visit. 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 n=75 Participants 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.	Ask 3 Questions + Open Communication n=75 Participants A combination of both the Ask 3 and Open Communication arms.
Patient Rating of Shared Decision Making	66.7 percentage of participants Standard Deviation 17.0	72.0 percentage of participants Standard Deviation 17.3	74.7 percentage of participants Standard Deviation 14.0	74.7 percentage of participants Standard Deviation 12.5

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Usual Care n=75 Participants Standard clinical care in primary care offices	Ask 3 Questions n=75 Participants Patients using 3 questions to their physicians when making medical decisions during the office visit. 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 n=75 Participants 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.	Ask 3 Questions + Open Communication n=75 Participants A combination of both the Ask 3 and Open Communication arms.
Doctor Facilitation Subscale of the Perceived Involvement in Care Scale	37.3 percentage of participants Standard Deviation 16.6	42.7 percentage of participants Standard Deviation 11.5	45.3 percentage of participants Standard Deviation 12.7	46.7 percentage of participants Standard Deviation 14.8

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Usual Care n=75 Participants Standard clinical care in primary care offices	Ask 3 Questions n=75 Participants Patients using 3 questions to their physicians when making medical decisions during the office visit. 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 n=75 Participants 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.	Ask 3 Questions + Open Communication n=75 Participants A combination of both the Ask 3 and Open Communication arms.
Patient Responses to Stakeholder Generated Questions Statement 1 (n=75)	86.7 percentage of participants Standard Deviation 12.6	96.0 percentage of participants Standard Deviation 6.3	90.5 percentage of participants Standard Deviation 11.4	81.3 percentage of participants Standard Deviation 10.3
Patient Responses to Stakeholder Generated Questions Statement 2 (n=75)	81.3 percentage of participants Standard Deviation 10.4	93.2 percentage of participants Standard Deviation 8.2	89.2 percentage of participants Standard Deviation 11.5	81.1 percentage of participants Standard Deviation 11.6
Patient Responses to Stakeholder Generated Questions Statement 3 (n=75)	80.0 percentage of participants Standard Deviation 9.2	96.0 percentage of participants Standard Deviation 6.0	90.7 percentage of participants Standard Deviation 9.4	83.6 percentage of participants Standard Deviation 12.6
Patient Responses to Stakeholder Generated Questions Statement 4 (n=75)	83.8 percentage of participants Standard Deviation 7.7	90.5 percentage of participants Standard Deviation 10.1	92.0 percentage of participants Standard Deviation 9.1	85.3 percentage of participants Standard Deviation 11.7
Patient Responses to Stakeholder Generated Questions Statement 5 (n=75)	82.2 percentage of participants Standard Deviation 11.7	87.7 percentage of participants Standard Deviation 7.8	91.8 percentage of participants Standard Deviation 8.6	81.9 percentage of participants Standard Deviation 12.5

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Usual Care n=75 Participants Standard clinical care in primary care offices	Ask 3 Questions n=75 Participants Patients using 3 questions to their physicians when making medical decisions during the office visit. 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 n=75 Participants 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.	Ask 3 Questions + Open Communication n=75 Participants A combination of both the Ask 3 and Open Communication arms.
Patients' Feeling of Respect by Their Doctor	96.0 percentage of participants Standard Deviation 4.6	98.7 percentage of participants Standard Deviation 3.0	97.3 percentage of participants Standard Deviation 2.4	90.7 percentage of participants Standard Deviation 6.6

SECONDARY outcome

Timeframe: Day 1 (outcomes measures were assessed once for each participant based on analysis of the audio recording of their visits)

Population: From the 75 patients at each of the 4 clinics, 10 appointments were randomly selected to be audio-recordinged. The Number of Participants Analyzed reflects the number of topics identified from the 10 recordings at each clinic.

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

Outcome measures

Outcome measures
Measure	Usual Care n=51 Participants Standard clinical care in primary care offices	Ask 3 Questions n=49 Participants Patients using 3 questions to their physicians when making medical decisions during the office visit. 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 n=48 Participants 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.	Ask 3 Questions + Open Communication n=52 Participants A combination of both the Ask 3 and Open Communication arms.
Option 5 Shared Decision Making Score Item 1 (out of 20)	6.7 scores on a scale Standard Deviation 2.6	7.7 scores on a scale Standard Deviation 3.2	7.6 scores on a scale Standard Deviation 2.9	6.4 scores on a scale Standard Deviation 2.6
Option 5 Shared Decision Making Score Item 2 (out of 20)	4.1 scores on a scale Standard Deviation 3.0	4.9 scores on a scale Standard Deviation 3.5	4.9 scores on a scale Standard Deviation 3.8	3.3 scores on a scale Standard Deviation 3.1
Option 5 Shared Decision Making Score Item 3 (out of 20)	5.6 scores on a scale Standard Deviation 3.6	7.2 scores on a scale Standard Deviation 4.3	6.7 scores on a scale Standard Deviation 4.3	5.8 scores on a scale Standard Deviation 3.8
Option 5 Shared Decision Making Score Item 4 (out of 20)	3.8 scores on a scale Standard Deviation 3.2	4.5 scores on a scale Standard Deviation 3.8	5.1 scores on a scale Standard Deviation 3.8	4.6 scores on a scale Standard Deviation 4.0
Option 5 Shared Decision Making Score Item 5 (out of 20)	3.7 scores on a scale Standard Deviation 3.2	4.4 scores on a scale Standard Deviation 3.7	5.0 scores on a scale Standard Deviation 3.8	4.4 scores on a scale Standard Deviation 3.8
Option 5 Shared Decision Making Score Overall Score (out of 100)	23.9 scores on a scale Standard Deviation 11.8	28.8 scores on a scale Standard Deviation 16.8	29.2 scores on a scale Standard Deviation 16.8	24.5 scores on a scale Standard Deviation 14.6

Adverse Events

Usual Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Ask 3 Questions

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Open Communication

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Ask 3 Questions + Open Communication

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Ming Tai-Seale

Palo Alto Medical Foundation Research Institute

Phone: 650-853-4779

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place