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Creating a Zone of Openness to Increase Patient-Centered Care

Creating a Zone of Openness to Increase Patient-Centered Care

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02522286
Enrollment
300
Registered
2015-08-13
Start date
2014-06-30
Completion date
2015-05-31
Last updated
2018-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

patient engagement, physician's role, patient- centered care, communication

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).

Interventions

BEHAVIORALAsk 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.

BEHAVIORALOpen 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.

Sponsors

Gordon and Betty Moore Foundation
CollaboratorOTHER
Dartmouth College
CollaboratorOTHER
University of Rochester
CollaboratorOTHER
Ideo
CollaboratorINDUSTRY
PRN Consulting
CollaboratorUNKNOWN
Palo Alto Medical Foundation
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Patient Rating of Shared Decision MakingDay 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 ScaleDay 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 QuestionsDay 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.
Patients' Feeling of Respect by Their DoctorDay 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.

Secondary

MeasureTime frameDescription
Option 5 Shared Decision Making ScoreDay 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

Participant flow

Recruitment details

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.

Pre-assignment details

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.

Participants by arm

ArmCount
Usual Care
Standard clinical care in primary care offices
75
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.
75
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.
75
Ask 3 Questions + Open Communication
A combination of both the Ask 3 and Open Communication arms.
75
Total300

Withdrawals & dropouts

PeriodReasonFG000FG001FG002FG003
Overall StudyWithdrawal by Subject3003

Baseline characteristics

CharacteristicUsual CareAsk 3 QuestionsOpen CommunicationAsk 3 Questions + Open CommunicationTotal
Age, Continuous54.7 years
STANDARD_DEVIATION 16.2
50.7 years
STANDARD_DEVIATION 15.6
49.0 years
STANDARD_DEVIATION 15
61.4 years
STANDARD_DEVIATION 15.3
54.0 years
STANDARD_DEVIATION 16.2
Race/Ethnicity, Customized
Asian or Pacific Islander
15 participants24 participants20 participants3 participants62 participants
Race/Ethnicity, Customized
Caucasian
45 participants38 participants44 participants63 participants190 participants
Race/Ethnicity, Customized
Other
15 participants13 participants11 participants9 participants48 participants
Sex: Female, Male
Female
50 Participants34 Participants44 Participants54 Participants182 Participants
Sex: Female, Male
Male
25 Participants41 Participants31 Participants21 Participants118 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —— / —
other
Total, other adverse events
0 / 750 / 750 / 750 / 75
serious
Total, serious adverse events
0 / 750 / 750 / 750 / 75

Outcome results

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.

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

ArmMeasureValue (MEAN)Dispersion
Usual CareDoctor Facilitation Subscale of the Perceived Involvement in Care Scale37.3 percentage of participantsStandard Deviation 16.6
Ask 3 QuestionsDoctor Facilitation Subscale of the Perceived Involvement in Care Scale42.7 percentage of participantsStandard Deviation 11.5
Open CommunicationDoctor Facilitation Subscale of the Perceived Involvement in Care Scale45.3 percentage of participantsStandard Deviation 12.7
Ask 3 Questions + Open CommunicationDoctor Facilitation Subscale of the Perceived Involvement in Care Scale46.7 percentage of participantsStandard Deviation 14.8
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.

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

ArmMeasureValue (MEAN)Dispersion
Usual CarePatient Rating of Shared Decision Making66.7 percentage of participantsStandard Deviation 17
Ask 3 QuestionsPatient Rating of Shared Decision Making72.0 percentage of participantsStandard Deviation 17.3
Open CommunicationPatient Rating of Shared Decision Making74.7 percentage of participantsStandard Deviation 14
Ask 3 Questions + Open CommunicationPatient Rating of Shared Decision Making74.7 percentage of participantsStandard Deviation 12.5
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.

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

ArmMeasureGroupValue (MEAN)Dispersion
Usual CarePatient Responses to Stakeholder Generated QuestionsStatement 1 (n=75)86.7 percentage of participantsStandard Deviation 12.6
Usual CarePatient Responses to Stakeholder Generated QuestionsStatement 2 (n=75)81.3 percentage of participantsStandard Deviation 10.4
Usual CarePatient Responses to Stakeholder Generated QuestionsStatement 3 (n=75)80.0 percentage of participantsStandard Deviation 9.2
Usual CarePatient Responses to Stakeholder Generated QuestionsStatement 4 (n=75)83.8 percentage of participantsStandard Deviation 7.7
Usual CarePatient Responses to Stakeholder Generated QuestionsStatement 5 (n=75)82.2 percentage of participantsStandard Deviation 11.7
Ask 3 QuestionsPatient Responses to Stakeholder Generated QuestionsStatement 3 (n=75)96.0 percentage of participantsStandard Deviation 6
Ask 3 QuestionsPatient Responses to Stakeholder Generated QuestionsStatement 4 (n=75)90.5 percentage of participantsStandard Deviation 10.1
Ask 3 QuestionsPatient Responses to Stakeholder Generated QuestionsStatement 2 (n=75)93.2 percentage of participantsStandard Deviation 8.2
Ask 3 QuestionsPatient Responses to Stakeholder Generated QuestionsStatement 5 (n=75)87.7 percentage of participantsStandard Deviation 7.8
Ask 3 QuestionsPatient Responses to Stakeholder Generated QuestionsStatement 1 (n=75)96.0 percentage of participantsStandard Deviation 6.3
Open CommunicationPatient Responses to Stakeholder Generated QuestionsStatement 4 (n=75)92.0 percentage of participantsStandard Deviation 9.1
Open CommunicationPatient Responses to Stakeholder Generated QuestionsStatement 3 (n=75)90.7 percentage of participantsStandard Deviation 9.4
Open CommunicationPatient Responses to Stakeholder Generated QuestionsStatement 1 (n=75)90.5 percentage of participantsStandard Deviation 11.4
Open CommunicationPatient Responses to Stakeholder Generated QuestionsStatement 2 (n=75)89.2 percentage of participantsStandard Deviation 11.5
Open CommunicationPatient Responses to Stakeholder Generated QuestionsStatement 5 (n=75)91.8 percentage of participantsStandard Deviation 8.6
Ask 3 Questions + Open CommunicationPatient Responses to Stakeholder Generated QuestionsStatement 4 (n=75)85.3 percentage of participantsStandard Deviation 11.7
Ask 3 Questions + Open CommunicationPatient Responses to Stakeholder Generated QuestionsStatement 3 (n=75)83.6 percentage of participantsStandard Deviation 12.6
Ask 3 Questions + Open CommunicationPatient Responses to Stakeholder Generated QuestionsStatement 1 (n=75)81.3 percentage of participantsStandard Deviation 10.3
Ask 3 Questions + Open CommunicationPatient Responses to Stakeholder Generated QuestionsStatement 5 (n=75)81.9 percentage of participantsStandard Deviation 12.5
Ask 3 Questions + Open CommunicationPatient Responses to Stakeholder Generated QuestionsStatement 2 (n=75)81.1 percentage of participantsStandard Deviation 11.6
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.

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

ArmMeasureValue (MEAN)Dispersion
Usual CarePatients' Feeling of Respect by Their Doctor96.0 percentage of participantsStandard Deviation 4.6
Ask 3 QuestionsPatients' Feeling of Respect by Their Doctor98.7 percentage of participantsStandard Deviation 3
Open CommunicationPatients' Feeling of Respect by Their Doctor97.3 percentage of participantsStandard Deviation 2.4
Ask 3 Questions + Open CommunicationPatients' Feeling of Respect by Their Doctor90.7 percentage of participantsStandard Deviation 6.6
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

Time frame: 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.

ArmMeasureGroupValue (MEAN)Dispersion
Usual CareOption 5 Shared Decision Making ScoreItem 1 (out of 20)6.7 scores on a scaleStandard Deviation 2.6
Usual CareOption 5 Shared Decision Making ScoreItem 2 (out of 20)4.1 scores on a scaleStandard Deviation 3
Usual CareOption 5 Shared Decision Making ScoreItem 4 (out of 20)3.8 scores on a scaleStandard Deviation 3.2
Usual CareOption 5 Shared Decision Making ScoreOverall Score (out of 100)23.9 scores on a scaleStandard Deviation 11.8
Usual CareOption 5 Shared Decision Making ScoreItem 3 (out of 20)5.6 scores on a scaleStandard Deviation 3.6
Usual CareOption 5 Shared Decision Making ScoreItem 5 (out of 20)3.7 scores on a scaleStandard Deviation 3.2
Ask 3 QuestionsOption 5 Shared Decision Making ScoreItem 2 (out of 20)4.9 scores on a scaleStandard Deviation 3.5
Ask 3 QuestionsOption 5 Shared Decision Making ScoreItem 3 (out of 20)7.2 scores on a scaleStandard Deviation 4.3
Ask 3 QuestionsOption 5 Shared Decision Making ScoreItem 5 (out of 20)4.4 scores on a scaleStandard Deviation 3.7
Ask 3 QuestionsOption 5 Shared Decision Making ScoreItem 1 (out of 20)7.7 scores on a scaleStandard Deviation 3.2
Ask 3 QuestionsOption 5 Shared Decision Making ScoreOverall Score (out of 100)28.8 scores on a scaleStandard Deviation 16.8
Ask 3 QuestionsOption 5 Shared Decision Making ScoreItem 4 (out of 20)4.5 scores on a scaleStandard Deviation 3.8
Open CommunicationOption 5 Shared Decision Making ScoreItem 5 (out of 20)5.0 scores on a scaleStandard Deviation 3.8
Open CommunicationOption 5 Shared Decision Making ScoreItem 3 (out of 20)6.7 scores on a scaleStandard Deviation 4.3
Open CommunicationOption 5 Shared Decision Making ScoreItem 4 (out of 20)5.1 scores on a scaleStandard Deviation 3.8
Open CommunicationOption 5 Shared Decision Making ScoreItem 2 (out of 20)4.9 scores on a scaleStandard Deviation 3.8
Open CommunicationOption 5 Shared Decision Making ScoreItem 1 (out of 20)7.6 scores on a scaleStandard Deviation 2.9
Open CommunicationOption 5 Shared Decision Making ScoreOverall Score (out of 100)29.2 scores on a scaleStandard Deviation 16.8
Ask 3 Questions + Open CommunicationOption 5 Shared Decision Making ScoreOverall Score (out of 100)24.5 scores on a scaleStandard Deviation 14.6
Ask 3 Questions + Open CommunicationOption 5 Shared Decision Making ScoreItem 3 (out of 20)5.8 scores on a scaleStandard Deviation 3.8
Ask 3 Questions + Open CommunicationOption 5 Shared Decision Making ScoreItem 2 (out of 20)3.3 scores on a scaleStandard Deviation 3.1
Ask 3 Questions + Open CommunicationOption 5 Shared Decision Making ScoreItem 1 (out of 20)6.4 scores on a scaleStandard Deviation 2.6
Ask 3 Questions + Open CommunicationOption 5 Shared Decision Making ScoreItem 5 (out of 20)4.4 scores on a scaleStandard Deviation 3.8
Ask 3 Questions + Open CommunicationOption 5 Shared Decision Making ScoreItem 4 (out of 20)4.6 scores on a scaleStandard Deviation 4

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026