Patient EngagementNCT02522286

Creating a Zone of Openness to Increase Patient-Centered Care

A study testing Ask 3 Questions and Open Communication in people with Patient Engagement and Physician's Role, run by Palo Alto Medical Foundation.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Patient Engagement, Physician's Role, Physician-Patient Relationship
What is being tested?: Ask 3 Questions and Open Communication
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 300 participants
Where: No sites listed yet
Study dates: Jun 2014to May 2015
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

Non-English speakers
Patients younger than 18

About this study

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.

Read the 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).

Conditions: Patient Engagement, Physician's Role, Physician-Patient Relationship
Being tested: Ask 3 Questions, Open Communication
Keywords: patient engagement, physician's role, patient- centered care, communication
Medical subject headings: Patient Participation, Communication

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Ask 3 QuestionsBehavioural
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 CommunicationBehavioural
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.
1. Patients watched a short, informational cartoon video to better understand the Visit Companion Booklet.
2. 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.

Study groups in NCT02522286
Study group	Role	What they receive
Usual Care	No intervention	Standard clinical care in primary care offices
Ask 3 Questions	Experimental	Patients using 3 questions to their physicians when making medical decisions during the office visit. Receives: Behavioral: Ask 3 Questions
Open Communication	Experimental	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. Receives: Behavioral: Open Communication
Ask 3 Questions + Open Communication	Experimental	A combination of both the Ask 3 and Open Communication arms. Receives: Behavioral: Ask 3 Questions; Behavioral: Open Communication

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (1)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2014May 2015

First posted13 Aug 2015 (estimated)
Study startJun 2014
Primary completionApr 2015
Study completionMay 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Patient EngagementStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Health services research
Allocation: Randomised
Intervention model: Factorial
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 300 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02522286
Sponsor's protocol ID: 37930708
Other IDs: PCORI-1IP2PI000055-01
Status last verified: Sep 2017
First submitted: 16 May 2015
Last updated: 20 Jul 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 24389354
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. doi: 10.1007/BF02602306.
PubMed 2299426
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. doi: 10.1111/j.1369-7625.2004.00311.x.
PubMed 15713169
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. doi: 10.1377/hlthaff.2015.1398.
PubMed 27044959

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 20 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Creating a Zone of Openness to Increase Patient-Centered Care
ClinicalTrials.gov ID: NCT02522286
Acronym / sponsor ID: 37930708
Conditions: Patient Engagement, Physician's Role, Physician-Patient Relationship
Keywords: patient engagement, physician's role, patient- centered care, communication
Study type: Interventional
Recruitment status: Completed
Enrolment: 300 participants (actual)
Lead sponsor: Palo Alto Medical FoundationUniversity, hospital or other
Collaborators: Gordon and Betty Moore Foundation, Dartmouth College, University of Rochester, Ideo, PRN Consulting
Study start: Jun 2014
Primary completion: Apr 2015 (actual)
Study completion: May 2015 (actual)
First posted: 13 Aug 2015 (estimated)
Results: Posted 20 Jul 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Factorial
Masking: Single blind (outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Usual Care	No intervention	–Standard clinical care in primary care offices
Ask 3 Questions	Experimental	Behavioral: Ask 3 QuestionsPatients using 3 questions to their physicians when making medical decisions during the office visit.
Open Communication	Experimental	Behavioral: Open CommunicationThis 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	Experimental	Behavioral: Ask 3 Questions, Behavioral: Open CommunicationA combination of both the Ask 3 and Open Communication arms.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

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

Key exclusion criteria (2 listed)

Non-English speakers
Patients younger than 18

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Ask 3 QuestionsParticipants 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.	Behavioural	Ask 3 Questions, Ask 3 Questions + Open Communication
Open CommunicationOpen 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.	Behavioural	Ask 3 Questions + Open Communication, Open Communication

Primary outcome

Patient Rating of Shared Decision Making
Time frame: 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
Time frame: 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
Time frame: 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.
Patients' Feeling of Respect by Their Doctor
Time frame: 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.

1 secondary outcome

Option 5 Shared Decision Making Score
Time frame: Day 1 (outcomes measures were assessed once for each participant based on analysis of the audio recording of their visits)

Results and safety

Results posted to the registry on 20 Jul 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Usual Care	78	75
Ask 3 Questions	75	75
Open Communication	75	75
Ask 3 Questions + Open Communication	78	75

Primary outcome: Patient Rating of Shared Decision Making

Time frame: Day 1 (outcomes measures were assessed once for each participant). Mean (Standard Deviation). Unit: percentage of participants

Measure	Usual Care n = 75	Ask 3 Questions n = 75	Open Communication n = 75	Ask 3 Questions + Open Communication n = 75
Value	66.7 (17.0)	72.0 (17.3)	74.7 (14.0)	74.7 (12.5)

Primary outcome: Doctor Facilitation Subscale of the Perceived Involvement in Care Scale

Time frame: Day 1 (outcomes measures were assessed once for each participant). Mean (Standard Deviation). Unit: percentage of participants

Measure	Usual Care n = 75	Ask 3 Questions n = 75	Open Communication n = 75	Ask 3 Questions + Open Communication n = 75
Value	37.3 (16.6)	42.7 (11.5)	45.3 (12.7)	46.7 (14.8)

Primary outcome: Patient Responses to Stakeholder Generated Questions

Time frame: Day 1 (outcomes measures were assessed once for each participant). Mean (Standard Deviation). Unit: percentage of participants

Measure	Usual Care n = 75	Ask 3 Questions n = 75	Open Communication n = 75	Ask 3 Questions + Open Communication n = 75
Statement 1 (n=75)	86.7 (12.6)	96.0 (6.3)	90.5 (11.4)	81.3 (10.3)
Statement 2 (n=75)	81.3 (10.4)	93.2 (8.2)	89.2 (11.5)	81.1 (11.6)
Statement 3 (n=75)	80.0 (9.2)	96.0 (6.0)	90.7 (9.4)	83.6 (12.6)
Statement 4 (n=75)	83.8 (7.7)	90.5 (10.1)	92.0 (9.1)	85.3 (11.7)
Statement 5 (n=75)	82.2 (11.7)	87.7 (7.8)	91.8 (8.6)	81.9 (12.5)

Primary outcome: Patients' Feeling of Respect by Their Doctor

Time frame: Day 1 (outcomes measures were assessed once for each participant). Mean (Standard Deviation). Unit: percentage of participants

Measure	Usual Care n = 75	Ask 3 Questions n = 75	Open Communication n = 75	Ask 3 Questions + Open Communication n = 75
Value	96.0 (4.6)	98.7 (3.0)	97.3 (2.4)	90.7 (6.6)

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Usual Care	0 of 75 (0%)	0 of 75 (0%)	Not reported
Ask 3 Questions	0 of 75 (0%)	0 of 75 (0%)	Not reported
Open Communication	0 of 75 (0%)	0 of 75 (0%)	Not reported
Ask 3 Questions + Open Communication	0 of 75 (0%)	0 of 75 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 24389354Barr 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.
Background: PubMed 2299426Lerman 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. doi: 10.1007/BF02602306.
Background: PubMed 15713169Elwyn 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. doi: 10.1111/j.1369-7625.2004.00311.x.
Results publication: PubMed 27044959Tai-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. doi: 10.1377/hlthaff.2015.1398.
Open Communication VideoLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Ming Tai-Seale, PhD, MPH principal investigator

Palo Alto Medical Foundation

Questions about this trial

What is this clinical trial studying?

A study testing Ask 3 Questions and Open Communication in people with Patient Engagement and Physician's Role, run by Palo Alto Medical Foundation.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Jul 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patient Rating of Shared Decision Making (time frame: Day 1 (outcomes measures were assessed once for each participant)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02522286, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2018.