Creating a Zone of Openness to Increase Patient-Centered Care
2 other identifiers
interventional
300
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2014
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2015
CompletedFirst Submitted
Initial submission to the registry
May 16, 2015
CompletedFirst Posted
Study publicly available on registry
August 13, 2015
CompletedResults Posted
Study results publicly available
July 20, 2018
CompletedJuly 20, 2018
September 1, 2017
10 months
May 16, 2015
June 1, 2016
September 24, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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)
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)
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)
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 Outcomes (1)
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)
Study Arms (4)
Usual Care
NO INTERVENTIONStandard clinical care in primary care offices
Ask 3 Questions
EXPERIMENTALPatients using 3 questions to their physicians when making medical decisions during the office visit.
Open Communication
EXPERIMENTALThis 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
EXPERIMENTALA combination of both the Ask 3 and Open Communication arms.
Interventions
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 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.
Eligibility Criteria
You may qualify if:
- Any patient with a scheduled appointment with the participating family medicine and internal medicine physicians during the study period.
You may not qualify if:
- Non-English speakers
- Patients younger than 18
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Palo Alto Medical Foundationlead
- Gordon and Betty Moore Foundationcollaborator
- Dartmouth Collegecollaborator
- University of Rochestercollaborator
- Ideocollaborator
- PRN Consultingcollaborator
Related 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.
PMID: 24389354BACKGROUNDLerman 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.
PMID: 2299426BACKGROUNDElwyn 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.
PMID: 15713169BACKGROUNDTai-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.
PMID: 27044959RESULT
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Ming Tai-Seale
- Organization
- Palo Alto Medical Foundation Research Institute
Study Officials
- PRINCIPAL INVESTIGATOR
Ming Tai-Seale, PhD, MPH
Palo Alto Medical Foundation
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Senior Scientist
Study Record Dates
First Submitted
May 16, 2015
First Posted
August 13, 2015
Study Start
June 1, 2014
Primary Completion
April 1, 2015
Study Completion
May 1, 2015
Last Updated
July 20, 2018
Results First Posted
July 20, 2018
Record last verified: 2017-09