Creating a Zone of Openness to Increase Patient-Centered Care

NCT ID: NCT02522286

Last Updated: 2018-07-20

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2015-05-31

Brief Summary

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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

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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

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Patient Engagement Physician's Role Physician-Patient Relationship

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Usual Care

Standard clinical care in primary care offices

Group Type NO_INTERVENTION

No interventions assigned to this group

Ask 3 Questions

Patients using 3 questions to their physicians when making medical decisions during the office visit.

Group Type EXPERIMENTAL

Ask 3 Questions

Intervention Type BEHAVIORAL

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

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.

Group Type EXPERIMENTAL

Open Communication

Intervention Type BEHAVIORAL

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.

Group Type EXPERIMENTAL

Ask 3 Questions

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Gordon and Betty Moore Foundation

OTHER

Sponsor Role collaborator

Dartmouth College

OTHER

Sponsor Role collaborator

University of Rochester

OTHER

Sponsor Role collaborator

Ideo

INDUSTRY

Sponsor Role collaborator

PRN Consulting

UNKNOWN

Sponsor Role collaborator

Palo Alto Medical Foundation

OTHER

Sponsor Role lead

Responsible Party

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Ming Tai-Seale, Phd, MPH

Senior Scientist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ming Tai-Seale, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

Palo Alto Medical Foundation

References

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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.

Reference Type BACKGROUND
PMID: 24389354 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 2299426 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15713169 (View on PubMed)

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.

Reference Type RESULT
PMID: 27044959 (View on PubMed)

Related Links

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Other Identifiers

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PCORI-1IP2PI000055-01

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

37930708

Identifier Type: -

Identifier Source: org_study_id

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