Clinical trial NCT02522286: Creating a Zone of Openness to Increase Patient-Centered Care
Official title: Creating a Zone of Openness to Increase Patient-Centered Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patient Engagement
Physician's Role
Physician-Patient Relationship
Keywords: patient engagement
physician's role
patient- centered care
communication
Lead sponsor: Palo Alto Medical Foundation
Sponsor class: OTHER
Collaborators: name: Gordon and Betty Moore Foundation
name: Dartmouth College
name: University of Rochester
name: Ideo
name: PRN Consulting
First posted: 2015-08-13
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

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).

Eligibility criteria: 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

Primary outcomes:
measure: Patient Rating of Shared Decision Making
timeFrame: Day 1 (outcomes measures were assessed once for each participant)
measure: Doctor Facilitation Subscale of the Perceived Involvement in Care Scale
timeFrame: Day 1 (outcomes measures were assessed once for each participant)
measure: Patient Responses to Stakeholder Generated Questions
timeFrame: Day 1 (outcomes measures were assessed once for each participant)
measure: Patients' Feeling of Respect by Their Doctor
timeFrame: Day 1 (outcomes measures were assessed once for each participant)
Secondary outcomes:
measure: Option 5 Shared Decision Making Score
timeFrame: Day 1 (outcomes measures were assessed once for each participant based on analysis of the audio recording of their visits)
Other outcomes:
Locations:
Study officials:
affiliation: Palo Alto Medical Foundation
name: Ming Tai-Seale, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.