Creating a Zone of Openness to Increase Patient-Centered Care

Sutter Health

Status: Completed

Conditions: Physician-Patient Relationship; Physician's Role; Patient Engagement

Treatments: Behavioral: Ask 3 Questions; Behavioral: Open Communication

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02522286

PCORI-1IP2PI000055-01 (Other Grant/Funding Number)

37930708

Details and patient eligibility

About

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.

Full 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).

Enrollment: 300 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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300 participants in 4 patient groups

Usual Care

No Intervention group

Description:

Standard clinical care in primary care offices

Ask 3 Questions

Experimental group

Description:

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

Treatment:

Behavioral: Ask 3 Questions

Open Communication

Experimental group

Description:

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.

Treatment:

Behavioral: Open Communication

Ask 3 Questions + Open Communication

Experimental group

Description:

A combination of both the Ask 3 and Open Communication arms.

Treatment:

Behavioral: Open Communication

Behavioral: Ask 3 Questions