OPEN & ASK: Improving Patient-Centered Communication in Primary Care

Summary

This large scale multi-center cluster randomized controlled trial (RCT) is designed to assess the comparative effectiveness of three interventions in diverse ambulatory care settings and patient populations. Findings will help healthcare systems decide which approach to adopt to empower patients and enable providers to engage in patient centered communication. The specific aims are to:

1. Engage with patients and healthcare providers who have used the tools in the pilot study (ClinicalTrials.gov Identifier NCT02522286) at the Sutter Health Palo Alto Medical Foundation (PAMF), as well as new stakeholders at University of California San Diego Health System and Meyers Primary Care Institute at University of Massachusetts and Reliant Medical Group, to further refine and adapt these patient-centered interventions to be integrated into real world primary care clinics.
2. Conduct a large scale cluster RCT with three arms, to evaluate the comparative effectiveness of three interventions: OPEN with in-person SPI training (High Touch), OPEN with online SPI training (High Tech), and ASK. Primary outcomes will include patient perceptions of how well their PCPs have engaged them in patient centered communication. The investigators will also measure patients' confidence in managing their health, intention to follow through with care plans, and downstream behaviors in following through with care plans, use of services such as phone calls, secure messaging, and additional visits.
3. Identify the strategy that has the most potential for sustained impact and replication within and across healthcare systems. The investigators will analyze the fidelity to the intervention protocols, including consistency of delivery as intended and the time/effort involved in implementing the interventions. The investigators will also assess the extent to which the programs become institutionalized.

The investigators anticipate that this multi-level healthcare system intervention will result in significant improvement in: patient satisfaction with how PCP has engaged them in the visit, confidence in selfcare; patients' intention to adhere to care plan, and clinical indicators. Furthermore, more effective communication would lower health service utilization after the visit. The investigators further expect that the intervention will affect physicians', medical assistants' and nurses' experience as well as healthcare system leaders' intention to implement in routine practice.

Conditions

• Patient Engagement
• Physician's Role
• Physician-Patient Relations
• Patient Activation

Interventions

BEHAVIORAL

OPEN High Touch

This arm will contain three components: (a) a pre-visit questionnaire delivered through the patient portal of the EHR, asking patients what they most want to discuss with their physician in the upcoming visit; (b) an animated video for patients providing coaching on how to best prepare for their upcoming visits and get the most from the visits; and (c) Standardized Patient Instructor (SPI) providing communication coaching for physicians on how to incorporate what matter most to patients in the visit, with empathy, and clarity.

BEHAVIORAL

OPEN High Tech

The patient components of the intervention will be identical to the patient components of the High Touch arm (i.e., the pre-visit survey and patient coaching video). The difference will be in the PCP training: we will replace the in-person SPI with a mobile app program.

BEHAVIORAL

ASK Poster in Exam Rooms

This arm is intended to activate patients by encouraging them to ask three questions during their primary care visit: (1) What are my options? (2) What are the possible benefits and risks of each option? (3) How likely are the benefits and risks of each option to occur to me? This will involve placing posters with these questions in all exam rooms used by providers in clinics randomized to the ASK arm of the trial.

Sponsors & Collaborators

• Reliant Medical Group

  collaborator OTHER

• University of Massachusetts, Worcester

  collaborator OTHER

• Palo Alto Medical Foundation

  collaborator OTHER

• Patient-Centered Outcomes Research Institute

  collaborator OTHER

• University of California, San Diego

  lead OTHER

Principal Investigators

• Ming Tai-Seale, PhD, MPH · University of California, San Diego

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2018-01-23

Primary Completion

2022-09-30

Completion

2022-09-30

Countries

• United States

Study Locations