OPEN & ASK Cluster Randomized Controlled Trial

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. We will also measure patients' confidence in managing their health, their
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. We will analyze the fidelity to the intervention
protocols, including consistency of delivery as intended and the time/effort involved in
implementing the interventions. We will also assess the extent to which the programs
become institutionalized.

We 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, their
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. We 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.