NCT03385512

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

Completed NA Last updated 14 November 2022

What this trial tests

NA trial testing OPEN High Touch in Patient Engagement in 5,565 participants. Completed in 30 September 2022.

Timeline

23 January 2018

Primary endpoint
30 September 2022

30 September 2022

Quick facts

Lead sponsor	University of California, San Diego
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	health services research
Enrollment	5,565
Start date	23 January 2018
Primary completion	30 September 2022
Estimated completion	30 September 2022
Sites	3 locations across United States

Drugs / interventions tested

• OPEN High Touch
• OPEN High Tech
• ASK Poster in Exam Rooms

Conditions studied

• Patient Engagement — all drugs for Patient Engagement →
• Physician's Role — all drugs for Physician's Role →
• Physician-Patient Relations — all drugs for Physician-Patient Relations →
• Patient Activation — all drugs for Patient Activation →

Sponsor

University of California, San Diego

Who can join

18 and older, any sex, with Patient Engagement or Physician's Role. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Implementation of Patient Engagement Tools in Electronic Health Records to Enhance Patient-Centered Communication: Protocol for Feasibility Evaluation and Preliminary Results.
   Tai-Seale M, Rosen R, Ruo B, Hogarth M, et al · · 2021 · cited 16× · PMID 34435960 · DOI 10.2196/30431
2. Patient-Clinician Communication Interventions Across Multiple Primary Care Sites: A Cluster Randomized Clinical Trial.
   Tai-Seale M, Cheung M, Vaida F, Ruo B, et al · · 2024 · cited 1× · PMID 39671203 · DOI 10.1001/jamahealthforum.2024.4436
3. Patients' Perspectives on Plans Generated During Primary Care Visits and Self-Reported Adherence at 3 Months: Data From a Randomized Trial.
   Stults CD, Mazor KM, Cheung M, Ruo B, et al · · 2024 · cited 1× · PMID 38483458 · DOI 10.2196/50242
4. Comparing Ways to Support Communication between Patients and Their Primary Care Providers
   Tai-Seale M, Mazor K, Stults CD, Vaida F, et al · · 2024 · PMID 42013220