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

Improving Patient-Centered Communication in Primary Care: A Cluster Randomized Controlled Trial of the Comparative Effectiveness of Three Interventions

Sponsors

Lead Sponsor: University of California, San Diego

Collaborator: Reliant Medical Group
University of Massachusetts, Worcester
Palo Alto Medical Foundation
Patient-Centered Outcomes Research Institute

Source University of California, San Diego
Brief 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.

Overall Status Recruiting
Start Date January 23, 2018
Completion Date May 1, 2021
Primary Completion Date August 1, 2020
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Patient reported experience with care: CollaboRATE Within 7 days of a regularly scheduled appointment (the indexed visit) and 3 months after the indexed visit.
Patient reported experience with care: Doctor Facilitation subscale of the Perceived Involvement in Care Scale Within 7 days of a regularly scheduled appointment (the indexed visit) and 3 months after the indexed visit.
Secondary Outcome
Measure Time Frame
Action Plan This will be measured within 7 days of the indexed appointment for intervention patients.
Patient reported confidence to adhere to action plan This will be measured within 7 days and again 3 months after the indexed visits for intervention patients.
Patient reported intention to adhere to action plan This will be measured within 7 days and again 3 months after the indexed visits for intervention patients.
Adherence to action plans This will be measured within 7 days and again 3 months after the indexed visits for intervention patients.
The Veterans RAND 12-item health survey (VR12) This will be measured within 7 days and again 3 months after the indexed visits for intervention patients.
Blood pressure 12 months after indexed visits for intervention patients.
A1c 12 months after indexed visits for intervention patients.
LDL 12 months after indexed visits for intervention patients.
Patient-initiated calls 12 months after indexed visits for intervention patients.
E-messages 12 months after indexed visits for intervention patients.
Office visits 12 months after indexed visits for intervention patients.
Enrollment 5565
Condition
Intervention

Intervention Type: Behavioral

Intervention Name: OPEN High Touch

Description: 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.

Arm Group Label: OPEN High Touch

Intervention Type: Behavioral

Intervention Name: OPEN High Tech

Description: 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.

Arm Group Label: OPEN High Tech

Intervention Type: Behavioral

Intervention Name: ASK

Description: 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.

Arm Group Label: ASK

Eligibility

Criteria:

Inclusion Criteria:

For patient participants:

- Adults 18 years and older,

- Have an activated account to the patient portal of the electronic health record

- Able to read/write in English or Spanish

- Have an appointment with their PCP, who has volunteered to be participate in the study, during the data collection period

- Willing and able to provide informed consent and complete brief questionnaires online.

For health care team (primary care providers, nurse and medical assistants) participants:

- Employed at one of the participating study clinics

- Willing and able to provide informed consent and complete brief questionnaires online.

Exclusion Criteria:

For patient participants:

- People who don't speak English or Spanish

- People who do not have an active My Chart/My Health Online account.

- Younger than 18 years old.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Ming Tai-Seale, PhD, MPH Principal Investigator University of California, San Diego
Overall Contact

Last Name: Ming Tai-Seale, PhD, MPH

Phone: 858-246-1939

Email: [email protected]

Location
Facility: Status: Contact: Investigator:
Palo Alto Medical Foundation Research Institute | Mountain View, California, 94040, United States Not yet recruiting Cheryl Stults, PhD 650-853-2346 [email protected] Cheryl Stults, PdH Principal Investigator
University of California San Diego Health System | San Diego, California, 92093, United States Not yet recruiting Ming Tai-Seale, PhD, MPH 858-246-1939 [email protected] Ming Tai-Seale, PhD, MPH Principal Investigator
Meyers Primary Care Institute at University of Massachusetts Medical School/Reliant Medical Group | Worcester, Massachusetts, 01605, United States Recruiting Kathy Mazor, PhD 508-791-7392 [email protected] Kathy Mazor, PhD Principal Investigator
Location Countries

United States

Verification Date

April 2019

Responsible Party

Type: Principal Investigator

Investigator Affiliation: University of California, San Diego

Investigator Full Name: Ming Tai-Seale

Investigator Title: Professor of Family Medicine and Public Health, and Director of Outcomes Analytics

Keywords
Has Expanded Access No
Number Of Arms 3
Arm Group

Label: OPEN High Touch

Type: Experimental

Description: Participants in this arm will experience the OPEN High Touch intervention.

Label: OPEN High Tech

Type: Experimental

Description: Participants in this arm will experience the OPEN High Tech intervention.

Label: ASK

Type: Experimental

Description: Participants in this arm will experience the ASK intervention.

Patient Data Yes
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Intervention Model Description: Patient and health care team participants and the clinics in which they practice will be randomly assigned to one of three groups for the duration of their participation in the study: 1) OPEN High Tech, 2) OPEN High Touch and 3) ASK. Unit of randomization is clinic. Physicians will be clustered in clinics and patients clustered within physicians.

Primary Purpose: Health Services Research

Masking: None (Open Label)

Source: ClinicalTrials.gov