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

NCT03385512 | Completed

• 1 other identifier: IHS-1608-35689
• Study Type: interventional
• Target: 5,565
• Locations: 1 country
• Sites: 3

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. 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. 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. 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.

Conditions

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

Keywords

Virtual standardized patient coaching; Standardized patient instructor coaching; Patient centered communication

Outcome Measures

Primary Outcomes (2)

• Patient reported experience with care: CollaboRATE

  Responses from CollaboRATE, a validated 3-item, patient-reported measure of shared decision making compared between baseline and intervention patients; immediately after the indexed visit and 3 months after the indexed visit with their PCP for intervention patients; and across interventions for variations. The 3 questions, which will be answered on a scale of o "No effort was made" to 9 "Every effort was made" are: 1. How much effort was made to help you understand your health issue? 2. How much effort was made to listen to the things that matter most to you about your health issues? 3. How much effort was made to include what matters most to you in choosing what to do next?

  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

  Responses from this validated 5-item, patient reported measure of their perceptions of how well their physician facilitated their involvement in decision making are compared between baseline and intervention patients; immediately after the indexed visit with their PCP and 3 months after the indexed visit for intervention patients; and across interventions for variations. The 5 questions, which will answered on a scale of 0 "Definitely Disagree" to 9 "Definitely Agree" are: 1. My doctor asked me whether I agree with his/her decisions 2. My doctor gave me a complete explanation for my medical symptoms or treatment 3. My doctor asked me what I believe is causing my medical symptoms 4. My doctor encouraged me to talk about personal concerns related to my medical symptoms 5. My doctor encouraged me to give my opinion about my medical treatment.

  Within 7 days of a regularly scheduled appointment (the indexed visit) and 3 months after the indexed visit.

Secondary Outcomes (11)

• 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.

Study Arms (3)

OPEN High Touch

EXPERIMENTAL

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

Behavioral: OPEN High Touch

OPEN High Tech

EXPERIMENTAL

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

Behavioral: OPEN High Tech

ASK Poster

EXPERIMENTAL

Participants in this arm will experience the ASK intervention.

Behavioral: ASK Poster in Exam Rooms

Interventions

OPEN High Touch BEHAVIORAL

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.

OPEN High Touch

OPEN High Tech BEHAVIORAL

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.

OPEN High Tech

ASK Poster in Exam Rooms BEHAVIORAL

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.

ASK Poster

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Diego: lead
• Reliant Medical Group: collaborator
• University of Massachusetts, Worcester: collaborator
• Palo Alto Medical Foundation: collaborator
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (3)

Palo Alto Medical Foundation Research Institute

Mountain View, California, 94040, United States

Location

University of California San Diego Health System

San Diego, California, 92093, United States

Location

Meyers Primary Care Institute at University of Massachusetts Medical School/Reliant Medical Group

Worcester, Massachusetts, 01605, United States

Location

Related Publications (6)

• Tai-Seale M, Elwyn G, Wilson CJ, Stults C, Dillon EC, Li M, Chuang J, Meehan A, Frosch DL. Enhancing Shared Decision Making Through Carefully Designed Interventions That Target Patient And Provider Behavior. Health Aff (Millwood). 2016 Apr;35(4):605-12. doi: 10.1377/hlthaff.2015.1398.

  PMID: 27044959 BACKGROUND

• Tai-Seale M, Sullivan G, Cheney A, Thomas K, Frosch D. The Language of Engagement: "Aha!" Moments from Engaging Patients and Community Partners in Two Pilot Projects of the Patient-Centered Outcomes Research Institute. Perm J. 2016 Spring;20(2):89-92. doi: 10.7812/TPP/15-123. Epub 2016 Feb 22.

  PMID: 26909777 BACKGROUND

• Dillon EC, Stults CD, Wilson C, Chuang J, Meehan A, Li M, Elwyn G, Frosch DL, Yu E, Tai-Seale M. An evaluation of two interventions to enhance patient-physician communication using the observer OPTION5 measure of shared decision making. Patient Educ Couns. 2017 Oct;100(10):1910-1917. doi: 10.1016/j.pec.2017.04.020. Epub 2017 May 1.

  PMID: 28532861 BACKGROUND

• Tai-Seale M, Cheung M, Vaida F, Ruo B, Walker A, Rosen RL, Hogarth M, Fisher KA, Singh S, Yood RA, Garber L, Saphirak C, Li M, Chan AS, Yu EE, Kallenberg G, Longhurst CA, Millen M, Stults CD, Mazor KM. Patient-Clinician Communication Interventions Across Multiple Primary Care Sites: A Cluster Randomized Clinical Trial. JAMA Health Forum. 2024 Dec 6;5(12):e244436. doi: 10.1001/jamahealthforum.2024.4436.

  PMID: 39671203 DERIVED

• Stults CD, Mazor KM, Cheung M, Ruo B, Li M, Walker A, Saphirak C, Vaida F, Singh S, Fisher KA, Rosen R, Yood R, Garber L, Longhurst C, Kallenberg G, Yu E, Chan A, Millen M, Tai-Seale M. Patients' Perspectives on Plans Generated During Primary Care Visits and Self-Reported Adherence at 3 Months: Data From a Randomized Trial. J Particip Med. 2024 Mar 14;16:e50242. doi: 10.2196/50242.

  PMID: 38483458 DERIVED

• Tai-Seale M, Rosen R, Ruo B, Hogarth M, Longhurst CA, Lander L, Walker AL, Stults CD, Chan A, Mazor K, Garber L, Millen M. Implementation of Patient Engagement Tools in Electronic Health Records to Enhance Patient-Centered Communication: Protocol for Feasibility Evaluation and Preliminary Results. JMIR Res Protoc. 2021 Aug 26;10(8):e30431. doi: 10.2196/30431.

  PMID: 34435960 DERIVED

MeSH Terms

Conditions

Patient Participation

Condition Hierarchy (Ancestors)

Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Ming Tai-Seale, PhD, MPH

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Family Medicine and Public Health, and Director of Outcomes Analytics

Model Details: 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.

Study Record Dates

• First Submitted: December 20, 2017
• First Posted: December 28, 2017
• Study Start: January 23, 2018
• Primary Completion: September 30, 2022
• Study Completion: September 30, 2022
• Last Updated: November 14, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Within 9 months after the completion of the study.
• Access Criteria: A Data Use Agreement will be implemented for other researchers interested in using our data for replication of research findings or for additional areas of research. We will request that outside investigators discuss their manuscript ideas with the PI (Dr. Tai-Seale) and Site-PIs (Dr. Cheryl Stults and Dr. Kathy Mazor) before proceeding. Furthermore, we will request that manuscripts using data from our project be approved by the PI and Site-PIs prior to submission for publication. Members of this project team may contribute as co-authors when data from this study are used. We will request that manuscripts, abstracts, presentations, and chapters developed by other investigators credit this study and credit PCORI as the funding source for the data. This process will allow for a central repository and access point for all papers, abstracts, posters, and presentations by any individual or organization using our data.

Locations

US (3)