Clinical trial NCT03385512: OPEN & ASK: Improving Patient-Centered Communication in Primary Care
Official title: Improving Patient-Centered Communication in Primary Care: A Cluster Randomized Controlled Trial of the Comparative Effectiveness of Three Interventions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patient Engagement
Physician's Role
Physician-Patient Relations
Patient Activation
Keywords: Virtual standardized patient coaching
Standardized patient instructor coaching
Patient centered communication
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: Reliant Medical Group
name: University of Massachusetts, Worcester
name: Palo Alto Medical Foundation
name: Patient-Centered Outcomes Research Institute
First posted: 2017-12-28
Enrollment: 5565
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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

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.

Detailed description: This is a three-arm, multi-site, cluster-randomized controlled trial, comparing three approaches to improve communication between patients and their doctors. Three health systems will participate in the study: UCSD Health, Reliant Medical Group, and Sutter Health.

The study will be carried out in 2 phases.

Phase 1: Phase 1 includes intervention and survey development work to take place prior to the RCT.

OPEN High Touch intervention - The High Touch intervention will be modeled after the Open Communication intervention developed in the pilot (ClinicalTrials.gov Identifier NCT02522286) which contained three components: (a) a one question pre-visit survey 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 Tech intervention - For the High Tech arm, 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 with embedded audio and video vignettes demonstrating the communication challenges (e.g., patient with a big list of issues, patients who resist physician recommendations, and patients who disagree with physician) and recommended strategies. A mobile app offers several advantages, including being accessible at a convenient time for busy providers, being easily disseminated, and easily updated. The app will be interactive, posing questions to learners in association with video vignettes and asking learners to answer how they would handle the situation. We will start with the idea of building a set of short mobile modules that mirror the High Touch approach, honing skills on acknowledging patient's agenda, negotiate a joint agenda, invite patient to teachback and incorporate it in the After Visit Summary in the EHR.

ASK intervention - The ASK intervention 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 each of the benefits and risks to happen to me? These questions will be printed on posters and placed in exam rooms used by providers in clinics randomized to the ASK arm of the trial.

Phase 2: Phase 2 covers the trial recruitment, and three waves of data collection. Prior to the start of the RCT we will collect baseline (T0) data to allow measurement of primary care provider (PCP) performance prior to the trial. Patients participating in the T0 phase will provide only post-visit ratings of their encounters; we will not collect other outcome data or clinical indicators for these patients. For all patients in the intervention phase, we will be collecting information at two time points: 1) immediately post-encounter (T1); and 2) three months post-encounter (T2). We will further sample the top 5% high users of services after the intervention and review their medical records including the indexed visit and subsequent services that had occurred within four weeks after the indexed visit. The chart review will enable us to decipher the reasons for high volume of services after the indexed visit. We will also use existing patient survey data (Press-Ganey and/or NRC) to supplement our data sources.

Analytical approach: We will apply intention to treat analysis, providing descriptive statistics on relevant outcome measures across patients, PCPs, and clinics according to their randomized assignments in the RCT. We will then use generalized estimating equations logistic regression analysis to examine the impact of the assignment into the intervention arms and the outcomes, while controlling for patient and physician covariates.

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.

Primary outcomes:
measure: Patient reported experience with care: CollaboRATE
timeFrame: Within 7 days of a regularly scheduled appointment (the indexed visit) and 3 months after the indexed visit.
measure: Patient reported experience with care: Doctor Facilitation subscale of the Perceived Involvement in Care Scale
timeFrame: Within 7 days of a regularly scheduled appointment (the indexed visit) and 3 months after the indexed visit.
Secondary outcomes:
measure: Action Plan
timeFrame: This will be measured within 7 days of the indexed appointment for intervention patients.
measure: Patient reported confidence to adhere to action plan
timeFrame: This will be measured within 7 days and again 3 months after the indexed visits for intervention patients.
measure: Patient reported intention to adhere to action plan
timeFrame: This will be measured within 7 days and again 3 months after the indexed visits for intervention patients.
measure: Adherence to action plans
timeFrame: This will be measured within 7 days and again 3 months after the indexed visits for intervention patients.
measure: The Veterans RAND 12-item health survey (VR12)
timeFrame: This will be measured within 7 days and again 3 months after the indexed visits for intervention patients.
measure: Blood pressure
timeFrame: 12 months after indexed visits for intervention patients.
measure: A1c
timeFrame: 12 months after indexed visits for intervention patients.
measure: LDL
timeFrame: 12 months after indexed visits for intervention patients.
measure: Patient-initiated calls
timeFrame: 12 months after indexed visits for intervention patients.
measure: E-messages
timeFrame: 12 months after indexed visits for intervention patients.
measure: Office visits
timeFrame: 12 months after indexed visits for intervention patients.
Other outcomes:
Locations:
city: Mountain View
country: United States
facility: Palo Alto Medical Foundation Research Institute
state: California
city: San Diego
country: United States
facility: University of California San Diego Health System
state: California
city: Worcester
country: United States
facility: Meyers Primary Care Institute at University of Massachusetts Medical School/Reliant Medical Group
state: Massachusetts
Study officials:
affiliation: University of California, San Diego
name: Ming Tai-Seale, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.