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

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ClinicalTrials.gov Identifier: NCT03385512
Recruitment Status : Recruiting
First Posted : December 28, 2017
Last Update Posted : February 26, 2018
Sponsor:
Collaborators:
Reliant Medical Group
University of Massachusetts, Worcester
Palo Alto Medical Foundation
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
Ming Tai-Seale, 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.


Condition or disease Intervention/treatment Phase
Patient Engagement Physician's Role Physician-Patient Relations Patient Activation Behavioral: OPEN High Touch Behavioral: OPEN High Tech Behavioral: ASK Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 5565 participants
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.
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Improving Patient-Centered Communication in Primary Care: A Cluster Randomized Controlled Trial of the Comparative Effectiveness of Three Interventions
Actual Study Start Date : January 23, 2018
Estimated Primary Completion Date : August 1, 2020
Estimated Study Completion Date : May 1, 2021

Arm Intervention/treatment
Experimental: OPEN High Touch
Participants in this arm will experience the OPEN High Touch intervention.
Behavioral: OPEN High Touch
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.

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

Experimental: ASK
Participants in this arm will experience the ASK intervention.
Behavioral: ASK
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.




Primary Outcome Measures :
  1. Patient reported experience with care: CollaboRATE [ Time Frame: Within 7 days of a regularly scheduled appointment (the indexed visit) and 3 months after the indexed visit. ]

    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?

  2. Patient reported experience with care: Doctor Facilitation subscale of the Perceived Involvement in Care Scale [ Time Frame: Within 7 days of a regularly scheduled appointment (the indexed visit) and 3 months after the indexed visit. ]

    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.


Secondary Outcome Measures :
  1. Action Plan [ Time Frame: This will be measured within 7 days of the indexed appointment for intervention patients. ]
    The "Patient Instructions" field of the After Visit Summary that patients receive in paper and/or through their online patient portal after the indexed visit with their provider.

  2. Patient reported confidence to adhere to action plan [ Time Frame: This will be measured within 7 days and again 3 months after the indexed visits for intervention patients. ]
    Responses from a patient reported measure of their confidence to adhere to their action plan. This will be measured by the question "Overall, how confident are you about your ability to take good care of your health?" using a 5-point Likert scale from 1=not confident at all to 5=Completely confident. This is a question used in the Health Information National Trends Survey (HINTS), a biennial, cross-sectional survey of a nationally-representative sample of American adults, developed and used by the Center for Disease Control and Prevention and National Cancer Institute (https://www.healthypeople.gov/2020/data-source/health-information-national-trends-survey).

  3. Patient reported intention to adhere to action plan [ Time Frame: This will be measured within 7 days and again 3 months after the indexed visits for intervention patients. ]
    Responses from this patient reported measure of intention to adhere to their action plan. We will examine the psychometric property of these measures and expect that they will enable us to form a factor that measures the construct of intention to adhere to care plans. We call this measure INTENTION.

  4. Adherence to action plans [ Time Frame: This will be measured within 7 days and again 3 months after the indexed visits for intervention patients. ]
    A patient reported measure that will be adapted from the Medical Outcomes Study (MOS) general adherence survey instrument with help from our study stakeholders.

  5. The Veterans RAND 12-item health survey (VR12) [ Time Frame: This will be measured within 7 days and again 3 months after the indexed visits for intervention patients. ]
    A 12-item patient reported health status measure.

  6. Blood pressure [ Time Frame: 12 months after indexed visits for intervention patients. ]
    This will be extracted from the electronic health record and used as a clinical indicator of health outcomes.

  7. A1c [ Time Frame: 12 months after indexed visits for intervention patients. ]
    This will be extracted from the electronic health record and used as a clinical indicator of health outcomes.

  8. LDL [ Time Frame: 12 months after indexed visits for intervention patients. ]
    This will be extracted from the electronic health record and used as a clinical indicator of health outcomes.

  9. Patient-initiated calls [ Time Frame: 12 months after indexed visits for intervention patients. ]
    These will be measured using structured fields in the electronic health record and access log. The investigators will review the charts of the top 5% of telephone callers.

  10. E-messages [ Time Frame: 12 months after indexed visits for intervention patients. ]
    These will be measured using structured fields in the electronic health record and access log. The investigators will review the charts of the top 5% of e-message senders.

  11. Office visits [ Time Frame: 12 months after indexed visits for intervention patients. ]
    These will be measured using structured fields in the electronic health record. The investigators will review the charts of the top 5% of office visit generators.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03385512


Contacts
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Contact: Ming Tai-Seale, PhD, MPH 858-246-1939 mtaiseale@ucsd.edu
Contact: Amy Meehan, MPH 650-853-4758 meehana@pamfri.org

Locations
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United States, California
Palo Alto Medical Foundation Research Institute Not yet recruiting
Mountain View, California, United States, 94040
Contact: Cheryl Stults, PhD    650-853-2346    stultsc@pamfri.org   
Principal Investigator: Cheryl Stults, PdH         
University of California San Diego Health System Not yet recruiting
San Diego, California, United States, 92093
Contact: Ming Tai-Seale, PhD, MPH    858-246-1939    mtaiseale@ucsd.edu   
Principal Investigator: Ming Tai-Seale, PhD, MPH         
United States, Massachusetts
Meyers Primary Care Institute at University of Massachusetts Medical School/Reliant Medical Group Recruiting
Worcester, Massachusetts, United States, 01605
Contact: Kathy Mazor, PhD    508-791-7392    Kathy.Mazor@meyersprimary.org   
Contact: Cassandra Saphirak, MA       Cassandra.Saphirak@meyersprimary.org   
Principal Investigator: Kathy Mazor, PhD         
Sponsors and Collaborators
University of California, San Diego
Reliant Medical Group
University of Massachusetts, Worcester
Palo Alto Medical Foundation
Patient-Centered Outcomes Research Institute
Investigators
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Principal Investigator: Ming Tai-Seale, PhD, MPH University of California, San Diego

Publications:
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Responsible Party: Ming Tai-Seale, Professor of Family Medicine and Public Health, and Director of Outcomes Analytics, University of California, San Diego
ClinicalTrials.gov Identifier: NCT03385512     History of Changes
Other Study ID Numbers: IHS-1608-35689
First Posted: December 28, 2017    Key Record Dates
Last Update Posted: February 26, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: We will make a complete, cleaned, de-identified copy of the final data set used in conducting the final analyses available within 9 months after the completion of the study. Researchers interested in replicating our methods and study findings will have full access to the study protocol, samples of intervention prototypes, analytic methods and codebook. We will deliver our final protocol, prototypes, toolkit, codebook documents, and instructions regarding how other researchers can access our study documents to PCORI.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ming Tai-Seale, University of California, San Diego:
Virtual standardized patient coaching
Standardized patient instructor coaching
Patient centered communication