Patient Engagement Clinical Trial
Official title:
Improving Patient-Centered Communication in Primary Care: A Cluster Randomized Controlled Trial of the Comparative Effectiveness of Three Interventions
Verified date | November 2022 |
Source | University of California, San Diego |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 5565 |
Est. completion date | September 30, 2022 |
Est. primary completion date | September 30, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Palo Alto Medical Foundation Research Institute | Mountain View | California |
United States | University of California San Diego Health System | San Diego | California |
United States | Meyers Primary Care Institute at University of Massachusetts Medical School/Reliant Medical Group | Worcester | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
University of California, San Diego | Palo Alto Medical Foundation, Patient-Centered Outcomes Research Institute, Reliant Medical Group, University of Massachusetts, Worcester |
United States,
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 OPTION(5) 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. — View 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. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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:
How much effort was made to help you understand your health issue? 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. | |
Primary | 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:
My doctor asked me whether I agree with his/her decisions My doctor gave me a complete explanation for my medical symptoms or treatment My doctor asked me what I believe is causing my medical symptoms My doctor encouraged me to talk about personal concerns related to my medical symptoms 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 | Action Plan | 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. | This will be measured within 7 days of the indexed appointment for intervention patients. | |
Secondary | Patient reported confidence to adhere to action plan | 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). | This will be measured within 7 days and again 3 months after the indexed visits for intervention patients. | |
Secondary | Patient reported intention to adhere to action plan | 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. | This will be measured within 7 days and again 3 months after the indexed visits for intervention patients. | |
Secondary | Adherence to action plans | A patient reported measure that will be adapted from the Medical Outcomes Study (MOS) general adherence survey instrument with help from our study stakeholders. | This will be measured within 7 days and again 3 months after the indexed visits for intervention patients. | |
Secondary | The Veterans RAND 12-item health survey (VR12) | A 12-item patient reported health status measure. | This will be measured within 7 days and again 3 months after the indexed visits for intervention patients. | |
Secondary | Blood pressure | This will be extracted from the electronic health record and used as a clinical indicator of health outcomes. | 12 months after indexed visits for intervention patients. | |
Secondary | A1c | This will be extracted from the electronic health record and used as a clinical indicator of health outcomes. | 12 months after indexed visits for intervention patients. | |
Secondary | LDL | This will be extracted from the electronic health record and used as a clinical indicator of health outcomes. | 12 months after indexed visits for intervention patients. | |
Secondary | Patient-initiated calls | 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. | 12 months after indexed visits for intervention patients. | |
Secondary | E-messages | 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. | 12 months after indexed visits for intervention patients. | |
Secondary | Office visits | 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. | 12 months after indexed visits for intervention patients. |
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