Contributions to the literature
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This study applies a sequential multiple assignment randomized trial design to understand and accelerate the impact of a co-created health prevention program designed to address COVID-19 vaccine equity and primary care engagement for communities of color served in a Federally Qualified Health Center.
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This study integrates methods from community engagement, implementation science, health equity, health communication, infectious disease, and public health perspectives to mitigate health disparities and advance health equity.
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This study focuses on the rarely examined implementation outcome of sustained engagement in preventive services among historically underserved communities.
Background
COVID-19 disparities experienced by underserved communities in California
Multi-level factors driving vaccine hesitancy and vaccine uptake: individual, structural, systemic, and technological
Promise of implementation science in addressing vaccine hesitancy and uptake for underserved communities
Implementation strategies
Co-creation with CABs led by Community Weavers
Use of mobile health (mHealth) technologies for health communication
Care coordination
Theory of change and implementation science framework
Theory of change (ToC)
Practical, Robust Implementation, and Sustainability Model
Aims
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Aim 1: Optimize a multicomponent health program to promote COVID-19 vaccine uptake and engagement in preventive healthcare using our established co-creation approach to address multi-level (individual, community, systemic) barriers to vaccine uptake and preventive services engagement.
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Aim 2: Evaluate the implementation, effectiveness, and sustainment of the multicomponent COVID-19 vaccine and preventive services engagement program using a hybrid type 3 effectiveness-implementation sequential multiple assignment randomized trial (SMART) design across immigrant, refugee, Latino, and BIPOC communities in Central, North, and East San Diego.
Methods
Design
Setting
Clinic 1 | Clinic 2 | Clinic 3 | |
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Patient volume | |||
Total no. of patients/site | 2573 | 1751 | 1528 |
Race/ethnicity | |||
Asian | 44% | 68% | 5% |
Black | 9% | 2% | 5% |
White | 26% | 24% | 55% |
Latino | 22% | 7% | 44% |
Preferred language | |||
Arabic | 0.1% | 68% | 0.4% |
Spanish | 7% | 3% | 18% |
Vietnamese | 32% | No data | 0% |
Preventive health services | |||
Blood pressure (any time) | 74% | 93% | 89% |
HbA1c screening (any time) | 57% | 56% | 71% |
Community-level data by zip codea | |||
COVID-19 positivity (rate per 100,000) | 22,589 | 24,530 | 23,427 |
COVID-19 vaccination (rate per 1000) | 807 | 745 | 803 |
Participants
Procedures
Community engagement through CABs and Community Weavers
mHealth development and outreach
Care coordination
Standard of Care | Multi-component health program |
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Aligned with patient-centered medical home components and quality-of-care measures | Community Weaver led Co-Creation Overarching strategy |
Care coordination | mHealth Outreach |
• Routine immunization efforts • Annual physical exam • Eligibility: defined medical conditions (e.g., uncontrolled diabetes, hypertension), high health services utilization (e.g., > 5 medications), social determinants of health and referred by care team | Community outreach led by Community Weavers via SMS and voice messages about COVID-19 vaccines (importance, reminders, how to access) and preventive services engagement (importance, reminders, how to access) in languages spoken by patients (i.e., Spanish, Arabic, Vietnamese) |
Care Coordination | |
Inclusive
of standard of care coordination with added focus on completing
outstanding preventive services (e.g., HbA1c, blood pressure
screenings, mammograms, colorectal cancer screening) |
Measures
Data source name | Type | Origin | PRISM domains |
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mHealth message delivery study database (QUANT + QUAL) | #, timing, type, content of message delivery for each language groups | mHealth specialist | Implementation Maintenance |
Care coordination study database (QUANT + QUAL) | #, timing, type of care coordination activities | Care coordinators | Implementation Maintenance |
Community Weaver study database (QUANT + QUAL) | #, timing, type of interactions with communities | Community Weavers | Implementation Maintenance |
Periodic reflections (QUAL) | Key lessons learned, facilitators, challenges of implementation of and adaptations to program components | mHealth specialist Community Weavers Care coordinators Research team | Intervention characteristics Implementation & sustainability infrastructure External environment |
Participant user engagement check-in (QUANT) | Acceptability, appropriateness, utility, and value of text/voice messages and care coordination | All participants in mHealth or mHealth & care coordination arm | Reach Implementation Intervention characteristics |
Participant evaluation surveys (QUANT) | Satisfaction, engagement, and impact of the multicomponent health program | All participants in mHealth or mHealth and care coordination arm | Implementation Effectiveness Maintenance |
Participant interview (QUANT + QUAL) | Acceptability, appropriateness, utility, and value of text/voice messages and care coordination | Subset of participants (n = 60, 20 from each clinic) | Implementation Effectiveness Maintenance |
Participant vaccine and preventive service status & health characteristics (QUANT) | EHR data on study primary and secondary outcomes, patient demographic, other health characteristics | Care coordinators | Reach Recipient characteristics |
Delivery agent survey (QUANT) | Demographic and professional characteristics of Community Weavers and care coordinators | Community Weavers Care coordinators | Recipient characteristics Adoption |
Implementation outcomes | Reach | The absolute number, proportion, and representativeness of participants who are compared to all eligible patients on key characteristics. Reasons for nonparticipation |
Adoption | Demographic and professional characteristics of Community Weavers and care coordinators | |
Implementation | #, timing, type, content of delivery of mHealth messages, care coordination, and Community Weaver activities | |
Maintenance | Ongoing delivery of mHealth messages, care coordination, and Community Weaver activities during the sustainment phase. Ongoing impact on vaccine acceptance and confidence, COVID-19 vaccine uptake, and preventive services engagement | |
Effectiveness (clinical) outcomes | Vaccine confidence | Adapted vaccine confidence survey |
Intention to engage in preventive services | Measured as scheduled appointments for due or overdue preventive services | |
COVID-19 vaccine uptake | Up-to-date vaccine record defined as completed vaccine series and required boosters as recommended by Centers for Disease Control guidelines for COVID-19 vaccination at the time of implementation to be confirmed through electronic health records | |
Preventive services engagement | Up-to-date age- and gender-specific preventive services (e.g., mammograms, adult immunizations, blood pressure screenings, A1c screenings, colorectal cancer screenings). Standards will be defined for each participant based on their demographic and health characteristics |