Clinical trial NCT04870307: Community-engaged Approaches to Testing in Community and Healthcare Settings for Underserved Populations
Official title: Community-engaged Approaches to Testing in Community and Healthcare Settings for Underserved Populations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Covid19
Keywords: COVID-19
RADx-UP
Health Services Research
Implementation Science
Evidence-based practice
Social determinants of health
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute of General Medical Sciences (NIGMS)
First posted: 2021-05-03
Enrollment: 323
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Dissemination and Implementation Research (D\&I): Involves assisting primary care practices to address SARS-CoV-2 testing using evidence-based practices as well as increased testing in mobile-based community settings. The D\&I model also involves Practice Assessment, Academic Detailing, Practice Facilitation, Health Information Technology Support, Performance Feedback and Benchmarking, and a Virtual Learning Community.
Primary purpose: OTHER

Brief summary: The pandemic caused by the novel coronavirus, Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), has resulted in substantial global morbidity and mortality including in Oklahoma and caused unprecedented interruptions in nearly all aspects of our lives. The population of the state of Oklahoma is at particular risk to SARS-CoV-2 due to its large rural population, strained healthcare system, and poor overall health. The Community-Engaged Approaches to Testing in Community and Healthcare Settings for Underserved Populations (CATCH-UP) program will involve both practice-based and community-based approaches to maximize the reach of the Rapid Acceleration of Diagnostics - Underserved Populations (RADx-UP) consortium, broaden the potential perspectives that could be captured, and compare the effectiveness of strategies. The interventions will be pragmatic to allow CATCH-UP to respond to changing attitudes, barriers, and environments as the pandemic progresses as well as expected technology developments to produce more effective viral testing that can provide rapid results to patients. The investigators will assist 50 small primary care practices to implement guidelines-based testing and patient education about Coronavirus Disease 2019 (COVID-19) and risk mitigation strategies. The project's community-based approach is designed to rapidly respond to community testing needs by deploying mobile testing sites that will provide operational support to increase the efficiency and the existing capacity for state-wide testing by Oklahoma's public health authorities. Together, the investigators estimate that the CATCH-UP program will result in at least 105,000 SARS-CoV-2 tests performed during the first year of implementation. A comprehensive, ongoing evaluation will be performed to analyze patient and provider attitudes, barriers and facilitators of viral testing, identified health disparities caused by COVID-19, effectiveness of the intervention in both settings, and to allow robust collaboration with other RADx-UP consortium sites.

Detailed description: The broad RADx-UP initiative aims to understand the factors associated with COVID-19 morbidity and mortality disparities and to lay the foundation to reduce disparities for underserved and vulnerable populations disproportionately affected by the pandemic through efforts to increase access and effectiveness of diagnostic methods. The approach used in this project will leverage the investigators' experiences in designing and implementing evidence-based interventions in primary care settings, partnerships with Native American and Latino communities, investments in the development of community- driven and responsive organizations developed primarily in rural counties, and the capacity and needs of Oklahoma's government testing and contact tracing infrastructure to develop, test, and evaluate a culturally- responsive SARS-CoV-2 testing intervention, collection of additional data on COVID-19 related health disparities, and identification of additional attitudes, facilitators, and barriers to testing and eventual vaccination.

The investigators have designed an approach that not only allows for collecting essential information about community, provider, and patient-relevant impediments to viral testing but also meeting the critical need to increase testing in testing deserts in Oklahoma as rapidly as possible. The investigators believe that a singular focus on one testing strategy will be ineffective in truly understanding the barriers to testing. No one strategy would be effective in reaching all of the population, due to issues such as lack of access to a primary care provider, lack of insurance, transportation, available time, or individual/community perceptions on testing itself (e.g., safety, necessity, availability, trust). Thus, the investigators have chosen to develop the Community-engaged Approaches to Testing in Community and Healthcare settings for Underserved Populations (CATCH-UP) program with practice-based and community-based approaches to maximize the reach of the RADx-UP consortium, broaden the potential perspectives that could be captured, and compare the effectiveness of strategies. Rather than developing an inflexible practice-based intervention a priori, the investigators believe that the ever-changing barriers, attitudes and conditions in the pandemic, as well as the development and deployment of more effective diagnostic technologies over the next few months, necessitate a pragmatic approach in which increased testing is initiated quickly while simultaneously collaborating with stakeholders and collecting participant survey data in real-time, which will allow the intervention to evolve to changing needs, and provide rapid-cycle evaluation of effectiveness of these activities to provide timely feedback to the partners and other RADx-UP initiatives.

The specific aims of the CATCH-UP Project are as follows:

1. Provide technical support to a minimum of 50 Oklahoma primary care practices to implement a person-centered approach to SARS-CoV-2 testing based on best available evidence and current guidelines. The implementation approach will include 1) development of implementation support resources for COVID-19 testing and risk mitigation strategies to meet the needs of vulnerable populations through continuous adaption to changing guidelines, testing protocols and availability, and information learned from the project's provider network and the broader RADx-UP community, 2) support practices to integrate tailored, guideline- based SARS-CoV-2 testing protocols and resources into the workflows through proven methodologies of academic detailing from peer-physician experts, practice change facilitation through quality improvement implementation professionals, and health information technology support. Based on the average number of providers and daily caseload in rural Oklahoma practices the investigators estimate this will result in approximately 60,000 viral tests performed in the first year.
2. Rapidly respond to community testing needs by deploying mobile testing units in community settings that will provide operational support to increase the efficiency and the existing capacity for statewide testing by Oklahoma's public health authorities. The model used by the Chickasaw Nation in deploying a high-efficiency community testing system will be combined with ongoing observation and analysis to identify facilitators and barriers to implementing community testing sites to accelerate convergence on effective and replicable methods to increase access and acceptance of testing. The investigators will adapt to ongoing disease outbreaks and community needs, but anticipate that this aim will result in more than 250 testing events at sites throughout the state and 45,000 viral tests performed in the first year.
3. Conduct a comprehensive evaluation of the impact of the CATCH-UP program, collaborate closely with other RADx-UP projects in sharing data and adapting processes, and continuously communicate with our community partners to assess effectiveness and disseminate research findings. This evaluation will include measurement and dissemination of data related to 1) Provider-level Outcomes that include knowledge and attitudes of disease prevalence, clinical characteristics including typical and atypical symptoms and disease severity, testing importance and strategies, vaccination, importance and use of personal protective equipment, availability of testing and delays in return of results, and provider observations of patient attitudes and other reported barriers, 2) Care Process Outcomes such as testing, test positivity, and test refusal rates, influenza, pneumococcal, and zoster vaccination rates, 3) Community-level Outcomes that include the number of tests conducted by mobile testing units and the resulting test positivity rate, 4) Patient-level Outcomes such as knowledge and attitudes of disease prevalence, disease characteristics including severity and acute and chronic symptoms, risk perspective and preferences, importance and use of personal protective equipment, patient acceptance of various testing options, and facilitators and barriers to participating in testing and future vaccination programs, 5) Patient Factors such as demographics, social determinants of health, and clinical characteristics that may be associated with COVID-19 morbidity and mortality disparities or reach of each testing modality, and 6) Qualitative Outcomes including perceptions of facilitators and barriers to testing and the utility, effectiveness, and generalizability of the program, explored through key informant interviews, exit interviews, and in-depth program implementation process observations.

Eligibility criteria: Inclusion Criteria:

* Practices:

  1. Primary care practices located in Oklahoma.
  2. Priority to practices serving a majority of patients that are underserved or vulnerable populations (rural, minority, elderly).
  3. Practices routinely using a certified electronic health record (EHR) will be eligible to participate, as practices that are still using paper records are either planning to close due to clinician retirement or will likely be implementing an EHR during the project, which would compromise their ability to participate.
  4. Practice-wide participation will be encouraged, but participation of all members within a practice (both clinicians and staff members) will not be required. The minimum acceptable level of participation will be one clinician and nurse/medical assistant dyad plus anyone else who would have to be involved to make changes in the processes of care (e.g. clinic manager) for that unit of care.
  5. Clinicians and staff members 18 years of age and older at the time of enrollment (consent).
* Patients survey participants:

  1. Patients (or caregivers of patients) who are seen in eligible practices or community testing sites and received a recommendation for the patient to receive a SARS-CoV-2 diagnostic test.
  2. Patients (or their caregivers) who are 18 or older

Exclusion Criteria:

* Practices:

  1. Practices that are uninterested in reducing missed opportunities for guidelines-based testing for SARS-CoV-2
  2. Solo practices with a clinician planning to retire within 12 months of enrollment will not be eligible for participation.
  3. Practices likely to experience ownership change in the next 12 months will not be eligible for participation.
* Patient survey participants:

  1. Patients unable to complete the consent process or survey instruments in English or Spanish.
  2. Patients or caregivers of patients who are under the age of 18.

Primary outcomes:
measure: Change in SARS-CoV-2 Testing Rate (Practices)
timeFrame: Baseline to 12 months
measure: Change in SARS-CoV-2 Test Positivity Rate
timeFrame: Baseline to 12 months
measure: Barriers to SARS-CoV-2 Testing
timeFrame: Baseline
measure: Barriers to SARS-CoV-2 Testing (Practices)
timeFrame: Month 3
measure: Barriers to SARS-CoV-2 Testing (Practices)
timeFrame: Month 6
measure: Barriers to SARS-CoV-2 Testing (Practices)
timeFrame: Month 9
measure: Barriers to SARS-CoV-2 Testing (Practices)
timeFrame: Month 12
Secondary outcomes:
measure: Change in Influenza Vaccination Rate (NQF #41)
timeFrame: Baseline to 12 months
measure: Change in Pneumococcal Vaccination Rate (NQF #127)
timeFrame: Baseline to 12 months
measure: Change in Zoster Vaccination Rate
timeFrame: Baseline to 12 months
measure: COVID-19 Referrals
timeFrame: Baseline
measure: COVID-19 Referrals
timeFrame: Month 3
measure: COVID-19 Referrals
timeFrame: Month 6
measure: COVID-19 Referrals
timeFrame: Month 9
measure: COVID-19 Referrals
timeFrame: Month 12
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: Oklahoma Clinical and Translational Science Institute
state: Oklahoma
Study officials:
affiliation: University of Oklahoma
name: Judith A James, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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