N/A
N=323
Community-engaged Approaches to Testing in Community and Healthcare Settings for Underserved Populations
Covid19
Bottom Line
View on ClinicalTrials.gov: NCT04870307 ↗Enrolled (actual)
323
Serious AEs
0.0%
Results posted
Jan 2025
Primary outcome: Primary: Change in SARS-CoV-2 Testing Rate (Practices) — 0.9928; 1 proportion of patients (ranging 0-1)
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Dissemination and Implementation Research (Other)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- University of Oklahoma
- Primary completion
- Jun 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in SARS-CoV-2 Testing Rate (Practices) |
0.9928; 1 | — |
| PRIMARY Change in SARS-CoV-2 Test Positivity Rate |
0.0660; 0.2545 | — |
| PRIMARY Barriers to SARS-CoV-2 Testing |
134; 41; 119; 69; 95; 87 | — |
| PRIMARY Barriers to SARS-CoV-2 Testing (Practices) |
48; 3; 39; 24; 16; 9 | — |
| PRIMARY Barriers to SARS-CoV-2 Testing (Practices) |
48; 3; 39; 24; 16; 9 | — |
| PRIMARY Barriers to SARS-CoV-2 Testing (Practices) |
48; 3; 39; 24; 16; 9 | — |
| PRIMARY Barriers to SARS-CoV-2 Testing (Practices) |
48; 3; 39; 24; 16; 9 | — |
| SECONDARY Change in Influenza Vaccination Rate (NQF #41) |
0.2376; 0.1110 | — |
| SECONDARY Change in Pneumococcal Vaccination Rate (NQF #127) |
0.1240; 0.1053 | — |
| SECONDARY Change in Zoster Vaccination Rate |
— | — |
| SECONDARY COVID-19 Referrals |
46; 36; 5; 1 | — |
| SECONDARY COVID-19 Referrals |
46; 36; 5; 1 | — |
| SECONDARY COVID-19 Referrals |
46; 36; 5; 1 | — |
| SECONDARY COVID-19 Referrals |
46; 36; 5; 1 | — |
| SECONDARY COVID-19 Referrals |
46; 36; 5; 1 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Practices:
- Primary care practices located in Oklahoma.
- Priority to practices serving a majority of patients that are underserved or vulnerable populations (rural, minority, elderly).
- 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.
- 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.
- Clinicians and staff members 18 years of age and older at the time of enrollment (consent).
- Patients survey participants:
- 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.
- Patients (or their caregivers) who are 18 or older
Exclusion Criteria
- Practices:
- Practices that are uninterested in reducing missed opportunities for guidelines-based testing for SARS-CoV-2
- Solo practices with a clinician planning to retire within 12 months of enrollment will not be eligible for participation.
- Practices likely to experience ownership change in the next 12 months will not be eligible for participation.
- Patient survey participants:
- Patients unable to complete the consent process or survey instruments in English or Spanish.
- Patients or caregivers of patients who are under the age of 18.
Data sourced from ClinicalTrials.gov (NCT04870307). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.