Community-engaged Approaches to Testing in Community and Healthcare Settings for Underserved Populations

NCT04870307 | Completed Results

• 2 other identifiers: 12582U54GM104938-08S1
• Study Type: interventional
• Target: 323
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19

Keywords

COVID-19; RADx-UP; Health Services Research; Implementation Science; Evidence-based practice; Social determinants of health

Outcome Measures

Primary Outcomes (7)

• Change in SARS-CoV-2 Testing Rate (Practices)

  Change in the proportion of patients eligible for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) testing based on screening that receive SARS-CoV-2 test. The proportion ranges between zero and one.

  Baseline to 12 months

• Change in SARS-CoV-2 Test Positivity Rate

  Change in the proportion of SARS-CoV-2 test results that are positive.

  Baseline to 12 months

• Barriers to SARS-CoV-2 Testing

  Number (and type) of barriers to SARS-CoV-2 testing reported by practice members based on what they experienced during practice encounters with patients during the study.

  Baseline

• Barriers to SARS-CoV-2 Testing (Practices)

  Number (and type) of barriers to SARS-CoV-2 testing reported by practice members based on what they experienced during practice encounters with patients during the study.

  Month 3

• Barriers to SARS-CoV-2 Testing (Practices)

  Number (and type) of barriers to SARS-CoV-2 testing reported by practice members based on what they experienced during practice encounters with patients during the study.

  Month 6

• Barriers to SARS-CoV-2 Testing (Practices)

  Number (and type) of barriers to SARS-CoV-2 testing reported by practice members based on what they experienced during practice encounters with patients during the study.

  Month 9

• Barriers to SARS-CoV-2 Testing (Practices)

  Number (and type) of barriers to SARS-CoV-2 testing reported by practice members based on what they experienced during practice encounters with patients during the study.

  Month 12

Secondary Outcomes (8)

• Change in Influenza Vaccination Rate (NQF #41)

  Baseline to 12 months

• Change in Pneumococcal Vaccination Rate (NQF #127)

  Baseline to 12 months

• Change in Zoster Vaccination Rate

  Baseline to 12 months

• COVID-19 Referrals

  Baseline

• COVID-19 Referrals

  Month 3

Study Arms (1)

Primary Care Practices

OTHER

A practice-based implementation study was conducted with 35 practices, with baseline data collection, and overlapping with interim measurements of care quality and process outcomes, followed by a final data collection at the end of the intervention. Patients were not direct subjects in this part of the study. The intervention targeted practices and practice members.

Other: Dissemination and Implementation Research

Interventions

Dissemination and Implementation Research OTHER

Dissemination and Implementation research 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 Care Practices

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Oklahoma: lead
• National Institutes of Health (NIH): collaborator
• National Institute of General Medical Sciences (NIGMS): collaborator

Study Sites (1)

Oklahoma Clinical and Translational Science Institute

Oklahoma City, Oklahoma, 73104, United States

Location

Related Publications (31)

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Related Links

• Abrams EM, Szefler SJ. COVID-19 and the impact of social determinants of health. The Lancet Respiratory Medicine. 2020;8(7):659-61. doi: 10.1016/s2213-2600(20)30234-4.
• 2020 Rural Hospital Sustainability Index 2020 \[cited 2020\]
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MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Dr. Juell Homco
• Organization: University of Oklahoma Tulsa

juell-homco@ouhsc.edu

918-660-3038

Study Officials

• Judith A James, MD, PhD

  University of Oklahoma

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 15, 2021
• First Posted: May 3, 2021
• Study Start: September 30, 2020
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: January 30, 2025
• Results First Posted: January 30, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)