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Community-engaged Approaches to Testing in Community and Healthcare Settings for Underserved Populations (CATCH-UP)

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ClinicalTrials.gov Identifier: NCT04870307
Recruitment Status : Recruiting
First Posted : May 3, 2021
Last Update Posted : May 3, 2021
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute of General Medical Sciences (NIGMS)
Information provided by (Responsible Party):
University of Oklahoma

Brief Summary:
The pandemic caused by the novel coronavirus 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 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 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.

Condition or disease Intervention/treatment Phase
Covid19 Other: Dissemination and Implementation Research Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 780 participants
Allocation: N/A
Intervention Model: Single Group Assignment
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.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Community-engaged Approaches to Testing in Community and Healthcare Settings for Underserved Populations
Actual Study Start Date : September 30, 2020
Estimated Primary Completion Date : September 2023
Estimated Study Completion Date : September 2023

Arm Intervention/treatment
Primary Care Practices
A practice-based implementation study will be conducted with 50 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 (including baseline measures plus semi-structured interviews. The practice based approach to increasing testing will be compared to a community-based approach using mobile-setting to increase testing. Additional, non-clinical trial components of this study include patient surveys to understand facilitators and barriers to SARS-CoV-2 testing and identification of legal/ethical, socioeconomic, and behavioral implications of increased testing. Patients are not direct subjects in this part of the study. Intervention will target practices and practice members.
Other: Dissemination and Implementation Research
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 Outcome Measures :
  1. Change in SARS-CoV-2 Testing Rate (Practices) [ Time Frame: Baseline to 12 months ]
    Change in the proportion of patients eligible for SARS-CoV-2 testing based on screening that receive SARS-CoV-2 test.

  2. Change in SARS-CoV-2 Test Positivity Rate (Community Sites) [ Time Frame: Baseline to 12 months ]
    Change in the proportion of SARS-CoV-2 test results that are positive.

  3. Barriers to SARS-CoV-2 Testing (Practices) [ Time Frame: Baseline ]
    Number (and type) of barriers to SARS-CoV-2 testing.

  4. Barriers to SARS-CoV-2 Testing (Practices) [ Time Frame: Month 3 ]
    Number (and type) of barriers to SARS-CoV-2 testing.

  5. Barriers to SARS-CoV-2 Testing (Practices) [ Time Frame: Month 6 ]
    Number (and type) of barriers to SARS-CoV-2 testing.

  6. Barriers to SARS-CoV-2 Testing (Practices) [ Time Frame: Month 9 ]
    Number (and type) of barriers to SARS-CoV-2 testing.

  7. Barriers to SARS-CoV-2 Testing (Practices) [ Time Frame: Month 12 ]
    Number (and type) of barriers to SARS-CoV-2 testing.


Secondary Outcome Measures :
  1. Change in Influenza Vaccination Rate (NQF #41) [ Time Frame: Baseline to 12 months ]
    Change in the proportion of patients aged 6 months and older who receive an influenza immunization or report receipt of a influenza immunization.

  2. Change in Pneumococcal Vaccination Rate (NQF #127) [ Time Frame: Baseline to 12 months ]
    Change in the proportion of patients 65 years of age or older who have ever received a pneumococcal vaccine.

  3. Change in Zoster Vaccination Rate [ Time Frame: Baseline to 12 months ]
    Change in the proportion of patients aged 50 years and older who have had the Shingrix zoster (shingles) vaccination.

  4. COVID-19 Referrals [ Time Frame: Baseline ]
    Number (and type) of referrals for COVID-19 treatment.

  5. COVID-19 Referrals [ Time Frame: Month 3 ]
    Number (and type) of referrals for COVID-19 treatment.

  6. COVID-19 Referrals [ Time Frame: Month 6 ]
    Number (and type) of referrals for COVID-19 treatment.

  7. COVID-19 Referrals [ Time Frame: Month 9 ]
    Number (and type) of referrals for COVID-19 treatment.

  8. COVID-19 Referrals [ Time Frame: Month 12 ]
    Number (and type) of referrals for COVID-19 treatment.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04870307


Contacts
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Contact: Timothy M VanWagoner, PhD (405) 271-3480 Timothy-VanWagoner@ouhsc.edu
Contact: Juell B Homco, PhD (918) 660-3808 juell-homco@ouhsc.edu

Locations
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United States, Oklahoma
Oklahoma Clinical and Translational Science Institute Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Timothy VanWagoner, PhD    405-271-3480    timothy-vanwagoner@ouhsc.edu   
Sponsors and Collaborators
University of Oklahoma
National Institutes of Health (NIH)
National Institute of General Medical Sciences (NIGMS)
Investigators
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Principal Investigator: Judith A James, MD, PhD University of Oklahoma
Additional Information:
Publications:
Kenney C. Transforming Health Care. Virginia Mason Medical Center's Pursuit of the Perfect Patient Experience.: Productivity Press.; 2010

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Responsible Party: University of Oklahoma
ClinicalTrials.gov Identifier: NCT04870307    
Other Study ID Numbers: 12582
U54GM104938-08S1 ( U.S. NIH Grant/Contract )
First Posted: May 3, 2021    Key Record Dates
Last Update Posted: May 3, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Oklahoma:
COVID-19
RADx-UP
Health Services Research
Implementation Science
Evidence-based practice
Social determinants of health