Covid19CATCH-UPNCT04870307
Community-engaged Approaches to Testing in Community and Healthcare Settings for Underserved Populations
A study testing Dissemination and Implementation Research in people with Covid19, run by University of Oklahoma at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Covid19
- What is being tested?
- Dissemination and Implementation Research
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 323 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2020to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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).
Show all 9Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Oklahoma Clinical and Translational Science Institute
Oklahoma City, Oklahoma, 73104
About this study
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.
Read the 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:
- 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.
- 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.
- 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.
- Conditions
- Covid19
- Being tested
- Dissemination and Implementation Research
- Keywords
- COVID-19, RADx-UP, Health Services Research, Implementation Science, Evidence-based practice, Social determinants of health
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dissemination and Implementation ResearchOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Dissemination and Implementation Research |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Month 12
Secondary outcomes (8)
Change in Influenza Vaccination Rate (NQF #41)
Change in the proportion of patients aged 6 months and older who received an influenza immunization or reported receipt of an influenza immunization. Influenza Vaccination Rate was defined in alignment with National Quality Forum (NQF) measure #41 and was recorded as a proportion ranging between zero and one.
Measured: Baseline to 12 months
Change in Pneumococcal Vaccination Rate (NQF #127)
Change in the proportion of patients 65 years of age or older who have ever received a pneumococcal vaccine. Pneumococcal Vaccination Rate was defined in alignment with National Quality Forum (NQF) measure #41 and was recorded as a proportion ranging between zero and one.
Measured: Baseline to 12 months
Change in Zoster Vaccination Rate
Change in the proportion of patients aged 50 years and older who have had the Shingrix zoster (shingles) vaccination. Proportion ranges from zero to one.
Measured: Baseline to 12 months
COVID-19 Referrals
Practices that reported not administering the COVID-19 vaccine were asked "Where do you send your patients that require a COVID-19 vaccine?" on the Practice Member Survey.
Measured: Baseline
COVID-19 Referrals
Practices that reported not administering the COVID-19 vaccine were asked "Where do you send your patients that require a COVID-19 vaccine?" on the Practice Member Survey.
Measured: Month 3
COVID-19 Referrals
Practices that reported not administering the COVID-19 vaccine were asked "Where do you send your patients that require a COVID-19 vaccine?" on the Practice Member Survey.
Measured: Month 6
COVID-19 Referrals
Practices that reported not administering the COVID-19 vaccine were asked "Where do you send your patients that require a COVID-19 vaccine?" on the Practice Member Survey.
Measured: Month 9
COVID-19 Referrals
Practices that reported not administering the COVID-19 vaccine were asked "Where do you send your patients that require a COVID-19 vaccine?" on the Practice Member Survey.
Measured: Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2021
- Study start30 Sep 2020
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (32)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by University of OklahomaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 323 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of General Medical Sciences (NIGMS)
- Responsible party
- Sponsor
- Investigators
- Judith A James, MD, PhD, Principal investigator, University of Oklahoma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04870307
- Sponsor's protocol ID
- 12582
- Other IDs
- U54GM104938-08S1
- Acronym
- CATCH-UP
- Status last verified
- Jan 2025
- First submitted
- 15 Feb 2021
- Last updated
- 30 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
CDC COVID-19 Response Team. Geographic Differences in COVID-19 Cases, Deaths, and Incidence - United States, February 12-April 7, 2020. MMWR Morb Mortal Wkly Rep. 2020 Apr 17;69(15):465-471. doi: 10.15585/mmwr.mm6915e4.
PubMed 32298250Zhang CH, Schwartz GG. Spatial Disparities in Coronavirus Incidence and Mortality in the United States: An Ecological Analysis as of May 2020. J Rural Health. 2020 Jun;36(3):433-445. doi: 10.1111/jrh.12476. Epub 2020 Jun 16.
PubMed 32543763Shahid Z, Kalayanamitra R, McClafferty B, Kepko D, Ramgobin D, Patel R, Aggarwal CS, Vunnam R, Sahu N, Bhatt D, Jones K, Golamari R, Jain R. COVID-19 and Older Adults: What We Know. J Am Geriatr Soc. 2020 May;68(5):926-929. doi: 10.1111/jgs.16472. Epub 2020 Apr 20.
PubMed 32255507Iaccarino G, Grassi G, Borghi C, Ferri C, Salvetti M, Volpe M; SARS-RAS Investigators. Age and Multimorbidity Predict Death Among COVID-19 Patients: Results of the SARS-RAS Study of the Italian Society of Hypertension. Hypertension. 2020 Aug;76(2):366-372. doi: 10.1161/HYPERTENSIONAHA.120.15324. Epub 2020 Jun 22.
PubMed 32564693CDC COVID-19 Response Team. Preliminary Estimates of the Prevalence of Selected Underlying Health Conditions Among Patients with Coronavirus Disease 2019 - United States, February 12-March 28, 2020. MMWR Morb Mortal Wkly Rep. 2020 Apr 3;69(13):382-386. doi: 10.15585/mmwr.mm6913e2.
PubMed 32240123Wang X, Fang X, Cai Z, Wu X, Gao X, Min J, Wang F. Comorbid Chronic Diseases and Acute Organ Injuries Are Strongly Correlated with Disease Severity and Mortality among COVID-19 Patients: A Systemic Review and Meta-Analysis. Research (Wash D C). 2020 Apr 19;2020:2402961. doi: 10.34133/2020/2402961. eCollection 2020.
PubMed 32377638Turner-Musa J, Ajayi O, Kemp L. Examining Social Determinants of Health, Stigma, and COVID-19 Disparities. Healthcare (Basel). 2020 Jun 12;8(2):168. doi: 10.3390/healthcare8020168.
PubMed 32545647Rollston R, Galea S. COVID-19 and the Social Determinants of Health. Am J Health Promot. 2020 Jul;34(6):687-689. doi: 10.1177/0890117120930536b. No abstract available.
PubMed 32551932Hawkins D. Differential occupational risk for COVID-19 and other infection exposure according to race and ethnicity. Am J Ind Med. 2020 Sep;63(9):817-820. doi: 10.1002/ajim.23145. Epub 2020 Jun 15.
PubMed 32539166Terry DL, Woo MJ. Burnout, job satisfaction, and work-family conflict among rural medical providers. Psychol Health Med. 2021 Feb;26(2):196-203. doi: 10.1080/13548506.2020.1750663. Epub 2020 Apr 13.
PubMed 32281405Kaufman BG, Whitaker R, Pink G, Holmes GM. Half of Rural Residents at High Risk of Serious Illness Due to COVID-19, Creating Stress on Rural Hospitals. J Rural Health. 2020 Sep;36(4):584-590. doi: 10.1111/jrh.12481. Epub 2020 Jun 30.
PubMed 32603030Davoodi NM, Healy M, Goldberg EM. Rural America's Hospitals are Not Prepared to Protect Older Adults From a Surge in COVID-19 Cases. Gerontol Geriatr Med. 2020 Jul 7;6:2333721420936168. doi: 10.1177/2333721420936168. eCollection 2020 Jan-Dec.
PubMed 32685610James CV, Moonesinghe R, Wilson-Frederick SM, Hall JE, Penman-Aguilar A, Bouye K. Racial/Ethnic Health Disparities Among Rural Adults - United States, 2012-2015. MMWR Surveill Summ. 2017 Nov 17;66(23):1-9. doi: 10.15585/mmwr.ss6623a1.
PubMed 29145359Henning-Smith C, Tuttle M, Kozhimannil KB. Unequal Distribution of COVID-19 Risk Among Rural Residents by Race and Ethnicity. J Rural Health. 2021 Jan;37(1):224-226. doi: 10.1111/jrh.12463. Epub 2020 Jun 25. No abstract available.
PubMed 32396220Bavel JJV, Baicker K, Boggio PS, Capraro V, Cichocka A, Cikara M, Crockett MJ, Crum AJ, Douglas KM, Druckman JN, Drury J, Dube O, Ellemers N, Finkel EJ, Fowler JH, Gelfand M, Han S, Haslam SA, Jetten J, Kitayama S, Mobbs D, Napper LE, Packer DJ, Pennycook G, Peters E, Petty RE, Rand DG, Reicher SD, Schnall S, Shariff A, Skitka LJ, Smith SS, Sunstein CR, Tabri N, Tucker JA, Linden SV, Lange PV, Weeden KA, Wohl MJA, Zaki J, Zion SR, Willer R. Using social and behavioural science to support COVID-19 pandemic response. Nat Hum Behav. 2020 May;4(5):460-471. doi: 10.1038/s41562-020-0884-z. Epub 2020 Apr 30.
PubMed 32355299
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community-engaged Approaches to Testing in Community and Healthcare Settings for Underserved Populations
- ClinicalTrials.gov ID
- NCT04870307
- Acronym / sponsor ID
- CATCH-UP / 12582
- Conditions
- Covid19
- Keywords
- COVID-19, RADx-UP, Health Services Research, Implementation Science, Evidence-based practice, Social determinants of health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 323 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of General Medical Sciences (NIGMS)
- Study start
- 30 Sep 2020 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 3 May 2021 (actual)
- Results
- Posted 30 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
- 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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Primary Care Practices | Other | Other: Dissemination and Implementation ResearchA 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Practices:
- Patients survey participants:
Key exclusion criteria (7 listed)
- Practices:
- Patient survey participants:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dissemination and Implementation ResearchDissemination 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. | Other | Primary Care Practices |
Primary outcome
Change in SARS-CoV-2 Testing Rate (Practices)
Time frame: Baseline to 12 months
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.
Change in SARS-CoV-2 Test Positivity Rate
Time frame: Baseline to 12 months
Change in the proportion of SARS-CoV-2 test results that are positive.
Barriers to SARS-CoV-2 Testing
Time frame: Baseline
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.
Barriers to SARS-CoV-2 Testing (Practices)
Time frame: Month 3
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.
Barriers to SARS-CoV-2 Testing (Practices)
Time frame: Month 6
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.
Barriers to SARS-CoV-2 Testing (Practices)
Time frame: Month 9
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.
Barriers to SARS-CoV-2 Testing (Practices)
Time frame: Month 12
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.
8 secondary outcomes
Change in Influenza Vaccination Rate (NQF #41)
Time frame: Baseline to 12 months
Change in Pneumococcal Vaccination Rate (NQF #127)
Time frame: Baseline to 12 months
Change in Zoster Vaccination Rate
Time frame: Baseline to 12 months
COVID-19 Referrals
Time frame: Baseline
COVID-19 Referrals
Time frame: Month 3
COVID-19 Referrals
Time frame: Month 6
COVID-19 Referrals
Time frame: Month 9
COVID-19 Referrals
Time frame: Month 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 32298250CDC COVID-19 Response Team. Geographic Differences in COVID-19 Cases, Deaths, and Incidence - United States, February 12-April 7, 2020. MMWR Morb Mortal Wkly Rep. 2020 Apr 17;69(15):465-471. doi: 10.15585/mmwr.mm6915e4.
- Background: PubMed 32543763Zhang CH, Schwartz GG. Spatial Disparities in Coronavirus Incidence and Mortality in the United States: An Ecological Analysis as of May 2020. J Rural Health. 2020 Jun;36(3):433-445. doi: 10.1111/jrh.12476. Epub 2020 Jun 16.
- Background: PubMed 32255507Shahid Z, Kalayanamitra R, McClafferty B, Kepko D, Ramgobin D, Patel R, Aggarwal CS, Vunnam R, Sahu N, Bhatt D, Jones K, Golamari R, Jain R. COVID-19 and Older Adults: What We Know. J Am Geriatr Soc. 2020 May;68(5):926-929. doi: 10.1111/jgs.16472. Epub 2020 Apr 20.
- Background: PubMed 32564693Iaccarino G, Grassi G, Borghi C, Ferri C, Salvetti M, Volpe M; SARS-RAS Investigators. Age and Multimorbidity Predict Death Among COVID-19 Patients: Results of the SARS-RAS Study of the Italian Society of Hypertension. Hypertension. 2020 Aug;76(2):366-372. doi: 10.1161/HYPERTENSIONAHA.120.15324. Epub 2020 Jun 22.
- Background: PubMed 32240123CDC COVID-19 Response Team. Preliminary Estimates of the Prevalence of Selected Underlying Health Conditions Among Patients with Coronavirus Disease 2019 - United States, February 12-March 28, 2020. MMWR Morb Mortal Wkly Rep. 2020 Apr 3;69(13):382-386. doi: 10.15585/mmwr.mm6913e2.
- Background: PubMed 32377638Wang X, Fang X, Cai Z, Wu X, Gao X, Min J, Wang F. Comorbid Chronic Diseases and Acute Organ Injuries Are Strongly Correlated with Disease Severity and Mortality among COVID-19 Patients: A Systemic Review and Meta-Analysis. Research (Wash D C). 2020 Apr 19;2020:2402961. doi: 10.34133/2020/2402961. eCollection 2020.
- Background: PubMed 32545647Turner-Musa J, Ajayi O, Kemp L. Examining Social Determinants of Health, Stigma, and COVID-19 Disparities. Healthcare (Basel). 2020 Jun 12;8(2):168. doi: 10.3390/healthcare8020168.
- Background: PubMed 32551932Rollston R, Galea S. COVID-19 and the Social Determinants of Health. Am J Health Promot. 2020 Jul;34(6):687-689. doi: 10.1177/0890117120930536b. No abstract available.
- Background: PubMed 32539166Hawkins D. Differential occupational risk for COVID-19 and other infection exposure according to race and ethnicity. Am J Ind Med. 2020 Sep;63(9):817-820. doi: 10.1002/ajim.23145. Epub 2020 Jun 15.
- Background: PubMed 32281405Terry DL, Woo MJ. Burnout, job satisfaction, and work-family conflict among rural medical providers. Psychol Health Med. 2021 Feb;26(2):196-203. doi: 10.1080/13548506.2020.1750663. Epub 2020 Apr 13.
- Background: PubMed 32603030Kaufman BG, Whitaker R, Pink G, Holmes GM. Half of Rural Residents at High Risk of Serious Illness Due to COVID-19, Creating Stress on Rural Hospitals. J Rural Health. 2020 Sep;36(4):584-590. doi: 10.1111/jrh.12481. Epub 2020 Jun 30.
- Background: PubMed 32685610Davoodi NM, Healy M, Goldberg EM. Rural America's Hospitals are Not Prepared to Protect Older Adults From a Surge in COVID-19 Cases. Gerontol Geriatr Med. 2020 Jul 7;6:2333721420936168. doi: 10.1177/2333721420936168. eCollection 2020 Jan-Dec.
- 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.Link provided by the sponsor.
- 2020 Rural Hospital Sustainability Index 2020 \[cited 2020\]Link provided by the sponsor.
- United States Department of Agriculture ERS. State Fact Sheet: United States.Link provided by the sponsor.
- United States Department of Agriculture ERS. State Fact Sheets: OklahomaLink provided by the sponsor.
- Foundation UH. America's Health Rankings: Summary of OklahomaLink provided by the sponsor.
- Oklahoma Primary Healthcare Improvement Cooperative (OPHIC). The Research to Practice to Research Exchange 2018Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Judith A James, MD, PhD principal investigator
University of Oklahoma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dissemination and Implementation Research in people with Covid19, run by University of Oklahoma at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in SARS-CoV-2 Testing Rate (Practices) (time frame: Baseline to 12 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04870307, which also lists 32 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2025.