Surveillance and care for confirmed and suspected patients with COVID-19 in general practice (CovidCare): study protocol for an observational trial

Abstract Background A SARS-CoV-2 infection can lead from asymptomatic through to critical disease in a dynamic and unpredictable course within a few days. The challenge in outpatient monitoring the highly contagious COVID-19 disease during the ongoing pandemic is to filter severe courses followed by...

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Main Authors: Mariell Hoffmann, Sandra Stengel, Johanna Forstner, Annika Baldauf, Gunter Laux, Frank Aluttis, Markus Qreini, Peter Engeser, Joachim Szecsenyi, Frank Peters-Klimm
Format: Article
Language:English
Published: BMC 2021-09-01
Series:BMC Family Practice
Subjects:
Online Access:https://doi.org/10.1186/s12875-021-01515-8
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spelling doaj-63932cd5cc1f4808890043a9e233902a2021-09-05T11:41:41ZengBMCBMC Family Practice1471-22962021-09-0122111010.1186/s12875-021-01515-8Surveillance and care for confirmed and suspected patients with COVID-19 in general practice (CovidCare): study protocol for an observational trialMariell Hoffmann0Sandra Stengel1Johanna Forstner2Annika Baldauf3Gunter Laux4Frank Aluttis5Markus Qreini6Peter Engeser7Joachim Szecsenyi8Frank Peters-Klimm9Department of General Practice and Health Services Research, Heidelberg UniversityDepartment of General Practice and Health Services Research, Heidelberg UniversityDepartment of General Practice and Health Services Research, Heidelberg UniversityDepartment of General Practice and Health Services Research, Heidelberg UniversityDepartment of General Practice and Health Services Research, Heidelberg UniversityDepartment of General Practice and Health Services Research, Heidelberg UniversityDepartment of General Practice and Health Services Research, Heidelberg UniversityDepartment of General Practice and Health Services Research, Heidelberg UniversityDepartment of General Practice and Health Services Research, Heidelberg UniversityDepartment of General Practice and Health Services Research, Heidelberg UniversityAbstract Background A SARS-CoV-2 infection can lead from asymptomatic through to critical disease in a dynamic and unpredictable course within a few days. The challenge in outpatient monitoring the highly contagious COVID-19 disease during the ongoing pandemic is to filter severe courses followed by admission to hospital with the aim of preventing an overburdening of clinics. However, little is known of the effect of risk factors on the course of the infection of outpatient patients. To support general practices in managing high risk patients, we designed a COVID-19 surveillance and care tool (CovidCare). It includes an initial assessment of yet known risk factors and symptoms and a continuous telephone monitoring of signs and symptoms. This study aims to investigate the effects of different risk factors on the course of the COVID-19 disease, utilisation of different health care services and to gain insights into the utilisation of CovidCare in general practices. Methods We will conduct a multi-centered prospective, longitudinal non-controlled observational trial of COVID-19 patients in general practices. Overall, 700 GPs who participate in general-practice centered care by the AOK Baden-Württemberg (large German sickness fund) are eligible and will be invited for study participation, including adult, outpatient COVID-19 patients (or urgent suspicion and ≥ 50 years) with at least one additional known risk factor, who participate in general-practice centered care. The primary outcome is hospitalisation due to COVID-19. Secondary outcomes are diagnosis of pneumonia, utilisation of palliative care, mortality rate, anxiety and identification of predictive risk factors. Quantitative data analysis will focus on valid descriptive figures and mixed regression models. The accompanying process evaluation is based on interviews and questionnaires from general practice staff and patients. The analysis of the process evaluation is descriptive and explorative. Discussion The use of the COVID-19 surveillance and care tool is expected to encourage the provision of structured quality of care during the ongoing pandemic. This trial will provide an understanding of the COVID-19-disease and the effect of several risk factors on the course of the disease and health care utilisation. The results can be used for a better management of the COVID-19 pandemic and its consequences. Trial registration German Clinical Trials Register DRKS00022054 .https://doi.org/10.1186/s12875-021-01515-8COVID-19PandemicSurveillance toolCare toolManagementGeneral practitioner
collection DOAJ
language English
format Article
sources DOAJ
author Mariell Hoffmann
Sandra Stengel
Johanna Forstner
Annika Baldauf
Gunter Laux
Frank Aluttis
Markus Qreini
Peter Engeser
Joachim Szecsenyi
Frank Peters-Klimm
spellingShingle Mariell Hoffmann
Sandra Stengel
Johanna Forstner
Annika Baldauf
Gunter Laux
Frank Aluttis
Markus Qreini
Peter Engeser
Joachim Szecsenyi
Frank Peters-Klimm
Surveillance and care for confirmed and suspected patients with COVID-19 in general practice (CovidCare): study protocol for an observational trial
BMC Family Practice
COVID-19
Pandemic
Surveillance tool
Care tool
Management
General practitioner
author_facet Mariell Hoffmann
Sandra Stengel
Johanna Forstner
Annika Baldauf
Gunter Laux
Frank Aluttis
Markus Qreini
Peter Engeser
Joachim Szecsenyi
Frank Peters-Klimm
author_sort Mariell Hoffmann
title Surveillance and care for confirmed and suspected patients with COVID-19 in general practice (CovidCare): study protocol for an observational trial
title_short Surveillance and care for confirmed and suspected patients with COVID-19 in general practice (CovidCare): study protocol for an observational trial
title_full Surveillance and care for confirmed and suspected patients with COVID-19 in general practice (CovidCare): study protocol for an observational trial
title_fullStr Surveillance and care for confirmed and suspected patients with COVID-19 in general practice (CovidCare): study protocol for an observational trial
title_full_unstemmed Surveillance and care for confirmed and suspected patients with COVID-19 in general practice (CovidCare): study protocol for an observational trial
title_sort surveillance and care for confirmed and suspected patients with covid-19 in general practice (covidcare): study protocol for an observational trial
publisher BMC
series BMC Family Practice
issn 1471-2296
publishDate 2021-09-01
description Abstract Background A SARS-CoV-2 infection can lead from asymptomatic through to critical disease in a dynamic and unpredictable course within a few days. The challenge in outpatient monitoring the highly contagious COVID-19 disease during the ongoing pandemic is to filter severe courses followed by admission to hospital with the aim of preventing an overburdening of clinics. However, little is known of the effect of risk factors on the course of the infection of outpatient patients. To support general practices in managing high risk patients, we designed a COVID-19 surveillance and care tool (CovidCare). It includes an initial assessment of yet known risk factors and symptoms and a continuous telephone monitoring of signs and symptoms. This study aims to investigate the effects of different risk factors on the course of the COVID-19 disease, utilisation of different health care services and to gain insights into the utilisation of CovidCare in general practices. Methods We will conduct a multi-centered prospective, longitudinal non-controlled observational trial of COVID-19 patients in general practices. Overall, 700 GPs who participate in general-practice centered care by the AOK Baden-Württemberg (large German sickness fund) are eligible and will be invited for study participation, including adult, outpatient COVID-19 patients (or urgent suspicion and ≥ 50 years) with at least one additional known risk factor, who participate in general-practice centered care. The primary outcome is hospitalisation due to COVID-19. Secondary outcomes are diagnosis of pneumonia, utilisation of palliative care, mortality rate, anxiety and identification of predictive risk factors. Quantitative data analysis will focus on valid descriptive figures and mixed regression models. The accompanying process evaluation is based on interviews and questionnaires from general practice staff and patients. The analysis of the process evaluation is descriptive and explorative. Discussion The use of the COVID-19 surveillance and care tool is expected to encourage the provision of structured quality of care during the ongoing pandemic. This trial will provide an understanding of the COVID-19-disease and the effect of several risk factors on the course of the disease and health care utilisation. The results can be used for a better management of the COVID-19 pandemic and its consequences. Trial registration German Clinical Trials Register DRKS00022054 .
topic COVID-19
Pandemic
Surveillance tool
Care tool
Management
General practitioner
url https://doi.org/10.1186/s12875-021-01515-8
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