Implementation of C-reactive protein point of care testing to improve antibiotic targeting in respiratory illness in Vietnamese primary care (ICAT): a study protocol for a cluster randomised controlled trial
Introduction C-reactive protein (CRP), a biomarker of infection, has been used widely in high-income settings to guide antibiotic treatment in patients presenting with respiratory illnesses in primary care. Recent trials in low- and middle-income countries showed that CRP testing could safely reduce...
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BMJ Publishing Group
2020-12-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/10/12/e040977.full |
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| author | H Rogier van Doorn Behzad Nadjm Yoel Lubell Rachel Claire Greer Sabine Dittrich Sonia Lewycka Nga Thi Thuy Do Maida Vandendorpe Van Anh Nguyen Pham Ngoc Thach Ta Thi Dieu Ngan Nguyen Van Kinh Cao Hung Thai Le Thi Kim Dung Tu Nguyen Thi Cam Thanh Ha Nguyen |
| author_facet | H Rogier van Doorn Behzad Nadjm Yoel Lubell Rachel Claire Greer Sabine Dittrich Sonia Lewycka Nga Thi Thuy Do Maida Vandendorpe Van Anh Nguyen Pham Ngoc Thach Ta Thi Dieu Ngan Nguyen Van Kinh Cao Hung Thai Le Thi Kim Dung Tu Nguyen Thi Cam Thanh Ha Nguyen |
| author_sort | H Rogier van Doorn |
| collection | DOAJ |
| description | Introduction C-reactive protein (CRP), a biomarker of infection, has been used widely in high-income settings to guide antibiotic treatment in patients presenting with respiratory illnesses in primary care. Recent trials in low- and middle-income countries showed that CRP testing could safely reduce antibiotic use in patients with non-severe acute respiratory infections (ARIs) and fever in primary care. The studies, however, were conducted in a research-oriented context, with research staff closely monitoring healthcare behaviour thus potentially influencing healthcare workers’ prescribing practices. For policy-makers to consider wide-scale roll-out, a pragmatic implementation study of the impact of CRP point of care (POC) testing in routine care is needed.Methods and analysis A pragmatic, cluster-randomised controlled trial, with two study arms, consisting of 24 commune health centres (CHC) in the intervention arm (provision of CRP tests with additional healthcare worker guidance) and 24 facilities acting as controls (routine care). Comparison between the treatment arms will be through logistic regression, with the treatment assignment as a fixed effect, and the CHC as a random effect. With 48 clusters, an average of 10 consultations per facility per week will result in approximately 520 over 1 year, and 24 960 in total (12 480 per arm). We will be able to detect a reduction of 12% to 23% or more in immediate antibiotic prescription as a result of the CRP POC intervention. The primary endpoint is the proportion of patient consultations for ARI resulting in immediate antibiotic prescription. Secondary endpoints include the proportion of all patients receiving an antibiotic prescription regardless of ARI diagnosis, frequency of re-consultation, subsequent antibiotic use when antibiotics are not prescribed, referral and hospitalisation.Ethics and dissemination The study protocol was approved by the Oxford University Tropical Research Ethics Committee (OxTREC, Reference: 53–18), and the ethical committee of the National Hospital for Tropical Diseases in Vietnam (Reference:07/HDDD-NDTW/2019). Results from this study will be disseminated via meetings with stakeholders, conferences and publications in peer-reviewed journals. Authorship and reporting of this work will follow international guidelines.Trial registration details NCT03855215; Pre-results. |
| format | Article |
| id | doaj-art-dbcdcbb460a74764acb595b7db092603 |
| institution | OA Journals |
| issn | 2044-6055 |
| language | English |
| publishDate | 2020-12-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-dbcdcbb460a74764acb595b7db0926032025-08-20T02:18:59ZengBMJ Publishing GroupBMJ Open2044-60552020-12-01101210.1136/bmjopen-2020-040977Implementation of C-reactive protein point of care testing to improve antibiotic targeting in respiratory illness in Vietnamese primary care (ICAT): a study protocol for a cluster randomised controlled trialH Rogier van Doorn0Behzad Nadjm1Yoel Lubell2Rachel Claire Greer3Sabine Dittrich4Sonia Lewycka5Nga Thi Thuy Do6Maida Vandendorpe7Van Anh Nguyen8Pham Ngoc Thach9Ta Thi Dieu Ngan10Nguyen Van Kinh11Cao Hung Thai12Le Thi Kim Dung13Tu Nguyen Thi Cam14Thanh Ha Nguyen15Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, Oxfordshire, UKclinical lecturerNuffield Department of Medicine, University of Oxford, Oxford, UK5 Mathematical/Economic Modelling, Mahidol Oxford Tropical Medicine Research Unit, Bangkok, ThailandMalaria/Fever Program, Foundation for Innovative New Diagnostics (FIND), Geneva, SwitzerlandOxford University Clinical Research Unit, Hanoi, VietnamOxford University Clinical Research Unit, Hanoi, VietnamMalaria/Fever Program, Foundation for Innovative New Diagnostics (FIND), Geneva, SwitzerlandTakeda Development Center Americas Inc, Lexington, Massachusetts, USANational Hospital of Tropical Diseases, Hanoi, VietnamNational Hospital of Tropical Diseases, Hanoi, VietnamNational Hospital of Tropical Diseases, Hanoi, VietnamMedical Services Administration, Ministry of Health, Hanoi, VietnamMedical Services Administration, Ministry of Health, Hanoi, VietnamOxford University Clinical Research Unit, Hanoi, VietnamOxford University Clinical Research Unit, Hanoi, VietnamIntroduction C-reactive protein (CRP), a biomarker of infection, has been used widely in high-income settings to guide antibiotic treatment in patients presenting with respiratory illnesses in primary care. Recent trials in low- and middle-income countries showed that CRP testing could safely reduce antibiotic use in patients with non-severe acute respiratory infections (ARIs) and fever in primary care. The studies, however, were conducted in a research-oriented context, with research staff closely monitoring healthcare behaviour thus potentially influencing healthcare workers’ prescribing practices. For policy-makers to consider wide-scale roll-out, a pragmatic implementation study of the impact of CRP point of care (POC) testing in routine care is needed.Methods and analysis A pragmatic, cluster-randomised controlled trial, with two study arms, consisting of 24 commune health centres (CHC) in the intervention arm (provision of CRP tests with additional healthcare worker guidance) and 24 facilities acting as controls (routine care). Comparison between the treatment arms will be through logistic regression, with the treatment assignment as a fixed effect, and the CHC as a random effect. With 48 clusters, an average of 10 consultations per facility per week will result in approximately 520 over 1 year, and 24 960 in total (12 480 per arm). We will be able to detect a reduction of 12% to 23% or more in immediate antibiotic prescription as a result of the CRP POC intervention. The primary endpoint is the proportion of patient consultations for ARI resulting in immediate antibiotic prescription. Secondary endpoints include the proportion of all patients receiving an antibiotic prescription regardless of ARI diagnosis, frequency of re-consultation, subsequent antibiotic use when antibiotics are not prescribed, referral and hospitalisation.Ethics and dissemination The study protocol was approved by the Oxford University Tropical Research Ethics Committee (OxTREC, Reference: 53–18), and the ethical committee of the National Hospital for Tropical Diseases in Vietnam (Reference:07/HDDD-NDTW/2019). Results from this study will be disseminated via meetings with stakeholders, conferences and publications in peer-reviewed journals. Authorship and reporting of this work will follow international guidelines.Trial registration details NCT03855215; Pre-results.https://bmjopen.bmj.com/content/10/12/e040977.full |
| spellingShingle | H Rogier van Doorn Behzad Nadjm Yoel Lubell Rachel Claire Greer Sabine Dittrich Sonia Lewycka Nga Thi Thuy Do Maida Vandendorpe Van Anh Nguyen Pham Ngoc Thach Ta Thi Dieu Ngan Nguyen Van Kinh Cao Hung Thai Le Thi Kim Dung Tu Nguyen Thi Cam Thanh Ha Nguyen Implementation of C-reactive protein point of care testing to improve antibiotic targeting in respiratory illness in Vietnamese primary care (ICAT): a study protocol for a cluster randomised controlled trial BMJ Open |
| title | Implementation of C-reactive protein point of care testing to improve antibiotic targeting in respiratory illness in Vietnamese primary care (ICAT): a study protocol for a cluster randomised controlled trial |
| title_full | Implementation of C-reactive protein point of care testing to improve antibiotic targeting in respiratory illness in Vietnamese primary care (ICAT): a study protocol for a cluster randomised controlled trial |
| title_fullStr | Implementation of C-reactive protein point of care testing to improve antibiotic targeting in respiratory illness in Vietnamese primary care (ICAT): a study protocol for a cluster randomised controlled trial |
| title_full_unstemmed | Implementation of C-reactive protein point of care testing to improve antibiotic targeting in respiratory illness in Vietnamese primary care (ICAT): a study protocol for a cluster randomised controlled trial |
| title_short | Implementation of C-reactive protein point of care testing to improve antibiotic targeting in respiratory illness in Vietnamese primary care (ICAT): a study protocol for a cluster randomised controlled trial |
| title_sort | implementation of c reactive protein point of care testing to improve antibiotic targeting in respiratory illness in vietnamese primary care icat a study protocol for a cluster randomised controlled trial |
| url | https://bmjopen.bmj.com/content/10/12/e040977.full |
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