A stepped wedge cluster randomized control trial to evaluate the implementation and effectiveness of optimized initiatives in improving quality of care for ST segment elevation myocardial infarction in response to the COVID-19 outbreak
Abstract Background The National Chest Pain Center Accreditation Program (CHANGE) is the first hospital-based, multifaceted, nationwide quality improvement (QI) initiative, to monitor and improve the quality of the ST segment elevation myocardial infarction (STEMI) care in China. The QI initiatives,...
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| Format: | Article |
| Language: | English |
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BMC
2021-04-01
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| Series: | Implementation Science |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s13012-021-01107-1 |
| _version_ | 1819087634039832576 |
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| author | Shuduo Zhou Xuejie Dong Fangjing Liu Yan Zhang Dahai Yue Qiang Zhou Yinzi Jin Zhi-Jie Zheng |
| author_facet | Shuduo Zhou Xuejie Dong Fangjing Liu Yan Zhang Dahai Yue Qiang Zhou Yinzi Jin Zhi-Jie Zheng |
| author_sort | Shuduo Zhou |
| collection | DOAJ |
| description | Abstract Background The National Chest Pain Center Accreditation Program (CHANGE) is the first hospital-based, multifaceted, nationwide quality improvement (QI) initiative, to monitor and improve the quality of the ST segment elevation myocardial infarction (STEMI) care in China. The QI initiatives, as implementation strategies, include a bundle of evidence-based interventions adapted for implementation in China. During the pandemic of coronavirus disease 2019 (COVID-19), fear of infection with severe acute respiratory syndrome coronavirus 2, national lockdowns, and altered health care priorities have highlighted the program’s importance in improving STEMI care quality. This study aims to minimize the adverse impact of the COVID-19 pandemic on the quality of STEMI care, by developing interventions that optimize the QI initiatives, implementing and evaluating the optimized QI initiatives, and developing scale-up activities of the optimized QI initiatives in response to COVID-19 and other public health emergencies. Methods A stepped wedge cluster randomized control trial will be conducted in three selected cities of China: Wuhan, Suzhou, and Shenzhen. Two districts have been randomly selected in each city, yielding a total of 24 registered hospitals. This study will conduct a rollout in these hospitals every 3 months. The 24 hospitals will be randomly assigned to four clusters, and each cluster will commence the intervention (optimized QI initiatives) at one of the four steps. We will conduct hospital-based assessments, questionnaire surveys among health care providers, community-based household surveys, and key informant interviews during the trial. All outcome measures will be organized using the RE-AIM (reach, effectiveness, adoption, implementation, maintenance) framework, including implementation outcomes, service outcomes (e.g., treatment time), and patient outcomes (e.g., in-hospital mortality and 1-year complication). The Consolidated Framework for Implementation Research framework will be used to identify factors that influence implementation of the optimized QI interventions. Discussion The study findings could be translated into a systematic solution to implementing QI initiatives in response to COVID-19 and future potential major public health emergencies. Such actionable knowledge is critical for implementors of scale-up activities in low- and middle-income settings. Trial registration ChiCTR 2100043319 . Registered on 10 February 2021 |
| first_indexed | 2024-12-21T21:39:15Z |
| format | Article |
| id | doaj.art-29fc2f1f685a48939e4b41bea425fbf8 |
| institution | Directory Open Access Journal |
| issn | 1748-5908 |
| language | English |
| last_indexed | 2024-12-21T21:39:15Z |
| publishDate | 2021-04-01 |
| publisher | BMC |
| record_format | Article |
| series | Implementation Science |
| spelling | doaj.art-29fc2f1f685a48939e4b41bea425fbf82022-12-21T18:49:23ZengBMCImplementation Science1748-59082021-04-0116111510.1186/s13012-021-01107-1A stepped wedge cluster randomized control trial to evaluate the implementation and effectiveness of optimized initiatives in improving quality of care for ST segment elevation myocardial infarction in response to the COVID-19 outbreakShuduo Zhou0Xuejie Dong1Fangjing Liu2Yan Zhang3Dahai Yue4Qiang Zhou5Yinzi Jin6Zhi-Jie Zheng7Department of Global Health, School of Public Health, Peking UniversityDepartment of Global Health, School of Public Health, Peking UniversityDepartment of Global Health, School of Public Health, Peking UniversityInstitute of Cardiovascular Disease, Peking University First HospitalUniversity of MarylandShenzhen Center for Prehospital CareDepartment of Global Health, School of Public Health, Peking UniversityDepartment of Global Health, School of Public Health, Peking UniversityAbstract Background The National Chest Pain Center Accreditation Program (CHANGE) is the first hospital-based, multifaceted, nationwide quality improvement (QI) initiative, to monitor and improve the quality of the ST segment elevation myocardial infarction (STEMI) care in China. The QI initiatives, as implementation strategies, include a bundle of evidence-based interventions adapted for implementation in China. During the pandemic of coronavirus disease 2019 (COVID-19), fear of infection with severe acute respiratory syndrome coronavirus 2, national lockdowns, and altered health care priorities have highlighted the program’s importance in improving STEMI care quality. This study aims to minimize the adverse impact of the COVID-19 pandemic on the quality of STEMI care, by developing interventions that optimize the QI initiatives, implementing and evaluating the optimized QI initiatives, and developing scale-up activities of the optimized QI initiatives in response to COVID-19 and other public health emergencies. Methods A stepped wedge cluster randomized control trial will be conducted in three selected cities of China: Wuhan, Suzhou, and Shenzhen. Two districts have been randomly selected in each city, yielding a total of 24 registered hospitals. This study will conduct a rollout in these hospitals every 3 months. The 24 hospitals will be randomly assigned to four clusters, and each cluster will commence the intervention (optimized QI initiatives) at one of the four steps. We will conduct hospital-based assessments, questionnaire surveys among health care providers, community-based household surveys, and key informant interviews during the trial. All outcome measures will be organized using the RE-AIM (reach, effectiveness, adoption, implementation, maintenance) framework, including implementation outcomes, service outcomes (e.g., treatment time), and patient outcomes (e.g., in-hospital mortality and 1-year complication). The Consolidated Framework for Implementation Research framework will be used to identify factors that influence implementation of the optimized QI interventions. Discussion The study findings could be translated into a systematic solution to implementing QI initiatives in response to COVID-19 and future potential major public health emergencies. Such actionable knowledge is critical for implementors of scale-up activities in low- and middle-income settings. Trial registration ChiCTR 2100043319 . Registered on 10 February 2021https://doi.org/10.1186/s13012-021-01107-1ST segment elevation myocardial infarctionQuality-improvedRE-AIMCFIROptimizedCOVID-19 |
| spellingShingle | Shuduo Zhou Xuejie Dong Fangjing Liu Yan Zhang Dahai Yue Qiang Zhou Yinzi Jin Zhi-Jie Zheng A stepped wedge cluster randomized control trial to evaluate the implementation and effectiveness of optimized initiatives in improving quality of care for ST segment elevation myocardial infarction in response to the COVID-19 outbreak Implementation Science ST segment elevation myocardial infarction Quality-improved RE-AIM CFIR Optimized COVID-19 |
| title | A stepped wedge cluster randomized control trial to evaluate the implementation and effectiveness of optimized initiatives in improving quality of care for ST segment elevation myocardial infarction in response to the COVID-19 outbreak |
| title_full | A stepped wedge cluster randomized control trial to evaluate the implementation and effectiveness of optimized initiatives in improving quality of care for ST segment elevation myocardial infarction in response to the COVID-19 outbreak |
| title_fullStr | A stepped wedge cluster randomized control trial to evaluate the implementation and effectiveness of optimized initiatives in improving quality of care for ST segment elevation myocardial infarction in response to the COVID-19 outbreak |
| title_full_unstemmed | A stepped wedge cluster randomized control trial to evaluate the implementation and effectiveness of optimized initiatives in improving quality of care for ST segment elevation myocardial infarction in response to the COVID-19 outbreak |
| title_short | A stepped wedge cluster randomized control trial to evaluate the implementation and effectiveness of optimized initiatives in improving quality of care for ST segment elevation myocardial infarction in response to the COVID-19 outbreak |
| title_sort | stepped wedge cluster randomized control trial to evaluate the implementation and effectiveness of optimized initiatives in improving quality of care for st segment elevation myocardial infarction in response to the covid 19 outbreak |
| topic | ST segment elevation myocardial infarction Quality-improved RE-AIM CFIR Optimized COVID-19 |
| url | https://doi.org/10.1186/s13012-021-01107-1 |
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