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

The coronavirus disease 2019 (COVID-19) pandemic requires enormous deployment of health care resources worldwide. Fear of infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), national lockdowns, and altered health care priorities can compromise the quality of care for non-COVID-19 diseases. The downstream effects have been observed in the acute care sector, which has been oriented toward a “war footing” for COVID-19 through major reorganization of emergency care facilities. This is particularly true for China and other low- and middle-income countries, where financial, technical, and staff resources are limited.

Importance of improving quality of care for acute cardiac events in China

ST segment elevation myocardial infarction (STEMI) is the deadliest and most time-sensitive acute cardiac event. Poor quality of care for patients with STEMI contributes to increased mortality from cardiovascular diseases, which is the leading cause of death in China. STEMI cases require rapid coordination of care beginning at the time of symptom onset. Percutaneous coronary intervention (PCI) within 120 minutes from onset is the typically recommended treatment, according to American College of Cardiology/American Heart Association (ACC/AHA) guidelines [1]. Despite the widespread promulgation and endorsement of these guidelines and the strong evidence base underpinning many guideline recommendations, their translation into clinical practice remains suboptimal [2, 3]. On the basis of our prior study, the time from onset to PCI is approximately 291 minutes in China, and only 7% of patients receive timely PCI therapy. Therefore, reducing the treatment delay by organizing delivery of care on a regional basis is a priority for improving quality of STEMI care in China.

The Chinese Cardiovascular Association launched the National Chest Pain Center Accreditation Program (CHANGE) in January 2016. This is the first nationwide, hospital-based, multifaceted, continuous quality improvement (QI) initiative, with aims to monitor and improve the quality of care for acute cardiac events (ClinicalTrials.​gov, NCT04014972). The QI initiatives, as implementation strategies, include a bundle of evidence-based interventions adapted for implementation in China. These are in line with global best practices: (i) accreditation of hospital-based chest pain centers (CPCs), (ii) establishing a unified data registry for quality monitoring and assessment, and (iii) providing ongoing quality review and feedback. The operational structure was developed at the start of the program (Appendix Figure 1). The program is made available to all secondary and tertiary hospitals, and hospitals continue to join the program in a staggered manner. With the support of the National Health Commission (NHC), based on the CPC Accreditation Criteria issued by the Chinese Society of Cardiology, the CHANGE program has implemented the accreditation and development of CPCs (Appendix Figure 2). The CHANGE program developed the China CPC Data Reporting Platform, a web-based, unified national database serving as a national surveillance system for monitoring, evaluation, and feedback regarding quality of care for reported STEMI events (Appendix Table 1). As of June 30, 2019, there were 2,885 hospitals across 31 provinces of China and a total of 463,827 patients with a STEMI diagnosis enrolled in the program. Our preliminary analysis using baseline and quarterly data during January 2016 and June 2019 demonstrated that the QI initiatives can shorten onset to reperfusion times and subsequently reduce in-hospital mortality.

Challenges to quality improvement initiatives in response to COVID-19

The COVID-19 pandemic is challenging population health and health care systems in unprecedented ways, and the effects will last for decades to come [4]. Most countries have implemented stringent infection-control measures, including but not limited to social distancing measures, emergency infection protocols instituted in hospitals to contain COVID-19, and adjustment of clinical services. The response to COVID-19 can compromise rapid triage and may impact optimal treatment delivery for patients with acute cardiac events. Several studies have reported substantial declines in the number of patients presenting with acute cardiac events as well as the number of emergency coronary procedures, in both high-income and low- and middle-income countries [5‐7]. Preliminary available data from the CHANGE program show that hospital admissions among patients with STEMI decreased by more than 50% in February 2020 compared with the same period in 2019. The time from onset to PCI increased from 237 minutes in February 2019 to 342 minutes in February 2020.

There are two major public health concerns with respect to the care in STEMI and other acute cardiac events: (i) delays in presentation, and (ii) delays in treatment [8‐13]. First, causes for late presentation for STEMI are likely multifactorial and may include patient fear of contracting an infection from within the health care system. The lack of knowledge compounded by fear of the SARS-CoV-2 make patients with STEMI much less likely to seek help. The emphasis on social distancing might have inappropriately convinced patients to avoid in-person health care. Proper education including STEMI awareness and COVID-19 knowledge is warranted during a pandemic [8, 9, 14]. In the CHANGE program, accredited CPCs in hospitals should follow the criteria for establishing a medical consortium of STEMI care. Hospitals should be partnered with community health centers to form an information-sharing and resource-management model. Health workers at community health centers conduct health management of STEMI patients and health education among community residents, which are part of the essential public health services in China. Thus, community-based education supervised by hospitals within a medical consortium should be established within routine services delivery, to inform the public that the CPCs remain fully operational and have stringent infection-control protocols in place during the pandemic.

Second, delays in treatment may be prolonged because the emergency infection protocols (e.g., COVID-19 screening after hospital arrival) could result in a considerable delay in timely treatment. Additionally, care providers may be subject to travel restrictions or be dispatched to the front lines in fight against COVID-19, leading to a shortage of health workers and systemic overload. For example, over 40,000 medical professionals from other parts of China have been sent to Wuhan, Hubei Province, the epicenter of the outbreak, thereby draining the available resources for other disease conditions. Stresses on health systems are also likely to affect critical supply chains for essential medicines and equipment. Thus, it is imperative to improve the health care system’s ability to maintain care coordination for operational integrity with respect to patients with STEMI. A balance must be struck between identifying appropriate patients for PCI intervention for STEMI, regardless of their COVID-19 status, and maintaining the safety of health care workers who may be exposed to the virus as well as minimizing contamination of cardiac catheterization laboratory facilities [15, 16]. Prior studies have shown that a dedicated regional coordinator in charge of implementing systematic improvements within hospitals and EMS agencies in the region could play a critical role in maintaining coordination of care [17].

It is therefore necessary that health care systems develop plans for optimizing the existing QI initiatives, to mitigate the negative impact of the COVID-19 outbreak and to protect patients with acute cardiac events from nosocomial infection and limited access to care. This is not simply a problem limited to a single specialty or condition but rather a problem that holds lessons in acute illness care.

Contributions to current theory practice and policy

Following the positive preliminary phase and considering the needs in response to COVID-19, the QI initiatives should be optimized, as recommended by the NHC [18]. In collaboration with NHC partners and CHANGE program staff, this study will design an updated implementation strategy for this optimization, to enhance the adoption, implementation, and sustainability of QI initiatives in the context of COVID-19. However, little is known regarding identification of the best policy options and solutions based on China’s real-world situations, to improve the quality of care in response to COVID-19. Furthermore, to our knowledge, no studies have focused on implementation strategies to provide generalizable data that can inform replication and scale-up activities [17, 19]. Therefore, this study will add evidence-based interventions to current QI initiatives, to develop optimized QI initiatives from a multidisciplinary research perspective. The main contributions of the proposed project include the following.

First, a Consolidated Framework for Implementation Research (CFIR) framework will be used to identify multilevel factors that emerge within the context of COVID-19 and influence implementation of the current QI interventions [20], and where adjustments and refinements to the intervention could be made in response to COVID-19.

Second, a novel model will be used to measure the implementation strategy of the optimized QI initiatives, using a stepped wedge cluster randomized control design, under a modified RE-AIM (reach, effectiveness, adoption, implementation, maintenance) framework [21]. The RE-AIM model is a practical tool that assesses complex interventions in real-world health care system settings, including measures of clinical effectiveness and implementation strategies. The stepped wedge design will provide more generalizable estimates than traditional study designs because it allows for regular data analysis and iterative dissemination of results—internally, to support programmatic improvements and with partners for embedded research practices.

Third, the outcomes of this study could be translated into a systematic solution for implementing the QI initiatives in response to COVID-19 and other potential pandemics or health emergencies. The synthesis of the CFIR framework and RE-AIM evaluation framework will enhance the traditional stepped wedge design by including measures of implementation fidelity, and will generate knowledge about process outcomes and feasibility including barriers and facilitators, core components that are transferrable, and where local adaptation is needed for replication in other settings [22]. This actionable knowledge is a critical need for implementors of scale-up activities in low- and middle-income settings.

The COVID-19 pandemic compromises the quality of care for the acute cardiac events. How to minimize the untoward impact of the evolving COVID-19 pandemic on the health care quality has been an imminent agenda for policymakers as well as researchers. This project will be the first to develop and implement hospital-based interventions that improve the quality of care for acute cardiac events in response to COVID-19, and to develop strategic options in scale-up activities for the quality improvement initiatives in response to COVID-19 and other potential pandemics or health emergencies. We have described our rationale, study design, and implementation strategy details regarding this stepped wedge cluster randomized control design.