Study aims
The overall goal is to minimize the untoward impact of the evolving COVID-19 outbreak on the quality of STEMI care by optimizing the implementation of QI initiatives. The specific objectives of the study include the following:
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To develop hospital-based interventions that optimize the QI initiatives, adapted to China’s health care system.
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To implement the optimized QI initiatives, and evaluate the clinical effectiveness and implementation strategy using measures of reach, adoption, implementation, and maintenance.
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To develop strategic options in scale-up activities for the optimized QI initiatives under two scenarios, including the outbreak stage of a major public health emergency and the pandemic period.
Study Design
The theoretical model for this study is a synthesis of implementation and evaluation of the optimized QI initiatives under the theory of implementation science (Fig. 1). The RE-AIM framework will be used to evaluate the implementation strategy, in which three dimensions of outcomes will be included, namely, implementation outcome, service outcome, and patient outcome. Effectiveness is measured according to service outcome and patient outcome. Reach, adoption, implementation, and maintenance are measured according to implementation outcomes. The CFIR framework will be used to identify the barriers and facilitators influencing the implementation strategy. Based on the theoretical model, we will use a stepped wedge cluster randomized control design to evaluate the implementation and effectiveness of the optimized quality improvement initiatives.
Setting and facility selection
The study will be conducted in cities of Wuhan, Suzhou, and Shenzhen of China. Study sites are selected by the NHC partners and the CHANGE program staff based on region, population size, economic level, traffic conditions, and representativeness of the prehospital model. The prehospital model varies across cities. In general, there are now at least three prehospital models delivering emergency medical services (EMS). The first type operates independently (e.g., Wuhan), the second is under the authority of emergency centers (e.g., Suzhou), and the third is delivered by the emergency department of hospitals (e.g., Shenzhen). Two districts will be randomly selected in each of the three cities. All hospitals registered in the CHANGE program in the six selected districts will be included; finally, this study will include 24 registered hospitals. The intervention will be applied at hospital level. Intervention hospitals will carry out the optimized QI initiatives, and hospitals that have not been enrolled in the intervention will conduct the current QI initiatives (Table 1).
Table 1
Optimized and current QI initiatives in the CHANGE program
QI initiatives
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Details
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Classification
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(1) Accreditation of hospital-based CPCs
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• The comprehensive center criteria are applicable to the comprehensive CPCs at tertiary hospitals; while the basic center criteria targets at the basic CPCs at secondary hospitals.
• Both editions of the criteria include 5 dimensions of qualification: conditions of facilities, diagnosis and treatment process, integration of prehospital and hospital care, training and education, and real-time data reporting.
• Registered hospitals need to go through 3 stages including self-assessment, accreditation and re-accreditation every 3 years, to develop an accredited CPC.
• The accreditation process is jointly led by the China CPC Headquarters, Regional Accreditation Offices, and Provincial-level CPC Alliances.
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Current and optimized
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(2) Quality monitor and assessment
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• Accredited hospitals should continuously report data for monitoring and feedback.
• The indicators for measuring the CPC performance in the quarterly and annually benchmarked reports are developed by the China CPC Headquarters, based on the ACC/AHA Performance Measures and clinical practice guidelines.
• There are two sets of performance measures respectively for comprehensive and basic CPCs.
• Ranking of a CPC is calculated based on the percentile of each indicator and a weighted composite score. The score of 100, 80, 60, 40, 20 and 0 are for ranking the top 10%, 10–30%, 30–50%, 50–70%, 70–90% and 90–100% of the measure among the entire accredited CPCs.
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Current and optimized
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(3) Quality review and feedback
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• Improvement in adherence to the guideline recommendations is facilitated through monthly and quarterly hospital-specific performance feedback reports.
• The hospital-specific data are compared against a variety of internal and external benchmarks, including the temporal trend in performance and comparison points to regional or national performance thresholds.
• A series of regular meeting, QI analysis meeting and case study meeting are carried out at least once every quarter for sharing of ‘best practice’ clinical support tools.
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Current and optimized
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(4) Dedicated regional coordinator
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• Dedicated regional coordinator charged with implementing systematic improvements within every hospital and EMS agency will be assigned by city-level CPC Alliances.
• Dedicated regional coordinators will work with the local health bureau to promote the optimized QI initiatives.
• The work of dedicated regional coordinators will include synthesizing emergency infection protocols to contain COVID-19 with QI initiatives, coordinating care between community, hospitals and EMS agency, maintaining the safety of healthcare workers, minimizing contamination of laboratory facilities.
• The work of dedicated regional coordinators will be supervised by the city-level CPC Alliances and the China CPC Headquarters.
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Optimized
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(5) Education and training activities
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• The training on emergency infection protocols instituted in hospitals to contain COVID-19 targeting at healthcare professionals will be conducted by hospitals
• Education on STEMI awareness and COVID-19 knowledge targeting at community residents will be conducted by community health centers, which are trained and supervised by hospitals within the medical consortium.
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Optimized
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Abbreviations: QI: quality improvement; CHANGE: National Chest Pain Center Accreditation Program; CPC: chest pain center; EMS: emergency medical services; ACC/AHA: American College of Cardiology/American Heart Association; COVID-19: coronavirus disease 2019; STEMI: ST-segment elevation myocardial infarction. |
Sampling
In this study, we will conduct a rollout to registered hospitals every 3 months, which will be based on the pilot experience, local contextual factors, budgetary and feasibility considerations. Patients with STEMI in registered hospitals will be consecutively enrolled in five 3-month steps. No intervention will be applied in the first step among all registered hospitals. Hospitals will be randomly allocated to one of four clusters, with six hospitals in each cluster. Each cluster will commence the intervention at one of the four remaining steps. All hospitals will be on the intervention in the final step. Characteristics of hospitals with STEMI cases enrolled during January and June 2020 are shown in Table 2, by district (Table 2).
Table 2
Characteristics of sample hospitals, by district
City
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District
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Population
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Land area (sq.km)
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Number of hospitals
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STEMI patients
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In-hospital mortality
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Wuhan
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Jianghan
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496,289
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28.3
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3
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459
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1.53
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Qiaoko
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528,604
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40.1
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4
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319
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3.13
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Suzhou
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Gusu
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957,500
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83.4
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4
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167
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3.86
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Kunshan
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1,665,900
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931.5
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6
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157
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1.27
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Shenzhen
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Futian
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1,633,700
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78.5
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4
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250
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6.00
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Luohu
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1,039,900
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78.7
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3
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229
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4.37
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Abbreviation: STEMI: ST-segment elevation myocardial infarction. |
Randomization
Randomization will be done centrally among all 24 hospitals before initiating the intervention in the first-cluster hospitals. The allocation codes will be concealed by the statistician separately and will be provided to CHANGE program staff who are responsible for initiation of the intervention. The cluster order for implementation at each step will be determined randomly by an external technical advisor using a random number generator. Randomization will occur 6 months prior to rollout of the intervention in the next cluster. This will enable blinding to the random order of clusters for the NHC partners and CHANGE program staff involved in implementation while also allowing for an annual 6-month planning stage prior to starting the intervention.
Sample size
This study is powered to detect a change according to cluster in admissions and in-hospital mortality per 100 STEMI cases. A sample size of 1581 participants will provide 80% power to detect an estimated 15% reduction or greater in mortality from the estimated baseline of 3.18 per 100 STEMI cases, with an alpha of 0.05, intra-cluster correlation of 0.005, and 20% non-response rate. The effect size is a conservative estimate based on past pilot experience (ClinicalTrials.gov, NCT04014972).
Data will be collected via the China CPC Data Reporting Platform (http://data.chinacpc.org/). Registered hospitals are instructed to enroll consecutive patients admitted to hospitals with acute cardiac events, and real-time reporting, as required. To be eligible, we will collect data from patients who meet the following criteria: (1) age 18 years or older; (2) a discharge diagnosis of STEMI based on ischemic symptoms, ECG changes, or positive cardiac markers; (3) admitted via all kinds of modes including directly by self, via EMS, transferred in, or in-hospital
Project activities
Taking advantage of ongoing monitoring and evaluation of the quality of STEMI care and continuous data collection in the CHANGE program, this study will achieve the goals and objectives through the following tasks and approaches.
(1) Task 1. Design of optimized QI initiatives
Specific activities
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Summarize China’s current experience in improving the quality of STEMI care in response to COVID-19 and focusing on the selected cities.
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Identify priority intervention areas in quality of the care response to COVID-19.
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Identity key players and actors and their roles in optimizing QI initiatives in China.
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Develop hospital-based interventions based on the current QI initiatives.
Approaches
1) Case studies
We will carry out case studies in the three selected cities, and we will summarize practices in implementation of the current QI initiatives, analyze the development of health care systems and infection-control measures, and assess the demographic profile of the population and utilization of emergency and medical services.
2) Qualitative Interviews and formative research
This study will draw upon a series of interviews (face-to-face and by telephone and email) and focus group discussions conducted with key informants from governmental and nongovernmental agencies, organizations, and institutions. The interviews and discussions will be based on the initial outputs produced in the pilot study and case studies. A list of questions will then be developed and submitted to the study organization for consultation, review, comments, and further clarification.
(2) Task 2. Implementation and evaluation of optimized QI initiatives
Specific activities
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Implement the optimized QI initiatives in the 24 selected hospitals in a staggered manner.
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Compare longitudinal changes in the quality metrics of STEMI care and assess the clinical effectiveness of the optimized QI initiatives.
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Analyze changes in the measures of reach, adoption, implementation, and maintenance, to evaluate the implementation strategy of the optimized QI initiatives.
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Identify barriers and facilitators contributing to implementation of the optimized QI initiatives.
Approaches
1) Stepped wedge cluster randomized control trial
This pragmatic design leverages the staggered rollout of the optimized QI initiatives and will facilitate the assessment of effectiveness and implementation strategy. The trial will include four clusters in which the optimized QI initiatives are implemented sequentially every 3 months. A local project office in each district will be set up to manage the process of implementation. As detailed in Table 3, the optimized QI initiatives will be sequentially implemented by cluster. Baseline assessment will be conducted within 3 months prior to implementing the optimized QI initiatives.
Table 3. Optimized quality improvement (QI) initiatives: timeline and data collection based on staggered implementation
Note: Black portion in rows indicates the intervention phase and gray portion indicates the control phase.
2) Evaluation of the optimized QI initiatives
To evaluate the effectiveness and implementation of the optimized QI initiatives, we will conduct a pragmatic hybrid type II effectiveness-implementation study, as this allows for simultaneous mixed-methods evaluation. All measures will be organized using a modified RE-AIM framework. Table 4 summarizes outcomes, data collection, and analysis plans organized by objective and adapted RE-AIM domains.
Table 4
Outcomes, data collection and analysis plans organized by adapted RE-AIM domains
Outcomes
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Indicators
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Data source
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Indicator definition
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Service outcome
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Number of admissions
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Hospital-based assessments
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The number of admissions for STEMI patients
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PCI rate
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Hospital-based assessments
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The proportion of STEMI patients who receive PCI
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Percentage of EMS transfer
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Hospital-based assessments
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The percentage of STEMI patients who are transferred by EMS agency
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Onset-to-FMC time
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Hospital-based assessments
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The time from onset to first medical contact of STEMI patients
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Door-to-balloon time
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Hospital-based assessments
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The time from arrival in hospital to PCI of STEMI patients
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FMC-to-device time
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Hospital-based assessments
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The time from first medical contact to PCI of STEMI patients
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Percentage of onset-to-FMC time ≤ 60 min
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Hospital-based assessments
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Percentage of STEMI patients with the time from onset to first medical contact ≤ 60 min
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Percentage of Call-to-EMS time ≤ 15 min
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Hospital-based assessments
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Percentage of STEMI patients with the time from calling EMS agency to ambulance arrival ≤ 15 min
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Percentage of Door-to-balloon time ≤ 60 min
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Hospital-based assessments
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Percentage of STEMI patients with the time from arrival in hospital to PCI ≤ 60 min
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Percentage of FMC-to-device time ≤ 90 min
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Hospital-based assessments
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Percentage of STEMI patients with the time from first medical contact to PCI ≤ 90 min
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Patient outcome
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In-hospital mortality
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Hospital-based assessments
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Proportion of STEMI patients discharged death
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1-year mortality
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Community-based household survey by telephone
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Death rate of the STEMI patients within 1 year after hospitalization
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1-year complication rate
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Community-based household survey by telephone
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Incidence rate of new vascular events of STEMI patients within 1 year after hospitalization
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Implementation outcome -Reach
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Number of patients visits
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Community-based household survey
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Proportion of the STEMI patients reporting care at a health facility
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Number of residents receiving health education
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Community-based household survey
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Number of individuals who receive education on STEMI awareness and COVID-19 knowledge
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Training the QI initiatives for Health providers
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Questionnaire survey on healthcare providers
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Number and proportion of the healthcare providers who receive the QI initiatives training
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Implementation outcome -Adoption
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Community engagement
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Community-based household survey
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Number of community residents attending the optimized QI initiatives
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Health providers engagement
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Questionnaire survey on healthcare providers
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Number of health providers attending the the optimized QI initiatives
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Behavior change of healthcare providers
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Questionnaire survey on healthcare providers
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Change score of healthcare providers in compliance with protocol of clinical guidelines
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Health literacy change of residents
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Community-based household survey
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Change score of health literacy related to STEMI awareness and COVID-19 knowledge of individuals
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Attitude of health facility directors
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Key informant interviews
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Degree of acceptance of the optimized QI initiatives by directors from hospitals and EMS agency
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Implementation outcome - Implementation
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Fidelity
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Key informant interviews
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Degree that the optimized QI initiatives are implemented as
planned in original protocol
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Feasibility
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Key informant interviews
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Extent that the optimized QI initiatives can be carried out in a
specific setting
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Outer context
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Key informant interviews
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Macro-level external factors including social, funding, and
leadership
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Inner context
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Key informant interviews
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Micro-level internal factors including NHC partnership, the programmatic staff, feedback, hospitals, EMS agency, community, household, and individual level
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Implementation outcome -Maintenance
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Sustainable of the effectiveness
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Key informant interviews
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Views on maintaining effectiveness from policy makers, health facility directors, healthcare providers and residents
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Satisfactory of stakeholders
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Key informant interviews
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Satisfactory on effectiveness and implementation strategy of the optimized QI initiatives of policy makers, health facility directors, healthcare providers and residents
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Financial sustainable
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Key informant interviews
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Views on funding and return on investment from policy makers and health facility directors
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Institutionalization of interventions
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Key informant interviews
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Core components which are transferrable and where local adaptation is needed for replication in other settings
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Abbreviations: RE-AIM: reach, effectiveness, adoption, implementation, maintenance; PCI: percutaneous coronary intervention; STEMI: ST-segment elevation myocardial infarction; EMS: emergency medical services; FMC, first medical contact; QI: quality improvement; COVID-19: coronavirus disease 2019; NHC: National Health Commission. |
To measure outcomes, four components of the proposed work at each cluster will be conducted: i) hospital-based assessments, ii) questionnaire surveys of health care providers, iii) community-based household surveys, and iv) key informant interviews. Further details about each study component are described below, with Table 3 summarizing the timeline.
i) Hospital-based assessments
The assessments will be carried out at hospital level by collecting data via the China CPC Data Reporting Platform. Data elements for quality-of-care metrics will be selected based on the ACC/AHA clinical data standards. The assessments will be conducted in each cluster at baseline, at the start of the trial, and at subsequent 3-month intervals until the end of the trial.
ii) Questionnaire surveys of health care providers
Health care providers’ experiences and perceptions will be assessed via questionnaire surveys, to inform the consideration of reach and adoption efforts. Questionnaire survey data will be collected from dedicated regional coordinators, cardiologists, medical staff in emergency departments, and hospital managers. The assessments will be conducted in each cluster at baseline, at the start of the trial, and at subsequent 6-month intervals until the trial end.
iii) Community-based household surveys
Household surveys will be conducted at community level using a self-designed questionnaire to inform consideration regarding patient outcomes, as well as reach and adoption efforts. Surveys will target patients with STEMI and the general catchment population. The surveys will be conducted in each cluster at baseline, at the start of the trial, and at subsequent 6-month intervals until the trial end.
iv) Key informant interviews
Qualitative interviews will be completed with key informants to assess adoption and maintenance. Key informants will include implementing partners in the program and local governments, as well as clinical and administrative employees in hospitals and EMS agencies. The key informant interviews will be conducted in each cluster at baseline, at the start of the trial, and at subsequent 6-month intervals until trial end.
(3) Task 3. Development of scale-up activities in the optimized QI initiatives
Specific activities
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Identify barriers and facilitators to program implementation fidelity and feasibility while also documenting contextual factors.
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Investigate core requirements for implementing the optimized QI initiatives in response to COVID-19.
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Identify gaps between the current experience in China’s practices of implementing the optimized QI initiatives.
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Develop strategic and policy options for scale-up activities of the optimized QI initiatives under two scenarios, including the outbreak stage of a major public health emergency and the pandemic period.
Approaches
1) Stakeholder-based participatory research
Stakeholder-based participatory research will be conducted at the end of the stepped wedge cluster randomized control trial, to focus on partnerships, engagement, co-learning, and building on existing assets within China. Major stakeholder agencies and organizations will be invited to participate in this exercise. The exercise will help to identify factors influencing the implementation strategy using the CFIR framework, investigate core requirements for implementing the optimized QI initiatives in response to COVID-19, and identify gaps between the current experience in China’s practices in implementing the optimized QI initiatives according to the designed interview outline.
2) Policy dialogue and round-table discussion
We will translate the findings and results of this study into policy briefs and reports. Both electronic and paper-based briefs and internal policy analytic reports will be distributed through university think tank-based and extra-university channels to relevant decision-making bodies and agencies. A round-table discussion will be convened, to allow for feedback and comments on the results and findings of the study and provide opportunities for knowledge uptake among all stakeholders, decision makers, and executive entities, using push techniques to elicit pull by tailoring dissemination, to address the needs and concerns of decision makers.
Statistical methods
(1) Task 1. Design of the optimized QI initiatives
For Task 1, the analytic hierarchy process will be applied to identify the priority intervention areas in the quality-of-care response to COVID-19. A facilitated and structured interview matrix technique will be used to analyze the interview results for organizational analysis and strategic planning of priority settings. The structured interview matrix will follow a graded approach to collaboration involving discussion at three levels, using a three-step process: (1) interviews conducted by participants in the group; (2) small group deliberation; and (3) a facilitated, plenary discussion with the full group.
(2) Task 2. Implementation and evaluation of the optimized QI initiatives
1) To investigate the effectiveness of the optimized QI initiatives with respect to quality metrics of STEMI care in response to COVID-19
Primary analysis will be performed according to the intention-to-treat principle. All analyses of outcomes will be at individual level but will account for the clustering of patients at hospital level. Comparisons of quality metrics between intervention and control participants will be conducted using the t-test and χ2 test. To analyze intervention effects, generalized estimating equation models will be used to account for the clustering within hospitals. The primary model will include a fixed effect for time and a binary variable for the effect of the intervention. The intervention effects will be summarized as the resulting odds ratios and difference of proportions for binary outcomes or mean differences for continuous outcomes. We will also conduct two-level generalized linear mixed models with patient and hospital as the first and second levels, respectively, using covariate-adjusted analyses. The model will also include the severity of the COVID-19 pandemic as a confounding factor. Appendix Table 2 depicts how the results will be displayed.
2) To examine the implementation strategy of the optimized QI initiatives using measures of reach, adoption, implementation, and maintenance in response to COVID-19
We will use a mixed-effects generalized linear model to compare pre-intervention to post-intervention proportions for each metric of reach and adoption, while adjusting for clustering at the hospital level and time and allowing for hospital-level estimates to be random effects; Appendix Table 3 shows how the results will be displayed. Evaluation of implementation and maintenance will be completed using questionnaires and interviews following the CFIR framework. The results of CFIR domains will complement quantitative data collected to evaluate implementation strategy and will assess emerging themes in identifying barriers and facilitators contributing to implementation of the optimized QI initiatives, to minimize adverse impacts of COVID-19 outbreak (Appendix Table 2).
(3) Task 3. Development of scale-up activities of the optimized QI initiatives
For task 3, the CFIR framework will be used to identify factors that may emerge in various contexts and that influence intervention implementation and effectiveness. We will use a template-analysis approach to code and organize our data for analysis by CFIR domain, including intervention characteristics, inner setting, outer setting, characteristics of individuals involved in implementation, and implementation process. Then, we will populate analytic matrices with the information for cross-case analysis of patterns in barriers and facilitators related to each of the program components. Our analytic matrices will facilitate simultaneous viewing of a large volume of data, to make between-practice comparisons and identify similarities, differences, and trends in how practices have experienced implementation.