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Table 4 Outcomes, data collection, and analysis plans organized by adapted RE-AIM domains

From: 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

Outcomes Indicators Data source Indicator definition
Service outcome Number of admissions Hospital-based assessments The number of admissions for STEMI patients
  PCI rate Hospital-based assessments The proportion of STEMI patients who receive PCI
  Percentage of EMS transfer Hospital-based assessments The percentage of STEMI patients who are transferred by EMS agency
  Onset-to-FMC time Hospital-based assessments The time from onset to first medical contact of STEMI patients
  Door-to-balloon time Hospital-based assessments The time from arrival in hospital to PCI of STEMI patients
  FMC-to-device time Hospital-based assessments The time from first medical contact to PCI of STEMI patients
  Percentage of onset-to-FMC time ≤ 60 min Hospital-based assessments Percentage of STEMI patients with the time from onset to first medical contact ≤ 60 min
  Percentage of Call-to-EMS time ≤ 15 min Hospital-based assessments Percentage of STEMI patients with the time from calling EMS agency to ambulance arrival ≤ 15 min
  Percentage of Door-to-balloon time ≤ 60 min Hospital-based assessments Percentage of STEMI patients with the time from arrival in the hospital to PCI ≤ 60 min
  Percentage of FMC-to-device time ≤ 90 min Hospital-based assessments Percentage of STEMI patients with the time from first medical contact to PCI ≤90 min
Patient outcome In-hospital mortality Hospital-based assessments Proportion of STEMI patients discharged death
  1-year mortality Community-based household survey by telephone Death rate of the STEMI patients within 1 year after hospitalization
  1-year complication rate Community-based household survey by telephone Incidence rate of new vascular events of STEMI patients within 1 year after hospitalization
Implementation outcome—reach Number of patients visits Community-based household survey Proportion of the STEMI patients reporting care at a health facility
  Number of residents receiving health education Community-based household survey Number of individuals who receive education on STEMI awareness and COVID-19 knowledge
  Training the QI initiatives for Health providers Questionnaire survey on healthcare providers Number and proportion of the healthcare providers who receive the QI initiatives training
Implementation outcome —adoption Community engagement Community-based household survey Number of community residents attending the optimized QI initiatives
  Health providers engagement Questionnaire survey on healthcare providers Number of health providers attending the optimized QI initiatives
  Behavior change of healthcare providers Questionnaire survey on healthcare providers Change score of healthcare providers in compliance with protocol of clinical guidelines
  Health literacy change of residents Community-based household survey Change score of health literacy related to STEMI awareness and COVID-19 knowledge of individuals
  Attitude of health facility directors Key informant interviews Degree of acceptance of the optimized QI initiatives by directors from hospitals and EMS agency
Implementation outcome—implementation Fidelity Key informant interviews Degree that the optimized QI initiatives are implemented as
planned in original protocol
  Feasibility Key informant interviews Extent that the optimized QI initiatives can be carried out in a specific setting
  Outer context Key informant interviews Macro-level external factors including social, funding, and leadership
  Inner context Key informant interviews Micro-level internal factors including NHC partnership, the programmatic staff, feedback, hospitals, EMS agency, community, household, and individual level
Implementation outcome —maintenance Sustainable of the effectiveness Key informant interviews Views on maintaining effectiveness from policy makers, health facility directors, healthcare providers, and residents
  Satisfactory of stakeholders Key informant interviews Satisfactory on effectiveness and implementation strategy of the optimized QI initiatives of policy makers, health facility directors, healthcare providers, and residents
  Financial sustainable Key informant interviews Views on funding and return on investment from policy makers and health facility directors
  Institutionalization of interventions Key informant interviews Core components which are transferrable and where local adaptation is needed for replication in other settings
  1. 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