Research Proposal for Evaluating a Hub and Spoke System for STEMI Patients in a Catheterization Laboratory
A hub and spoke model for STEMI care is strongly recommended as it significantly improves patient outcomes through greater use of PCI and may reduce 1-year mortality. 1
Background and Rationale
- Hub and spoke systems have demonstrated effectiveness in improving STEMI care by facilitating rapid access to reperfusion therapy and reducing mortality 2
- The architecture of various STEMI models is based on a hub-and-spoke pattern, with each unit being called a STEMI cluster, allowing for increasing expertise as patients move through the system 2
- Recent evidence shows that implementation of hub and spoke models in low and middle-income countries has improved STEMI care through greater use of PCI and reduced 1-year mortality from 17.6% to 14.2% 1
- Telemedicine integration within hub and spoke systems has shown to improve door-to-balloon times from 120 to 48 minutes with overall STEMI mortality of 5.2% 3
Research Objectives
- Primary objective: To evaluate the impact of a hub and spoke catheterization laboratory system on mortality, reinfarction, and stroke rates in STEMI patients 2
- Secondary objectives:
- To assess time metrics including first medical contact-to-device time and door-to-balloon times 2
- To evaluate the rate of appropriate reperfusion therapy utilization 2
- To analyze the demographic characteristics of STEMI patients and identify potential disparities in care 4
- To measure the economic impact of implementing a hub and spoke system 2
Methodology
Study Design
- Prospective, multicenter, observational study with pre-implementation and post-implementation phases 1
- Minimum 12-week pre-implementation data collection followed by sequential implementation across clusters 1
- Post-implementation data collection for at least 32 weeks 1
Setting and Participants
- Include all PCI-capable hub hospitals and non-PCI-capable spoke centers in your network 2
- Enroll all patients ≥20 years with symptoms or signs consistent with STEMI presenting to any facility in the network 1
- Collect demographic data including age, gender, risk factors, and socioeconomic status 4
Data Collection
- Implement a robust information technology platform hosted securely on the cloud for real-time access 2
- Create standardized data collection modules specific to each facility level 2
- Collect the following key data points:
Implementation Framework
Level Classification System
- Categorize facilities into 5 levels based on capabilities 2:
- Level 1: Basic facilities without ECG capabilities
- Level 2: Facilities with ECG capabilities but no reperfusion therapy
- Level 3: Facilities capable of providing fibrinolytic therapy
- Level 4: PCI-capable centers without 24/7 primary PCI support
- Level 5: Hub centers with full spectrum of capabilities
Technology Integration
- Implement ECG transmission capabilities from spoke centers to hub hospitals 2
- Establish telemedicine consultation for rapid STEMI diagnosis and management decisions 3
- Develop standardized protocols and transfer algorithms for each level of facility 5
Quality Improvement Components
- Create a dashboard for administrators to access analytical and visual representations of performance metrics 2
- Provide regular feedback to sites on patient characteristics, process measures, and outcomes 2
- Establish a review committee to investigate mortality cases 6
Outcome Measures
Primary Outcomes
- Proportion of patients receiving reperfusion therapy 1
- Timely reperfusion rates 1
- Post-fibrinolysis angiography and PCI rates 1
- In-hospital and 1-year mortality 1
Secondary Outcomes
- Door-to-balloon times for primary PCI 3
- Door-to-needle times for fibrinolysis 2
- Major adverse cardiovascular events (death, reinfarction, stroke) 2
- Rate of cardiogenic shock 7
- Length of hospital stay 2
- Cost-effectiveness metrics 2
Statistical Analysis
- Calculate sample size based on expected improvement in primary outcome measures 1
- Use descriptive statistics to characterize the study population 4
- Compare pre-implementation and post-implementation outcomes using appropriate statistical tests 1
- Perform multivariate regression analysis to identify predictors of outcomes 4
- Conduct subgroup analyses based on:
Potential Challenges and Solutions
Challenge: Missing data, particularly for vital signs and MI location 1
- Solution: Implement electronic data capture with required fields and regular data quality audits 2
Challenge: Variability in ECG interpretation by non-physicians 2
Challenge: Delays in transfer from spoke to hub facilities 2
- Solution: Establish dedicated ambulance networks and clear transfer protocols 2
Challenge: Ensuring appropriate reperfusion strategy selection 2
- Solution: Develop decision algorithms based on time from symptom onset and transfer capabilities 5
Ethical Considerations
- Obtain ethical approval from institutional review boards at all participating centers 1
- Ensure patient confidentiality through secure data management systems 2
- Consider the ethical implications of potential disparities in care access 2
Expected Impact
- Reduction in STEMI mortality through improved access to timely reperfusion 1
- Increased utilization of evidence-based therapies 1
- Development of a sustainable model for STEMI care that can be replicated in other regions 6
- Creation of a continuous quality improvement framework for ongoing system enhancement 2
Timeline
- 3 months: Protocol development and ethical approvals
- 3 months: Pre-implementation data collection
- 6 months: Sequential implementation across clusters
- 8 months: Post-implementation data collection
- 3 months: Data analysis and report preparation
- 1 year: Follow-up for long-term outcomes
This research proposal provides a comprehensive framework for evaluating the effectiveness of your hub and spoke system for STEMI patients, focusing on the critical outcomes of mortality, morbidity, and quality of life while capturing the demographic characteristics of your patient population.