The impact of the HEART risk score in the early assessment of patients with acute chest pain: design of a stepped wedge, cluster randomised trial
Key result
This study protocol outlines a stepped wedge cluster randomized trial to evaluate if the HEART score safely guides clinical decisions in 6,600 chest pain patients without increasing 6-week MACE.
Why the study?
Does the use of the HEART score to guide clinical decisions improve outcomes and reduce costs in unselected chest pain patients presenting at the emergency department?
Population
6600 unselected chest pain patients presenting at the emergency department (ED) in 10 Dutch hospitals
Comparison
Calculation of the HEART score to guide clinical… vs Usual care
Design
RCT, stepped wedge, cluster randomised
Follow-up
6 weeks
Authors
Discussion
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Implication
This study protocol outlines a stepped wedge cluster randomized trial to evaluate the real-world impact of the HEART score on patient outcomes and healthcare costs in emergency department patients with chest pain.
Study Design
Type
RCT (n=6,600)
Blinding
Open-label
Randomization
Cluster randomized (stepped wedge)
Multicenter
Yes
Structured PICO
Does the use of the HEART score to guide clinical decisions improve outcomes and reduce costs in unselected chest pain patients presenting at the emergency department?
P
Population
A planned stepped wedge cluster randomized trial aiming to include 6,600 adult patients presenting with acute chest pain at the emergency department, followed for 6 weeks.
I
Intervention
Calculation of the HEART score to guide clinical decision (reassurance and discharge of patients with low scores and intensive monitoring and early intervention in patients with high HEART scores)
C
Comparator
Usual care
O
Outcome
Occurrence of major adverse cardiac events (MACE), including acute myocardial infarction, revascularisation or death within 6 weeks after presentationcomposite
This study protocol outlines a stepped wedge cluster randomized trial to evaluate the real-world impact of the HEART score on patient outcomes and healthcare costs in emergency department patients with chest pain.
Limitations
- This is a study protocol; no clinical results are reported.
Cite This Study
Poldervaart et al. (2013) conducted an RCT in Acute chest pain (n=6,600). HEART score vs. Usual care was evaluated on Occurrence of major adverse cardiac events (MACE) within 6 weeks. This study protocol outlines a stepped wedge cluster randomized trial to evaluate if the HEART score safely guides clinical decisions in 6,600 chest pain patients without increasing 6-week MACE.