Key result
Cluster RCT tests whether hs-cTnI-POCT decision rule safely reduces primary care chest pain referrals.
Why the study?
GPs refer 40%-70% of chest pain patients to rule out ACS, but only 10%-20% have ACS; a clinical decision rule with hs-cTnI-POCT may safely rule out ACS in primary care.
Does a clinical decision rule combining the Marburg Heart Score and hs-cTnI-POCT reduce hospital referrals for acute chest pain in primary care?
RCT (n=1,500)
Open-label with blinded endpoint adjudication
2:1 clustered variable block randomization
Yes
Does a clinical decision rule combining the Marburg Heart Score and hs-cTnI-POCT reduce hospital referrals for acute chest pain in primary care?
This study will determine whether adding a point-of-care high-sensitivity troponin test to a clinical risk score can safely reduce unnecessary hospital referrals for chest pain in primary care.
Answers are grounded in this paper and cite their sources.
Protocol tests Marburg score plus hs-cTnI-POCT for safe ACS rule-out in primary care; delivers first RCT evidence on reducing referrals.
INTRODUCTION: Chest pain is a common reason for consultation in primary care. To rule out acute coronary syndrome (ACS), general practitioners (GP) refer 40%-70% of patients with chest pain to the emergency department (ED). Only 10%-20% of those referred, are diagnosed with ACS. A clinical decision rule, including a high-sensitive cardiac troponin-I point-of-care test (hs-cTnI-POCT), may safely rule out ACS in primary care. Being able to safely rule out ACS at the GP level reduces referrals and thereby alleviates the burden on the ED. Moreover, prompt feedback to the patients may reduce anxiety and stress. METHODS AND ANALYSIS: The POB HELP study is a clustered randomised controlled diagnostic trial investigating the (cost-)effectiveness and diagnostic accuracy of a primary care decision rule for acute chest pain, consisting of the Marburg Heart Score combined with a hs-cTnI-POCT (limit of detection 1.6 ng/L, 99th percentile 23 ng/L, cut-off value between negative and positive used in this study 3.8 ng/L). General practices are 2:1 randomised to the intervention group (clinical decision rule) or control group (regular care). In total 1500 patients with acute chest pain are planned to be included by GPs in three regions in The Netherlands. Primary endpoints are the number of hospital referrals and the diagnostic accuracy of the decision rule 24 hours, 6 weeks and 6 months after inclusion. ETHICS AND DISSEMINATION: The medical ethics committee Leiden-Den Haag-Delft (the Netherlands) has approved this trial. Written informed consent will be obtained from all participating patients. The results of this trial will be disseminated in one main paper and additional papers on secondary endpoints and subgroup analyses. TRIAL REGISTRATION NUMBERS: NL9525 and NCT05827237.
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Bulk et al. (2023) conducted an RCT in Acute chest pain suspected of acute coronary syndrome (n=1,500). Clinical decision rule (Marburg Heart Score + hs-cTnI-POCT) vs. Regular standard care was evaluated on Hospital referral rate for acute chest pain within 24 hours and 6 weeks, and diagnostic accuracy of the decision rule. This protocol describes a clustered randomized controlled trial evaluating if a clinical decision rule with hs-cTnI-POCT safely reduces hospital referrals for acute chest pain in primary care.
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