Implementation of Syncope Algorithms in the Dutch emergency departments: an interventional trial

OBJECTIVE/ RESEARCH QUESTIONS


Syncope is very common and has a broad differential diagnosis. The frequent failure to identify benign or malignant causes results in high costs. Syncope Algorithms (SAs) abroad have shown to improve diagnostic yield and reduced costs.


HYPOTHESIS


Implementation of SAs in the Netherlands will increase diagnostic yield, avoid unnecessary admissions and improve quality of life (QoL) by offering timely diagnosis & treatment



STUDY DESIGN


Multicentre trial comparing the pre- and post-implementation period



STUDY POPULATION


Syncope patients in the emergency department (ED) of 1 university hospital & 3 regional hospitals



INTERVENTION
SA
implementation has multiple components:


- ED triage resulting in admission, outpatient or GP referral


- Innovative multilingual communication system facilitating active patient participation to maximize the yield of history taking in syncope


- Structured outpatient evaluation



OUTCOME MEASURES


Primary: proportion of patients with an accurate diagnosis (as determined by an expert panel at 1 year follow-up)


Secondary: number of admissions because of syncope, time to diagnosis following ED presentation, syncope recurrence, Healthcare and societal costs within 1 year following ED presentation, number of syncope-related tests and consultations, QoL

SAMPLE SIZE CALCULATION/ DATA ANALYSIS


Based on a power of 0.8 and alpha of 0.05, we need to recruit 360 per group, i.e. 52% of all eligible syncope cases. We will conduct a multi-level analysis comparing the effects of the intervention while accounting for differences per study centre


COST-EFFECTIVENESS ANALYSIS (CEA) & BUDGET IMPACT ANALYSIS (BIA):


Trial-based cost-effectiveness analysis (diagnostic costs per accurate diagnosis), trial-based cost-utility analysis (societal cost per QALY), and cost calculator spreadsheet model (BIA)


Implementation of Syncope Algorithms (SAs) in the Netherlands will increase diagnostic yield, avoid unnecessary admissions and improve quality of life (QoL) by offering timely diagnosis & treatment

- Diagnostic accuracy: evaluation of medical files by an expert panel at 1-year follow-up

- Syncope-related healthcare costs within 1 year following ED presentation.

- QoL measures (SFS & EQ-SD-5L) at baseline, 3, 6 and 12 months follow-up.

SA implementation has multiple components:

- ED triage resulting in admission, outpatient or GP referral

- Innovative multilingual communication system facilitating active patient participation to maximize the yield of history taking in syncope

- Structured outpatient evaluation