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ID
Bron
Verkorte titel
Aandoening
Syncope, fainting spells, transient loss of consciousness. Wegraking, flauwvallen.
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Proportion of cases with an accurate diagnosis (as determined by the expert panel at 1 year follow-up).
Achtergrond van het onderzoek
SUMMARY
Rationale
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.
Objective:
To determine the cost-effectiveness of SAs compared to usual care in those presenting with syncope at the ED
Study design:
Multicentre trial comparing the pre- and post-implementation period
SA implementation has multiple components:
- ED triage resulting in admission, outpatient or GP referral
- E-health system to maximize the yield of history taking in syncope
- Structured outpatient evaluation
Study population:
Syncope patients in the emergency department (ED) of 1 university hospital & 4 regional hospitals
Study intervention
Structured follow-up with questionnaires at baseline, 3, 6 and 12 months in two patient cohorts before and after SA implementation
Main study parameters/endpoints:
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
Country: The Netherlands
Doel van het onderzoek
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Onderzoeksopzet
In both groups (usual care and SA implementation) patients will be asked to fill out questionnaires at baseline, 3, 6 and 12 months of follow-up. The questionnaires include a check-list to assess health care consumption, productivity, and QoL measures: Syncope Functional Status (SFS) & EQ-5D-5L.
Onderzoeksproduct en/of interventie
Each emergency department will adopt the ESC/EHRA syncope algorithms including a standardized assessment of historical features, ECG, physical examination and orthostatic blood pressure measurements. Prior to implementation, an educational course will offered to all physicians involved in the ED management of syncope.
Usual syncope care at the emergency department. The inclusion of the control group will start prior to the implementation of the syncope algorithms at each hospital. Five hospitals will include patients (LUMC Leiden, Gelre ziekenhuis Apeldoorn, Rijnstate Arnhem, Maasstad ziekenhuis Rotterdam, Diaconessenhuis Utrecht)
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
All patients 18 years and older attending the ED for suspected syncope will be included.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
(1) Those aged <18 years
(2) Those in whom a serious life threatening condition is identified in the ED (massive bleeding, pulmonary embolus)
(3) Those who attended any ED because of syncope in the previous year
(4) Those with a learning disability
(5) Those who already attended the tertiary outpatient clinic “Syncope and autonomic disorders” in LUMC because of syncope and received a certain or highly likely diagnosis
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
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Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL6129 |
NTR-old | NTR6268 |
CCMO | NL58852.058.16 |
OMON | NL-OMON45663 |