We will conduct a multicentre trial to study the implementation of the ESC/EHRA syncope algorithms (SAs) in one university hospital & three regional hospitals. We will implement the SAs in both the ED (standardised triage system) as well as the…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
syncope
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Proportion of patients with an accurate diagnosis (as determined by an expert
panel at 1 year follow-up)
Secondary outcome
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
Background summary
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.
Study objective
We will conduct a multicentre trial to study the implementation of the ESC/EHRA
syncope algorithms (SAs) in one university hospital & three regional hospitals.
We will implement the SAs in both the ED (standardised triage system) as well
as the outpatient services (dedicated syncope facilities). We aim to compare
cost-effectiveness of SAs to usual care.
Study design
Multicentre trial comparing the pre- and post-implementation period
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
Study burden and risks
The study carries no risks. Study participants receive similar diagnostic
work-up and treatment as those who are not willing to participate.
Participation is limited to serial questionnaires. The questionnaires relate to
symptom burden, quality of life and health care costs. We do not believe that
the questionnaires are offensive to the study participants. Filling out these
questionnaires does, however, cost time. Patients are able to schedule this as
they like. Study participation has no benefit for their personal treatment. It
has however the advantage that the study will help to improve syncope care. We
believe that the lack of risks, the limited study burden and the possibility to
terminate the study at any time, justifies the study in this patient group.
Albinusdreef 2
Leiden 2300RC
NL
Albinusdreef 2
Leiden 2300RC
NL
Listed location countries
Age
Inclusion criteria
All patients at the emergency department because of suspected syncope
Exclusion criteria
(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 presenting with presyncope
(6) Those who already attented a tertiary syncope clinic
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL58852.058.16 |
| OMON | NL-OMON23988 |