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


- candidate number24749
- NTR NumberNTR6053
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR7-aug-2016
- Secondary IDsZonMW 80-84300-98-72056
- Public TitleImplementation of Syncope Algorithms in the Dutch emergency departments: an interventional trial
- Scientific TitleThe SYNERGY study. Syncope algorithms in the emergency department with structured follow-up. How effective is a standardised approach at improving diagnostic yield, quality of life and decreasing health care costs?
- ACRONYMSYNERGY trial
- hypothesisImplementation 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
- Healt Condition(s) or Problem(s) studiedSyncope
- Inclusion criteriaEmergency department presentation becasuse 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
- mec approval receivedno
- multicenter trialyes
- randomisedno
- group[default]
- Type[default]
- Studytypeintervention
- planned startdate 1-mrt-2017
- planned closingdate1-nov-2019
- Target number of participants720
- InterventionsSA 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
- Primary outcome- Proportion of cases with an accurate diagnosis (as determined by the expert panel at 1 year follow-up)
- Secondary outcome- Healthcare costs within 1 year following ED presentation.
- Time to a certain/highly likely diagnosis following ED presentation
- Number of diagnostic tests performed
- Number of syncope-related consultations (ED, outpatient & GP visits)
- Proportion of cases with recurrent syncope
- Syncope-related healthcare costs within 1 year following ED presentation.
- Quality of Life (QoL) measures (Syncope Function Scal(SFS) & EQ-5D-5L) during 1 year after ED presentation.
- Timepoints- 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.
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIESMD PhD R.D. Thijs
- CONTACT for SCIENTIFIC QUERIESMD PhD R.D. Thijs
- Sponsor/Initiator Leiden University Medical Center (LUMC)
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- Publications
- Brief summaryOBJECTIVE/ 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)

- Main changes (audit trail)
- RECORD7-aug-2016 - 3-nov-2016


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