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Longterm outcome of patients with fainting spells at the emergency department. How effective is a standardised approach at improving the time to correct diagnosis, quality of life and decreasing healthcare costs?


- candidate number26467
- NTR NumberNTR6268
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR11-jan-2017
- Secondary IDs NL58852.058.16/ P16.228 /// 843002707 CME LUMC /// ZonMW
- Public TitleLongterm outcome of patients with fainting spells at the emergency department. How effective is a standardised approach at improving the time to correct diagnosis, quality of life and decreasing healthcare costs?
- Scientific TitleSyncope 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?
- ACRONYMThe SYNERGY study
- hypothesis
- Healt Condition(s) or Problem(s) studiedSyncope
- Inclusion criteriaAll patients 18 years and older attending the ED for suspected syncope will be included.
- 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
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- group[default]
- Type[default]
- Studytype[default]
- planned startdate 1-mrt-2017
- planned closingdate15-nov-2019
- Target number of participants550
- InterventionsEach 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)
- Primary outcomeProportion of cases with an accurate diagnosis (as determined by the expert panel at 1 year follow-up).
- Secondary outcomeQuality of Life (SFS, EQ-5D-5L, STAI) during 1 year after ED presentation.
Number of syncope-related admissions
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.
- TimepointsIn 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 & the state trait anxiety inventory (STAI).
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIESDrs. M. Ghariq
- CONTACT for SCIENTIFIC QUERIESMD PhD R.D. Thijs
- Sponsor/Initiator Leiden University Medical Center (LUMC), Department of Neurology
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- Publications
- Brief summarySUMMARY
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
- Main changes (audit trail)14-mei-2017 - MT:
New exclusion criterium:
(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
Secondary outcome:
Quality of Life (SFS, EQ-5D-5L, STAI)... replaced by Quality of Life (SFS, EQ-5D-5L)...

Timepoints:
'Syncope Functional Status (SFS), EQ-5D-5L & the state trait anxiety inventory (STAI)' replaced by 'Syncope Functional Status (SFS) & EQ-5D-5L'
- RECORD11-jan-2017 - 14-mei-2017


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