National Congenital Heart Disease Audit

Congenital Heart Disease (CHD) Clinical Trial

Official title:

National Congenital Heart Disease Audit

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02303535
• Other study ID #: NICOR-CONGENITAL
• Status: Recruiting
• Phase: N/A
• First received: November 25, 2014
• Last updated: November 3, 2016
• Start date: April 2000
• Est. completion date: March 2017

Study information

• Verified date: October 2016
• Source: University College, London
• Contact: James CHAL, MHlthMgmnt
• Phone: 0203 549 5621
• Email: nicor-ics[@]ucl.ac.uk
• Is FDA regulated: No
• Health authority: United Kingdom: Department of HealthUnited Kingdom: National Advisory Group on Clinical Audit and EnquiriesUnited Kingdom: Healthcare Quality Improvement PartnershipUnited Kingdom: Research Ethics Committee
• Study type: Observational

Clinical Trial Summary

The National Institute of Cardiovascular Outcomes Research (NICOR) collects data and produces analysis to enable hospitals and healthcare improvement bodies to monitor and improve the quality of care and outcomes of cardiovascular patients.

The Congenital Heart Disease audit collects data on all cardiac surgery and therapeutic cardiac catheterisations procedures used to treat patients with congenital and acquired heart disease.

For acquired heart disease, the audit covers all arrhythmias & cardiomyopathies in patients less than 16 years old only. For congenital heart disease, the audit collects data on both children and adult patients. The audit covers all specialist centers in the UK and Republic of Ireland.

The project aims to improve the quality of care for children and adults with congenital heart disease by providing national comparative analysis of procedure specific activity and outcomes of cardiac surgery and therapeutic cardiac catheterisation procedures. The audit also provides quality indicators for the antenatal detection of major congenital heart disease.

The current dataset is available from here:

http://www.ucl.ac.uk/nicor/audits/congenital/datasets

Description:

The Congenital Heart Disease audit collects data on all cardiac surgery and therapeutic cardiac catheterisations procedures used to treat patients with congenital and acquired heart disease

Data collection:

Hospitals use Patient Administration Systems and manual data entry by cardiac database managers to submit data to NICOR.

Data are either assimilated locally using third party commercial software and imported as a .csv file, or entered directly onto the NICOR database.

Data quality:

NICOR provide tools that communicate possible errors to centres submitting data. A data submitting schedule has been agreed with the centres, data is submitted and a validation report is returned each quarter. Centres are responsible for updating errors in the records.

An import log highlights missing and invalid data as well as records that failed to import due to data quality or compatibility issues.

In addition, data is validated by on site visits with a NICOR representative.

Data linkage:

Data is annually linked with Office fot National Statistics (ONS) life status and Hospital Episodes Statistics (HES) admission data to verify case ascertainment and to track long term outcome measures.

Information governance:

NICOR has Section 251 approval and data protection registration. An organisation-wide standard operating procedure is in place for Information Security Incident Management. University College London has a robust information governance framework, to which NICOR adheres.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120000
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

Patient, judged by multidisciplinary team meeting as unsuitable for the procedure

Exclusion Criteria:

Patient, judged by multidisciplinary team meeting, as unsuitable for the procedure

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Congenital Heart Disease (CHD)
• Heart Defects, Congenital
• Heart Diseases

Intervention

Procedure:
• Cardiac Surgery
All patients with congential and acquired heart disease treated by cardiac surgery procedures.
• Therapeutic cardiac catheterisations procedures
All patients with congential and acquired heart disease treated by therapeutic cardiac catheterisations procedures .

Locations

Country	Name	City	State
United Kingdom	Royal Victoria Hospital Belfast	Belfast	Northern Ireland
United Kingdom	Queen Elizabeth Hospital (Edgbaston)	Birmingham
United Kingdom	Leeds General Infirmary	Leeds	West Yorkshire
United Kingdom	Alder Hey Hospital	Liverpool	Merseyside
United Kingdom	Royal Brompton Hospital	London
United Kingdom	The Harley Street Clinic	London
United Kingdom	The Heart Hospital	London
United Kingdom	Freeman Hospital	Newcastle upon Tyne	Tyne and Wear
United Kingdom	John Radcliffe Hospital	Oxford	Oxfordshire
United Kingdom	Southampton General Hospital	Southampton	Hampshire

Sponsors (3)

Lead Sponsor	Collaborator
University College, London	British Congenital Cardiac Association, Society for Cardiothoracic Surgery in Great Britain & Ireland

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

Pagel C, Utley M, Crowe S, Witter T, Anderson D, Samson R, McLean A, Banks V, Tsang V, Brown K. Real time monitoring of risk-adjusted paediatric cardiac surgery outcomes using variable life-adjusted display: implementation in three UK centres. Heart. 2013 Oct;99(19):1445-50. doi: 10.1136/heartjnl-2013-303671. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	30 day survival rates	The analysis shows the national survival rates at 30 days for each procedure and the national survival rates for individual procedures by age.	30 day survival from operation date	Yes
Secondary	1 year survival rates	Analysis include 1-year outcome but a death would not appear in the table until a full year has passed for the whole cohort of patients within that year. For example, the audit collection period is based on financial year of April 1st to March 31st. A patient that died in April would be reported within the same period as one that died 11 months later in March.	1 year survival rates after the date of the procedure	Yes

External Links

•   NICOR managed website for the congenital audit, contains datasets, information on data applications, research, links to congenital analyses and links to the Congenital Portal which provides specific porcedure anlayses over the last 13 years.