Impact on Management of the HEART Risk Score in Chest Pain Patients

Chest Pain Clinical Trial

— HEART-Impact  

Official title:

Cost-effectiveness Study of the HEART Score in the Management of Patients With Chest Pain Presenting in the Emergency Room

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01756846
• Other study ID #: 80-82310-97-12154
• Status: Completed
• Phase: N/A
• Start date: July 2013
• Est. completion date: March 2015

Study information

• Verified date: August 2018
• Source: UMC Utrecht
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Aim of this study is to quantify the impact of the use of the HEART risk score on patient outcome and on costs in patients with chest pain presenting at the emergency room, as compared to not using the score.

Description:

During 14 months, patients presenting with chest pain to the Emergency Department (ED) of participating hospitals will be included in the study. First, all hospitals will apply 'usual care' to all patients, i.e. risk assessment and subsequent management without application of the HEART score. Then, during a 14 month period, each 1,5 month 1 randomly allocated hospital will sequentially start to apply the HEART score in all chest pain patients (intervention period); during this intervention period patients with a HEART score 0-3 will not be admitted to the hospital (in accordance with the results of our validation studies), and patients with a HEART score above 3 will be treated according to current guidelines.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3666
• Est. completion date: March 2015
• Est. primary completion date: October 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All patients presenting with chest pain to the (cardiac) ED of ten participating Dutch hospitals, older than 18 years.

Exclusion Criteria:

• Children (age <18 years) are excluded from study participation. Subjects who are (for whatever reason) not able to fill in questionnaires are excluded from study participation. Legal incapacity of every patient will be assessed by the attending doctor, according to the guidelines of legal incapacity. In case of doubt, consultation of the cardiologist (primary local investigator) will be possible.

Related Conditions & MeSH terms

• Chest Pain

Intervention

Other:
• usual care
During 14 months, patients presenting with chest pain to the ED of participating hospitals will be included in the study. First, all hospitals will apply 'usual care' to all patients, i.e. risk assessment and subsequent management without application of the HEART score. Then, during a 14 month period, each 1,5 month 1 randomly allocated hospital will sequentially start to apply the HEART score in all chest pain patients (intervention period); during this intervention period patients with a HEART score 0-3 will not be admitted to the hospital, and patients with a HEART score above 3 will be treated according to current guidelines.
• use of HEART risk score
During 14 months, patients presenting with chest pain to the ED of participating hospitals will be included in the study. First, all hospitals will apply 'usual care' to all patients, i.e. risk assessment and subsequent management without application of the HEART score. Then, during a 14 month period, each 1,5 month 1 randomly allocated hospital will sequentially start to apply the HEART score in all chest pain patients (intervention period); during this intervention period patients with a HEART score 0-3 will not be admitted to the hospital, and patients with a HEART score above 3 will be treated according to current guidelines.

Locations

Country	Name	City	State
Netherlands	Amstelland Hospital	Amstelveen
Netherlands	VU Medical Center	Amsterdam
Netherlands	Gelderse Vallei	Ede
Netherlands	Catharina Hospital	Eindhoven
Netherlands	Atrium Medical Center	Heerlen
Netherlands	St. Antonius Hospital	Nieuwegein
Netherlands	Diakonessenhuis	Utrecht
Netherlands	University Medical Center	Utrecht
Netherlands	Zuwe Hofpoort	Woerden

Sponsors (2)

Lead Sponsor	Collaborator
UMC Utrecht	ZonMw: The Netherlands Organisation for Health Research and Development

Country where clinical trial is conducted

Netherlands, 

References & Publications (10)

Backus BE, Six AJ, Kelder JC, Bosschaert MA, Mast EG, Mosterd A, Veldkamp RF, Wardeh AJ, Tio R, Braam R, Monnink SH, van Tooren R, Mast TP, van den Akker F, Cramer MJ, Poldervaart JM, Hoes AW, Doevendans PA. A prospective validation of the HEART score for chest pain patients at the emergency department. Int J Cardiol. 2013 Oct 3;168(3):2153-8. doi: 10.1016/j.ijcard.2013.01.255. Epub 2013 Mar 7. — View Citation

Backus BE, Six AJ, Kelder JC, Mast TP, van den Akker F, Mast EG, Monnink SH, van Tooren RM, Doevendans PA. Chest pain in the emergency room: a multicenter validation of the HEART Score. Crit Pathw Cardiol. 2010 Sep;9(3):164-9. doi: 10.1097/HPC.0b013e3181ec36d8. — View Citation

Backus BE, Six AJ, Kelder JH, Gibler WB, Moll FL, Doevendans PA. Risk scores for patients with chest pain: evaluation in the emergency department. Curr Cardiol Rev. 2011 Feb;7(1):2-8. doi: 10.2174/157340311795677662. — View Citation

Nieuwets A, Poldervaart JM, Reitsma JB, Buitendijk S, Six AJ, Backus BE, Hoes AW, Doevendans PA. Medical consumption compared for TIMI and HEART score in chest pain patients at the emergency department: a retrospective cost analysis. BMJ Open. 2016 Jun 16;6(6):e010694. doi: 10.1136/bmjopen-2015-010694. — View Citation

Poldervaart JM, Langedijk M, Backus BE, Dekker IMC, Six AJ, Doevendans PA, Hoes AW, Reitsma JB. Comparison of the GRACE, HEART and TIMI score to predict major adverse cardiac events in chest pain patients at the emergency department. Int J Cardiol. 2017 J — View Citation

Poldervaart JM, Reitsma JB, Backus BE, Koffijberg H, Veldkamp RF, Ten Haaf ME, Appelman Y, Mannaerts HFJ, van Dantzig JM, van den Heuvel M, El Farissi M, Rensing BJWM, Ernst NMSKJ, Dekker IMC, den Hartog FR, Oosterhof T, Lagerweij GR, Buijs EM, van Hessen — View Citation

Poldervaart JM, Reitsma JB, Koffijberg H, Backus BE, Six AJ, Doevendans PA, Hoes AW. The impact of the HEART risk score in the early assessment of patients with acute chest pain: design of a stepped wedge, cluster randomised trial. BMC Cardiovasc Disord. 2013 Sep 26;13:77. doi: 10.1186/1471-2261-13-77. — View Citation

Six AJ, Backus BE, Doevendans PA. Rapid diagnostic protocol for patients with chest pain. Lancet. 2011 Jul 30;378(9789):398; author reply 398-9. doi: 10.1016/S0140-6736(11)61204-X. — View Citation

Six AJ, Backus BE, Kelder JC. Chest pain in the emergency room: value of the HEART score. Neth Heart J. 2008 Jun;16(6):191-6. — View Citation

Six AJ, Backus BE, Kingma A, Kaandorp SI. Consumption of diagnostic procedures and other cardiology care in chest pain patients after presentation at the emergency department. Neth Heart J. 2012 Dec;20(12):499-504. doi: 10.1007/s12471-012-0322-6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Gender-related Differences in Risk for MACE	with a women-specific questionnaire, we hope to identify risk factors specific for women (pregnancy diabetes/hypertension, Poly Cystic Ovarial Syndrome (PCOS), etc)	3 months
Other	Pre-specified Subgroup Analyses	To assess whether the effectiveness and/or safety of using the HEART (history, ecg, age, risk factors, troponin) score (scale 0-10, with higher scores meaning a higher risk on MACEs) is different between specific patient populations, the following pre-specified subgroup analyses will be performed: Age: below and above 62 years of age (median), Gender: Men vs Women, Diabetics vs non-diabetics, Ethnicity: Caucasian vs. other ethnicity.; RESULTS: None of the pre-specified subgroup analyses of women, elderly patients, and diabetic patients showed a statistically significantly different effect of HEART care with respect to incidence of MACEs. Ethnicity was unfortunately not possible to analyse due to too much missing data.; NB. I am currently not working in the organisation which has the data, and this will not be possible the coming period. Therefore, I cannot provide correct numbers currently on these subgroup analyses, only conclusions. I am sorry for this inconvenience.	6 weeks
Primary	MACE (Major Adverse Cardiac Events)	occurrence of major adverse cardiac events (MACE, i.e. acute myocardial infarction (AMI), Percutaneous Coronary Intervention (PCI), Coronary Artery Bypass Grafting (CABG) or death) within 6 weeks after presentation	6 weeks
Secondary	Cost-effectiveness (Costs, QoL, QALYs)	Information on quality of life (QoL) and costs was collected in 5 of the 9 hospitals. Costs for health care resource use were calculated based on Dutch guidelines and cost tables for hospitals. Different costs were used for academic and general hospitals, and costs were adjusted for inflation by using the consumer price indices provided by Statistics Netherlands. For each patient the costs were calculated based on the observed number and type of health care resources used and the type of hospital (academic/general). Data on resource use were collected for each patient in the 5 hospitals; no data were missing. QoL was derived from the EQ-5D-3L questionnaire, consisting of 5 questions (dimensions) with 3 answers each, from which QoL scores (utility values, 0-1, the higher the better) can be directly derived. Quality-adjusted life-years (scale 0-100, higher the better) were calculated over a period of 3 months, based on the estimated QoL values at 0 weeks, 2 weeks, and 3 months.	3 months

External Links

•   official website of the HEART risk score