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

Primary Purpose

Chest Pain

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
usual care
use of HEART risk score
Sponsored by
UMC Utrecht
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Chest Pain focused on measuring HEART score, risk score, impact, chest pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Amstelland Hospital
  • VU Medical Center
  • Gelderse Vallei
  • Catharina Hospital
  • Atrium Medical Center
  • St. Antonius Hospital
  • Diakonessenhuis
  • University Medical Center
  • Zuwe Hofpoort

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

usual care

use of HEART risk score

Arm Description

Daily practice of the cardiologist or attending emergency doctor, in order to diagnose a patient with chest pain. In this period attending doctors assess the risk of a patient with chest pain, based on his/hers experience and various criteria (for example described in European Society of Cardiology Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation, without a formal risk score).

see intervention

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
December 20, 2012
Last Updated
August 10, 2018
Sponsor
UMC Utrecht
Collaborators
ZonMw: The Netherlands Organisation for Health Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT01756846
Brief Title
Impact on Management of the HEART Risk Score in Chest Pain Patients
Acronym
HEART-Impact
Official Title
Cost-effectiveness Study of the HEART Score in the Management of Patients With Chest Pain Presenting in the Emergency Room
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
UMC Utrecht
Collaborators
ZonMw: The Netherlands Organisation for Health Research and Development

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chest Pain
Keywords
HEART score, risk score, impact, chest pain

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
this is a stepped wedge cluster randomized trial, meaning it is both parallel and cross-over. 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).
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
3666 (Actual)

8. Arms, Groups, and Interventions

Arm Title
usual care
Arm Type
Other
Arm Description
Daily practice of the cardiologist or attending emergency doctor, in order to diagnose a patient with chest pain. In this period attending doctors assess the risk of a patient with chest pain, based on his/hers experience and various criteria (for example described in European Society of Cardiology Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation, without a formal risk score).
Arm Title
use of HEART risk score
Arm Type
Other
Arm Description
see intervention
Intervention Type
Other
Intervention Name(s)
usual care
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
use of HEART risk score
Intervention Description
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.
Primary Outcome Measure Information:
Title
MACE (Major Adverse Cardiac Events)
Description
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
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Cost-effectiveness (Costs, QoL, QALYs)
Description
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.
Time Frame
3 months
Other Pre-specified Outcome Measures:
Title
Gender-related Differences in Risk for MACE
Description
with a women-specific questionnaire, we hope to identify risk factors specific for women (pregnancy diabetes/hypertension, Poly Cystic Ovarial Syndrome (PCOS), etc)
Time Frame
3 months
Title
Pre-specified Subgroup Analyses
Description
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.
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arno W Hoes, MD, PhD
Organizational Affiliation
UMC Utrecht
Official's Role
Principal Investigator
Facility Information:
Facility Name
Amstelland Hospital
City
Amstelveen
Country
Netherlands
Facility Name
VU Medical Center
City
Amsterdam
Country
Netherlands
Facility Name
Gelderse Vallei
City
Ede
Country
Netherlands
Facility Name
Catharina Hospital
City
Eindhoven
Country
Netherlands
Facility Name
Atrium Medical Center
City
Heerlen
Country
Netherlands
Facility Name
St. Antonius Hospital
City
Nieuwegein
Country
Netherlands
Facility Name
Diakonessenhuis
City
Utrecht
Country
Netherlands
Facility Name
University Medical Center
City
Utrecht
Country
Netherlands
Facility Name
Zuwe Hofpoort
City
Woerden
Country
Netherlands

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
No plans, always interested in collaboration
Citations:
PubMed Identifier
22294968
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.
Results Reference
background
PubMed Identifier
20802272
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.
Results Reference
background
PubMed Identifier
21803199
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. No abstract available.
Results Reference
background
PubMed Identifier
23090421
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.
Results Reference
background
PubMed Identifier
18665203
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. doi: 10.1007/BF03086144.
Results Reference
background
PubMed Identifier
27311905
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.
Results Reference
background
PubMed Identifier
24070098
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.
Results Reference
background
PubMed Identifier
23465250
Citation
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.
Results Reference
background
PubMed Identifier
28437795
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 MWJ, Landman MAJ, van Kimmenade RRJ, Cozijnsen L, Bucx JJJ, van Ofwegen-Hanekamp CEE, Cramer MJ, Six AJ, Doevendans PA, Hoes AW. Effect of Using the HEART Score in Patients With Chest Pain in the Emergency Department: A Stepped-Wedge, Cluster Randomized Trial. Ann Intern Med. 2017 May 16;166(10):689-697. doi: 10.7326/M16-1600. Epub 2017 Apr 25. Erratum In: Ann Intern Med. 2017 Jul 18;167(2):144.
Results Reference
result
PubMed Identifier
27810290
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 Jan 15;227:656-661. doi: 10.1016/j.ijcard.2016.10.080. Epub 2016 Oct 30.
Results Reference
result
Links:
URL
http://www.heartscore.nl
Description
official website of the HEART risk score

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

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