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| Name | Class |
|---|---|
| ZonMw: The Netherlands Organisation for Health Research and Development | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| usual care | Other | 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). |
|
| use of HEART risk score | Other | see intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| usual care | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Pre-specified Subgroup Analyses |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Arno W Hoes, MD, PhD | UMC Utrecht | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Amstelland Hospital | Amstelveen | Netherlands | ||||
| VU Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22294968 | Background | 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. | |
| 20802272 | Background | 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. |
| Label | URL |
|---|---|
| official website of the HEART risk score | View source |
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No plans, always interested in collaboration
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Exclusion criteria were evident ST-segment elevation myocardial infarction, language barriers, recurrent presentation, or unable or unwilling to give informed consent.
Inclusion at 9 Dutch Emergency departments, recruitment period between 1-7-2013 and 31-8-2014.
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| ID | Title | Description |
|---|---|---|
| FG000 | Usual Care | usual care was defined as 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). |
| FG001 | HEART Care | HEART care: usual care, complemented by calculation of the HEART score and following the recommended policy. During 14 months, patients presenting with chest pain to the emergency department (ED) of participating hospitals were included in the study. First, all hospitals applied '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 sequentially started to apply the HEART score in all chest pain patients (intervention period); during this intervention period patients with a HEART score 0-3 were advised not be admitted to the hospital, and patients with a HEART score above 3 were advised to be treated according to current guidelines. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Usual Care | standard care of the cardiologist according to current cardiological guidelines |
| BG001 | HEART Care | standard care of the cardiologist according to current cardiological guidelines, complemented by calculation of the HEART score and following the recommended policy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Count of Participants | Participants | 6 weeks |
|
6 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Usual Care | usual care was defined as 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). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac ischemia | Cardiac disorders | Systematic Assessment |
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Hesitance to refrain from admission and testing in patients with low scores could explain the low impact on health care costs.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Judith Poldervaart | University Medical Center Utrectht | 008875 55105 | j.poldervaart@umcutrecht.nl |
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| ID | Term |
|---|---|
| D002637 | Chest Pain |
| D014095 | Tooth, Impacted |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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).
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|
| use of HEART risk score | Other | 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. |
|
| 3 months |
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 |
| 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 | Netherlands |
| 21803199 | Background | 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. |
| 23090421 | Background | 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. |
| 18665203 | Background | 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. |
| 27311905 | Background | 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. |
| 24070098 | Background | 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. |
| 23465250 | Background | 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. |
| 28437795 | Result | 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. |
| 27810290 | Result | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| HEART Care |
HEART care: usual care, complemented by calculation of the HEART score and following the recommended policy. |
|
|
| 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. | Cost-effectiveness analysis was performed in 5 of 9 hospitals | Posted | Mean | 95% Confidence Interval | years | 3 months |
|
|
|
| Other Pre-specified | 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) | Not Posted | 3 months | Participants |
| Other Pre-specified | 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. | Not Posted | Jan 2019 | 6 weeks | Participants |
| 9 |
| 1,827 |
| 405 |
| 1,827 |
| 0 |
| 1,827 |
| EG001 | HEART Care | HEART care: usual care, complemented by calculation of the HEART score and following the recommended policy. During 14 months, patients presenting with chest pain to the ED of participating hospitals were included in the study. First, all hospitals applied '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 sequentially started to apply the HEART score in all chest pain patients (intervention period); during this intervention period patients with a HEART score 0-3 were advised not be admitted to the hospital, and patients with a HEART score above 3 were advised to be treated according to current guidelines. | 5 | 1,821 | 345 | 1,821 | 0 | 1,821 |
| Death | Cardiac disorders | Systematic Assessment |
|
| Significant stenosis (PCI, CABG, conservative) | Cardiac disorders | Systematic Assessment |
|
Not provided
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| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |