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

Not Applicable
Completed
Conditions
Chest Pain
Interventions
Other: usual care
Other: use of HEART risk score
Registration Number
NCT01756846
Lead Sponsor
UMC Utrecht
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
3666
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
usual careusual careDaily 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 scoreuse of HEART risk scoresee intervention
Primary Outcome Measures
NameTimeMethod
MACE (Major Adverse Cardiac Events)6 weeks

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
NameTimeMethod
Cost-effectiveness (Costs, QoL, QALYs)3 months

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.

Trial Locations

Locations (9)

Gelderse Vallei

πŸ‡³πŸ‡±

Ede, Netherlands

Diakonessenhuis

πŸ‡³πŸ‡±

Utrecht, Netherlands

VU Medical Center

πŸ‡³πŸ‡±

Amsterdam, Netherlands

Catharina Hospital

πŸ‡³πŸ‡±

Eindhoven, Netherlands

University Medical Center

πŸ‡³πŸ‡±

Utrecht, Netherlands

Atrium Medical Center

πŸ‡³πŸ‡±

Heerlen, Netherlands

St. Antonius Hospital

πŸ‡³πŸ‡±

Nieuwegein, Netherlands

Amstelland Hospital

πŸ‡³πŸ‡±

Amstelveen, Netherlands

Zuwe Hofpoort

πŸ‡³πŸ‡±

Woerden, Netherlands

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