*Cost-effectiveness study of the HEART score in the management of patients with chest pain presenting in the emergency room*

Chest pain is one of the most common reasons for patients to present to the
emergency department (ED). Decision making in these patients suspected of acute
coronary syndrome (ACS) is hampered by limited predictive power of individual
patient characteristics (reference 16-18 in protocol). Recently, the HEART
score was developed and extensively validated in various (external) patient
populations and its predictive effectiveness has been proven. Estimations of
total costs of cardiology care in low HEART score patients have been made in a
pilot study, revealing potential annual savings of >35 million euro per year
for the Netherlands.

To quantify the impact of the use of the HEART risk score on patient outcome
(major adverse cardiac events
(MACE) and quality of life) and on costs in patients with chest pain presenting
at the emergency room.

Prospective stepped wedge trial including 6600 patients in 10 Dutch hospitals.
During 11 months, patients presenting with chest pain to the ER of
participating hospitals will be included in the study. First, all hospitals
will apply *usual care* to all patients, i.e. assessment without application of
the HEART score. Then, during a 10 month period, each month 1 randomly
allocated hospital will sequentially start to apply the HEART score (previously
developed and validated by our group) 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.

The HEART score is a validated risk score for all patients presenting with
chest pain at the ED. The HEART score consists of the following clinical
elements: History, ECG, Age, Risk factors and Troponin. Each of the five
factors can be appreciated with 0, 1 or 2 points. The sum of all five elements
results in a score of 0-10, thus dividing patients in a low-, intermediate- or
high-risk group. The patients in the low-risk group are discharged, with a
troponin assessment at home within 72 hours. The patients in the intermediate
group are admitted to the hospital for observation and further investigation.
The high-risk group receives immediate intervention or treatment. At all times,
the attending doctor can decide to choose otherwise when he feels the risk
stratification is somehow not consistent will his own experienced view.

To prevent that during the intervention period, a subclinical / asymptomatic
ischemic cardiac event will not be detected in low-risk patients sent home, all
patients in the low risk group (who had there first troponin measurement at the
ED < 8 hours) will be visited at home by trained personnel from the local
ambulant laboratory to assess troponin levels within 72 hours after discharge.
The participating patients will be asked to fill in a quality of life
questionnaire at day one, and at two weeks and three months after presentation
at the ED. When indeed the HEART score would shown to be cost-effective and
safe, patient burden will decrease considerably, with less provocative testing
and/or coronary imaging before discharge. Also an extra blood sample will be
collected during primary ED presentation, during the first blood collection for
troponin measurement. Women will be asked to fill in an 2-page women-specific
questionnaire at the ED.