Henry Ford Heart Score Randomized Trial: Rapid Discharge of Patients Evaluated for Possible Myocardial Infarction

Study Overview
=================
Brief Summary
-----------------
This was a prospective randomized, controlled trial designed to quantify the reduction in cost and length of stay of early discharge of emergency department patients evaluated for acute myocardial infarction, who are deemed to be low risk based on a modified HEART score (a score that incorporates troponin biomarker, ecg, patient characteristics, and physician clinical judgment).

Detailed Description
-----------------
This was a prospective randomized, controlled trial conducted from February 2014 to May 2015 designed to quantify the reduction in cost and length of stay of early discharge of emergency department patients evaluated for acute myocardial infarction, in those deemed to be low risk based on a modified HEART score. Our study enrolled only those deemed low risk, as these are the patients we believe best served by utilization of the HEART score decision aid. A total of 105 patients evaluated for AMI in the ED with a modified HEART score ≤ 3 (which includes cardiac troponin I < 0.04 ng/ml at 0 and 3 hours) were randomized to immediate discharge (n = 53) vs management in an observation unit with stress testing (n = 52). The primary endpoints were 30-day total cost and length of stay. Secondary endpoints were all-cause death, nonfatal AMI, rehospitalization for evaluation of possible AMI, and coronary revascularization at 30 days. That such an early discharge strategy would decrease cost and length of stay is intuitively expected; our goal was to quantify such a reduction.

Official Title
-----------------
Henry Ford Heart Score Randomized Trial: Rapid Discharge of Patients Evaluated for Possible Myocardial Infarction

Conditions
-----------------
Chest Pain, Heart Attack, Coronary Artery Disease

Intervention / Treatment
-----------------
* Other: Deferral of admission for stress test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients 21 years or older patients who presented to the Emergency Department with symptoms suspicious for AMI. patients for whom the ED physician's intention to send the patient to the observation unit for stress testing Exclusion Criteria: Cardiac Troponin I > 0.04 ng/mL at 0 or 3 hours clinical presentation warranting admission inability or unwillingness to consent trauma as etiology of presenting symptoms.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Stress testing<br>Patient with chest pain, low risk by modified HEART score, undergoes whatever admission and stress testing plan is determined by ED and inheriting decision unit physicians. | |
| Active Comparator: Early discharge<br>Patient with chest pain, low risk by modified HEART score, is discharged from the emergency room without admission nor stress testing. | Other: Deferral of admission for stress test<br>* Early discharge; admission and stress test are deferred.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cost of hospitalization | Total charges accrued during index hospitalization, as well as costs related to index hospitalization up to 30 days after index discharge | 30 days | 
| Length of stay | Total length of stay of index hospitalization | up to 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 30-day MACE | Death, non-fatal myocardial infarction, stroke | 30 days after index hospitalization |