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

Not Applicable

Completed

• Conditions: Heart Attack; Coronary Artery Disease; Chest Pain
• Interventions: Other: Deferral of admission for stress test

• Registration Number: NCT03058120
• Lead Sponsor: Henry Ford Health System

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.

Study Timeline

• Study Start: 2014-02-19
• Primary Completion: 2015-05-08
• Study Completion: 2015-05-08
• Status Verified: 2017-02
• Study First Submitted: 2017-02-14
• Study First Submitted QC: 2017-02-15
• Last Update Submitted: 2017-02-15
• Study First Posted: 2017-02-20
• Last Update Posted: 2017-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 105

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Early discharge	Deferral of admission for stress test	Patient with chest pain, low risk by modified HEART score, is discharged from the emergency room without admission nor stress testing.

Primary Outcome Measures

Name	Time	Method
Cost of hospitalization	30 days	Total charges accrued during index hospitalization, as well as costs related to index hospitalization up to 30 days after index discharge
Length of stay	up to 1 week	Total length of stay of index hospitalization

Secondary Outcome Measures

Name	Time	Method
30-day MACE	30 days after index hospitalization	Death, non-fatal myocardial infarction, stroke