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

Sponsor

Henry Ford Health System (Other)

Overall Status

Completed

CT.gov ID

NCT03058120

Collaborator

(none)

105

Enrollment

Arms

14.6

Actual Duration (Months)

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Chest Pain Heart Attack Coronary Artery Disease	Other: Deferral of admission for stress test	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

105 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Investigator)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Feb 19, 2014

Actual Primary Completion Date :

May 8, 2015

Actual Study Completion Date :

May 8, 2015

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Stress testing 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 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 Early discharge; admission and stress test are deferred.

Arm

Intervention/Treatment

No Intervention: Stress testing

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

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

Early discharge; admission and stress test are deferred.

Outcome Measures

Primary Outcome Measures

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

30-day MACE [30 days after index hospitalization]
Death, non-fatal myocardial infarction, stroke

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Henry Ford Health System

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Tiberio Frisoli, MD, Member of Heart and Vascular Institute in the Division of Cardiology, Henry Ford Health System

ClinicalTrials.gov Identifier:

NCT03058120

Other Study ID Numbers:

IRB 8558

First Posted:

Feb 20, 2017

Last Update Posted:

Feb 20, 2017

Last Verified:

Feb 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Coronary Artery Disease

Myocardial Infarction

Infarction

Chest Pain

Study Results

No Results Posted as of Feb 20, 2017