Henry Ford Heart Score Randomized Trial: Rapid Discharge of Patients Evaluated for Possible Myocardial Infarction
Primary Purpose
Chest Pain, Heart Attack, Coronary Artery Disease
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Deferral of admission for stress test
Sponsored by
About this trial
This is an interventional other trial for Chest Pain
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
Stress testing
Early discharge
Arm Description
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.
Patient with chest pain, low risk by modified HEART score, is discharged from the emergency room without admission nor stress testing.
Outcomes
Primary Outcome Measures
Cost of hospitalization
Total charges accrued during index hospitalization, as well as costs related to index hospitalization up to 30 days after index discharge
Length of stay
Total length of stay of index hospitalization
Secondary Outcome Measures
30-day MACE
Death, non-fatal myocardial infarction, stroke
Full Information
NCT ID
NCT03058120
First Posted
February 14, 2017
Last Updated
February 15, 2017
Sponsor
Henry Ford Health System
1. Study Identification
Unique Protocol Identification Number
NCT03058120
Brief Title
Henry Ford Heart Score Randomized Trial: Rapid Discharge of Patients Evaluated for Possible Myocardial Infarction
Official Title
Henry Ford Heart Score Randomized Trial: Rapid Discharge of Patients Evaluated for Possible Myocardial Infarction
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
February 19, 2014 (Actual)
Primary Completion Date
May 8, 2015 (Actual)
Study Completion Date
May 8, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Henry Ford Health System
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chest Pain, Heart Attack, Coronary Artery Disease
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
105 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Stress testing
Arm Type
No Intervention
Arm Description
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.
Arm Title
Early discharge
Arm Type
Active Comparator
Arm Description
Patient with chest pain, low risk by modified HEART score, is discharged from the emergency room without admission nor stress testing.
Intervention Type
Other
Intervention Name(s)
Deferral of admission for stress test
Intervention Description
Early discharge; admission and stress test are deferred.
Primary Outcome Measure Information:
Title
Cost of hospitalization
Description
Total charges accrued during index hospitalization, as well as costs related to index hospitalization up to 30 days after index discharge
Time Frame
30 days
Title
Length of stay
Description
Total length of stay of index hospitalization
Time Frame
up to 1 week
Secondary Outcome Measure Information:
Title
30-day MACE
Description
Death, non-fatal myocardial infarction, stroke
Time Frame
30 days after index hospitalization
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
28954802
Citation
Frisoli TM, Nowak R, Evans KL, Harrison M, Alani M, Varghese S, Rahman M, Noll S, Flannery KR, Michaels A, Tabaku M, Jacobsen G, McCord J. Henry Ford HEART Score Randomized Trial: Rapid Discharge of Patients Evaluated for Possible Myocardial Infarction. Circ Cardiovasc Qual Outcomes. 2017 Oct;10(10):e003617. doi: 10.1161/CIRCOUTCOMES.117.003617.
Results Reference
derived
Learn more about this trial
Henry Ford Heart Score Randomized Trial: Rapid Discharge of Patients Evaluated for Possible Myocardial Infarction
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