Low-Risk Chest Pain Echo Study

Sponsor

University of Kansas Medical Center (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05785923

Collaborator

(none)

Enrollment

Arms

7.9

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Pilot study to assess if a bedside point-of-care echocardiogram performed on emergency department patients identified as low-risk chest pain prior to discharge significantly changes patient disposition or follow up instructions.

Condition or Disease	Intervention/Treatment	Phase
Chest Pain	Diagnostic Test: Point-of-Care Echocardiogram	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

70 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

The Impact of Point-of-Care Ultrasound Echocardiography on the Disposition of Low-Risk Chest Pain Patients in the Emergency Department

Anticipated Study Start Date :

Apr 5, 2023

Anticipated Primary Completion Date :

Jul 30, 2023

Anticipated Study Completion Date :

Nov 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Echo Arm Chest pain patients identified by their treating physician as being low-risk chest pain will undergo a point-of-care echocardiogram performed by a trained emergency medicine attending or resident prior to discharge from the emergency department. The physician of record will review this ultrasound and it will be documented whether the findings on the ultrasound changed the physician of record's disposition decision for the patient or the follow up instructions or medications.	Diagnostic Test: Point-of-Care Echocardiogram Four view ultrasound of the heart performed at the bedside by trained emergency medicine physicians.
No Intervention: Usual Care Chest pain patients identified by their treating physician as being low-risk chest pain will receive the usual care for their condition.

Arm

Intervention/Treatment

Experimental: Echo Arm

Chest pain patients identified by their treating physician as being low-risk chest pain will undergo a point-of-care echocardiogram performed by a trained emergency medicine attending or resident prior to discharge from the emergency department. The physician of record will review this ultrasound and it will be documented whether the findings on the ultrasound changed the physician of record's disposition decision for the patient or the follow up instructions or medications.

Diagnostic Test: Point-of-Care Echocardiogram

Four view ultrasound of the heart performed at the bedside by trained emergency medicine physicians.

No Intervention: Usual Care

Chest pain patients identified by their treating physician as being low-risk chest pain will receive the usual care for their condition.

Outcome Measures

Primary Outcome Measures

Disposition [Day of enrollment]
Will assess if the result of the point-of-care echocardiogram resulted in the physician of record changing subject disposition from discharge to admission. We will assess this by asking the physician of record what the disposition plan is for the patient and recording their answer on IRB approved data collection sheet.

Secondary Outcome Measures

Follow up instructions [day of enrollment]
Will assess if the result of the point-of-care echocardiogram changed the follow up instructions or discharge medication decision for the enrolled subject as determined by the physician of record by asking them if the echo results caused them to add any additional discharge instructions for the patient. We will record their answer on the IRB approved data collection sheet.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Adults presenting to the emergency department with an isolated chief complaint of chest pain with a HEART score of 3 or less
Emergency physician of record has decided to discharge this patient from the Emergency Department

Exclusion Criteria:

Patients who are unable to consent for themselves
History of cardiac transplant or LVAD
Pediatric patients
Patients presenting with multiple complaints in addition to chest pain
Echocardiogram already performed on patient during usual care
Patients with another non-cardiac admittable diagnosis
HEART score greater than or equal to 4

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University of Kansas Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Adrienne Malik, Principal Investigator, University of Kansas Medical Center

ClinicalTrials.gov Identifier:

NCT05785923

Other Study ID Numbers:

STUDY00149603

First Posted:

Mar 27, 2023

Last Update Posted:

Mar 27, 2023

Last Verified:

Mar 1, 2023

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:

Chest Pain

Study Results

No Results Posted as of Mar 27, 2023