The Chest Pain Choice trial: a pilot randomized trial of a decision aid for patients with chest pain in the emergency department.
BACKGROUND
Chest pain is a common presenting complaint in the emergency department (ED). Despite the frequency with which clinicians evaluate patients with chest pain, accurately determining the risk of acute coronary syndrome (ACS) and sharing risk information with patients is challenging. The aims of this study are (1) to develop a decision aid (CHEST PAIN CHOICE) that communicates the short-term risk of ACS and (2) to evaluate the impact of the decision aid on patient participation in decision-making and resource use.


METHODS
This is a protocol for a parallel, 2-arm randomized trial to compare an intervention group receiving CHEST PAIN CHOICE to a control group receiving usual ED care. Adults presenting to the Saint Mary's Hospital ED in Rochester, MN USA with a primary complaint of chest pain who are being considered for admission for prolonged ED observation in a specialized unit and urgent cardiac stress testing will be eligible for enrollment. We will measure the effect of CHEST PAIN CHOICE on six outcomes: (1) patient knowledge regarding their short-term risk for ACS and the risks of radiation exposure; (2) quality of the decision making process; (3) patient and clinician acceptability and satisfaction with the decision aid; (4) the proportion of patients who decided to undergo observation unit admission and urgent cardiac stress testing; (5) economic costs and healthcare utilization; and (6) the rate of delayed or missed ACS. To capture these outcomes, we will administer patient and clinician surveys after each visit, obtain video recordings of the clinical encounters, and conduct 30-day phone follow-up.


CONCLUSIONS
This pilot randomized trial will develop and evaluate a decision aid for use in ED chest pain patients at low risk for ACS and provide a preliminary estimate of its effect on patient participation in decision-making and resource use.


BACKGROUND
Clinical Trials.gov Identifier: NCT01077037.
Pierce
Meghan A
MA
Knowledge and Encounter Research Unit, Mayo Clinic, Rochester, Minnesota, USA.
Hess
Erik P
EP
Kline
Jeffrey A
JA
Shah
Nilay D
ND
Breslin
Maggie
M
Branda
Megan E
ME
Pencille
Laurie J
LJ
Asplin
Brent R
BR
Nestler
David M
DM
Sadosty
Annie T
AT
Stiell
Ian G
IG
Ting
Henry H
HH
Montori
Victor M
VM
D054058:Acute Coronary Syndrome / Q000150:complications / Q000175:diagnosis* / Q000191:economics / Q000628:therapy*; D002637:Chest Pain / Q000191:economics / Q000209:etiology*; D003142:Communication; D017023:Coronary Angiography; D020000:Decision Support Systems, Clinical / Q000191:economics / Q000706:statistics & numerical data; D003661:Decision Support Techniques; D003951:Diagnostic Errors / Q000517:prevention & control; D003935:Diagnostic Techniques, Cardiovascular / Q000191:economics / Q000706:statistics & numerical data; D004636:Emergency Service, Hospital / Q000191:economics / Q000706:statistics & numerical data; D005080:Exercise Test; D007722:Health Knowledge, Attitudes, Practice; D017721:Hospital Costs; D006801:Humans; D008910:Minnesota; D019370:Observation; D010342:Patient Acceptance of Health Care; D010353:Patient Education as Topic; D017060:Patient Satisfaction; D010817:Physician-Patient Relations; D010865:Pilot Projects; D011237:Predictive Value of Tests; D011829:Radiation Dosage; D012107:Research Design; D018570:Risk Assessment; D012307:Risk Factors; D011795:Surveys and Questionnaires; D013997:Time Factors; D014741:Video Recording