Abstract
BackgroundChest pain is the second most common reason patients visit emergency departments (EDs) and often results in very low-risk patients being admitted for prolonged observation and advanced cardiac testing. Shared decision-making, including educating patients regarding their 45-day risk for acute coronary syndrome (ACS) and management options, might safely decrease healthcare utilization.Methods/DesignThis is a protocol for a multicenter practical patient-level randomized trial to compare an intervention group receiving a decision aid, Chest Pain Choice (CPC), to a control group receiving usual care. Adults presenting to five geographically and ethnically diverse EDs who are being considered for admission for observation and advanced cardiac testing will be eligible for enrollment. We will measure the effect of CPC on (1) patient knowledge regarding their 45-day risk for ACS and the available management options (primary outcome); (2) patient engagement in the decision-making process; (3) the degree of conflict patients experience related to feeling uninformed (decisional conflict); (4) patient and clinician satisfaction with the decision made; (5) the rate of major adverse cardiac events at 30 days; (6) the proportion of patients admitted for advanced cardiac testing; and (7) healthcare utilization. To assess these outcomes, we will administer patient and clinician surveys immediately after each clinical encounter, obtain video recordings of the patient-clinician discussion, administer a patient healthcare utilization diary, analyze hospital billing records, review the electronic medical record, and conduct telephone follow-up.DiscussionThis multicenter trial will robustly assess the effectiveness of a decision aid on patient-centered outcomes, safety, and healthcare utilization in low-risk chest pain patients from a variety of geographically and ethnically diverse EDs.Trial registrationNCT01969240.
Highlights
Chest pain is the second most common reason patients visit emergency departments (EDs) and often results in very low-risk patients being admitted for prolonged observation and advanced cardiac testing
This multicenter trial will robustly assess the effectiveness of a decision aid on patient-centered outcomes, safety, and healthcare utilization in low-risk chest pain patients from a variety of geographically and ethnically diverse EDs
We have described the rationale and methodology for a multicenter randomized clinical trial to measure the effectiveness of a decision aid on validated patient-centered outcome measures, safety, and healthcare utilization in ED chest pain patients at low-risk for acute coronary syndrome (ACS)
Summary
Chest pain is the second most common reason patients visit emergency departments (EDs) and often results in very low-risk patients being admitted for prolonged observation and advanced cardiac testing. As missed ACS may lead to an acute myocardial infarction (AMI) and/or potentially preventable death or disability, clinicians have a low threshold to hospitalize patients with chest pain. This results in increased psychological morbidity for patients - including anxiety and depression and hospital overcrowding, increased false positive test results, unnecessary downstream procedures, and between 3 and 10 billion dollars spent annually for patients found not to have cardiac disease [3,4]. ED patients being evaluated for possible ACS are rarely aware of their risk for an adverse cardiac event, [11] and in one recent trial lower patient satisfaction was observed in the intervention arm in which clinicians used evidencebased decision support without explicit risk communication and patient engagement [12]
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