Effectiveness of the Chest Pain Choice decision aid in emergency department patients with low-risk chest pain: study protocol for a multicenter randomized trial

Abstract

Background: 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. 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/design: This 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.

Discussion: 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.

Trial registration: NCT01969240.

Figure 1

Flow diagram showing the integration of study procedures in the flow of patient care. *Candidacy for ED observation unit admission will be assessed after the results of the initial troponin are available in some cases. CTCA, computed tomographic coronary angiography; ED, emergency department; CAD, coronary artery disease; ECG, electrocardiogram.

Figure 2

The Decision Aid. The decision aid describes for patients the rationale for, and results of, the initial emergency department evaluation (electrocardiogram, initial cardiac troponin level) and the potential utility of additional cardiac testing. A reliable estimate of the risk of an acute coronary syndrome within 45 days, obtained from a quantitative pretest probability (QPTP) web-tool developed and tested by Kline et al. [5,15,16], is included. The decision aid will be individualized to the patient based on the results of the QPTP risk calculator. The risk estimate is displayed using a state-of-the-art risk communication pictograph using an ordered icon array displaying natural frequencies, and a prose description of patient risk (for example, out of every 100 patients with factors like yours, 1 had a heart attack or pre-heart attack diagnosis within 45 days, 99 did not) to account for differences in numeracy preferences between patients. The decision aid also provides explicit management options (admission with urgent cardiac stress testing, follow-up with a cardiologist or the patient’s own primary care physician within 24 to 72 hours, or have the clinician make the decision on the patient’s behalf) for the clinician and patient to consider when reaching a shared decision.

Figure 3

Decision aid that includes the option of coronary CT angiography. This version of the decision aid was developed for use at the University of Pennsylvania emergency department (Pennsylvania, United States) in which coronary CT angiography is frequently used in lieu of cardiac stress testing.