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Open Access Study protocol

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

Ryan T Anderson1, Victor M Montori234, Nilay D Shah245, Henry H Ting26, Laurie J Pencille2, Michel Demers7, Jeffrey A Kline89, Deborah B Diercks10, Judd E Hollander11, Carlos A Torres12, Jason T Schaffer8, Jeph Herrin1314, Megan Branda245, Annie Leblanc15245 and Erik P Hess16245*

Author Affiliations

1 Mayo Medical School, Mayo Clinic College of Medicine, 200 First Street SW, Rochester, MN 55905, USA

2 Knowledge and Evaluation Research Unit, Mayo Clinic, 200 First Street SW, Rochester, MN 55905, USA

3 Department of Internal Medicine, Division of Endocrinology, Mayo Clinic, 200 First Street SW, Rochester, MN 55905, USA

4 Department of Health Sciences, Division of Healthcare Policy and Research, Mayo Clinic, 200 First Street SW, Rochester, MN 55905, USA

5 Center for the Science of Healthcare Delivery, Mayo Clinic, 200 First Street SW, Rochester, MN 55905, USA

6 Department of Internal Medicine, Division of Cardiology, Mayo Clinic, 200 First Street SW, Rochester, MN 55905, USA

7 Patient representative, Rochester, MN, USA

8 Department of Emergency Medicine, Indiana University School of Medicine, 720 Eskanazi Ave IN, Indianapolis, IN 46202, USA

9 Department of Cellular and Integrative Physiology, Indiana University School of Medicine, 720 Eskanazi Ave IN, Indianapolis, IN 46202, USA

10 Department of Emergency Medicine, University of California Davis Medical Center, 2315 Stockton Boulevard, Sacramento, CA 95817, USA

11 Department of Emergency Medicine, University of Pennsylvania, 3400 Spruce Street, Philadelphia, PA 19104, USA

12 Department of Emergency Medicine, Mayo Clinic, 4500 San Pablo Road South, Jacksonville, FL 32224, USA

13 Department of Internal Medicine, Division of Cardiology, Yale University School of Medicine, 333 Cedar Street, New Haven, CT 06510, USA

14 Health Research and Educational Trust, 1 North Franklin Street, Chicago, IL 60606, USA

15 Caregiver Representative, Mayo Clinic, 200 First Street SW, Rochester, MN 55905, USA

16 Department of Emergency Medicine, Division of Emergency Medicine Research, Mayo Clinic, 200 First Street Southwest, Rochester, MN 55905, USA

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Trials 2014, 15:166  doi:10.1186/1745-6215-15-166

Published: 10 May 2014

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.

Keywords:
Chest pain; Acute coronary syndrome; Acute myocardial infarction; Unstable angina; Shared decision-making; Emergency department; Healthcare utilization