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Research

Shared decision making in patients with low risk chest pain: prospective randomized pragmatic trial

BMJ 2016; 355 doi: https://doi.org/10.1136/bmj.i6165 (Published 05 December 2016) Cite this as: BMJ 2016;355:i6165
  1. Erik P Hess, associate professor1 2 3,
  2. Judd E Hollander, professor4,
  3. Jason T Schaffer, assistant professor5,
  4. Jeffrey A Kline, professor5,
  5. Carlos A Torres6,
  6. Deborah B Diercks, professor7,
  7. Russell Jones, assistant professor8,
  8. Kelly P Owen, assistant professor8,
  9. Zachary F Meisel, assistant professor9,
  10. Michel Demers, patient adviser10,
  11. Annie Leblanc, research collaborator and caregiver adviser2 11,
  12. Nilay D Shah, associate professor11,
  13. Jonathan Inselman, statistical programmer analyst3,
  14. Jeph Herrin, biostatistician13,
  15. Ana Castaneda-Guarderas, resident1 2 14,
  16. Victor M Montori, professor2 15
  1. 1Department of Emergency Medicine, Mayo Clinic College of Medicine, 200 First Street SW, Rochester, MN 55906, USA
  2. 2Knowledge and Evaluation Research Unit, Mayo Clinic, Rochester, MN, USA
  3. 3Mayo Clinic Robert D and Patricia E Kern Center for the Science of Healthcare Delivery, Rochester, MN, USA
  4. 4Department of Emergency Medicine, Thomas Jefferson University, Philadelphia, PA, USA
  5. 5Department of Emergency Medicine, Indiana University, Indianapolis, IN, USA
  6. 6Department of Emergency Medicine, Mayo Clinic, Jacksonville, FL, USA
  7. 7Department of Emergency Medicine, University of Texas Southwestern Medical Center, Dallas, TX, USA
  8. 8Department of Emergency Medicine, University of California Davis Medical Center, Sacramento, CA, USA
  9. 9Department of Emergency Medicine, Perelman School of Medicine, Philadelphia, PA, USA
  10. 10Rochester, MN, USA
  11. 11Division of Health Care Policy and Research, Department of Health Sciences Research, Mayo Clinic, Rochester, MN, USA
  12. 12Yale University School of Medicine, New Haven, CT, USA
  13. 13Health Research & Educational Trust, Chicago IL, USA
  14. 14Department of Emergency Medicine, Aventura Hospital and Medical Center, Aventura, FL, USA
  15. 15Division of Endocrinology, Diabetes, Metabolism, and Nutrition, Department of Internal Medicine, Mayo Clinic, Rochester, MN, USA
  1. Correspondence to: E P Hess hess.erik{at}mayo.edu
  • Accepted 3 November 2016

Abstract

Objective To compare the effectiveness of shared decision making with usual care in choice of admission for observation and further cardiac testing or for referral for outpatient evaluation in patients with possible acute coronary syndrome.

Design Multicenter pragmatic parallel randomized controlled trial.

Setting Six emergency departments in the United States.

Participants 898 adults (aged >17 years) with a primary complaint of chest pain who were being considered for admission to an observation unit for cardiac testing (451 were allocated to the decision aid and 447 to usual care), and 361 emergency clinicians (emergency physicians, nurse practitioners, and physician assistants) caring for patients with chest pain.

Interventions Patients were randomly assigned (1:1) by an electronic, web based system to shared decision making facilitated by a decision aid or to usual care. The primary outcome, selected by patient and caregiver advisers, was patient knowledge of their risk for acute coronary syndrome and options for care; secondary outcomes were involvement in the decision to be admitted, proportion of patients admitted for cardiac testing, and the 30 day rate of major adverse cardiac events.

Results Compared with the usual care arm, patients in the decision aid arm had greater knowledge of their risk for acute coronary syndrome and options for care (questions correct: decision aid, 4.2 v usual care, 3.6; mean difference 0.66, 95% confidence interval 0.46 to 0.86), were more involved in the decision (observing patient involvement scores: decision aid, 18.3 v usual care, 7.9; 10.3, 9.1 to 11.5), and less frequently decided with their clinician to be admitted for cardiac testing (decision aid, 37% v usual care, 52%; absolute difference 15%; P<0.001). There were no major adverse cardiac events due to the intervention.

Conclusions Use of a decision aid in patients at low risk for acute coronary syndrome increased patient knowledge about their risk, increased engagement, and safely decreased the rate of admission to an observation unit for cardiac testing.

Trial registration ClinicalTrials.gov NCT01969240.

Footnotes

  • We thank Erica M Ward, who assisted with formatting the manuscript and submitting it for publication, the patients who participated in our trial, and all other contributors.

    Data safety monitoring board: JH (chairman; Yale University School of Medicine, New Haven, CT, USA), Chadwick Miller (Department of Emergency Medicine, Wake Forest Baptist Medical Center, Winston Salem, NC, USA), Simon Mahler (Department of Emergency Medicine, Wake Forest Baptist Medical Center), and Megan E Branda (Department of Health Sciences Research, Division of Biostatistics and Informatics, Mayo Clinic, Rochester, MN, USA).

  • Contributors: The steering committee (EPH, JEH, JAK, DBD, MD, AL, NDS, JH, VMM) designed the trial, and EPH obtained funding. The site investigators (EPH, JEH, JTS, CAT, DBD, RJ, KPO, ZFM) trained and supervised research coordinators in recruiting patients and gathering the data. JH and JI analyzed the data. EPH and JH wrote the report. All authors had full access to all of the data (including statistical reports and tables) in the study, can take responsibility for the integrity of the data and the accuracy of the data analysis, contributed to implementation of the study and data interpretation, and approved the final report for publication. EPH is the guarantor.

  • Funding: Research reported in this publication was funded through a Patient-Centered Outcomes Research Institute (PCORI) award (contract 952). The views presented in this publication are solely the responsibility of the authors and do not necessarily represent the views of PCORI, its board of governors, or the methodology committee. The funder of the study had no role in the study design, data collection, data analysis, data interpretation, or writing of the report. All involved researchers’ maintained independence from the funder of the study.

  • Competing interests: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf and declare: JEH has research funding from Alere, Trinity, Siemens, and Roche and has consulted for Janssen. DBD has research funding from Siemens and Roche and has consulted for Janssen. All other authors have no support from any organization for the submitted work; no financial relationships with any organizations that might have an interest in the submitted work in the previous three years; no other relationships or activities that could appear to have influenced the submitted work.

  • Ethical approval: All study procedures were approved by the institutional review boards at each of the participating hospitals.

  • Data sharing: A link to the probability web tool and the “chest pain choice” decision aid can be accessed at the Mayo Clinic Shared Decision Making National Resource Center at http://shareddecisions.mayoclinic.org/decision-aid-information/chest-pain-choice-decision-aid/. Deidentified patient level data and statistical code can be requested from the corresponding author at hess.erik@mayo.edu and provided to investigators who agree to adhere to a signed research data use agreement with the Mayo Clinic.

  • Transparency: The corresponding author (EPH) affirms that the manuscript is honest, accurate, and a transparent account of the study being reported; that no important aspects of the study have been omitted; and that any discrepancies from the study as planned and registered have been explained.

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 3.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/3.0/.

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