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

Erik P Hess, Judd E Hollander, Jason T Schaffer, Jeffrey A Kline, Carlos A Torres, Deborah B Diercks, Russell Jones, Kelly P Owen, Zachary F Meisel, Michel Demers, Annie Leblanc, Nilay D Shah, Jonathan Inselman, Jeph Herrin, Ana Castaneda-Guarderas, Victor M Montori, Erik P Hess, Judd E Hollander, Jason T Schaffer, Jeffrey A Kline, Carlos A Torres, Deborah B Diercks, Russell Jones, Kelly P Owen, Zachary F Meisel, Michel Demers, Annie Leblanc, Nilay D Shah, Jonathan Inselman, Jeph Herrin, Ana Castaneda-Guarderas, Victor M Montori

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.

Conflict of interest statement

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.

Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Figures

https://www.ncbi.nlm.nih.gov/pmc/articles/instance/5152707/bin/hese034721.f1_default.jpg
Fig 1 Decision aid to facilitate discussion between clinicians and patients on whether to be admitted to an observation unit in the emergency department for cardiac stress testing or to follow up with a clinician in 24-72 hours
https://www.ncbi.nlm.nih.gov/pmc/articles/instance/5152707/bin/hese034721.f2_default.jpg
Fig 2 Screen shot of quantitative pretest probability web tool. Figure displays 45 day probability of acute coronary syndrome for an African-American woman aged more than 50 years whose chest pain is not reproducible with palpation, is not diaphoretic, and there is no ST segment depression greater than 0.5 mm or T wave inversion deeper than −0.5 mm, incorporating the result of the first cardiac troponin test. In this case, a coordinator would select a decision aid demonstrating a 3 out of 100 risk, rounding up from 2.3% to prioritize patient safety
https://www.ncbi.nlm.nih.gov/pmc/articles/instance/5152707/bin/hese034721.f3_default.jpg
Fig 3 Participant flow diagram

References

    1. Niska R, Bhuiya F, Xu J. National Hospital Ambulatory Medical Care Survey: 2007 emergency department summary[published Online First: 2010/08/24] Natl Health Stat Report 2010;(26):1-31..
    1. Goodacre S, Cross E, Arnold J, Angelini K, Capewell S, Nicholl J. The health care burden of acute chest pain[published Online First: 2005/01/20] Heart 2005;91:229-30. 10.1136/hrt.2003.027599. .
    1. Bhuiya FA, Pitts SR, McCaig LF. Emergency department visits for chest pain and abdominal pain: United States, 1999-2008[published Online First: 2010/09/22] NCHS Data Brief 2010;(43):1-8..
    1. Graff LG, Chern CH, Radford M. Emergency physicians’ acute coronary syndrome testing threshold and diagnostic performance: acute coronary syndrome critical pathway with return visit feedback[published Online First: 2014/07/26] Crit Pathw Cardiol 2014;13:99-103. 10.1097/HPC.0000000000000021. .
    1. Than M, Herbert M, Flaws D, et al. What is an acceptable risk of major adverse cardiac event in chest pain patients soon after discharge from the Emergency Department?: a clinical survey[published Online First: 2012/10/23] Int J Cardiol 2013;166:752-4. 10.1016/j.ijcard.2012.09.171. .
    1. Nasrallah N, Steiner H, Hasin Y. The challenge of chest pain in the emergency room: now and the future. Eur Heart J 2011;32:656..
    1. Ladapo JA, Blecker S, Douglas PS. Physician decision making and trends in the use of cardiac stress testing in the United States: an analysis of repeated cross-sectional data[published Online First: 2014/10/07] Ann Intern Med 2014;161:482-90. 10.7326/M14-0296. .
    1. Kline JA, Johnson CL, Pollack CV Jr, et al. Pretest probability assessment derived from attribute matching. BMC Med Inform Decis Mak 2005;5:26 10.1186/1472-6947-5-26 .
    1. Mitchell AM, Garvey JL, Chandra A, Diercks D, Pollack CV, Kline JA. Prospective multicenter study of quantitative pretest probability assessment to exclude acute coronary syndrome for patients evaluated in emergency department chest pain units. Ann Emerg Med 2006;47:447 10.1016/j.annemergmed.2005.10.013 .
    1. Pierce MA, Hess EP, Kline JA, et al. The Chest Pain Choice trial: a pilot randomized trial of a decision aid for patients with chest pain in the emergency department[published Online First: 2010/05/19] Trials 2010;11:57 10.1186/1745-6215-11-57. .
    1. Hess EP, Knoedler MA, Shah ND, et al. The chest pain choice decision aid: a randomized trial[published Online First: 2012/04/13] Circ Cardiovasc Qual Outcomes 2012;5:251-9. 10.1161/CIRCOUTCOMES.111.964791. .
    1. Tunis SR, Stryer DB, Clancy CM. Practical clinical trials: increasing the value of clinical research for decision making in clinical and health policy. JAMA 2003;290:1624-32. 10.1001/jama.290.12.1624. .
    1. Anderson RT, Montori VM, Shah ND, et al. Effectiveness of the Chest Pain Choice decision aid in emergency department patients with low-risk chest pain: study protocol for a multicenter randomized trial[published Online First: 2014/06/03] Trials 2014;15:166 10.1186/1745-6215-15-166. .
    1. Kline JA, Jones AE, Shapiro NI, et al. Multicenter, randomized trial of quantitative pretest probability to reduce unnecessary medical radiation exposure in emergency department patients with chest pain and dyspnea[published Online First: 2013/11/28] Circ Cardiovasc Imaging 2014;7:66-73. 10.1161/CIRCIMAGING.113.001080. .
    1. Karanicolas PJ, Montori VM, Devereaux PJ, Schünemann H, Guyatt GH. A new 'mechanistic-practical" framework for designing and interpreting randomized trials[published Online First: 2008/05/13] J Clin Epidemiol 2009;62:479-84. 10.1016/j.jclinepi.2008.02.009. .
    1. Fergusson D, Aaron SD, Guyatt G, Hébert P. Post-randomisation exclusions: the intention to treat principle and excluding patients from analysis[published Online First: 2002/09/21] BMJ 2002;325:652-4. 10.1136/bmj.325.7365.652 .
    1. Pocock SJ, Simon R. Sequential treatment assignment with balancing for prognostic factors in the controlled clinical trial[published Online First: 1975/03/01] Biometrics 1975;31:103-15. 10.2307/2529712 .
    1. Hargraves I, LeBlanc A, Shah ND, Montori VM. Shared Decision Making: The Need For Patient-Clinician Conversation, Not Just Information. Health Aff (Millwood) 2016;35:627-9. 10.1377/hlthaff.2015.1354. .
    1. Montori VM, Breslin M, Maleska M, Weymiller AJ. Creating a conversation: insights from the development of a decision aid[published Online First: 2007/08/09] PLoS Med 2007;4:e233 10.1371/journal.pmed.0040233. .
    1. Schulz KF, Altman DG, Moher D. CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomized trials[published Online First: 2010/03/26] Ann Intern Med 2010;152:726-32. 10.7326/0003-4819-152-11-201006010-00232. .
    1. Elwyn G, Hutchings H, Edwards A, et al. The OPTION scale: measuring the extent that clinicians involve patients in decision-making tasks. Health Expect 2005;8:34-42. 10.1111/j.1369-7625.2004.00311.x .
    1. Accurint for Healthcare, LexisNexis Risk Solutions. GA, USA.
    1. Patient Centered Outcomes Research Institute. [accessed September 13 2016.
    1. Weymiller AJ, Montori VM, Jones LA, et al. Helping patients with type 2 diabetes mellitus make treatment decisions: statin choice randomized trial[published Online First: 2007/05/30] Arch Intern Med 2007;167:1076-82. 10.1001/archinte.167.10.1076. .
    1. O’Connor AM. Validation of a decisional conflict scale[published Online First: 1995/01/01] Med Decis Making 1995;15:25-30. 10.1177/0272989X9501500105 .
    1. Thom DH, Ribisl KM, Stewart AL, Luke DA. The Stanford Trust Study Physicians. Further validation and reliability testing of the Trust in Physician Scale. Med Care 1999;37:510-7. 10.1097/00005650-199905000-00010 .
    1. Gattellari M, Ward JE. Will men attribute fault to their GP for adverse effects arising from controversial screening tests? An Australian study using scenarios about PSA screening. J Med Screen 2004;11:165-9. 10.1258/0969141042467386 .
    1. Elwyn G, Edwards A, Wensing M, Hood K, Atwell C, Grol R. Shared decision making: developing the OPTION scale for measuring patient involvement[published Online First: 2003/04/08] Qual Saf Health Care 2003;12:93-9. 10.1136/qhc.12.2.93 .
    1. Cullen L, Than M, Brown AF, et al. Comprehensive standardized data definitions for acute coronary syndrome research in emergency departments in Australasia[published Online First: 2010/02/09] Emerg Med Australas 2010;22:35-55. 10.1111/j.1742-6723.2010.01256.x. .
    1. Thygesen K, Alpert JS, Jaffe AS, et al. Joint ESC/ACCF/AHA/WHF Task Force for the Universal Definition of Myocardial Infarction. Third universal definition of myocardial infarction[published Online First: 2012/08/28] Circulation 2012;126:2020-35. 10.1161/CIR.0b013e31826e1058. .
    1. Kline JA, Zeitouni RA, Hernandez-Nino J, et alRandomized trial of computerized quantitative pretest probability in low-risk chest pain patients: effect on safety and resource use. Ann Emerg Med 2009;53:727-35. .
    1. Hollander JE, Blomkalns AL, Brogan GX, et al. Multidisciplinary Standardized Reporting Criteria Task Force Standardized Reporting Criteria Working Group of Emergency Medicine Cardiac Research and Education Group-International. Standardized reporting guidelines for studies evaluating risk stratification of emergency department patients with potential acute coronary syndromes[published Online First: 2004/12/02] Ann Emerg Med 2004;44:589-98. 10.1016/j.annemergmed.2004.08.009. .
    1. Patient Protection and Affordable Care Act, Pub L No. 111-148, 124 Stat 727, §6301.
    1. Selby JV, Beal AC, Frank L. The Patient-Centered Outcomes Research Institute (PCORI) national priorities for research and initial research agenda. JAMA 2012;307:1583-4. 10.1001/jama.2012.500. .
    1. Hess EP, Grudzen CR, Thomson R, Raja AS, Carpenter CR. Shared Decision-making in the Emergency Department: Respecting Patient Autonomy When Seconds Count. Acad Emerg Med 2015;22:856-64. 10.1111/acem.12703. .
    1. Grudzen CR, Anderson JR, Carpenter CR, Hess EP. Shared Decision Making in the Emergency Department: Development of a Policy-Relevant Patient-Centered Research Agenda. Acad Emerg Med 2016; published online 11 July 2016. 10.1111/acem.13047 .
    1. Lindor RA, Kunneman M, Hanzel M, Schuur JD, Montori VM, Sadosty AT. Liability and informed consent in the context of shared decision making. Acad Emerg Med 2016; published online 8 September 2016. 10.1111/acem.13078 .
    1. Durand MA, Moulton B, Cockle E, et alCan shared decision-making reduce medical malpractice litigation? A systematic review. BMC Health Serv Res 2015;15:167 10.1186/s12913-015-0823-2.
    1. Huntington B, Kuhn N. Communication gaffes: a root cause of malpractice claims. Proc (Bayl Univ Med Cent) 2003;16:157-61, discussion 161..
    1. Stacey D, Légaré F, Col NF, et al. Decision aids for people facing health treatment or screening decisions. Cochrane Database Syst Rev 2014;(1):CD001431 10.1002/14651858.CD001431.pub4. .
    1. McNaughton C, Wallston KA, Rothman RL, Marcovitz DE, Storrow AB. Short, subjective measures of numeracy and general health literacy in an adult emergency department. Acad Emerg Med 2011;18:1148-55. 10.11/j.553-2712.011.01210.

Source: PubMed

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