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 Anderson, Victor M Montori, Nilay D Shah, Henry H Ting, Laurie J Pencille, Michel Demers, Jeffrey A Kline, Deborah B Diercks, Judd E Hollander, Carlos A Torres, Jason T Schaffer, Jeph Herrin, Megan Branda, Annie Leblanc, Erik P Hess, Ryan T Anderson, Victor M Montori, Nilay D Shah, Henry H Ting, Laurie J Pencille, Michel Demers, Jeffrey A Kline, Deborah B Diercks, Judd E Hollander, Carlos A Torres, Jason T Schaffer, Jeph Herrin, Megan Branda, Annie Leblanc, Erik P Hess

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.

Figures

Figure 1
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
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
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.

References

    1. Niska R, Bhuiya F, Xu J. National hospital ambulatory medical care survey, emergency department summary. Natl Health Stat Rep. 2007;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. Heart. 2005;91(2):229–230. doi: 10.1136/hrt.2003.027599.
    1. Healthcare utilization project statistical brief #26. Hospital stays for circulatory diseases. Rockville, Maryland, USA: Agency for healthcare research and quality; 2004. .
    1. Goodacre S, Mason S, Arnold J, Angelini K. Psychologic morbidity and health-related quality of life of patients assessed in a chest pain observation unit. Ann Emerg Med. 2001;38(4):369–376. doi: 10.1067/mem.2001.118010.
    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(5):447.
    1. Mahler SA, Hiestand BC, Goff DC Jr, Hoekstra JW, Miller CD. Can the heart score safely reduce stress testing and cardiac imaging in patients at low risk for major adverse cardiac events? Crit Pathw Cardiol. 2011;10(3):128–133. doi: 10.1097/HPC.0b013e3182315a85.
    1. Hess EP, Brison RJ, Perry JJ, Calder LA, Thiruganasambandamoorthy V, Agarwal D, Sadosty AT, Silvilotti ML, Jaffe AS, Montori VM, Wells GA, Stiell IG. Development of a clinical prediction rule for 30-day cardiac events in emergency department patients with chest pain and possible acute coronary syndrome. Ann Emerg Med. 2012;59(2):115–125. doi: 10.1016/j.annemergmed.2011.07.026. e1.
    1. Hess EP, Agarwal D, Chandra S, Murad MH, Erwin PJ, Hollander JE, Montori VM, Stiell IG. Diagnostic accuracy of the TIMI risk score in patients with chest pain in the emergency department: a meta-analysis. CMAJ. 2010;182(10):1039–1044. doi: 10.1503/cmaj.092119.
    1. Aldous SJ, Richards M, Cullen L, Troughton R, Than M. A 2-hour thrombolysis in myocardial infarction score outperforms other risk stratification tools in patients presenting with possible acute coronary syndromes: comparison of chest pain risk stratification tools. Am Heart J. 2012;164(4):516–523. doi: 10.1016/j.ahj.2012.06.025.
    1. Than M, Aldous S, Lord SJ, Goodacre S, Frampton CM, Troughton R, George P, Florkowski CM, Ardagh M, Smyth D, Jardine DL, Peacock WF, Young J, Hamilton G, Deely JM, Cullen L, Richards AM. A 2-hour diagnostic protocol for possible cardiac chest pain in the emergency department: a randomized clinical trial. JAMA Intern Med. 2014;174(1):51–58. doi: 10.1001/jamainternmed.2013.11362.
    1. Hess EP, Knoedler MA, Shah ND, Kline JA, Breslin M, Branda ME, Pencille LJ, Asplin BR, Nestler DM, Sadosty AT, Stiell IG, Ting HH, Montori VM. The chest pain choice decision aid: a randomized trial. Circ Cardiovasc Qual Outcomes. 2012;5(3):251–259. doi: 10.1161/CIRCOUTCOMES.111.964791.
    1. Kline JA, Jones AE, Shapiro NI, Hernandez J, Hogg MM, Troyer J, Nelson RD. Multicenter randomized trial of quantitative pretest probability to reduce unnecessary medical radiation exposure in emergency department patients with chest pain and dyspnea. Circ Cardiovasc Imaging. 2014;7(1):66–73. doi: 10.1161/CIRCIMAGING.113.001080.
    1. Charles C, Gafni A, Whelan T. Decision-making in the physician-patient encounter: revisiting the shared treatment decision-making model. Soc Sci Med. 1999;49(5):651–661. doi: 10.1016/S0277-9536(99)00145-8.
    1. Pierce MA, Hess EP, Kline JA, Shah ND, Breslin M, Branda ME, Pencille LJ, Asplin BR, Nestler DM, Sadosty AT, Stiell IG, Ting HH, Montori VM. The Chest Pain Choice trial: a pilot randomized trial of a decision aid for patients with chest pain in the emergency department. Trials. 2010;11:57. doi: 10.1186/1745-6215-11-57.
    1. Kline JA, Johnson CL, Pollack CV Jr, Diercks DB, Hollander JE, Newgard CD, Garvey JL. Pretest probability assessment derived from attribute matching. BMC Med Inform Decis Mak. 2005;5:26. doi: 10.1186/1472-6947-5-26.
    1. Kline JA, Zeitouni RA, Hernandez-Nino J, Jones AE. Randomized trial of computerized quantitative pretest probability in low-risk chest pain patients: effect on safety and resource use. Ann Emerg Med. 2009;53(6):727–735. doi: 10.1016/j.annemergmed.2008.09.034. e721.
    1. Karanicolas PJ, Montori VM, Devereaux PJ, Schunemann H, Guyatt GH. A new ‘mechanistic-practical’ framework for designing and interpreting randomized trials. J Clin Epidemiol. 2009;62(5):479–484. doi: 10.1016/j.jclinepi.2008.02.009.
    1. Schulz KF, Altman DG, Moher D. Consort statement: updated guidelines for reporting parallel group randomised trials. BMJ. 2010;340:c332. doi: 10.1136/bmj.c332.
    1. Pocock SJ, Simon R. Sequential treatment assignment with balancing for prognostic factors in the controlled clinical trial. Biometrics. 1975;31(1):103–115. doi: 10.2307/2529712.
    1. Elwyn G, O'Connor A, Stacey D, Volk R, Edwards A, Coulter A, Thomson R, Barratt A, Barry M, Bernstein S, Butow P, Clarke A, Entwistle V, Feldman-Stewart D, Holmes-Rovner M, Llewellyn-Thomas H, Moumjid N, Mulley A, Ruland C, Sepucha K, Sykes A, Whelan T. International Patient Decision Aids Standards (IPDAS) Collaboration. Developing a quality criteria framework for patient decision aids: online international Delphi consensus process. BMJ. 2006;333(7565):417. doi: 10.1136/.
    1. Elwyn G, Hutchings H, Edwards A, Rapport F, Wensing M, Cheung WY, Grol R. The OPTION scale: measuring the extent that clinicians involve patients in decision-making tasks. Health Expect. 2005;8(1):34–42. doi: 10.1111/j.1369-7625.2004.00311.x.
    1. O'Connor AM. Validation of a decisional conflict scale. Med Decis Making. 1995;15(1):25–30. doi: 10.1177/0272989X9501500105.
    1. Thom DH, Ribisl KM, Stewart AL, Luke DA. Further validation and reliability testing of the trust in physician scale. Stanford Trust Stud Phys Med Care. 1999;37(5):510–517.
    1. Cullen L, Than M, Brown AF, Richards M, Parsonage W, Flaws D, Hollander JE, Christenson RH, Kline JA, Goodacre S, Jaffe AS. Comprehensive standardized data definitions for acute coronary syndrome research in emergency departments in Australasia. Emerg Med Australas. 2010;22(1):35–55. doi: 10.1111/j.1742-6723.2010.01256.x.
    1. Thygesen K, Alpert JS, Jaffe AS, Simoons ML, Chaitman BR, White HD, Katus HA, Lindahl B, Morrow DA, Clemmensen PM, Johanson P, Hod H, Underwood R, Bax JJ, Bonow RO, Pinto F, Gibbons RJ, Fox KA, Atar D, Newby LK, Galvani M, Hamm CW, Uretsky BF, Steg PG, Wijns W, Bassand JP, Menasché P, Ravkilde J, Ohman EM. Joint ESC/ACCF/AHA/WHF Task Force for the Universal Definition of Myocardial Infarction et al.Third universal definition of myocardial infarction. Circulation. 2012;126(16):2020–2035. doi: 10.1161/CIR.0b013e31826e1058.
    1. Hollander JE, Blomkalns AL, Brogan GX, Diercks DB, Field JM, Garvey JL, Gibler WB, Henry TD, Hoekstra JW, Holroyd BR, Hong Y, Kirk JD, O'Neil BJ, Jackson RE. Multidisciplinary Standardized Reporting Criteria Task Force. Standardized reporting guidelines for studies evaluating risk stratification of emergency department patients with potential acute coronary syndromes. Ann Emerg Med. 2004;44(6):589–598. doi: 10.1016/j.annemergmed.2004.08.009.
    1. Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)–a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009;42(2):377–381. doi: 10.1016/j.jbi.2008.08.010.
    1. Fergusson D, Aaron SD, Guyatt G, Hebert P. Post-randomisation exclusions: the intention to treat principle and excluding patients from analysis. BMJ. 2002;325(7365):652–654. doi: 10.1136/bmj.325.7365.652.
    1. Elixhauser A, Steiner C, Harris DR, Coffey RM. Comorbidity measures for use with administrative data. Med Care. 1998;36(1):8–27. doi: 10.1097/00005650-199801000-00004.
    1. Harrison MB, Legare F, Graham ID, Fervers B. Adapting clinical practice guidelines to local context and assessing barriers to their use. CMAJ. 2010;182(2):E78–E84. doi: 10.1503/cmaj.081232.
    1. Murad MH, Montori VM, Guyatt GH. Incorporating patient preferences in evidence-based medicine. JAMA. 2008;300(21):2483–2484. 2483; author reply.

Source: PubMed

Sponsoren und Mitarbeiter

Krankheiten

Drogeninterventionen

3
Abonnieren