HEART Pathway Implementation

NCT02056964 | Completed

• 1 other identifier: IRB00025114
• Study Type: observational
• Target: 14,717
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the effectiveness of the HEART Pathway, a clinical decision aid for the care of patients with chest pain, in a "real-world" clinical setting. This will be accomplished through the building of a transformative collaboration between research, education, and health systems operations to more effectively and efficiently provide patient care.

Conditions

Chest Pain; Acute Coronary Syndrome; Chest Pain Atypical Syndrome; Chest Pain Rule Out Myocardial Infarction

Keywords

Acute Coronary Syndrome; Chest Pain; Risk Stratification; Clinical Decision Aid; Emergency Department; Low Risk Chest Pain; Non Cardiac Chest Pain

Outcome Measures

Primary Outcomes (1)

• Hospitalization rate

  30 Days after Emergency Department Visit

Study Arms (2)

Post-HEART Pathway Implementation

Data will be collected on patients presenting to the Emergency Department (ED) with chest pain after implementation of the HEART Pathway decision aid.

Pre-HEART Pathway Implementation

Data will be collected on patients presenting to the Emergency Department (ED) with chest pain prior to Implementation of the HEART Pathway decision aid.

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The target population is adult patients with acute chest pain, but without obvious Acute Coronary Syndrome (ACS) on Electrocardiogram (ECG). Therefore, adult patients (\>21 years old) with acute chest pain, for whom the provider orders troponins, and without evidence of an ST-segment elevation myocardial infarction (STEMI) on ECG, will be included. Based on STEMI rates at Wake Forest Baptist Medical Center (WFBMC) we expect less than 5% of patients with acute chest pain to be excluded due to ECG criteria.

You may qualify if:

• Age greater than or equal to 21 years of age at the time of Emergency Department (ED) visit
• Chest discomfort consistent with possible Acute Coronary Syndrome (ACS) as indicated by the treating physician obtaining an Electrocardiogram (ECG) and cardiac biomarkers for the patient's evaluation.

You may not qualify if:

• New ST-segment elevation in contiguous leads on any electrocardiogram (\>/= 1 mV)

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• Association of American Medical Colleges: collaborator
• Donaghue Medical Research Foundation: collaborator

Study Sites (1)

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, 27157, United States

Location

Related Publications (41)

• Rosamond W, Flegal K, Friday G, Furie K, Go A, Greenlund K, Haase N, Ho M, Howard V, Kissela B, Kittner S, Lloyd-Jones D, McDermott M, Meigs J, Moy C, Nichol G, O'Donnell CJ, Roger V, Rumsfeld J, Sorlie P, Steinberger J, Thom T, Wasserthiel-Smoller S, Hong Y; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2007 update: a report from the American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Circulation. 2007 Feb 6;115(5):e69-171. doi: 10.1161/CIRCULATIONAHA.106.179918. Epub 2006 Dec 28. No abstract available.

  PMID: 17194875 BACKGROUND

• McCaig LF, Nawar EW. National Hospital Ambulatory Medical Care Survey: 2004 emergency department summary. Adv Data. 2006 Jun 23;(372):1-29.

  PMID: 16841785 BACKGROUND

• Owens PL, Barrett ML, Gibson TB, Andrews RM, Weinick RM, Mutter RL. Emergency department care in the United States: a profile of national data sources. Ann Emerg Med. 2010 Aug;56(2):150-65. doi: 10.1016/j.annemergmed.2009.11.022. Epub 2010 Jan 15.

  PMID: 20074834 BACKGROUND

• Pope JH, Aufderheide TP, Ruthazer R, Woolard RH, Feldman JA, Beshansky JR, Griffith JL, Selker HP. Missed diagnoses of acute cardiac ischemia in the emergency department. N Engl J Med. 2000 Apr 20;342(16):1163-70. doi: 10.1056/NEJM200004203421603.

  PMID: 10770981 BACKGROUND

• Pines JM, Isserman JA, Szyld D, Dean AJ, McCusker CM, Hollander JE. The effect of physician risk tolerance and the presence of an observation unit on decision making for ED patients with chest pain. Am J Emerg Med. 2010 Sep;28(7):771-9. doi: 10.1016/j.ajem.2009.03.019. Epub 2010 Feb 25.

  PMID: 20837253 BACKGROUND

• Fleischmann KE, Goldman L, Johnson PA, Krasuski RA, Bohan JS, Hartley LH, Lee TH. Critical pathways for patients with acute chest pain at low risk. J Thromb Thrombolysis. 2002 Apr;13(2):89-96. doi: 10.1023/a:1016246814235.

  PMID: 12101386 BACKGROUND

• Roger VL, Go AS, Lloyd-Jones DM, Adams RJ, Berry JD, Brown TM, Carnethon MR, Dai S, de Simone G, Ford ES, Fox CS, Fullerton HJ, Gillespie C, Greenlund KJ, Hailpern SM, Heit JA, Ho PM, Howard VJ, Kissela BM, Kittner SJ, Lackland DT, Lichtman JH, Lisabeth LD, Makuc DM, Marcus GM, Marelli A, Matchar DB, McDermott MM, Meigs JB, Moy CS, Mozaffarian D, Mussolino ME, Nichol G, Paynter NP, Rosamond WD, Sorlie PD, Stafford RS, Turan TN, Turner MB, Wong ND, Wylie-Rosett J; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2011 update: a report from the American Heart Association. Circulation. 2011 Feb 1;123(4):e18-e209. doi: 10.1161/CIR.0b013e3182009701. Epub 2010 Dec 15.

  PMID: 21160056 BACKGROUND

• Goldstein JA, Gallagher MJ, O'Neill WW, Ross MA, O'Neil BJ, Raff GL. A randomized controlled trial of multi-slice coronary computed tomography for evaluation of acute chest pain. J Am Coll Cardiol. 2007 Feb 27;49(8):863-71. doi: 10.1016/j.jacc.2006.08.064. Epub 2007 Feb 12.

  PMID: 17320744 BACKGROUND

• Farkouh ME, Smars PA, Reeder GS, Zinsmeister AR, Evans RW, Meloy TD, Kopecky SL, Allen M, Allison TG, Gibbons RJ, Gabriel SE. A clinical trial of a chest-pain observation unit for patients with unstable angina. Chest Pain Evaluation in the Emergency Room (CHEER) Investigators. N Engl J Med. 1998 Dec 24;339(26):1882-8. doi: 10.1056/NEJM199812243392603.

  PMID: 9862943 BACKGROUND

• Heller GV, Stowers SA, Hendel RC, Herman SD, Daher E, Ahlberg AW, Baron JM, Mendes de Leon CF, Rizzo JA, Wackers FJ. Clinical value of acute rest technetium-99m tetrofosmin tomographic myocardial perfusion imaging in patients with acute chest pain and nondiagnostic electrocardiograms. J Am Coll Cardiol. 1998 Apr;31(5):1011-7. doi: 10.1016/s0735-1097(98)00057-6.

  PMID: 9562001 BACKGROUND

• Sprivulis PC, Da Silva JA, Jacobs IG, Frazer AR, Jelinek GA. The association between hospital overcrowding and mortality among patients admitted via Western Australian emergency departments. Med J Aust. 2006 Mar 6;184(5):208-12. doi: 10.5694/j.1326-5377.2006.tb00416.x.

  PMID: 16515429 BACKGROUND

• Miro O, Antonio MT, Jimenez S, De Dios A, Sanchez M, Borras A, Milla J. Decreased health care quality associated with emergency department overcrowding. Eur J Emerg Med. 1999 Jun;6(2):105-7. doi: 10.1097/00063110-199906000-00003.

  PMID: 10461551 BACKGROUND

• Braunwald E, Antman EM, Beasley JW, Califf RM, Cheitlin MD, Hochman JS, Jones RH, Kereiakes D, Kupersmith J, Levin TN, Pepine CJ, Schaeffer JW, Smith EE 3rd, Steward DE, Theroux P, Gibbons RJ, Alpert JS, Faxon DP, Fuster V, Gregoratos G, Hiratzka LF, Jacobs AK, Smith SC Jr; American College of Cardiology; American Heart Association. Committee on the Management of Patients With Unstable Angina. ACC/AHA 2002 guideline update for the management of patients with unstable angina and non-ST-segment elevation myocardial infarction--summary article: a report of the American College of Cardiology/American Heart Association task force on practice guidelines (Committee on the Management of Patients With Unstable Angina). J Am Coll Cardiol. 2002 Oct 2;40(7):1366-74. doi: 10.1016/s0735-1097(02)02336-7. No abstract available.

  PMID: 12383588 BACKGROUND

• Anderson JL, Adams CD, Antman EM, Bridges CR, Califf RM, Casey DE Jr, Chavey WE 2nd, Fesmire FM, Hochman JS, Levin TN, Lincoff AM, Peterson ED, Theroux P, Wenger NK, Wright RS, Smith SC Jr, Jacobs AK, Adams CD, Anderson JL, Antman EM, Halperin JL, Hunt SA, Krumholz HM, Kushner FG, Lytle BW, Nishimura R, Ornato JP, Page RL, Riegel B; American College of Cardiology; American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the 2002 Guidelines for the Management of Patients With Unstable Angina/Non-ST-Elevation Myocardial Infarction); American College of Emergency Physicians; Society for Cardiovascular Angiography and Interventions; Society of Thoracic Surgeons; American Association of Cardiovascular and Pulmonary Rehabilitation; Society for Academic Emergency Medicine. ACC/AHA 2007 guidelines for the management of patients with unstable angina/non-ST-Elevation myocardial infarction: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the 2002 Guidelines for the Management of Patients With Unstable Angina/Non-ST-Elevation Myocardial Infarction) developed in collaboration with the American College of Emergency Physicians, the Society for Cardiovascular Angiography and Interventions, and the Society of Thoracic Surgeons endorsed by the American Association of Cardiovascular and Pulmonary Rehabilitation and the Society for Academic Emergency Medicine. J Am Coll Cardiol. 2007 Aug 14;50(7):e1-e157. doi: 10.1016/j.jacc.2007.02.013. No abstract available.

  PMID: 17692738 BACKGROUND

• Ellestad MH, Savitz S, Bergdall D, Teske J. The false positive stress test. Multivariate analysis of 215 subjects with hemodynamic, angiographic and clinical data. Am J Cardiol. 1977 Nov;40(5):681-5. doi: 10.1016/0002-9149(77)90182-5. No abstract available.

  PMID: 920605 BACKGROUND

• Bamberg F, Abbara S, Schlett CL, Cury RC, Truong QA, Rogers IS, Nagurney JT, Brady TJ, Hoffmann U. Predictors of image quality of coronary computed tomography in the acute care setting of patients with chest pain. Eur J Radiol. 2010 Apr;74(1):182-8. doi: 10.1016/j.ejrad.2009.03.001. Epub 2009 Apr 5.

  PMID: 19346094 BACKGROUND

• Iskandrian AS, Heo J. Appraisal of false positive results in nuclear cardiac imaging. Am Heart J. 1990 Mar;119(3 Pt 1):708-9. doi: 10.1016/s0002-8703(05)80309-6. No abstract available.

  PMID: 2309622 BACKGROUND

• Bach DS, Muller DW, Gros BJ, Armstrong WF. False positive dobutamine stress echocardiograms: characterization of clinical, echocardiographic and angiographic findings. J Am Coll Cardiol. 1994 Oct;24(4):928-33. doi: 10.1016/0735-1097(94)90851-6.

  PMID: 7930226 BACKGROUND

• Einstein AJ, Henzlova MJ, Rajagopalan S. Estimating risk of cancer associated with radiation exposure from 64-slice computed tomography coronary angiography. JAMA. 2007 Jul 18;298(3):317-23. doi: 10.1001/jama.298.3.317.

  PMID: 17635892 BACKGROUND

• Thompson RC, Cullom SJ. Issues regarding radiation dosage of cardiac nuclear and radiography procedures. J Nucl Cardiol. 2006 Jan-Feb;13(1):19-23. doi: 10.1016/j.nuclcard.2005.11.004. No abstract available.

  PMID: 16464713 BACKGROUND

• Wagner EH. Chronic disease management: what will it take to improve care for chronic illness? Eff Clin Pract. 1998 Aug-Sep;1(1):2-4. No abstract available.

  PMID: 10345255 BACKGROUND

• Six AJ, Backus BE, Kelder JC. Chest pain in the emergency room: value of the HEART score. Neth Heart J. 2008 Jun;16(6):191-6. doi: 10.1007/BF03086144.

  PMID: 18665203 BACKGROUND

• Backus BE, Six AJ, Kelder JC, Mast TP, van den Akker F, Mast EG, Monnink SH, van Tooren RM, Doevendans PA. Chest pain in the emergency room: a multicenter validation of the HEART Score. Crit Pathw Cardiol. 2010 Sep;9(3):164-9. doi: 10.1097/HPC.0b013e3181ec36d8.

  PMID: 20802272 BACKGROUND

• Backus BE, Six AJ, Kelder JC, Bosschaert MA, Mast EG, Mosterd A, Veldkamp RF, Wardeh AJ, Tio R, Braam R, Monnink SH, van Tooren R, Mast TP, van den Akker F, Cramer MJ, Poldervaart JM, Hoes AW, Doevendans PA. A prospective validation of the HEART score for chest pain patients at the emergency department. Int J Cardiol. 2013 Oct 3;168(3):2153-8. doi: 10.1016/j.ijcard.2013.01.255. Epub 2013 Mar 7.

  PMID: 23465250 BACKGROUND

• 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 Sep;10(3):128-33. doi: 10.1097/HPC.0b013e3182315a85.

  PMID: 21989033 BACKGROUND

• Diercks DB, Peacock WF 4th, Hollander JE, Singer AJ, Birkhahn R, Shapiro N, Glynn T, Nowack R, Safdar B, Miller CD, Lewandrowski E, Nagurney JT. Diagnostic accuracy of a point-of-care troponin I assay for acute myocardial infarction within 3 hours after presentation in early presenters to the emergency department with chest pain. Am Heart J. 2012 Jan;163(1):74-80.e4. doi: 10.1016/j.ahj.2011.09.028.

  PMID: 22172439 BACKGROUND

• Mahler SA, Miller CD, Hollander JE, Nagurney JT, Birkhahn R, Singer AJ, Shapiro NI, Glynn T, Nowak R, Safdar B, Peberdy M, Counselman FL, Chandra A, Kosowsky J, Neuenschwander J, Schrock JW, Plantholt S, Diercks DB, Peacock WF. Identifying patients for early discharge: performance of decision rules among patients with acute chest pain. Int J Cardiol. 2013 Sep 30;168(2):795-802. doi: 10.1016/j.ijcard.2012.10.010. Epub 2012 Oct 30.

  PMID: 23117012 BACKGROUND

• Miller CD, Hwang W, Hoekstra JW, Case D, Lefebvre C, Blumstein H, Hiestand B, Diercks DB, Hamilton CA, Harper EN, Hundley WG. Stress cardiac magnetic resonance imaging with observation unit care reduces cost for patients with emergent chest pain: a randomized trial. Ann Emerg Med. 2010 Sep;56(3):209-219.e2. doi: 10.1016/j.annemergmed.2010.04.009. Epub 2010 May 31.

  PMID: 20554078 BACKGROUND

• 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 ED patients with potential acute coronary syndromes. Acad Emerg Med. 2004 Dec;11(12):1331-40. doi: 10.1197/j.aem.2004.08.033. No abstract available.

  PMID: 15576525 BACKGROUND

• Wright RS, Anderson JL, Adams CD, Bridges CR, Casey DE Jr, Ettinger SM, Fesmire FM, Ganiats TG, Jneid H, Lincoff AM, Peterson ED, Philippides GJ, Theroux P, Wenger NK, Zidar JP, Jacobs AK. 2011 ACCF/AHA Focused Update of the Guidelines for the Management of Patients With Unstable Angina/ Non-ST-Elevation Myocardial Infarction (Updating the 2007 Guideline): a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. Circulation. 2011 May 10;123(18):2022-60. doi: 10.1161/CIR.0b013e31820f2f3e. Epub 2011 Mar 28. No abstract available.

  PMID: 21444889 BACKGROUND

• O'Connor RE, Bossaert L, Arntz HR, Brooks SC, Diercks D, Feitosa-Filho G, Nolan JP, Vanden Hoek TL, Walters DL, Wong A, Welsford M, Woolfrey K; Acute Coronary Syndrome Chapter Collaborators. Part 9: Acute coronary syndromes: 2010 International Consensus on Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Science With Treatment Recommendations. Circulation. 2010 Oct 19;122(16 Suppl 2):S422-65. doi: 10.1161/CIRCULATIONAHA.110.985549. No abstract available.

  PMID: 20956257 BACKGROUND

• Miller CD, Hwang W, Case D, Hoekstra JW, Lefebvre C, Blumstein H, Hamilton CA, Harper EN, Hundley WG. Stress CMR imaging observation unit in the emergency department reduces 1-year medical care costs in patients with acute chest pain: a randomized study for comparison with inpatient care. JACC Cardiovasc Imaging. 2011 Aug;4(8):862-70. doi: 10.1016/j.jcmg.2011.04.016.

  PMID: 21835378 BACKGROUND

• Glasgow RE, Orleans CT, Wagner EH. Does the chronic care model serve also as a template for improving prevention? Milbank Q. 2001;79(4):579-612, iv-v. doi: 10.1111/1468-0009.00222.

  PMID: 11789118 BACKGROUND

• Bodenheimer T, Wagner EH, Grumbach K. Improving primary care for patients with chronic illness: the chronic care model, Part 2. JAMA. 2002 Oct 16;288(15):1909-14. doi: 10.1001/jama.288.15.1909.

  PMID: 12377092 BACKGROUND

• Thygesen K, Alpert JS, Jaffe AS, Simoons ML, Chaitman BR, White HD; Joint ESC/ACCF/AHA/WHF Task Force for the Universal Definition of Myocardial Infarction; 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, Menasche P, Ravkilde J, Ohman EM, Antman EM, Wallentin LC, Armstrong PW, Simoons ML, Januzzi JL, Nieminen MS, Gheorghiade M, Filippatos G, Luepker RV, Fortmann SP, Rosamond WD, Levy D, Wood D, Smith SC, Hu D, Lopez-Sendon JL, Robertson RM, Weaver D, Tendera M, Bove AA, Parkhomenko AN, Vasilieva EJ, Mendis S. Third universal definition of myocardial infarction. Circulation. 2012 Oct 16;126(16):2020-35. doi: 10.1161/CIR.0b013e31826e1058. Epub 2012 Aug 24. No abstract available.

  PMID: 22923432 BACKGROUND

• Ashburn NP, Snavely AC, Paradee BE, O'Neill JC, Stopyra JP, Mahler SA. Age differences in the safety and effectiveness of the HEART Pathway accelerated diagnostic protocol for acute chest pain. J Am Geriatr Soc. 2022 Aug;70(8):2246-2257. doi: 10.1111/jgs.17777. Epub 2022 Apr 5.

  PMID: 35383887 DERIVED

• Husain I, Mahler SA, Hiestand BC, Miller CD, Stopyra JP. The Impact of Accelerated Diagnostic Protocol Implementation on Chest Pain Observation Unit Utilization. Crit Pathw Cardiol. 2022 Mar 1;21(1):7-10. doi: 10.1097/HPC.0000000000000254.

  PMID: 33534506 DERIVED

• Smith LM, Ashburn NP, Snavely AC, Stopyra JP, Lenoir KM, Wells BJ, Hiestand BC, Herrington DM, Miller CD, Mahler SA. Identification of very low-risk acute chest pain patients without troponin testing. Emerg Med J. 2020 Nov;37(11):690-695. doi: 10.1136/emermed-2020-209698. Epub 2020 Aug 4.

  PMID: 32753395 DERIVED

• Stopyra J, Snavely AC, Hiestand B, Wells BJ, Lenoir KM, Herrington D, Hendley N, Ashburn NP, Miller CD, Mahler SA. Comparison of accelerated diagnostic pathways for acute chest pain risk stratification. Heart. 2020 Jul;106(13):977-984. doi: 10.1136/heartjnl-2019-316426. Epub 2020 Apr 8.

  PMID: 32269131 DERIVED

• Mahler SA, Lenoir KM, Wells BJ, Burke GL, Duncan PW, Case LD, Herrington DM, Diaz-Garelli JF, Futrell WM, Hiestand BC, Miller CD. Safely Identifying Emergency Department Patients With Acute Chest Pain for Early Discharge. Circulation. 2018 Nov 27;138(22):2456-2468. doi: 10.1161/CIRCULATIONAHA.118.036528.

  PMID: 30571347 DERIVED

• Mahler SA, Burke GL, Duncan PW, Case LD, Herrington DM, Riley RF, Wells BJ, Hiestand BC, Miller CD. HEART Pathway Accelerated Diagnostic Protocol Implementation: Prospective Pre-Post Interrupted Time Series Design and Methods. JMIR Res Protoc. 2016 Jan 22;5(1):e10. doi: 10.2196/resprot.4802.

  PMID: 26800789 DERIVED

Related Links

• Wake Forest Baptist Medical Center

MeSH Terms

Conditions

Chest Pain; Acute Coronary Syndrome; Emergencies

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Disease Attributes; Pathologic Processes

Study Officials

• Simon A Mahler, MD, MS

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2014
• First Posted: February 6, 2014
• Study Start: November 1, 2013
• Primary Completion: January 31, 2019
• Study Completion: January 31, 2019
• Last Updated: March 4, 2019

Record last verified: 2019-03

Locations

US (1)