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| ID | Type | Description | Link |
|---|---|---|---|
| 12CRP12000001 | Other Identifier | American Heart Association |
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| Name | Class |
|---|---|
| American Heart Association | OTHER |
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Our research will examine a chest pain care strategy, called the HEART pathway, which is designed to correctly identify Emergency Department patients at high-risk for cardiovascular events, likely to benefit from further testing, and patients at very-low-risk for cardiovascular events, who may be safely discharged home. By using an individual's risk assessment to determining testing, we hope to improve the quality and efficiency of the care delivered to Emergency Department patients with chest pain. Our study will determine if the HEART pathway, which combines a clinical decision rule, the HEART score, and two serial troponin measurements, will reduce stress testing and cardiovascular imaging, decrease hospital length of stay, and reduce cost compared to usual care, while maintaining safety.
Approximately 8-10 million patients complaining of chest pain present to an Emergency Department (ED) annually in the United States. The total cost of chest pain evaluations has been estimated at $5-10 billion annually, yet only 10% of these patients are ultimately diagnosed with an acute coronary syndrome. American College of Cardiology/ American Heart Association (ACC/AHA) guidelines recommend that patients at low-risk for acute coronary syndrome should receive serial cardiac markers followed by objective cardiac testing (stress testing or cardiac imaging). However, many have questioned the value of objective cardiac testing in all low-risk patients.Cardiac testing for all patients at low-risk for acute coronary syndrome (ACS) is not sustainable from a healthcare quality or economic perspective. In addition to increasing costs, objective cardiac testing is associated with a substantial number of false positive and non-diagnostic tests, which lead to additional unnecessary and often invasive procedures.
Implementation of accurate risk stratification care pathways designed to eliminate unnecessary cardiac testing could improve the efficiency and quality of care by decreasing false positive/non-diagnostic testing, radiation, and costs. The HEART pathway, which combines a clinical decision rule, the HEART score, and two serial troponin measurements, is a recently developed care pathway designed to identify chest pain patients for early discharge without objective testing.
Primary Hypothesis: The HEART Pathway, when compared to usual care, will reduce 30 day objective cardiac testing, hospital length of stay, and cost, while maintaining patient safety.
Methods: Participants (n=282) at risk for ACS will be recruited into a clinical trial from Wake Forest Baptist Medical Center (WFBMC) ED. Patients will be equally randomized to HEART Pathway or Usual Care. HEART Pathway participant's treating physician will follow HEART Pathway guidelines for identifying patients to be admitted to the hospital or observation unit for cardiac testing or to be discharged home without testing. Usual Care participant's treating physicians will decide whether the patients should be discharged home or admitted to the hospital or observation unit based on ACC/AHA guidelines without using the HEART pathway.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HEART Pathway | Experimental | The HEART Pathway will be used for real time clinical decision making. Physicians will receive care recommendations according to the HEART Pathway, based on HEART score and serial cardiac biomarkers. This will help physicians identify low-risk patients for early discharge with no objective cardiac testing. |
|
| Usual Care | No Intervention | Conventional Care cardiac testing. Patients will undergo cardiac testing as determined by their treating physicians. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HEART Pathway | Other | During ED evaluation, patients are randomized to HEART Pathway or usual care arms. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective cardiac testing (stress testing or cardiac imaging) within 30 days | Rate of objective cardiac testing within 30 days | 30 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Cost, length of stay, recurrent ED visits and non-index hospitalization for chest pain. | 30 Days | |
| Objective cardiac testing (stress testing or cardiac imaging), cost, length of stay, and recurrent ED visits and non-index hospitalization for chest pain. |
| Measure | Description | Time Frame |
|---|---|---|
| Major adverse cardiac events (MACE) | 30 Days and 1 Year | |
| Missed MACE | MACE occurring in patients discharged without objective cardiac testing. | 30 Days and 1 Year |
Inclusion Criteria:
Exclusion Criteria:
Sub-study I & II
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Simon A Mahler, MD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest Wake Forest University Baptist Medical Center - Emergency Department | Winston-Salem | North Carolina | 27157 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17194875 | Background | 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. | |
| 16841785 |
| Label | URL |
|---|---|
| Wake Forest Baptist Health | View source |
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| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| D002637 | Chest Pain |
| D004630 | Emergencies |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| 1 Year |
| Index objective cardiac testing rate | proportion of patients receiving any stress testing modality, coronary computed tomography angiography, or invasive catheter angiography at the index visit | Duration of Index Hospitalization, average of 1 to 2 days |
| Index Hospital Admission Rate | Proportion of patients hospitalized for admission or observation during the index visit | Duration of Index Hospitalization, average of 1 to 2 days |
| Early discharge rate | Proportion of patients that are discharged from the Emergency Department without meeting the composite endpoint of index hospital admission or index objective cardiac testing | Duration of Index Hospitalization, average of 1 to 2 days |
| Composite of 30 day hospital admission and objective cardiac testing | 30 Days |
| Provider adherence to the HEART Pathway | Duration of Index Hospitalization, average of 1 to 2 days |
| Inter-rater reliability of the HEART Pathway | Duration of the Index ED visit, less than 1 day |
| Background |
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| 8752791 | Background | Gomez MA, Anderson JL, Karagounis LA, Muhlestein JB, Mooers FB. An emergency department-based protocol for rapidly ruling out myocardial ischemia reduces hospital time and expense: results of a randomized study (ROMIO). J Am Coll Cardiol. 1996 Jul;28(1):25-33. doi: 10.1016/0735-1097(96)00093-9. |
| 25737484 | Derived | Mahler SA, Riley RF, Hiestand BC, Russell GB, Hoekstra JW, Lefebvre CW, Nicks BA, Cline DM, Askew KL, Elliott SB, Herrington DM, Burke GL, Miller CD. The HEART Pathway randomized trial: identifying emergency department patients with acute chest pain for early discharge. Circ Cardiovasc Qual Outcomes. 2015 Mar;8(2):195-203. doi: 10.1161/CIRCOUTCOMES.114.001384. Epub 2015 Mar 3. |
| D010146 |
| Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |