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| Name | Class |
|---|---|
| Agency for Healthcare Research and Quality (AHRQ) | FED |
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Overtesting for Acute Coronary Syndrome(ACS) and Pulmonary Embolism (PE) in low risk Emergency Department(ED) patients can increase exposure of nondiseased patients to radiation, intravenous contrast and anticoagulation. This project addresses question of whether quantitative Pre-Test Probability(PTP) assessed from two validated web-based computer algorithms (the project "webtool"), can improve the diagnostic evaluation of adult patients with charted evidence of chest pain and dyspnea. After a validation phase, the main study will randomize patients to either the Standard care group or the Intervention group, which will receive the output of the ACS and PE webtool that includes the PTP estimates of ACS and PE and one of three recommendations regarding next steps: 1. No further testing, 2. Exclusion with a biomarker protocol, or 3. Immediate imaging +/- empiric anticoagulation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Webtool Output | Experimental | The webtool output group will receive the numeric PTP estimate from webtool output. |
|
| Standard of Care/No Webtool Output | No Intervention | The control group will not receive the numeric PTP estimate. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Webtool | Device | Webtool provides the numeric PTP estimate for ACS and PE, and one of three testing recommendations. For ACS, PTP <2.5% with low clinical suspicion and available follow-up, no further testing; PTP 2.5 to 5.5%: obtain a troponin I measurement at presentation and 120 minutes later, and if both are normal, no further testing; PTP >5.5%: proceed to provocative testing. For PE, PTP<2.5% with low clinical suspicion and available follow-up, no further testing; PTP 2.5-10%, obtain a quantitative D-dimer and if normal, no further testing. PTP 10-20%, proceed directly to pulmonary vascular imaging, and if PTP>20% consider empiric anticoagulation with heparin if no contraindications. |
| Measure | Description | Time Frame |
|---|---|---|
| Efficiency--Mean Cost of Care | Only costs at the enrollment hospital will be used, and only for patients who indicate that they did not visit any other hospital at the time of phone follow-up. Costs would exclude unexpected and unrelated events such as trauma. Additionally, estimated costs associated with the time required of the clinician to gather and enter the 17 variables are included. | Day 30 |
| Measure | Description | Time Frame |
|---|---|---|
| Efficiency--Total Charge of Medical Care | Amount charged for medical care. | Day 30 |
| Safety--Radiation Dose to the Chest | in millisievert (mSv) |
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Inclusion Criteria
Randomization Exclusions
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey A Kline, MD | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States | ||
| University of Mississippi Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24594550 | Derived | Peitz GW, Troyer J, Jones AE, Shapiro NI, Nelson RD, Hernandez J, Kline JA. Association of body mass index with increased cost of care and length of stay for emergency department patients with chest pain and dyspnea. Circ Cardiovasc Qual Outcomes. 2014 Mar;7(2):292-8. doi: 10.1161/CIRCOUTCOMES.113.000702. Epub 2014 Mar 4. | |
| 24275953 | Derived | 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 Jan;7(1):66-73. doi: 10.1161/CIRCIMAGING.113.001080. Epub 2013 Nov 25. |
| Label | URL |
|---|---|
| Article "Multicenter, randomized trial of quantitative pretest probability to reduce unnecessary medical radiation exposure in emergency department patients with chest pain and dyspnea" | View source |
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550 subjects signed consent. 8 subjects screenfailed. 1 subject withdrew consent. 541 subjects were randomized.
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| ID | Title | Description |
|---|---|---|
| FG000 | Webtool Output | The webtool output group will receive the numeric PTP estimate from webtool output. |
| FG001 | Standard of Care/No Webtool Output | The control group will not receive the numeric PTP estimate. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Webtool Output | The webtool output group will receive the numeric PTP estimate from webtool output. |
| BG001 | Standard of Care/No Webtool Output | The control group will not receive the numeric PTP estimate. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Efficiency--Mean Cost of Care | Only costs at the enrollment hospital will be used, and only for patients who indicate that they did not visit any other hospital at the time of phone follow-up. Costs would exclude unexpected and unrelated events such as trauma. Additionally, estimated costs associated with the time required of the clinician to gather and enter the 17 variables are included. | Posted | Mean | Standard Deviation | US Dollars | Day 30 |
|
Baseline through Day 90
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Webtool Output | The webtool output group will receive the numeric PTP estimate from webtool output. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| death | General disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| jeffrey kline | indiana university school of medicine | 317 880 3869 | jefkline@iu.edu |
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| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| D011655 | Pulmonary Embolism |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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|
| Day 90 |
| Effectiveness--Length of Stay in Hospital | Day 7 |
| Effectiveness--Length of Stay Emergency Department | Day 7 |
| Jackson |
| Mississippi |
| 39216 |
| United States |
| Carolinas Medical Center | Charlotte | North Carolina | 28203 | United States |
| Forsyth Medical Center | Winston-Salem | North Carolina | 27103 | United States |
| 24120629 | Derived | Kline JA, Shapiro NI, Jones AE, Hernandez J, Hogg MM, Troyer J, Nelson RD. Outcomes and radiation exposure of emergency department patients with chest pain and shortness of breath and ultralow pretest probability: a multicenter study. Ann Emerg Med. 2014 Mar;63(3):281-8. doi: 10.1016/j.annemergmed.2013.09.009. Epub 2013 Oct 10. |
| 24070658 | Derived | Kline JA, Stubblefield WB. Clinician gestalt estimate of pretest probability for acute coronary syndrome and pulmonary embolism in patients with chest pain and dyspnea. Ann Emerg Med. 2014 Mar;63(3):275-80. doi: 10.1016/j.annemergmed.2013.08.023. Epub 2013 Sep 23. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Efficiency--Total Charge of Medical Care | Amount charged for medical care. | Posted | Mean | Standard Deviation | US Dollars | Day 30 |
|
|
|
| Secondary | Safety--Radiation Dose to the Chest | in millisievert (mSv) | Posted | Mean | Standard Deviation | mSv | Day 90 |
|
|
|
| Secondary | Effectiveness--Length of Stay in Hospital | Posted | Mean | Standard Deviation | hours | Day 7 |
|
|
|
| Secondary | Effectiveness--Length of Stay Emergency Department | Posted | Mean | Standard Deviation | Hours | Day 7 |
|
|
|
| 0 |
| 264 |
| 34 |
| 264 |
| 0 |
| 264 |
| EG001 | Standard of Care/No Webtool Output | The control group will not receive the numeric PTP estimate. | 2 | 277 | 49 | 277 | 0 | 277 |
| death | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| acute coronary syndrome | Cardiac disorders | Non-systematic Assessment |
|
| syncope | General disorders | Non-systematic Assessment |
|
| asthma exacerbation | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| anemia | Vascular disorders | Non-systematic Assessment |
|
| bile leak | Hepatobiliary disorders | Non-systematic Assessment |
|
| non-ST-elevation myocardial infarction (NSTEMI) | Cardiac disorders | Non-systematic Assessment |
|
| atrial fibrillation | Cardiac disorders | Non-systematic Assessment |
|
| acute worsening of abdominal pain | Gastrointestinal disorders | Non-systematic Assessment |
|
| left sided neck pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| urinary tract infection | Renal and urinary disorders | Non-systematic Assessment |
|
| congestive heart failure | Cardiac disorders | Non-systematic Assessment |
|
| restless leg syndrome | Nervous system disorders | Non-systematic Assessment |
|
| hypertension | Vascular disorders | Non-systematic Assessment |
|
| pulmonary embolism | Vascular disorders | Non-systematic Assessment |
|
| gastric ulcers | Gastrointestinal disorders | Non-systematic Assessment |
|
| worsening abdominal pain | Gastrointestinal disorders | Non-systematic Assessment |
|
| right rotator cuff repair | Surgical and medical procedures | Non-systematic Assessment |
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| right bicep repair | Surgical and medical procedures | Non-systematic Assessment |
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| tenosynovitis repair | Surgical and medical procedures | Non-systematic Assessment |
|
| Group B streptococcal sepsis | Infections and infestations | Non-systematic Assessment |
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| cellulitis | Infections and infestations | Non-systematic Assessment |
|
| cocaine induced chest pain | Cardiac disorders | Non-systematic Assessment |
|
| cocaine induced cardiomyopathy | Cardiac disorders | Non-systematic Assessment |
|
| cardiogenic shock | Cardiac disorders | Non-systematic Assessment |
|
| right ventricular failure | Cardiac disorders | Non-systematic Assessment |
|
| bronchiectasis pseudomas pneumonia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| unstable angina | Cardiac disorders | Non-systematic Assessment |
|
| acute alcohol withdrawal | General disorders | Non-systematic Assessment |
|
| alcohol dependence | General disorders | Non-systematic Assessment |
|
| mixed state bipolar disorder | Psychiatric disorders | Non-systematic Assessment |
|
| noncompliance with medical treatment | General disorders | Non-systematic Assessment |
|
| Chronic Obstructive Pulmonary Disease (COPD) exacerbation | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| non-small cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| bone pain from lytic lesions secondary to multiple myeloma | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| dermatomyositis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| metastatic adenocarcinoma of the left humerus causing pathological fracture | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| liver hematoma | Hepatobiliary disorders | Non-systematic Assessment |
|
| coronary artery bypass grafting | Cardiac disorders | Non-systematic Assessment |
|
| left ventricular thrombus | Cardiac disorders | Non-systematic Assessment |
|
| Ventricular tachycardia | Cardiac disorders | Non-systematic Assessment |
|
| ST-elevation myocardial infarction (STEMI) | Cardiac disorders | Non-systematic Assessment |
|
| chest pain | Cardiac disorders | Non-systematic Assessment |
|
| lower extremity bypass | Surgical and medical procedures | Non-systematic Assessment |
|
| multiple myeloma | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| hypertensive urgency | Cardiac disorders | Non-systematic Assessment |
|
| headache | Nervous system disorders | Non-systematic Assessment |
|
| urticaria | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| planned elective electrophysiology study | Surgical and medical procedures | Non-systematic Assessment |
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| atrial flutter ablation | Surgical and medical procedures | Non-systematic Assessment |
|
| gall stone pain | Hepatobiliary disorders | Non-systematic Assessment |
|
| sepsis | Infections and infestations | Non-systematic Assessment |
|
| hospitalization for unknown reason | General disorders | Non-systematic Assessment |
|
| severe vomiting | Gastrointestinal disorders | Non-systematic Assessment |
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| severe diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
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| congestive heart failure exacerbation | Cardiac disorders | Non-systematic Assessment |
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| suicidal ideation | Psychiatric disorders | Non-systematic Assessment |
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| lymphocytic leukemia | Blood and lymphatic system disorders | Non-systematic Assessment |
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| altered mental status | Psychiatric disorders | Non-systematic Assessment |
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| skin fungal infection | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| right femoral neck fracture | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| lupus flare | Immune system disorders | Non-systematic Assessment |
|
| vitamin D deficiency | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| iron deficiency | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| spina bifida occulta | Nervous system disorders | Non-systematic Assessment |
|
| post right popliteal superficial femoral thrombectomy | Surgical and medical procedures | Non-systematic Assessment |
|
| gastroesophageal reflux disease | Gastrointestinal disorders | Non-systematic Assessment |
|
| coronary artery disease | Cardiac disorders | Non-systematic Assessment |
|
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| acute renal insufficiency | Renal and urinary disorders | Non-systematic Assessment |
|
| accute appendicitis | Gastrointestinal disorders | Non-systematic Assessment |
|
| malignant polyp within the sigmoid colon | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| atypical chest pain | Cardiac disorders | Non-systematic Assessment |
|
| intentional drug overdose | Psychiatric disorders | Non-systematic Assessment |
|
| dizziness | Ear and labyrinth disorders | Non-systematic Assessment |
|
| benign right lobe lung nodules | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| lower extremity paralysis | Nervous system disorders | Non-systematic Assessment |
|
| diuresis | Renal and urinary disorders | Non-systematic Assessment |
|
| heart catheterization | Surgical and medical procedures | Non-systematic Assessment |
|
| heart failure | Cardiac disorders | Non-systematic Assessment |
|
| esophagogastrodeudenoscopy | Surgical and medical procedures | Non-systematic Assessment |
|
| mitral valve replacement | Surgical and medical procedures | Non-systematic Assessment |
|
| deep vein thrombosis in right lower extremity and right common femoral vein | Vascular disorders | Non-systematic Assessment |
|
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| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D004617 | Embolism |
| D016769 | Embolism and Thrombosis |