Acute Coronary Syndrome, Pulmonary Embolism
Conditions
Keywords
Computer-derived, quantitative pretest probability (PTP), Overtesting, Radiation, Intravenous Contrast, Anticoagulation
Brief summary
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.
Interventions
DEVICEWebtool
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.
Sponsors
Agency for Healthcare Research and Quality (AHRQ)
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* Adult (\>17 years) ED patient reports a history of chest discomfort and new or worsened shortness of breath or breathing difficulty, documented in the written history of present illness or review of systems. * Patient must understand English or have a certified translator present. * Physician has ordered or plans to order a 12-lead electrocardiogram. * Patient indicates the site hospital was his or her hospital of choice in the event of return visit within 14 days. Randomization Exclusions * Positive urine cocaine test. * Incarceration within 14 days of enrollment. * Patient elopement from medical care (i.e., patients who leave against medical advice).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficiency--Mean Cost of Care | Day 30 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efficiency--Total Charge of Medical Care | Day 30 | Amount charged for medical care. |
| Safety--Radiation Dose to the Chest | Day 90 | in millisievert (mSv) |
| Effectiveness--Length of Stay in Hospital | Day 7 | — |
| Effectiveness--Length of Stay Emergency Department | Day 7 | — |
Countries
United States
Participant flow
Recruitment details
550 subjects signed consent. 8 subjects screenfailed. 1 subject withdrew consent. 541 subjects were randomized.
Participants by arm
| Arm | Count |
|---|---|
| Webtool Output The webtool output group will receive the numeric PTP estimate from webtool output. | 264 |
| Standard of Care/No Webtool Output The control group will not receive the numeric PTP estimate. | 277 |
| Total | 541 |
Baseline characteristics
| Characteristic | Webtool Output | Standard of Care/No Webtool Output | Total |
|---|---|---|---|
| Age, Continuous | 48 years STANDARD_DEVIATION 15 | 49 years STANDARD_DEVIATION 14 | 49 years STANDARD_DEVIATION 16 |
| Race/Ethnicity, Customized Black or African American | 124 participants | 148 participants | 272 participants |
| Race/Ethnicity, Customized Unkown or Not reported | 140 participants | 129 participants | 269 participants |
| Region of Enrollment United States | 264 participants | 277 participants | 541 participants |
| Sex: Female, Male Female | 154 Participants | 149 Participants | 303 Participants |
| Sex: Female, Male Male | 110 Participants | 128 Participants | 238 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 264 | 2 / 277 |
| other Total, other adverse events | 0 / 264 | 0 / 277 |
| serious Total, serious adverse events | 34 / 264 | 49 / 277 |
Outcome results
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.
Time frame: Day 30
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard of Care/No Webtool Output | Efficiency--Mean Cost of Care | 3933 US Dollars | Standard Deviation 12639 |
| Webtool Output | Efficiency--Mean Cost of Care | 2761 US Dollars | Standard Deviation 7965 |
Secondary
Effectiveness--Length of Stay Emergency Department
Time frame: Day 7
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard of Care/No Webtool Output | Effectiveness--Length of Stay Emergency Department | 5.7 Hours | Standard Deviation 2.5 |
| Webtool Output | Effectiveness--Length of Stay Emergency Department | 5.7 Hours | Standard Deviation 3 |
Secondary
Effectiveness--Length of Stay in Hospital
Time frame: Day 7
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard of Care/No Webtool Output | Effectiveness--Length of Stay in Hospital | 31.7 hours | Standard Deviation 63.3 |
| Webtool Output | Effectiveness--Length of Stay in Hospital | 27.1 hours | Standard Deviation 74.6 |
Secondary
Efficiency--Total Charge of Medical Care
Amount charged for medical care.
Time frame: Day 30
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard of Care/No Webtool Output | Efficiency--Total Charge of Medical Care | 16413 US Dollars | Standard Deviation 38993 |
| Webtool Output | Efficiency--Total Charge of Medical Care | 11916 US Dollars | Standard Deviation 26288 |
Secondary
Safety--Radiation Dose to the Chest
in millisievert (mSv)
Time frame: Day 90
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard of Care/No Webtool Output | Safety--Radiation Dose to the Chest | 5.2 mSv | Standard Deviation 7 |
| Webtool Output | Safety--Radiation Dose to the Chest | 4.2 mSv | Standard Deviation 6 |