Trial Outcomes & Findings for Assessment of Acute Disease to Reduce Imaging Costs (NCT NCT01059500)
NCT ID: NCT01059500
Last Updated: 2023-03-23
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
550 participants
Primary outcome timeframe
Day 30
Results posted on
2023-03-23
Participant Flow
550 subjects signed consent. 8 subjects screenfailed. 1 subject withdrew consent. 541 subjects were randomized.
Participant milestones
| Measure |
Webtool Output
The webtool output group will receive the numeric PTP estimate from webtool output.
|
Standard of Care/No Webtool Output
The control group will not receive the numeric PTP estimate.
|
|---|---|---|
|
Overall Study
STARTED
|
264
|
277
|
|
Overall Study
COMPLETED
|
264
|
277
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Assessment of Acute Disease to Reduce Imaging Costs
Baseline characteristics by cohort
| Measure |
Webtool Output
n=264 Participants
The webtool output group will receive the numeric PTP estimate from webtool output.
|
Standard of Care/No Webtool Output
n=277 Participants
The control group will not receive the numeric PTP estimate.
|
Total
n=541 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
48 years
STANDARD_DEVIATION 15 • n=5 Participants
|
49 years
STANDARD_DEVIATION 14 • n=7 Participants
|
49 years
STANDARD_DEVIATION 16 • n=5 Participants
|
|
Sex: Female, Male
Female
|
154 Participants
n=5 Participants
|
149 Participants
n=7 Participants
|
303 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
110 Participants
n=5 Participants
|
128 Participants
n=7 Participants
|
238 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
124 participants
n=5 Participants
|
148 participants
n=7 Participants
|
272 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unkown or Not reported
|
140 participants
n=5 Participants
|
129 participants
n=7 Participants
|
269 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
264 participants
n=5 Participants
|
277 participants
n=7 Participants
|
541 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 30Only 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.
Outcome measures
| Measure |
Standard of Care/No Webtool Output
n=277 Participants
The control group will not receive the numeric PTP estimate.
|
Webtool Output
n=264 Participants
The webtool output group will receive the numeric PTP estimate from webtool output.
|
|---|---|---|
|
Efficiency--Mean Cost of Care
|
3933 US Dollars
Standard Deviation 12639
|
2761 US Dollars
Standard Deviation 7965
|
SECONDARY outcome
Timeframe: Day 30Amount charged for medical care.
Outcome measures
| Measure |
Standard of Care/No Webtool Output
n=277 Participants
The control group will not receive the numeric PTP estimate.
|
Webtool Output
n=264 Participants
The webtool output group will receive the numeric PTP estimate from webtool output.
|
|---|---|---|
|
Efficiency--Total Charge of Medical Care
|
16413 US Dollars
Standard Deviation 38993
|
11916 US Dollars
Standard Deviation 26288
|
SECONDARY outcome
Timeframe: Day 90in millisievert (mSv)
Outcome measures
| Measure |
Standard of Care/No Webtool Output
n=277 Participants
The control group will not receive the numeric PTP estimate.
|
Webtool Output
n=264 Participants
The webtool output group will receive the numeric PTP estimate from webtool output.
|
|---|---|---|
|
Safety--Radiation Dose to the Chest
|
5.2 mSv
Standard Deviation 7.0
|
4.2 mSv
Standard Deviation 6.0
|
SECONDARY outcome
Timeframe: Day 7Outcome measures
| Measure |
Standard of Care/No Webtool Output
n=277 Participants
The control group will not receive the numeric PTP estimate.
|
Webtool Output
n=264 Participants
The webtool output group will receive the numeric PTP estimate from webtool output.
|
|---|---|---|
|
Effectiveness--Length of Stay in Hospital
|
31.7 hours
Standard Deviation 63.3
|
27.1 hours
Standard Deviation 74.6
|
SECONDARY outcome
Timeframe: Day 7Outcome measures
| Measure |
Standard of Care/No Webtool Output
n=277 Participants
The control group will not receive the numeric PTP estimate.
|
Webtool Output
n=264 Participants
The webtool output group will receive the numeric PTP estimate from webtool output.
|
|---|---|---|
|
Effectiveness--Length of Stay Emergency Department
|
5.7 Hours
Standard Deviation 2.5
|
5.7 Hours
Standard Deviation 3.0
|
Adverse Events
Webtool Output
Serious events: 34 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard of Care/No Webtool Output
Serious events: 49 serious events
Other events: 0 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Webtool Output
n=264 participants at risk
The webtool output group will receive the numeric PTP estimate from webtool output.
|
Standard of Care/No Webtool Output
n=277 participants at risk
The control group will not receive the numeric PTP estimate.
|
|---|---|---|
|
Vascular disorders
pulmonary embolism
|
0.76%
2/264 • Number of events 2 • Baseline through Day 90
|
2.5%
7/277 • Number of events 7 • Baseline through Day 90
|
|
Gastrointestinal disorders
gastric ulcers
|
0.38%
1/264 • Number of events 1 • Baseline through Day 90
|
0.00%
0/277 • Baseline through Day 90
|
|
Gastrointestinal disorders
worsening abdominal pain
|
0.38%
1/264 • Number of events 1 • Baseline through Day 90
|
0.00%
0/277 • Baseline through Day 90
|
|
Surgical and medical procedures
right rotator cuff repair
|
0.38%
1/264 • Number of events 1 • Baseline through Day 90
|
0.00%
0/277 • Baseline through Day 90
|
|
Surgical and medical procedures
right bicep repair
|
0.38%
1/264 • Number of events 1 • Baseline through Day 90
|
0.00%
0/277 • Baseline through Day 90
|
|
Surgical and medical procedures
tenosynovitis repair
|
0.38%
1/264 • Number of events 1 • Baseline through Day 90
|
0.00%
0/277 • Baseline through Day 90
|
|
Infections and infestations
Group B streptococcal sepsis
|
0.38%
1/264 • Number of events 1 • Baseline through Day 90
|
0.00%
0/277 • Baseline through Day 90
|
|
Infections and infestations
cellulitis
|
0.38%
1/264 • Number of events 1 • Baseline through Day 90
|
0.36%
1/277 • Number of events 1 • Baseline through Day 90
|
|
Cardiac disorders
cocaine induced chest pain
|
0.38%
1/264 • Number of events 1 • Baseline through Day 90
|
0.00%
0/277 • Baseline through Day 90
|
|
Cardiac disorders
cocaine induced cardiomyopathy
|
0.38%
1/264 • Number of events 1 • Baseline through Day 90
|
0.00%
0/277 • Baseline through Day 90
|
|
Cardiac disorders
cardiogenic shock
|
0.38%
1/264 • Number of events 1 • Baseline through Day 90
|
0.00%
0/277 • Baseline through Day 90
|
|
Cardiac disorders
right ventricular failure
|
0.38%
1/264 • Number of events 1 • Baseline through Day 90
|
0.00%
0/277 • Baseline through Day 90
|
|
Respiratory, thoracic and mediastinal disorders
bronchiectasis pseudomas pneumonia
|
0.38%
1/264 • Number of events 1 • Baseline through Day 90
|
0.00%
0/277 • Baseline through Day 90
|
|
Cardiac disorders
unstable angina
|
0.38%
1/264 • Number of events 1 • Baseline through Day 90
|
0.36%
1/277 • Number of events 1 • Baseline through Day 90
|
|
General disorders
acute alcohol withdrawal
|
0.38%
1/264 • Number of events 1 • Baseline through Day 90
|
0.00%
0/277 • Baseline through Day 90
|
|
General disorders
alcohol dependence
|
0.38%
1/264 • Number of events 1 • Baseline through Day 90
|
0.00%
0/277 • Baseline through Day 90
|
|
Psychiatric disorders
mixed state bipolar disorder
|
0.38%
1/264 • Number of events 1 • Baseline through Day 90
|
0.00%
0/277 • Baseline through Day 90
|
|
General disorders
noncompliance with medical treatment
|
0.38%
1/264 • Number of events 1 • Baseline through Day 90
|
0.00%
0/277 • Baseline through Day 90
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease (COPD) exacerbation
|
0.76%
2/264 • Number of events 2 • Baseline through Day 90
|
0.36%
1/277 • Number of events 1 • Baseline through Day 90
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/264 • Baseline through Day 90
|
0.36%
1/277 • Number of events 1 • Baseline through Day 90
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
non-small cell carcinoma
|
0.38%
1/264 • Number of events 1 • Baseline through Day 90
|
0.00%
0/277 • Baseline through Day 90
|
|
Musculoskeletal and connective tissue disorders
bone pain from lytic lesions secondary to multiple myeloma
|
0.38%
1/264 • Number of events 1 • Baseline through Day 90
|
0.00%
0/277 • Baseline through Day 90
|
|
Musculoskeletal and connective tissue disorders
dermatomyositis
|
0.38%
1/264 • Number of events 1 • Baseline through Day 90
|
0.00%
0/277 • Baseline through Day 90
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
metastatic adenocarcinoma of the left humerus causing pathological fracture
|
0.38%
1/264 • Number of events 1 • Baseline through Day 90
|
0.00%
0/277 • Baseline through Day 90
|
|
Hepatobiliary disorders
liver hematoma
|
0.38%
1/264 • Number of events 1 • Baseline through Day 90
|
0.00%
0/277 • Baseline through Day 90
|
|
Cardiac disorders
coronary artery bypass grafting
|
0.38%
1/264 • Number of events 1 • Baseline through Day 90
|
0.00%
0/277 • Baseline through Day 90
|
|
Cardiac disorders
left ventricular thrombus
|
0.38%
1/264 • Number of events 1 • Baseline through Day 90
|
0.00%
0/277 • Baseline through Day 90
|
|
Cardiac disorders
Ventricular tachycardia
|
0.38%
1/264 • Number of events 1 • Baseline through Day 90
|
0.00%
0/277 • Baseline through Day 90
|
|
Cardiac disorders
ST-elevation myocardial infarction (STEMI)
|
0.38%
1/264 • Number of events 1 • Baseline through Day 90
|
0.00%
0/277 • Baseline through Day 90
|
|
Cardiac disorders
chest pain
|
0.00%
0/264 • Baseline through Day 90
|
0.36%
1/277 • Number of events 1 • Baseline through Day 90
|
|
Surgical and medical procedures
lower extremity bypass
|
0.00%
0/264 • Baseline through Day 90
|
0.36%
1/277 • Number of events 1 • Baseline through Day 90
|
|
Blood and lymphatic system disorders
multiple myeloma
|
0.00%
0/264 • Baseline through Day 90
|
0.36%
1/277 • Number of events 1 • Baseline through Day 90
|
|
Cardiac disorders
hypertensive urgency
|
0.00%
0/264 • Baseline through Day 90
|
0.72%
2/277 • Number of events 2 • Baseline through Day 90
|
|
Nervous system disorders
headache
|
0.00%
0/264 • Baseline through Day 90
|
0.72%
2/277 • Number of events 2 • Baseline through Day 90
|
|
Skin and subcutaneous tissue disorders
urticaria
|
0.00%
0/264 • Baseline through Day 90
|
0.36%
1/277 • Number of events 1 • Baseline through Day 90
|
|
Surgical and medical procedures
planned elective electrophysiology study
|
0.00%
0/264 • Baseline through Day 90
|
0.36%
1/277 • Number of events 1 • Baseline through Day 90
|
|
Surgical and medical procedures
atrial flutter ablation
|
0.00%
0/264 • Baseline through Day 90
|
0.36%
1/277 • Number of events 1 • Baseline through Day 90
|
|
Hepatobiliary disorders
gall stone pain
|
0.00%
0/264 • Baseline through Day 90
|
0.36%
1/277 • Number of events 1 • Baseline through Day 90
|
|
Infections and infestations
sepsis
|
0.00%
0/264 • Baseline through Day 90
|
0.36%
1/277 • Number of events 1 • Baseline through Day 90
|
|
General disorders
hospitalization for unknown reason
|
0.00%
0/264 • Baseline through Day 90
|
0.36%
1/277 • Number of events 1 • Baseline through Day 90
|
|
Gastrointestinal disorders
severe vomiting
|
0.00%
0/264 • Baseline through Day 90
|
0.36%
1/277 • Number of events 1 • Baseline through Day 90
|
|
Gastrointestinal disorders
severe diarrhea
|
0.00%
0/264 • Baseline through Day 90
|
0.36%
1/277 • Number of events 1 • Baseline through Day 90
|
|
Cardiac disorders
congestive heart failure exacerbation
|
0.00%
0/264 • Baseline through Day 90
|
0.36%
1/277 • Number of events 1 • Baseline through Day 90
|
|
Psychiatric disorders
suicidal ideation
|
0.00%
0/264 • Baseline through Day 90
|
0.72%
2/277 • Number of events 2 • Baseline through Day 90
|
|
Blood and lymphatic system disorders
lymphocytic leukemia
|
0.00%
0/264 • Baseline through Day 90
|
0.36%
1/277 • Number of events 1 • Baseline through Day 90
|
|
Psychiatric disorders
altered mental status
|
0.00%
0/264 • Baseline through Day 90
|
0.36%
1/277 • Number of events 1 • Baseline through Day 90
|
|
Skin and subcutaneous tissue disorders
skin fungal infection
|
0.00%
0/264 • Baseline through Day 90
|
0.36%
1/277 • Number of events 1 • Baseline through Day 90
|
|
Musculoskeletal and connective tissue disorders
right femoral neck fracture
|
0.00%
0/264 • Baseline through Day 90
|
0.36%
1/277 • Number of events 1 • Baseline through Day 90
|
|
General disorders
death
|
0.00%
0/264 • Baseline through Day 90
|
0.36%
1/277 • Number of events 1 • Baseline through Day 90
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
death
|
0.00%
0/264 • Baseline through Day 90
|
0.36%
1/277 • Number of events 1 • Baseline through Day 90
|
|
Cardiac disorders
acute coronary syndrome
|
0.76%
2/264 • Number of events 2 • Baseline through Day 90
|
1.4%
4/277 • Number of events 4 • Baseline through Day 90
|
|
General disorders
syncope
|
0.38%
1/264 • Number of events 1 • Baseline through Day 90
|
0.36%
1/277 • Number of events 1 • Baseline through Day 90
|
|
Respiratory, thoracic and mediastinal disorders
asthma exacerbation
|
0.38%
1/264 • Number of events 1 • Baseline through Day 90
|
0.00%
0/277 • Baseline through Day 90
|
|
Vascular disorders
anemia
|
0.38%
1/264 • Number of events 1 • Baseline through Day 90
|
0.36%
1/277 • Number of events 1 • Baseline through Day 90
|
|
Hepatobiliary disorders
bile leak
|
0.38%
1/264 • Number of events 1 • Baseline through Day 90
|
0.00%
0/277 • Baseline through Day 90
|
|
Cardiac disorders
non-ST-elevation myocardial infarction (NSTEMI)
|
1.9%
5/264 • Number of events 5 • Baseline through Day 90
|
1.4%
4/277 • Number of events 4 • Baseline through Day 90
|
|
Cardiac disorders
atrial fibrillation
|
0.38%
1/264 • Number of events 1 • Baseline through Day 90
|
0.00%
0/277 • Baseline through Day 90
|
|
Gastrointestinal disorders
acute worsening of abdominal pain
|
0.38%
1/264 • Number of events 1 • Baseline through Day 90
|
0.00%
0/277 • Baseline through Day 90
|
|
Musculoskeletal and connective tissue disorders
left sided neck pain
|
0.38%
1/264 • Number of events 1 • Baseline through Day 90
|
0.00%
0/277 • Baseline through Day 90
|
|
Renal and urinary disorders
urinary tract infection
|
0.38%
1/264 • Number of events 1 • Baseline through Day 90
|
0.36%
1/277 • Number of events 1 • Baseline through Day 90
|
|
Cardiac disorders
congestive heart failure
|
0.76%
2/264 • Number of events 2 • Baseline through Day 90
|
0.00%
0/277 • Baseline through Day 90
|
|
Nervous system disorders
restless leg syndrome
|
0.38%
1/264 • Number of events 1 • Baseline through Day 90
|
0.00%
0/277 • Baseline through Day 90
|
|
Vascular disorders
hypertension
|
0.38%
1/264 • Number of events 1 • Baseline through Day 90
|
0.00%
0/277 • Baseline through Day 90
|
|
Immune system disorders
lupus flare
|
0.00%
0/264 • Baseline through Day 90
|
0.36%
1/277 • Number of events 1 • Baseline through Day 90
|
|
Blood and lymphatic system disorders
vitamin D deficiency
|
0.00%
0/264 • Baseline through Day 90
|
0.36%
1/277 • Number of events 1 • Baseline through Day 90
|
|
Blood and lymphatic system disorders
iron deficiency
|
0.00%
0/264 • Baseline through Day 90
|
0.36%
1/277 • Number of events 1 • Baseline through Day 90
|
|
Nervous system disorders
spina bifida occulta
|
0.00%
0/264 • Baseline through Day 90
|
0.36%
1/277 • Number of events 1 • Baseline through Day 90
|
|
Surgical and medical procedures
post right popliteal superficial femoral thrombectomy
|
0.00%
0/264 • Baseline through Day 90
|
0.36%
1/277 • Number of events 1 • Baseline through Day 90
|
|
Gastrointestinal disorders
gastroesophageal reflux disease
|
0.00%
0/264 • Baseline through Day 90
|
0.36%
1/277 • Number of events 1 • Baseline through Day 90
|
|
Cardiac disorders
coronary artery disease
|
0.00%
0/264 • Baseline through Day 90
|
0.36%
1/277 • Number of events 1 • Baseline through Day 90
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/264 • Baseline through Day 90
|
0.36%
1/277 • Number of events 1 • Baseline through Day 90
|
|
Renal and urinary disorders
acute renal insufficiency
|
0.00%
0/264 • Baseline through Day 90
|
0.36%
1/277 • Number of events 1 • Baseline through Day 90
|
|
Gastrointestinal disorders
accute appendicitis
|
0.00%
0/264 • Baseline through Day 90
|
0.36%
1/277 • Number of events 1 • Baseline through Day 90
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
malignant polyp within the sigmoid colon
|
0.00%
0/264 • Baseline through Day 90
|
0.36%
1/277 • Number of events 1 • Baseline through Day 90
|
|
Cardiac disorders
atypical chest pain
|
0.00%
0/264 • Baseline through Day 90
|
0.36%
1/277 • Number of events 1 • Baseline through Day 90
|
|
Psychiatric disorders
intentional drug overdose
|
0.00%
0/264 • Baseline through Day 90
|
0.72%
2/277 • Number of events 2 • Baseline through Day 90
|
|
Ear and labyrinth disorders
dizziness
|
0.00%
0/264 • Baseline through Day 90
|
0.36%
1/277 • Number of events 1 • Baseline through Day 90
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
benign right lobe lung nodules
|
0.00%
0/264 • Baseline through Day 90
|
0.36%
1/277 • Number of events 1 • Baseline through Day 90
|
|
Nervous system disorders
lower extremity paralysis
|
0.00%
0/264 • Baseline through Day 90
|
0.36%
1/277 • Number of events 1 • Baseline through Day 90
|
|
Renal and urinary disorders
diuresis
|
0.00%
0/264 • Baseline through Day 90
|
0.36%
1/277 • Number of events 1 • Baseline through Day 90
|
|
Surgical and medical procedures
heart catheterization
|
0.00%
0/264 • Baseline through Day 90
|
0.72%
2/277 • Number of events 2 • Baseline through Day 90
|
|
Cardiac disorders
heart failure
|
0.00%
0/264 • Baseline through Day 90
|
0.36%
1/277 • Number of events 1 • Baseline through Day 90
|
|
Surgical and medical procedures
esophagogastrodeudenoscopy
|
0.00%
0/264 • Baseline through Day 90
|
0.36%
1/277 • Number of events 1 • Baseline through Day 90
|
|
Surgical and medical procedures
mitral valve replacement
|
0.00%
0/264 • Baseline through Day 90
|
0.36%
1/277 • Number of events 1 • Baseline through Day 90
|
|
Vascular disorders
deep vein thrombosis in right lower extremity and right common femoral vein
|
0.00%
0/264 • Baseline through Day 90
|
0.36%
1/277 • Number of events 1 • Baseline through Day 90
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place