Study Of Costs Realized After Percutaneous Coronary intervenTion Employing Same Day Discharge
Status: | Terminated |
---|---|
Conditions: | Peripheral Vascular Disease, Cardiology |
Therapuetic Areas: | Cardiology / Vascular Diseases |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/17/2018 |
Start Date: | August 11, 2014 |
End Date: | September 1, 2015 |
A Randomized Cost Minimization Analysis Comparing Same Day Discharge With Overnight Hospital Stay Following Elective and Low Risk Urgent Percutaneous Coronary Intervention.
The purpose of this study is to determine whether the total costs of care associated with
uncomplicated elective or low-risk urgent percutaneous coronary intervention (PCI) through
30-day follow up are lower among patients who are randomly assigned to same day discharge
(SDD) or overnight hospital stay (ON).
uncomplicated elective or low-risk urgent percutaneous coronary intervention (PCI) through
30-day follow up are lower among patients who are randomly assigned to same day discharge
(SDD) or overnight hospital stay (ON).
This is a prospective randomized clinical trial of same day discharge versus overnight stay
for patients undergoing uncomplicated elective or low-risk urgent PCI with uncomplicated
post-PCI recovery. The outcome is total cost accrued by patients from the time of index
hospital presentation through 30-day post-PCI follow-up.
Conduct of PCI procedures and provision of post-PCI care will be in accordance with routine
institutional practices and will not be protocol-driven.
Consented patients will be assigned to SDD or ON stay using a block randomization schedule.
Randomization will occur once the patient has completed an uncomplicated 6-hour post PCI
observation period.
for patients undergoing uncomplicated elective or low-risk urgent PCI with uncomplicated
post-PCI recovery. The outcome is total cost accrued by patients from the time of index
hospital presentation through 30-day post-PCI follow-up.
Conduct of PCI procedures and provision of post-PCI care will be in accordance with routine
institutional practices and will not be protocol-driven.
Consented patients will be assigned to SDD or ON stay using a block randomization schedule.
Randomization will occur once the patient has completed an uncomplicated 6-hour post PCI
observation period.
Inclusion Criteria:
- Consecutive patients who undergo elective or low-risk, (i.e., in the setting of
unstable angina but not non-ST segment elevation myocardial infarction) urgent PCI.
- No sociodemographic factors that would preclude SDD (prohibitive factors include no
family member/friend available to remain with patient until nurse phone call the
following day, no working phone, no reliable transportation, home > 60 minutes from
medical infrastructure, unable to obtain/pay for medications).
- PCI procedures performed between 08/04/14 and 08/03/16.
- Short term risk of in-hospital death, transfusion or contrast-induced nephropathy
during the index hospitalization at or below 1% using Blue Cross Blue Shield of
Michigan Cardiovascular Consortium (BMC2) PCI registry risk prediction models.
- No in-lab complications (prolonged angina, acute closure, no reflow, significant or
untreated dissection, vessel perforation, side branch occlusion, rescue glycoprotein
IIb/IIIa inhibitor use, ventricular tachycardia or fibrillation requiring
cardioversion/defibrillation, tamponade, pulmonary edema, stroke or transient ischemic
attack, shock).
- Contrast Volume/Calculated Creatinine Clearance ratio < 3
- No recurrent chest pain, shortness of breath, hemodynamic instability, bleeding or
vascular complications during 6 hours in recovery area post-PCI
Exclusion Criteria:
- Use of rotational atherectomy
- Use of a glycoprotein IIb/IIIa inhibitor infusion post-PCI
We found this trial at
2
sites
Ypsilanti, Michigan 48197
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Ypsilanti, Michigan 48197
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