Study Of Costs Realized After Percutaneous Coronary intervenTion Employing Same Day Discharge

Not Applicable

Terminated

• Conditions: Coronary Artery Disease
• Interventions: Behavioral: Overnight Stay; Behavioral: Same day discharge

• Registration Number: NCT02207270
• Lead Sponsor: Saint Joseph Mercy Health System

Brief Summary

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).

Detailed Description

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.

Study Timeline

• Study First Submitted: 2014-07-28
• Study First Submitted QC: 2014-07-30
• Study First Posted: 2014-08-04
• Study Start: 2014-08-11
• Primary Completion: 2015-09-01
• Study Completion: 2015-09-01
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-20
• Last Update Posted: 2018-03-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Overnight stay standard care	Overnight Stay	Patients who experienced uncomplicated PCI, as well as an uncomplicated 6-hour observation period, will be randomly assigned to an overnight stay, generally considered standard care.
Same day discharge	Same day discharge	Patients who experienced uncomplicated PCI as well as an uncomplicated 6-hour observation period, will be randomly assigned to same day discharge.

Primary Outcome Measures

Name	Time	Method
Total costs from a modified societal perspective	Index hospital admission to 30-days post-PCI	Costs will be determined from a modified societal perspective (physician labor, office visit and outpatient drug costs will not be included) and will be reported in 2014 dollars.

Secondary Outcome Measures

Name	Time	Method
Total costs from a 3rd party payer perspective	Index hospital admission to 30-days post-PCI	Costs will be determined from a from a 3rd party payer perspective (physician labor, office visit and outpatient drug costs will also be included) and will be reported in 2014 dollars.
Adverse clinical outcomes	Index hospital admission to 30-days post-PCI	Includes death, myocardial infarction, stroke, unplanned cardiac catheterization or coronary revascularization, vascular or hemorrhagic complications.
Rehospitalization	From discharge through 30-day post-PCI	Inclusive of rehospitalization for any reason.

Trial Locations

Locations (2)

Saint Joseph Mercy Health System, St. Joseph Mercy [Hospital] Ann Arbor, Cardiac Catheterization Laboratory; 🇺🇸 Ypsilanti, Michigan, United States

Saint Jospeh Mercy Health System, St. Joseph Mercy [Hospital] Ann Arbor, Cardiac Catheterization Laboratory; 🇺🇸 Ypsilanti, Michigan, United States