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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomized Cost Minimization Analysis Comparing Same Day Discharge With Overnight Hospital Stay Following Elective and Low Risk Urgent Percutaneous Coronary Intervention.

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Behavioral: Same day discharge
* Behavioral: Overnight Stay


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized clinical trail
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Same day discharge<br>Patients who experienced uncomplicated PCI as well as an uncomplicated 6-hour observation period, will be randomly assigned to same day discharge. | Behavioral: Same day discharge<br>* Patients randomized to SDD will be discharged home on the day of their PCI, at least 6 hours following its completion. They will receive a follow up phone call from a study coordinator the next day and at 30 days to ascertain what costs (if any) were accrued and whether any adverse outcomes occurred.<br>* Other names: SOCRATES;|
| Other: Overnight stay standard care<br>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. | Behavioral: Overnight Stay<br>* 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 or routine care. Patients randomized to overnight stay will be discharged the following morning to receive a follow up phone call at 30 days to ascertain what costs (if any) were accrued and whether any adverse outcomes occurred.<br>* Other names: Standard Care;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total costs from a modified societal perspective | 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. | Index hospital admission to 30-days post-PCI | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total costs from a 3rd party payer perspective | 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. | Index hospital admission to 30-days post-PCI | 
| Adverse clinical outcomes | Includes death, myocardial infarction, stroke, unplanned cardiac catheterization or coronary revascularization, vascular or hemorrhagic complications. | Index hospital admission to 30-days post-PCI | 
| Rehospitalization | Inclusive of rehospitalization for any reason. | From discharge through 30-day post-PCI | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronary artery disease, Costs, Cost minimization, Percutaneous coronary intervention, Risk score, Same day discharge