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

Saint Joseph Mercy Health System

Status: Terminated

Conditions: Coronary Artery Disease

Treatments: Behavioral: Same day discharge; Behavioral: Overnight Stay

Study type: Interventional

Funder types: Other

Identifiers

NCT02207270

HSR-14-1479

2033.11 (Other Grant/Funding Number)

Details and patient eligibility

About

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).

Full 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.

Enrollment: 4 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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4 participants in 2 patient groups

Same day discharge

Experimental group

Description:

Patients who experienced uncomplicated PCI as well as an uncomplicated 6-hour observation period, will be randomly assigned to same day discharge.

Treatment:

Behavioral: Same day discharge

Overnight stay standard care

Other group

Description:

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.

Treatment:

Behavioral: Overnight Stay