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

Primary Purpose

Coronary Artery Disease

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Same day discharge
Overnight Stay
Sponsored by
Saint Joseph Mercy Health System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Coronary Artery Disease focused on measuring Coronary artery disease, Costs, Cost minimization, Percutaneous coronary intervention, Risk score, Same day discharge

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Saint Joseph Mercy Health System, St. Joseph Mercy [Hospital] Ann Arbor, Cardiac Catheterization Laboratory
  • Saint Jospeh Mercy Health System, St. Joseph Mercy [Hospital] Ann Arbor, Cardiac Catheterization Laboratory

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Same day discharge

Overnight stay standard care

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Adverse clinical outcomes
Includes death, myocardial infarction, stroke, unplanned cardiac catheterization or coronary revascularization, vascular or hemorrhagic complications.
Rehospitalization
Inclusive of rehospitalization for any reason.

Full Information

First Posted
July 28, 2014
Last Updated
March 20, 2018
Sponsor
Saint Joseph Mercy Health System
Collaborators
Michigan Heart, PC, Blue Cross Blue Shield of Michigan Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT02207270
Brief Title
Study Of Costs Realized After Percutaneous Coronary intervenTion Employing Same Day Discharge
Acronym
SOCRATES
Official Title
A Randomized Cost Minimization Analysis Comparing Same Day Discharge With Overnight Hospital Stay Following Elective and Low Risk Urgent Percutaneous Coronary Intervention.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Terminated
Why Stopped
Unable to meet projected enrollment
Study Start Date
August 11, 2014 (Actual)
Primary Completion Date
September 1, 2015 (Actual)
Study Completion Date
September 1, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Saint Joseph Mercy Health System
Collaborators
Michigan Heart, PC, Blue Cross Blue Shield of Michigan Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Coronary artery disease, Costs, Cost minimization, Percutaneous coronary intervention, Risk score, Same day discharge

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized clinical trail
Masking
None (Open Label)
Allocation
Randomized
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Same day discharge
Arm Type
Experimental
Arm Description
Patients who experienced uncomplicated PCI as well as an uncomplicated 6-hour observation period, will be randomly assigned to same day discharge.
Arm Title
Overnight stay standard care
Arm Type
Other
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Same day discharge
Other Intervention Name(s)
SOCRATES
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Overnight Stay
Other Intervention Name(s)
Standard Care
Intervention 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 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.
Primary Outcome Measure Information:
Title
Total costs from a modified societal perspective
Description
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.
Time Frame
Index hospital admission to 30-days post-PCI
Secondary Outcome Measure Information:
Title
Total costs from a 3rd party payer perspective
Description
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.
Time Frame
Index hospital admission to 30-days post-PCI
Title
Adverse clinical outcomes
Description
Includes death, myocardial infarction, stroke, unplanned cardiac catheterization or coronary revascularization, vascular or hemorrhagic complications.
Time Frame
Index hospital admission to 30-days post-PCI
Title
Rehospitalization
Description
Inclusive of rehospitalization for any reason.
Time Frame
From discharge through 30-day post-PCI

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Herbert D. Aronow, MD, MPH
Organizational Affiliation
Michigan Heart, PC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Saint Joseph Mercy Health System, St. Joseph Mercy [Hospital] Ann Arbor, Cardiac Catheterization Laboratory
City
Ypsilanti
State/Province
Michigan
ZIP/Postal Code
48197
Country
United States
Facility Name
Saint Jospeh Mercy Health System, St. Joseph Mercy [Hospital] Ann Arbor, Cardiac Catheterization Laboratory
City
Ypsilanti
State/Province
Michigan
ZIP/Postal Code
48197
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
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Study Of Costs Realized After Percutaneous Coronary intervenTion Employing Same Day Discharge

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