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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified July 2014 by Saint Joseph Mercy Health System
Sponsor:
Collaborators:
Michigan Heart
Blue Cross Blue Shield of Michigan Foundation
Information provided by (Responsible Party):
Herbert D. Aronow, MD, MPH, Saint Joseph Mercy Health System
ClinicalTrials.gov Identifier:
NCT02207270
First received: July 28, 2014
Last updated: July 30, 2014
Last verified: July 2014
  Purpose

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).


Condition Intervention
Coronary Artery Disease
Procedure: Same day discharge

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: A Randomized Cost Minimization Analysis Comparing Same Day Discharge With Overnight Hospital Stay Following Elective and Low Risk Urgent Percutaneous Coronary Intervention.

Resource links provided by NLM:


Further study details as provided by Saint Joseph Mercy Health System:

Primary Outcome Measures:
  • Total costs from a modified societal perspective [ Time Frame: Index hospital admission to 30-days post-PCI ] [ Designated as safety issue: No ]
    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 [ Time Frame: Index hospital admission to 30-days post-PCI ] [ Designated as safety issue: No ]
    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 [ Time Frame: Index hospital admission to 30-days post-PCI ] [ Designated as safety issue: No ]
    Includes death, myocardial infarction, stroke, unplanned cardiac catheterization or coronary revascularization, vascular or hemorrhagic complications.

  • Rehospitalization [ Time Frame: From discharge through 30-day post-PCI ] [ Designated as safety issue: No ]
    Inclusive of rehospitalization for any reason.


Estimated Enrollment: 224
Study Start Date: August 2014
Estimated Study Completion Date: October 2016
Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Same day discharge
Patients who experienced uncomplicated PCI as well as uncomplicated 6-hour observation period, randomly assigned to same day discharge
Procedure: Same day discharge

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.

Patients randomized to ON will receive usual overnight care and will be discharged the following morning. Costs and outcomes will be identified in-hospital by study personnel. They will receive a follow up phone call from a study coordinator at 30 days to ascertain what costs (if any) were accrued and whether any adverse outcomes occurred.

Other Name: SOCRATES
No Intervention: Overnight stay
Patients who experienced uncomplicated PCI as well as uncomplicated 6-hour observation period, randomly assigned to overnight stay.

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02207270

Contacts
Contact: Herbert D. Aronow, MD, MPH 734-712-8000 haronow@MichiganHeart.com

Locations
United States, Michigan
Saint Joseph Mercy Health System, St. Joseph Mercy [Hospital] Ann Arbor, Cardiac Catheterization Laboratory
Ypsilanti, Michigan, United States, 48197
Sponsors and Collaborators
Saint Joseph Mercy Health System
Michigan Heart
Blue Cross Blue Shield of Michigan Foundation
Investigators
Principal Investigator: Herbert D. Aronow, MD, MPH Michigan Heart
  More Information

Publications:
Brayton KM, Patel VG, Stave C, de Lemos JA, Kumbhani DJ. Same-day discharge after percutaneous coronary intervention: a meta-analysis. J Am Coll Cardiol. 2013;62:275-285.
Gurm HS, Seth M, Kooiman J, Share D. A novel tool for reliable and accurate prediction of renal complications in patients undergoing percutaneous coronary intervention. J Am Coll Cardiol. 2013;61:2242-2248.
Peterson ED, Dai D, DeLong ER, Brennan JM, Singh M, Rao SV, Shaw RE, Roe MT, Ho KK, Klein LW, Krone RJ, Weintraub WS, Brindis RG, Rumsfeld JS, Spertus JA. Contemporary mortality risk prediction for percutaneous coronary intervention: results from 588,398 procedures in the National Cardiovascular Data Registry. J Am Coll Cardiol. 2010;55:1923-1932.

Responsible Party: Herbert D. Aronow, MD, MPH, Interventional Cardiologist, Michigan Heart, Saint Joseph Mercy Health System
ClinicalTrials.gov Identifier: NCT02207270     History of Changes
Other Study ID Numbers: HSR-14-1479, 2033.11
Study First Received: July 28, 2014
Last Updated: July 30, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Saint Joseph Mercy Health System:
Angina
Coronary artery disease
Costs
Cost minimization
Percutaneous coronary intervention
Randomized trial
Risk score
Same day discharge
Unstable angina

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on September 16, 2014