Patient Satisfaction and Safety Outcomes After Enrollment in a Same-Day (SD) Percutaneous Coronary Intervention Program

This study is currently recruiting participants.
Verified June 2012 by University of Chicago
Sponsor:
Information provided by (Responsible Party):
Atman Shah, University of Chicago
ClinicalTrials.gov Identifier:
NCT01276132
First received: January 10, 2011
Last updated: June 27, 2012
Last verified: June 2012
  Purpose

Subjects in this study have recently had or are scheduled for a (percutaneous coronary intervention) PCI as part of their normal, routine medical care. This procedure should restore the blood flow in the vessels of the heart.

Recent studies have shown that stable patients who undergo PCI and are discharged home after 4 hours of observation do not suffer any more complications compared to patients who stay in the hospital overnight. In addition, studies suggest that patients express increased satisfaction at being discharged after 4 hours.

The University of Chicago is one of the first US medical centers to institute a formal program of same-day discharge after PCI. This study will seek, through a analysis of medical information and satisfaction questionnaires, to assess whether this particular same-day discharge program can improve patient satisfaction and preserve patient safety.


Condition
To Evaluate Clinical Outcomes, Safety, and Satisfaction of Patients Who Have Participated in a Same Day Outpatient Percutaneous Coronary Artery Intervention

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Patient Satisfaction and Safety Outcomes After Enrollment in a Same-Day (SD) Percutaneous Coronary Intervention Program

Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • To evaluate clinical outcomes, safety, and satisfaction of patients who have participated in a same-day outpatient percutaneous coronary artery intervention program [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 250
Study Start Date: June 2010
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Subjects who are designated to receive same-day PCI
Subjects who had been admitted to the hospital after their PCI

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Every patient who presents to the Cardiac Catheterization Laboratory for coronary angiography will be given the opportunity to participate in this program. The determination on whether or not a patient is selected to undergo Same-Day PCI is based on the clinical decision of the practicing physician according to conventionally accepted inclusion and exclusion criteria. The decision on whether or not to participate in the questionnaire study will not affect any treatment decisions. The only exclusion criteria will be if the patient declines participation. The investigators would like to enroll 250 patients over a three year period.

Criteria

Inclusion Criteria:

  • age 18 and up
  • undergoes coronary angiography in the Cardiac Catheterization Laboratory

Exclusion Criteria:

  • if the subject declines participation
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01276132

Contacts
Contact: Melanie Norstrom (773) 702-0347 mnorstrom@medicine.bsd.uchicago.edu

Locations
United States, Illinois
University of Chicago Medical Center Recruiting
Chicago, Illinois, United States, 60637
Contact: Melanie Norstrom, PhD    773-702-0347    mnorstrom@medicine.bsd.uchicago.edu   
Sponsors and Collaborators
University of Chicago
Investigators
Principal Investigator: Atman Shah, MD University of Chicago
  More Information

No publications provided

Responsible Party: Atman Shah, Asst Prof of Medicine, University of Chicago
ClinicalTrials.gov Identifier: NCT01276132     History of Changes
Other Study ID Numbers: 10-291-A
Study First Received: January 10, 2011
Last Updated: June 27, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Chicago:
percutaneous coronary artery intervention
coronary disease

ClinicalTrials.gov processed this record on April 16, 2014