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

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.

Study Overview

• Status: Completed
• Conditions: To Evaluate Clinical Outcomes, Safety, and Satisfaction of Patients Who Have Participated in a Same Day Outpatient Percutaneous Coronary Artery Intervention

• Study Type: Observational
• Enrollment (Actual): 59

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• if the subject declines participation

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Subjects who are designated to receive same-day PCI
Subjects who had been admitted to the hospital after their PCI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To evaluate clinical outcomes, safety, and satisfaction of patients who have participated in a same-day outpatient percutaneous coronary artery intervention program	2 years

Collaborators and Investigators

• Sponsor: University of Chicago
• Investigators: Principal Investigator: Atman Shah, MD, University of Chicago

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2010
• Primary Completion (Actual): September 1, 2020
• Study Completion (Actual): September 1, 2020

Study Registration Dates

• First Submitted: January 10, 2011
• First Submitted That Met QC Criteria: January 12, 2011
• First Posted (Estimate): January 13, 2011

Study Record Updates

• Last Update Posted (Actual): April 26, 2023
• Last Update Submitted That Met QC Criteria: April 24, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: coronary disease; percutaneous coronary artery intervention
• Other Study ID Numbers: 10-291-A