Patient Satisfaction and Safety Outcomes After Enrollment in a Same-Day (SD) Percutaneous Coronary Intervention Program
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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 |
- 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 |
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.
Inclusion Criteria:
- age 18 and up
- undergoes coronary angiography in the Cardiac Catheterization Laboratory
Exclusion Criteria:
- if the subject declines participation
Contacts and Locations| Contact: Melanie Norstrom | (773) 702-0347 | mnorstrom@medicine.bsd.uchicago.edu |
| 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 | |
| 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 June 18, 2013