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Clinical Trials/NCT01625104
NCT01625104
Completed
Not Applicable

Randomized Trial of Aggressive Process of Care Quality Improvement Intervention to Decrease Door to Balloon Time in Primary PCI for Acute Myocardial Infarction

University of Michigan1 site in 1 country882 target enrollmentSeptember 2003
ConditionsSTEMI

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
STEMI
Sponsor
University of Michigan
Enrollment
882
Locations
1
Primary Endpoint
Percentage of Sites With Reduction in Door to Balloon Time
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

The primary objective of this study is to assess whether an aggressive quality improvement intervention strategy will decrease time from hospital presentation to first balloon inflation in non-transfer patients with acute ST segment elevation MI (STEMI) treated with primary percutaneous coronary intervention (PCI). Twelve hospitals in Michigan were randomized to either aggressive intervention or control. The intervention consisted of Grand Rounds at each hospital, sharing of best practices, and coordinating center staff working closely with staff at each intervention hospital to discuss solutions to barriers to rapid treatment for STEMI patients.

Detailed Description

The participating hospitals randomized to the aggressive intervention strategy actively worked to create teams to analyze processes of care for STEMI patients, identify areas needing improvement, and implemented strategies to streamline treatment. Hospitals randomized to control were instructed to conduct "business as usual".

Registry
clinicaltrials.gov
Start Date
September 2003
End Date
December 2006
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Eva Kline-Rogers

Study Coordinator

University of Michigan

Eligibility Criteria

Inclusion Criteria

  • Acute ST segment myocardial infarction, non transfer patients, with symptom onset to balloon time less than or equal to 24 hours.

Exclusion Criteria

  • Patients transferred from one facility to another,
  • non ST segment myocardial infarction patients.

Outcomes

Primary Outcomes

Percentage of Sites With Reduction in Door to Balloon Time

Time Frame: Arrival to balloon inflation, measured in minutes (generally less than 120 mins)

Arrival time in Emergency Department to first balloon inflation in the coronary artery. Any reduction in median Door to Balloon Time from baseline to follow-up was counted as reduction in time

Study Sites (1)

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