Randomized Trial of a Quality Improvement Intervention to Decrease D2B Time in Primary PCI for AMI

STEMI Clinical Trial

— RAPID-PCI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01625104
• Other study ID #: 1998-0080
• Status: Completed
• Phase: N/A
• First received: June 19, 2012
• Last updated: May 15, 2017
• Start date: September 2003
• Est. completion date: December 2006

Study information

• Verified date: May 2017
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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".

Recruitment information / eligibility

• Status: Completed
• Enrollment: 882
• Est. completion date: December 2006
• Est. primary completion date: February 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Myocardial Infarction
• STEMI

Intervention

Other:
• Non Intervention
Business as usual
• Agressive Intervention Process Improvement Strategies

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	Blue Cross Blue Shield of Michigan Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Sites With Reduction in Door to Balloon Time	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	Arrival to balloon inflation, measured in minutes (generally less than 120 mins)