Randomized Trial of a Quality Improvement Intervention to Decrease D2B Time in Primary PCI for AMI (RAPID-PCI)
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|ClinicalTrials.gov Identifier: NCT01625104|
Recruitment Status : Completed
First Posted : June 21, 2012
Results First Posted : December 15, 2017
Last Update Posted : December 15, 2017
|Condition or disease||Intervention/treatment||Phase|
|STEMI||Other: Non Intervention Other: Agressive Intervention Process Improvement Strategies||Not Applicable|
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".
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||882 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|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|
|Study Start Date :||September 2003|
|Actual Primary Completion Date :||February 2006|
|Actual Study Completion Date :||December 2006|
Experimental: Group 1: Aggressive Intervention Strategy
Hospitals were randomized to an aggressive intervention strategy or to "business as usual". The hospitals randomized to the aggressive intervention strategy underwent the following:
Other: Agressive Intervention Process Improvement Strategies
Placebo Comparator: Group 2: Control Strategy
Hospitals randomized to the control group were instructed to conduct "business as usual".
Other: Non Intervention
Business as usual
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01625104
|United States, Michigan|
|University of Michigan|
|Ann Arbor, Michigan, United States, 48109|
|Principal Investigator:||Mauro Moscucci, M.D.||University of Michigan|
|Study Director:||Eva M Kline-Rogers, MS, RN||University of Michigan|