ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01625104
Recruitment Status : Completed
First Posted : June 21, 2012
Results First Posted : December 15, 2017
Last Update Posted : December 15, 2017
Sponsor:
Collaborator:
Blue Cross Blue Shield of Michigan Foundation
Information provided by (Responsible Party):
Eva Kline-Rogers, University of Michigan

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.

Condition or disease Intervention/treatment Phase
STEMI Other: Non Intervention Other: Agressive Intervention Process Improvement Strategies Not Applicable

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".


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 882 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Arm Intervention/treatment
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:

  1. Grand Rounds conducted by physician and nurse from the Coordinating Center. This included a formal presentation on the evidence supporting rapid time to treatment in STEMI patients and evidence based strategies for reducing treatment delays.
  2. Discussion with staff regarding perceived barriers to treatment and suggestions/ideas for strategies to overcome these barriers
  3. Follow-up monthly phone conferences to continue to discuss strategies and ideas sharing
  4. Written plan from sites detailing plans to change processes of care.
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




Primary Outcome Measures :
  1. 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




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Locations
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Blue Cross Blue Shield of Michigan Foundation
Investigators
Principal Investigator: Mauro Moscucci, M.D. University of Michigan
Study Director: Eva M Kline-Rogers, MS, RN University of Michigan

Responsible Party: Eva Kline-Rogers, Study Coordinator, University of Michigan
ClinicalTrials.gov Identifier: NCT01625104     History of Changes
Other Study ID Numbers: 1998-0080
First Posted: June 21, 2012    Key Record Dates
Results First Posted: December 15, 2017
Last Update Posted: December 15, 2017
Last Verified: May 2017

Keywords provided by Eva Kline-Rogers, University of Michigan:
Myocardial Infarction
Time to Treatment
Door to Balloon Time

Additional relevant MeSH terms:
Myocardial Infarction
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases