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

This study has been completed.
Sponsor:
Collaborator:
Blue Cross Blue Shield of Michigan Foundation
Information provided by (Responsible Party):
Eva Kline-Rogers MS, RN, University of Michigan Health System
ClinicalTrials.gov Identifier:
NCT01625104
First received: June 19, 2012
Last updated: June 20, 2012
Last verified: June 2012
  Purpose

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
STEMI

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • Median Door to Balloon Time [ Time Frame: 2003 to 2006 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Risk adjusted mortality in STEMI patients in both groups [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment: 882
Study Start Date: September 2003
Study Completion Date: December 2006
Primary Completion Date: February 2006 (Final data collection date for primary outcome measure)
Groups/Cohorts
1

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.
2
Hospitals randomized to the control group were instructed to conduct "business as usual".

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".

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

All patients diagnosed with an STEMI at participating sites in a large, regional registry of consecutive percutaneous coronary interventions were included.

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Eva Kline-Rogers MS, RN, Study Coordinator, University of Michigan Health System
ClinicalTrials.gov Identifier: NCT01625104     History of Changes
Other Study ID Numbers: 1998-0080
Study First Received: June 19, 2012
Last Updated: June 20, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Michigan:
Myocardial Infarction
Time to Treatment
Door to Balloon Time

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

ClinicalTrials.gov processed this record on November 27, 2014