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

Not Applicable

Completed

• Conditions: STEMI
• Interventions: Other: Agressive Intervention Process Improvement Strategies; Other: Non Intervention

• Registration Number: NCT01625104
• Lead Sponsor: 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.

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".

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2003-09
• Primary Completion: 2006-02
• Study Completion: 2006-12
• Study First Submitted: 2012-06-19
• Study First Submitted QC: 2012-06-20
• Study First Posted: 2012-06-21
• Results First Submitted: 2013-12-10
• Status Verified: 2017-05
• Results First Submitted QC: 2017-05-15
• Last Update Submitted: 2017-05-15
• Results First Posted: 2017-12-15
• Last Update Posted: 2017-12-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 882

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1: Aggressive Intervention Strategy	Agressive Intervention Process Improvement Strategies	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.
Group 2: Control Strategy	Non Intervention	Hospitals randomized to the control group were instructed to conduct "business as usual".

Primary Outcome Measures

Name	Time	Method
Percentage of Sites With Reduction in Door to Balloon Time	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

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States