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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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STEMI

Intervention / Treatment
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* Other: Non Intervention
* Other: Agressive Intervention Process Improvement Strategies


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1: Aggressive Intervention Strategy<br>Hospitals were randomized to an aggressive intervention strategy or to business as usual. The hospitals randomized to the aggressive intervention strategy underwent the following: 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. Discussion with staff regarding perceived barriers to treatment and suggestions/ideas for strategies to overcome these barriers Follow-up monthly phone conferences to continue to discuss strategies and ideas sharing Written plan from sites detailing plans to change processes of care. | Other: Agressive Intervention Process Improvement Strategies<br> <br> |
| Placebo Comparator: Group 2: Control Strategy<br>Hospitals randomized to the control group were instructed to conduct business as usual. | Other: Non Intervention<br>* Business as usual<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Myocardial Infarction, Time to Treatment, Door to Balloon Time