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

University of Michigan

Status: Completed

Conditions: STEMI

Treatments: Other: Non Intervention; Other: Agressive Intervention Process Improvement Strategies

Study type: Interventional

Funder types: Other

Identifiers

NCT01625104

1998-0080

Details and patient eligibility

About

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.

Full 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".

Enrollment: 882 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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882 participants in 2 patient groups, including a placebo group

Group 1: Aggressive Intervention Strategy

Experimental group

Description:

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.

Treatment:

Other: Agressive Intervention Process Improvement Strategies

Group 2: Control Strategy

Placebo Comparator group

Description:

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

Treatment:

Other: Non Intervention