STEMI
Conditions
Keywords
Myocardial Infarction, Time to Treatment, Door to Balloon Time
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.
Interventions
OTHERNon Intervention
Business as usual
OTHERAgressive Intervention Process Improvement Strategies
Sponsors
Blue Cross Blue Shield of Michigan Foundation
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Participant flow
Recruitment details
6 sites were randomized to the aggressive strategy and 6 sites were randomized to control.
Pre-assignment details
Site were randomized according to baseline Door to Balloon times.
Participants by arm
| Arm | Count |
|---|---|
| Group 1: Agressive Intervention 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. | 448 |
| Group 2: Control Strategy Hospitals randomized to the control group were instructed to conduct business as usual.
Business as usual was described as site specific protocol for treatment of STEMI patient +/- any ongoing quality improvement efforts. No specific recommendations were given to sites from the coordinating center. | 434 |
| Total | 882 |
Baseline characteristics
| Characteristic | Group 1: Agressive Intervention | Group 2: Control Strategy | Total |
|---|---|---|---|
| Age, Continuous | 61.2 years STANDARD_DEVIATION 13.2 | 60.2 years STANDARD_DEVIATION 12.4 | 60.7 years STANDARD_DEVIATION 12.8 |
| Sex: Female, Male Female | 136 Participants | 134 Participants | 270 Participants |
| Sex: Female, Male Male | 312 Participants | 300 Participants | 612 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 448 | 0 / 434 |
| serious Total, serious adverse events | 0 / 448 | 0 / 434 |
Outcome results
Primary
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
Time frame: Arrival to balloon inflation, measured in minutes (generally less than 120 mins)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1: Aggressive Stategy | Percentage of Sites With Reduction in Door to Balloon Time | 83 percentage of sites with improved D2B |
| Group 2: Control Strategy | Percentage of Sites With Reduction in Door to Balloon Time | 50 percentage of sites with improved D2B |