Trial Outcomes & Findings for Randomized Trial of a Quality Improvement Intervention to Decrease D2B Time in Primary PCI for AMI (NCT NCT01625104)
NCT ID: NCT01625104
Last Updated: 2017-12-15
Results Overview
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
COMPLETED
NA
882 participants
Arrival to balloon inflation, measured in minutes (generally less than 120 mins)
2017-12-15
Participant Flow
6 sites were randomized to the aggressive strategy and 6 sites were randomized to control.
Site were randomized according to baseline Door to Balloon times.
Participant milestones
| Measure |
Group 1: Agressive Strategy
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
Hospitals randomized to the control group were instructed to conduct "business as usual".
|
|---|---|---|
|
Overall Study
STARTED
|
448
|
434
|
|
Overall Study
COMPLETED
|
448
|
434
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Randomized Trial of a Quality Improvement Intervention to Decrease D2B Time in Primary PCI for AMI
Baseline characteristics by cohort
| Measure |
Group 1: Agressive Intervention
n=448 Participants
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
n=434 Participants
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.
|
Total
n=882 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.2 years
STANDARD_DEVIATION 13.2 • n=5 Participants
|
60.2 years
STANDARD_DEVIATION 12.4 • n=7 Participants
|
60.7 years
STANDARD_DEVIATION 12.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
136 Participants
n=5 Participants
|
134 Participants
n=7 Participants
|
270 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
312 Participants
n=5 Participants
|
300 Participants
n=7 Participants
|
612 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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
Outcome measures
| Measure |
Group 1: Aggressive Stategy
n=448 Participants
|
Group 2: Control Strategy
n=434 Participants
Hospitals randomized to the control group were instructed to conduct "business as usual".
|
|---|---|---|
|
Percentage of Sites With Reduction in Door to Balloon Time
|
83 percentage of sites with improved D2B
|
50 percentage of sites with improved D2B
|
Adverse Events
Group 1: Agressive Intervention
Group 2: Control Strategy
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place