Randomized Trial of Aggressive Process of Care Quality Improvement Intervention to Decrease Door to Balloon Time in Primary PCI for Acute Myocardial Infarction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 882
- 试验地点
- 2
- 主要终点
- Percentage of Sites With Reduction in Door to Balloon Time
研究概览
简要总结
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.
详细描述
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".
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute ST segment myocardial infarction, non transfer patients, with symptom onset to balloon time less than or equal to 24 hours.
排除标准
- •Patients transferred from one facility to another,
- •non ST segment myocardial infarction patients.
研究组 & 干预措施
Group 1: Aggressive Intervention 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:
- 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.
干预措施: Agressive Intervention Process Improvement Strategies (Other)
Group 2: Control Strategy
Hospitals randomized to the control group were instructed to conduct "business as usual".
干预措施: Non Intervention (Other)
结局指标
主要结局
Percentage of Sites With Reduction in Door to Balloon Time
时间窗: 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
次要结局
未报告次要终点
研究者
Eva Kline-Rogers
Study Coordinator
University of Michigan