Trial of Feedback on Blood Use
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 426
- 试验地点
- 10
- 主要终点
- Proportion of patients transfused
研究概览
简要总结
Trial of Feedback on Blood Use (TOFU)
The TOFU study will represent the first attempt to rigorously assess the impact of audit-feedback on changing transfusion practice. The primary hypothesis is that providing individual feedback on transfusion practice to orthopedic surgeons will reduce elective RBC transfusions in the postoperative period.
TOFU is a two-arm, cluster-randomized controlled trial. Initially, baseline blood use data will be collected at all study sites. Next, the PI at each site will give a short educational presentation to the orthopedic surgeons. The presentation will consist of a standardized 10-minute presentation reviewing the data from the FOCUS trial and the recommended red blood cell (RBC) transfusion trigger of 8 g/dL (or symptomatic anemia) based on that data. Clusters of orthopedic surgeons will then be randomized to either the Control arm (no feedback) or the Intervention arm (monthly feedback). All of the surgeons at a given site will either receive or not receive feedback. The feedback will take the form of emailed monthly reports detailing blood use by each surgeon post-hip surgery. Surgeons will be anonymized in the reports as "A, B, C . . ." but each surgeon will know which data are his own. The primary end point is the decrease from baseline in the proportion of patients transfused with a pretransfusion hemoglobin of > 8 g/dL.
TOFU will be conducted at 8 sites in Europe and North and South America. Care has been taken to minimize the labor and costs required to conduct this study. The only data collected will be: patient age/gender; procedure; surgeon (anonymized); surgery & discharge dates; RBC units transfused; Hgb levels. The data will be entered at each site into a web-based Case Report Form, and will be stored centrally by the Data Coordinating Center (DCC). The DCC will generate monthly feedback reports and email them to each Intervention arm site PI. The site PI will then email the reports to each local orthopedic surgeon.
详细描述
Trial of Feedback on Blood Use (TOFU)
Background & Rationale Many studies have demonstrated substantial variability in blood use among both physicians and hospitals, suggesting the need to standardize transfusion practices and reduce unnecessary transfusions.To that end, national regulatory agencies in many countries require that hospitals monitor local blood use. However, the utility of this monitoring is unclear. A small number of prospective studies aimed at improving physician transfusion behavior have been published, but well-supported, generalizable findings are currently lacking. The proposed study will test the hypothesis that providing feedback of individual blood use data to transfusing physicians will reduce unnecessary RBC transfusions. A limited number of studies conducted in a range of settings have examined whether audit and feedback can improve physician practice and clinical outcomes. Results have been mixed. The proposed study would represent the first attempt to rigorously assess the impact of audit/feedback on changing transfusion practice.
The recently completed FOCUS trial presents a unique opportunity in that it provides high-quality data on which to base transfusion practice recommendations for a specific patient population. In the FOCUS trial, 2016 adult patients with a history of or risk factors for cardiovascular disease undergoing surgical hip fracture repair were randomized to be transfused with RBCs for a Hgb <10 g/dL (liberal group) or for symptoms of anemia and/or a Hgb <8 g/dL (restrictive group). The primary end point was the ability to ambulate independently at 60 days, and key secondary endpoints included 30-day and long-term mortality, myocardial infarction, and stroke. No significant difference was observed in any end point, demonstrating that -- as in the earlier TRICC trial -- a restrictive strategy was as safe as a liberal transfusion strategy. An earlier multicenter RCT similarly showed no difference in the rate of silent myocardial ischemia among 260 knee and hip surgery patients randomized to be transfused for a Hgb <8 g/dL or <10g/dL. With no demonstrable benefit of transfusing at a higher Hgb, and given the high costs and multiple risks of transfusion, adoption of the lower (8 g/dL) transfusion trigger in hip surgery patients seems logical. A small preliminary study was conducted at 9 BEST institutions. Each participating institution contributed data on a minimum of 10 consecutive patients who underwent total hip replacement surgery during 2010-11. Out of 186 patients, 63 (34%) were transfused postoperatively. 41/122 (34%) of the postoperative RBC units were transfused at a pretransfusion hemoglobin of > 8 g/dL, suggesting that a practice improvement opportunity exists.
Research Question In orthopedic surgeons performing adult elective hip surgery, does providing individual feedback data on transfusion practice in the context of the FOCUS trial data reduce postoperative RBC utilization compared with providing no feedback?
Primary Hypothesis Providing individual feedback on transfusion practice to orthopedic surgeons performing adult hip arthroplasty will reduce elective RBC transfusions in the postoperative period.
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
- •Patients >= 18 years old undergoing total hip arthroplasty or hip hemiarthroplasty
排除标准
- •Refusal of blood transfusions
- •Surgeons utilizing "fast track" protocols (planned discharge on postoperative day 1 or 2 following surgery.)
结局指标
主要结局
Proportion of patients transfused
时间窗: 12 months
Decrease from baseline in the proportion of patients transfused with pretransfusion hemoglobin of \> 8 g/dL.
次要结局
未报告次要终点
研究者
Kaufman, Richard Max,M.D.
Medical Director, Adult Transfusion Service
Brigham and Women's Hospital
