Trial of Feedback on Blood Use (TOFU)
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|ClinicalTrials.gov Identifier: NCT02232568|
Recruitment Status : Terminated (Insufficient numbers of participating sites and hip surgery cases.)
First Posted : September 5, 2014
Last Update Posted : May 18, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Compliance With Restrictive RBC Transfusion Guideline||Behavioral: Feedback||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||426 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Trial of Feedback on Blood Use|
|Actual Study Start Date :||September 1, 2014|
|Actual Primary Completion Date :||February 1, 2017|
|Actual Study Completion Date :||November 1, 2017|
Experimental: Feedback Arm
Orthopedic surgeons in the Feedback Arm will receive monthly reports providing individualized data on compliance with the FOCUS trial RBC transfusion guideline (pretransfusion Hb <8 g/dL for hip surgery patients in the postoperative period.) Feedback data will be anonymized, but surgeons will be able to see their own data in comparison with their peers.
No Intervention: Control Arm
Orthopedic surgeons in the Control Arm will not receive any feedback on their use of RBC transfusion in hip surgery patients.
- Proportion of patients transfused [ Time Frame: 12 months ]Decrease from baseline in the proportion of patients transfused with pretransfusion hemoglobin of > 8 g/dL.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02232568
|United States, Massachusetts|
|Richard Kaufman MD|
|Boston, Massachusetts, United States, 02115|
|United States, Minnesota|
|University of Minnesota|
|Minneapolis, Minnesota, United States, 55455|
|United States, Missouri|
|Ronald Jackups MD, PhD|
|Saint Louis, Missouri, United States, 63110|
|United States, Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19140|
|United States, Washington|
|University of Washington|
|Seattle, Washington, United States, 98195|
|Principal Investigator:||Richard M Kaufman, MD||Brigham and Women's Hospital|