Trial of Feedback on Blood Use

NCT02232568 | Terminated

• 1 other identifier: 2013P001165
• Study Type: interventional
• Target: 426
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Compliance With Restrictive RBC Transfusion Guideline

Keywords

Patient blood management; RBC transfusion; Restrictive transfusion strategy

Outcome Measures

Primary Outcomes (1)

• Proportion of patients transfused

  Decrease from baseline in the proportion of patients transfused with pretransfusion hemoglobin of \> 8 g/dL.

  12 months

Study Arms (2)

Feedback Arm

EXPERIMENTAL

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.

Behavioral: Feedback

Control Arm

NO INTERVENTION

Orthopedic surgeons in the Control Arm will not receive any feedback on their use of RBC transfusion in hip surgery patients.

Interventions

Feedback BEHAVIORAL

Feedback Arm

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients \>= 18 years old undergoing total hip arthroplasty or hip hemiarthroplasty

You may not qualify if:

• Refusal of blood transfusions
• Surgeons utilizing "fast track" protocols (planned discharge on postoperative day 1 or 2 following surgery.)

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (5)

Richard Kaufman MD

Boston, Massachusetts, 02115, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Ronald Jackups MD, PhD

St Louis, Missouri, 63110, United States

Location

Temple University

Philadelphia, Pennsylvania, 19140, United States

Location

University of Washington

Seattle, Washington, 98195, United States

Location

Related Publications (1)

• Radford M, Estcourt LJ, Sirotich E, Pitre T, Britto J, Watson M, Brunskill SJ, Fergusson DA, Doree C, Arnold DM. Restrictive versus liberal red blood cell transfusion strategies for people with haematological malignancies treated with intensive chemotherapy or radiotherapy, or both, with or without haematopoietic stem cell support. Cochrane Database Syst Rev. 2024 May 23;5(5):CD011305. doi: 10.1002/14651858.CD011305.pub3.

  PMID: 38780066 DERIVED

Study Officials

• Richard M Kaufman, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director, Adult Transfusion Service

Study Record Dates

• First Submitted: September 3, 2014
• First Posted: September 5, 2014
• Study Start: September 1, 2014
• Primary Completion: February 1, 2017
• Study Completion: November 1, 2017
• Last Updated: May 18, 2020

Record last verified: 2020-05

Locations

US (5)