Clinical Trial Details
— Status: Terminated
Administrative data
| NCT number |
NCT02232568 |
| Other study ID # |
2013P001165 |
| Secondary ID |
|
| Status |
Terminated |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 1, 2014 |
| Est. completion date |
November 1, 2017 |
Study information
| Verified date |
May 2020 |
| Source |
Brigham and Women's Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
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.
Study Population:
The unit of study is orthopedic surgical attending physicians who perform hip arthroplasty.
There is no restriction by underlying causal orthopedic factors (e.g. arthritis or traumatic
fracture), or whether surgery is primary or secondary/revision.
Clinical Trial Design:
Study type: Two-arm, multicenter, cluster-randomized controlled clinical trial.
Subjects: Each cluster will be comprised of the set of orthopedic surgeons that perform hip
surgery at a single study site.
Procedures: Baseline blood use in hip arthroplasty cases will be assessed for each surgeon
for the 3-month period just prior to the start of the intervention phase. Baseline blood use
measurements on each surgeon will consist of:
1. Hip arthroplasty cases (n).
2. Total postoperative RBC units (n) transfused to hip surgery patients. (Here,
"postoperative" is defined as the interval beginning the day after surgery
("postoperative day 1") and ending when the patient is discharged from the hospital or
at postoperative day 14, whichever comes first.
3. Pretransfusion hemoglobin levels.
Baseline characteristics for each orthopedic center will also be collected:
Facility type (e.g. academic hospital, community hospital) Orthopedic surgeons performing hip
surgery (n) Annual number of hip surgery procedures (n)
Prior to randomization, the site PI will provide a brief educational presentation to the
orthopedic surgeons at each site. The presentation will consist of a standardized 10-minute
PowerPoint presentation reviewing the data from the FOCUS study and the recommended RBC
transfusion trigger of 8 g/dL (or symptomatic anemia) based on that data. The presentation
will also cover published data on hemoglobin levels and postoperative rehabilitation/quality
of life measures8. The surgeons will be advised that a study of blood use in hip surgery will
be commencing, and that they may be randomized to receive feedback about their individual
postoperative. Clusters of orthopedic surgeons will then be randomized to either the Control
arm (no feedback) or Intervention arm (monthly feedback).
The intervention phase will be conducted for 12 months. Surgeons randomized to the
Intervention arm will be given feedback at the end of each month. The feedback will be
provided in the form of a standardized email report sent by the site PI to each surgeon
individually. The monthly feedback report will show:
The number of hip surgery cases performed and postoperative RBCs transfused by each surgeon
for the month.
The percentage of postoperative RBCs transfused at a Hgb above or below 8 g/dL by each
surgeon for the previous month.
The percentage of postoperative RBCs transfused at a Hgb below 8 g/dL by each surgeon,
trended over time.
In the reports, surgeon names will be anonymized (e.g. Surgeon A, B, C etc.) However,
individual surgeons will be told which data is their own, so that they may compare themselves
with their peers. No blood utilization data will be reported to the Control arm surgeons.
Measurements: For data collection purposes, each attending orthopedic surgeon will be
assigned a letter code. Surgeon identity will be kept confidential within each site, and will
not be shared with other sites or the Data Coordinating Center.
Data collection: The following information will be collected for each patient:
Patient Study Number Age/Gender Surgical procedure (primary or reoperative hip replacement,
hip fracture) Surgeon study number Date of surgery Date of discharge Postoperative RBC
transfusions (number of units and date) Pretransfusion Hgb levels (g/dL) Hgb (g/dL) at
admission/discharge
Data will be collected using electronic CRFs completed by each site. If desired, sites may
first record data on an optional paper CRF, then upload the data electronically. The feedback
reports will be generated by a central data coordinating center. The feedback reports will be
emailed to each site PI monthly for subsequent email distribution to the local orthopedic
surgeons. Surgeon names and patient identifiers will be maintained locally at each site and
will not be shared with the data coordinating center or with other study sites. Read receipts
will be used for emailed reports to the surgeons; site PIs will track the number of feedback
reports read or not read each month by surgeon.
