<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02232568</url>
  </required_header>
  <id_info>
    <org_study_id>2013P001165</org_study_id>
    <nct_id>NCT02232568</nct_id>
  </id_info>
  <brief_title>Trial of Feedback on Blood Use</brief_title>
  <acronym>TOFU</acronym>
  <official_title>Trial of Feedback on Blood Use</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Brigham and Women's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Brigham and Women's Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Trial of Feedback on Blood Use (TOFU)&#xD;
&#xD;
      The TOFU study will represent the first attempt to rigorously assess the impact of&#xD;
      audit-feedback on changing transfusion practice. The primary hypothesis is that providing&#xD;
      individual feedback on transfusion practice to orthopedic surgeons will reduce elective RBC&#xD;
      transfusions in the postoperative period.&#xD;
&#xD;
      TOFU is a two-arm, cluster-randomized controlled trial. Initially, baseline blood use data&#xD;
      will be collected at all study sites. Next, the PI at each site will give a short educational&#xD;
      presentation to the orthopedic surgeons. The presentation will consist of a standardized&#xD;
      10-minute presentation reviewing the data from the FOCUS trial and the recommended red blood&#xD;
      cell (RBC) transfusion trigger of 8 g/dL (or symptomatic anemia) based on that data. Clusters&#xD;
      of orthopedic surgeons will then be randomized to either the Control arm (no feedback) or the&#xD;
      Intervention arm (monthly feedback). All of the surgeons at a given site will either receive&#xD;
      or not receive feedback. The feedback will take the form of emailed monthly reports detailing&#xD;
      blood use by each surgeon post-hip surgery. Surgeons will be anonymized in the reports as &quot;A,&#xD;
      B, C . . .&quot; but each surgeon will know which data are his own. The primary end point is the&#xD;
      decrease from baseline in the proportion of patients transfused with a pretransfusion&#xD;
      hemoglobin of &gt; 8 g/dL.&#xD;
&#xD;
      TOFU will be conducted at 8 sites in Europe and North and South America. Care has been taken&#xD;
      to minimize the labor and costs required to conduct this study. The only data collected will&#xD;
      be: patient age/gender; procedure; surgeon (anonymized); surgery &amp; discharge dates; RBC units&#xD;
      transfused; Hgb levels. The data will be entered at each site into a web-based Case Report&#xD;
      Form, and will be stored centrally by the Data Coordinating Center (DCC). The DCC will&#xD;
      generate monthly feedback reports and email them to each Intervention arm site PI. The site&#xD;
      PI will then email the reports to each local orthopedic surgeon.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Trial of Feedback on Blood Use (TOFU)&#xD;
&#xD;
      Background &amp; Rationale Many studies have demonstrated substantial variability in blood use&#xD;
      among both physicians and hospitals, suggesting the need to standardize transfusion practices&#xD;
      and reduce unnecessary transfusions.To that end, national regulatory agencies in many&#xD;
      countries require that hospitals monitor local blood use. However, the utility of this&#xD;
      monitoring is unclear. A small number of prospective studies aimed at improving physician&#xD;
      transfusion behavior have been published, but well-supported, generalizable findings are&#xD;
      currently lacking. The proposed study will test the hypothesis that providing feedback of&#xD;
      individual blood use data to transfusing physicians will reduce unnecessary RBC transfusions.&#xD;
      A limited number of studies conducted in a range of settings have examined whether audit and&#xD;
      feedback can improve physician practice and clinical outcomes. Results have been mixed. The&#xD;
      proposed study would represent the first attempt to rigorously assess the impact of&#xD;
      audit/feedback on changing transfusion practice.&#xD;
&#xD;
      The recently completed FOCUS trial presents a unique opportunity in that it provides&#xD;
      high-quality data on which to base transfusion practice recommendations for a specific&#xD;
      patient population. In the FOCUS trial, 2016 adult patients with a history of or risk factors&#xD;
      for cardiovascular disease undergoing surgical hip fracture repair were randomized to be&#xD;
      transfused with RBCs for a Hgb &lt;10 g/dL (liberal group) or for symptoms of anemia and/or a&#xD;
      Hgb &lt;8 g/dL (restrictive group). The primary end point was the ability to ambulate&#xD;
      independently at 60 days, and key secondary endpoints included 30-day and long-term&#xD;
      mortality, myocardial infarction, and stroke. No significant difference was observed in any&#xD;
      end point, demonstrating that -- as in the earlier TRICC trial -- a restrictive strategy was&#xD;
      as safe as a liberal transfusion strategy. An earlier multicenter RCT similarly showed no&#xD;
      difference in the rate of silent myocardial ischemia among 260 knee and hip surgery patients&#xD;
      randomized to be transfused for a Hgb &lt;8 g/dL or &lt;10g/dL. With no demonstrable benefit of&#xD;
      transfusing at a higher Hgb, and given the high costs and multiple risks of transfusion,&#xD;
      adoption of the lower (8 g/dL) transfusion trigger in hip surgery patients seems logical. A&#xD;
      small preliminary study was conducted at 9 BEST institutions. Each participating institution&#xD;
      contributed data on a minimum of 10 consecutive patients who underwent total hip replacement&#xD;
      surgery during 2010-11. Out of 186 patients, 63 (34%) were transfused postoperatively. 41/122&#xD;
      (34%) of the postoperative RBC units were transfused at a pretransfusion hemoglobin of &gt; 8&#xD;
      g/dL, suggesting that a practice improvement opportunity exists.&#xD;
&#xD;
      Research Question In orthopedic surgeons performing adult elective hip surgery, does&#xD;
      providing individual feedback data on transfusion practice in the context of the FOCUS trial&#xD;
      data reduce postoperative RBC utilization compared with providing no feedback?&#xD;
&#xD;
      Primary Hypothesis Providing individual feedback on transfusion practice to orthopedic&#xD;
      surgeons performing adult hip arthroplasty will reduce elective RBC transfusions in the&#xD;
      postoperative period.&#xD;
&#xD;
      Study Population:&#xD;
&#xD;
      The unit of study is orthopedic surgical attending physicians who perform hip arthroplasty.&#xD;
&#xD;
      There is no restriction by underlying causal orthopedic factors (e.g. arthritis or traumatic&#xD;
      fracture), or whether surgery is primary or secondary/revision.&#xD;
&#xD;
      Clinical Trial Design:&#xD;
&#xD;
      Study type: Two-arm, multicenter, cluster-randomized controlled clinical trial.&#xD;
&#xD;
      Subjects: Each cluster will be comprised of the set of orthopedic surgeons that perform hip&#xD;
      surgery at a single study site.&#xD;
&#xD;
      Procedures: Baseline blood use in hip arthroplasty cases will be assessed for each surgeon&#xD;
      for the 3-month period just prior to the start of the intervention phase. Baseline blood use&#xD;
      measurements on each surgeon will consist of:&#xD;
&#xD;
        1. Hip arthroplasty cases (n).&#xD;
&#xD;
        2. Total postoperative RBC units (n) transfused to hip surgery patients. (Here,&#xD;
           &quot;postoperative&quot; is defined as the interval beginning the day after surgery&#xD;
           (&quot;postoperative day 1&quot;) and ending when the patient is discharged from the hospital or&#xD;
           at postoperative day 14, whichever comes first.&#xD;
&#xD;
        3. Pretransfusion hemoglobin levels.&#xD;
&#xD;
      Baseline characteristics for each orthopedic center will also be collected:&#xD;
&#xD;
      Facility type (e.g. academic hospital, community hospital) Orthopedic surgeons performing hip&#xD;
      surgery (n) Annual number of hip surgery procedures (n)&#xD;
&#xD;
      Prior to randomization, the site PI will provide a brief educational presentation to the&#xD;
      orthopedic surgeons at each site. The presentation will consist of a standardized 10-minute&#xD;
      PowerPoint presentation reviewing the data from the FOCUS study and the recommended RBC&#xD;
      transfusion trigger of 8 g/dL (or symptomatic anemia) based on that data. The presentation&#xD;
      will also cover published data on hemoglobin levels and postoperative rehabilitation/quality&#xD;
      of life measures8. The surgeons will be advised that a study of blood use in hip surgery will&#xD;
      be commencing, and that they may be randomized to receive feedback about their individual&#xD;
      postoperative. Clusters of orthopedic surgeons will then be randomized to either the Control&#xD;
      arm (no feedback) or Intervention arm (monthly feedback).&#xD;
&#xD;
      The intervention phase will be conducted for 12 months. Surgeons randomized to the&#xD;
      Intervention arm will be given feedback at the end of each month. The feedback will be&#xD;
      provided in the form of a standardized email report sent by the site PI to each surgeon&#xD;
      individually. The monthly feedback report will show:&#xD;
&#xD;
      The number of hip surgery cases performed and postoperative RBCs transfused by each surgeon&#xD;
      for the month.&#xD;
&#xD;
      The percentage of postoperative RBCs transfused at a Hgb above or below 8 g/dL by each&#xD;
      surgeon for the previous month.&#xD;
&#xD;
      The percentage of postoperative RBCs transfused at a Hgb below 8 g/dL by each surgeon,&#xD;
      trended over time.&#xD;
&#xD;
      In the reports, surgeon names will be anonymized (e.g. Surgeon A, B, C etc.) However,&#xD;
      individual surgeons will be told which data is their own, so that they may compare themselves&#xD;
      with their peers. No blood utilization data will be reported to the Control arm surgeons.&#xD;
&#xD;
      Measurements: For data collection purposes, each attending orthopedic surgeon will be&#xD;
      assigned a letter code. Surgeon identity will be kept confidential within each site, and will&#xD;
      not be shared with other sites or the Data Coordinating Center.&#xD;
&#xD;
      Data collection: The following information will be collected for each patient:&#xD;
&#xD;
      Patient Study Number Age/Gender Surgical procedure (primary or reoperative hip replacement,&#xD;
      hip fracture) Surgeon study number Date of surgery Date of discharge Postoperative RBC&#xD;
      transfusions (number of units and date) Pretransfusion Hgb levels (g/dL) Hgb (g/dL) at&#xD;
      admission/discharge&#xD;
&#xD;
      Data will be collected using electronic CRFs completed by each site. If desired, sites may&#xD;
      first record data on an optional paper CRF, then upload the data electronically. The feedback&#xD;
      reports will be generated by a central data coordinating center. The feedback reports will be&#xD;
      emailed to each site PI monthly for subsequent email distribution to the local orthopedic&#xD;
      surgeons. Surgeon names and patient identifiers will be maintained locally at each site and&#xD;
      will not be shared with the data coordinating center or with other study sites. Read receipts&#xD;
      will be used for emailed reports to the surgeons; site PIs will track the number of feedback&#xD;
      reports read or not read each month by surgeon.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Insufficient numbers of participating sites and hip surgery cases.&#xD;
  </why_stopped>
  <start_date type="Actual">September 1, 2014</start_date>
  <completion_date type="Actual">November 1, 2017</completion_date>
  <primary_completion_date type="Actual">February 1, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of patients transfused</measure>
    <time_frame>12 months</time_frame>
    <description>Decrease from baseline in the proportion of patients transfused with pretransfusion hemoglobin of &gt; 8 g/dL.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">426</enrollment>
  <condition>Compliance With Restrictive RBC Transfusion Guideline</condition>
  <arm_group>
    <arm_group_label>Feedback Arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Orthopedic surgeons in the Feedback Arm will receive monthly reports providing individualized data on compliance with the FOCUS trial RBC transfusion guideline (pretransfusion Hb &lt;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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Arm</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Orthopedic surgeons in the Control Arm will not receive any feedback on their use of RBC transfusion in hip surgery patients.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Feedback</intervention_name>
    <arm_group_label>Feedback Arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients &gt;= 18 years old undergoing total hip arthroplasty or hip hemiarthroplasty&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Refusal of blood transfusions&#xD;
&#xD;
          -  Surgeons utilizing &quot;fast track&quot; protocols (planned discharge on postoperative day 1 or&#xD;
             2 following surgery.)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Richard M Kaufman, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Brigham and Women's Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Richard Kaufman MD</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Minnesota</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55455</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ronald Jackups MD, PhD</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Temple University</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19140</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Washington</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98195</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Brazil</country>
  </removed_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>September 3, 2014</study_first_submitted>
  <study_first_submitted_qc>September 3, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 5, 2014</study_first_posted>
  <last_update_submitted>May 14, 2020</last_update_submitted>
  <last_update_submitted_qc>May 14, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 18, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Brigham and Women's Hospital</investigator_affiliation>
    <investigator_full_name>Kaufman, Richard Max,M.D.</investigator_full_name>
    <investigator_title>Medical Director, Adult Transfusion Service</investigator_title>
  </responsible_party>
  <keyword>Patient blood management</keyword>
  <keyword>RBC transfusion</keyword>
  <keyword>Restrictive transfusion strategy</keyword>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02232568
org study id: 2013P001165
nct id: NCT02232568
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Proportion of patients transfused
time frame: 12 months
description: Decrease from baseline in the proportion of patients transfused with pretransfusion hemoglobin of > 8 g/dL.
arm group label: Feedback Arm
arm group type: Experimental
description: 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.
arm group label: Control Arm
arm group type: No Intervention
description: Orthopedic surgeons in the Control Arm will not receive any feedback on their use of RBC transfusion in hip surgery patients.
intervention type: Behavioral
intervention name: Feedback
arm group label: Feedback Arm
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Richard M Kaufman, MD
role: Principal Investigator
affiliation: Brigham and Women's Hospital
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: Brigham and Women's Hospital
investigator full name: Kaufman, Richard Max,M.D.
investigator title: Medical Director, Adult Transfusion Service