<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/NCT03243708</url>
  </required_header>
  <id_info>
    <org_study_id>17-396</org_study_id>
    <nct_id>NCT03243708</nct_id>
  </id_info>
  <brief_title>Title: Randomized Trial of an EHR Embedded Risk Calculator vs. Standard VTE Prophylaxis for Medical Patients</brief_title>
  <official_title>Title: EHR Embedded Risk Calculator vs. Standard VTE Prophylaxis for Medical Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Cleveland Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Cleveland Clinic</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Venous thromboembolism (VTE) is a serious source of hospital morbidity and mortality.&#xD;
      Chemoprophylaxis with heparin has been shown to reduce the occurrence of VTE, but it&#xD;
      increases the risk of bleeding and it is uncomfortable to receive. For that reason, VTE&#xD;
      prophylaxis should be reserved for patients at moderate to high risk of VTE and low risk of&#xD;
      bleeding. However, identifying patients at low risk for VTE can be difficult, because most&#xD;
      patients have at least one risk factor for VTE and there are no validated risk prediction&#xD;
      tools for use in US hospitals. Instead, many hospitals have opted for a one-size-fits-all&#xD;
      approach with near-universal prophylaxis, putting many patients at unnecessary risk of&#xD;
      bleeding. However, to provide care that is truly patient-centered, US physicians face several&#xD;
      challenges. First, there is no accepted risk calculator that they can use to estimate an&#xD;
      individual patient's risk. Second, risk calculators are not readily available at the point of&#xD;
      care. As a result, prophylaxis rates have remained stubbornly low in some institutions, while&#xD;
      in others the rate of prophylaxis is high, but the rate of inappropriate prophylaxis is also&#xD;
      high. This study uses a risk prediction tool developed at the Cleveland Clinic to assess an&#xD;
      individual patient's risk of VTE. The tool is incorporated into the electronic health record&#xD;
      in the form of a smart order set. In this randomized trial, we will assess the effects of the&#xD;
      order set on physician behavior and patient outcomes . Examining the effectiveness of an&#xD;
      electronic decision aid embedded in an EHR in routine clinical practice will test whether a&#xD;
      smart order set can improve patient care by incorporating patient-specific factors into a&#xD;
      complex decision process.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Specific Aim:&#xD;
&#xD;
      Assess the effects of a VTE risk calculator embedded in the admission order set vs. usual&#xD;
      care on physician behavior and patient outcomes in a randomized trial&#xD;
&#xD;
      Research Strategy:&#xD;
&#xD;
      Utilizing a Step-Wedge design, this randomized controlled trial (RCT) will be conducted at 10&#xD;
      Cleveland Clinic hospitals in efforts to assess the effects of a VTE (venous thromboembolism)&#xD;
      risk calculator embedded in the admission order set vs. usual care on physician behavior and&#xD;
      patient outcomes. Hospitals will be randomized to display the risk calculator to physicians&#xD;
      admitting patients or to the usual order set that contains only a description of VTE risk&#xD;
      factors. The risk calculator will produce a predicted risk of VTE together with a&#xD;
      recommendation regarding the use of prophylaxis for an individual patient. Physicians will be&#xD;
      free to ignore the calculator or override its results if they so choose.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 4, 2017</start_date>
  <completion_date type="Actual">April 14, 2019</completion_date>
  <primary_completion_date type="Actual">April 14, 2019</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>Sequential Assignment</intervention_model>
    <intervention_model_description>Step-Wedge Randomized controlled trial (RCT)</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Appropriate VTE prophylaxis</measure>
    <time_frame>within 48 hours of index hospitalization admission</time_frame>
    <description>Proportion of patients at high risk of VTE who receive prophylaxis and the proportion of patients at low risk who do not receive prophylaxis</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Total patients receiving prophylaxis</measure>
    <time_frame>14 days</time_frame>
    <description>All patients who received any chemoprophylaxis during hospitalization, regardless of risk status.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of VTE among high risk patients</measure>
    <time_frame>14 days</time_frame>
    <description>Symptomatic VTE events not present on admission occurring among patients at high risk for VTE according to the risk calculator.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of VTE among high risk patients</measure>
    <time_frame>45 days</time_frame>
    <description>Symptomatic VTE events not present on admission occurring among patients at high risk for VTE according to the risk calculator.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of major bleeding among high risk patients</measure>
    <time_frame>14 days</time_frame>
    <description>Major bleeding events among patients with risk factors for bleeding.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Average cost of prophylaxis</measure>
    <time_frame>14 days</time_frame>
    <description>Total cost of prophylaxis received during hospitalization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Average cost of hospitalization</measure>
    <time_frame>Up to 30 days</time_frame>
    <description>Cost of hospitalization as determined by the hospital cost accounting system</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Average length of stay</measure>
    <time_frame>Up to 30 days</time_frame>
    <description>Total days in hospital</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">90537</enrollment>
  <condition>Venous Thromboembolism</condition>
  <arm_group>
    <arm_group_label>Usual Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Control: Standard order set without risk calculator (usual care)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Risk calculator</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Intervention: VTE risk calculator embedded in the smart order set incorporated into the EHR and activated for all medical patients</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Risk calculator</intervention_name>
    <description>Venous thromboembolism (VTE) risk calculator embedded in the admission order set with personalized recommendation for prophylaxis</description>
    <arm_group_label>Risk calculator</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All adult patients (age ≥18 years) admitted to a medical service, including intensive&#xD;
             care units, between September 1, 2017 and August 31, 2018 will be eligible.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients not eligible to receive VTE prophylaxis because they are already receiving&#xD;
             anticoagulation for another purpose (e.g. warfarin for atrial fibrillation or LMWH for&#xD;
             DVT or PE present on admission),&#xD;
&#xD;
          -  patients admitted with a terminal condition who are receiving comfort care only&#xD;
&#xD;
          -  Surgical patients who are admitted to the medical service temporarily (e.g. hip&#xD;
             fracture)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michael Rothberg</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Cleveland Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cleveland Clinic Health System</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44195</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Lederle FA, Zylla D, MacDonald R, Wilt TJ. Venous thromboembolism prophylaxis in hospitalized medical patients and those with stroke: a background review for an American College of Physicians Clinical Practice Guideline. Ann Intern Med. 2011 Nov 1;155(9):602-15. doi: 10.7326/0003-4819-155-9-201111010-00008.</citation>
    <PMID>22041949</PMID>
  </reference>
  <reference>
    <citation>Kakkar AK, Cimminiello C, Goldhaber SZ, Parakh R, Wang C, Bergmann JF; LIFENOX Investigators. Low-molecular-weight heparin and mortality in acutely ill medical patients. N Engl J Med. 2011 Dec 29;365(26):2463-72. doi: 10.1056/NEJMoa1111288.</citation>
    <PMID>22204723</PMID>
  </reference>
  <reference>
    <citation>Rothberg MB, Lahti M, Pekow PS, Lindenauer PK. Venous thromboembolism prophylaxis among medical patients at US hospitals. J Gen Intern Med. 2010 Jun;25(6):489-94. doi: 10.1007/s11606-010-1296-y. Epub 2010 Mar 30.</citation>
    <PMID>20352366</PMID>
  </reference>
  <reference>
    <citation>Cohen AT, Tapson VF, Bergmann JF, Goldhaber SZ, Kakkar AK, Deslandes B, Huang W, Zayaruzny M, Emery L, Anderson FA Jr; ENDORSE Investigators. Venous thromboembolism risk and prophylaxis in the acute hospital care setting (ENDORSE study): a multinational cross-sectional study. Lancet. 2008 Feb 2;371(9610):387-94. doi: 10.1016/S0140-6736(08)60202-0. Erratum In: Lancet. 2008 Jun 7;371(9628):1914.</citation>
    <PMID>18242412</PMID>
  </reference>
  <reference>
    <citation>Khanna R, Vittinghoff E, Maselli J, Auerbach A. Unintended consequences of a standard admission order set on venous thromboembolism prophylaxis and patient outcomes. J Gen Intern Med. 2012 Mar;27(3):318-24. doi: 10.1007/s11606-011-1871-x. Epub 2011 Sep 24.</citation>
    <PMID>21948203</PMID>
  </reference>
  <reference>
    <citation>Qaseem A, Chou R, Humphrey LL, Starkey M, Shekelle P; Clinical Guidelines Committee of the American College of Physicians. Venous thromboembolism prophylaxis in hospitalized patients: a clinical practice guideline from the American College of Physicians. Ann Intern Med. 2011 Nov 1;155(9):625-32. doi: 10.7326/0003-4819-155-9-201111010-00011.</citation>
    <PMID>22041951</PMID>
  </reference>
  <reference>
    <citation>Barbar S, Noventa F, Rossetto V, Ferrari A, Brandolin B, Perlati M, De Bon E, Tormene D, Pagnan A, Prandoni P. A risk assessment model for the identification of hospitalized medical patients at risk for venous thromboembolism: the Padua Prediction Score. J Thromb Haemost. 2010 Nov;8(11):2450-7. doi: 10.1111/j.1538-7836.2010.04044.x.</citation>
    <PMID>20738765</PMID>
  </reference>
  <reference>
    <citation>Kucher N, Koo S, Quiroz R, Cooper JM, Paterno MD, Soukonnikov B, Goldhaber SZ. Electronic alerts to prevent venous thromboembolism among hospitalized patients. N Engl J Med. 2005 Mar 10;352(10):969-77. doi: 10.1056/NEJMoa041533.</citation>
    <PMID>15758007</PMID>
  </reference>
  <reference>
    <citation>Dunn AS, Brenner A, Halm EA. The magnitude of an iatrogenic disorder: a systematic review of the incidence of venous thromboembolism for general medical inpatients. Thromb Haemost. 2006 May;95(5):758-62.</citation>
    <PMID>16676063</PMID>
  </reference>
  <reference>
    <citation>Bhalla R, Berger MA, Reissman SH, Yongue BG, Adelman JS, Jacobs LG, Billett H, Sinnett MJ, Kalkut G. Improving hospital venous thromboembolism prophylaxis with electronic decision support. J Hosp Med. 2013 Mar;8(3):115-20. doi: 10.1002/jhm.1993. Epub 2012 Nov 26.</citation>
    <PMID>23184857</PMID>
  </reference>
  <reference>
    <citation>Zeidan AM, Streiff MB, Lau BD, Ahmed SR, Kraus PS, Hobson DB, Carolan H, Lambrianidi C, Horn PB, Shermock KM, Tinoco G, Siddiqui S, Haut ER. Impact of a venous thromboembolism prophylaxis &quot;smart order set&quot;: Improved compliance, fewer events. Am J Hematol. 2013 Jul;88(7):545-9. doi: 10.1002/ajh.23450. Epub 2013 Jun 12.</citation>
    <PMID>23553743</PMID>
  </reference>
  <reference>
    <citation>Baio G, Copas A, Ambler G, Hargreaves J, Beard E, Omar RZ. Sample size calculation for a stepped wedge trial. Trials. 2015 Aug 17;16:354. doi: 10.1186/s13063-015-0840-9.</citation>
    <PMID>26282553</PMID>
  </reference>
  <reference>
    <citation>Shekelle PG, Wachter RM, Pronovost PJ, Schoelles K, McDonald KM, Dy SM, Shojania K, Reston J, Berger Z, Johnsen B, Larkin JW, Lucas S, Martinez K, Motala A, Newberry SJ, Noble M, Pfoh E, Ranji SR, Rennke S, Schmidt E, Shanman R, Sullivan N, Sun F, Tipton K, Treadwell JR, Tsou A, Vaiana ME, Weaver SJ, Wilson R, Winters BD. Making health care safer II: an updated critical analysis of the evidence for patient safety practices. Evid Rep Technol Assess (Full Rep). 2013 Mar;(211):1-945.</citation>
    <PMID>24423049</PMID>
  </reference>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>July 10, 2017</study_first_submitted>
  <study_first_submitted_qc>August 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 9, 2017</study_first_posted>
  <last_update_submitted>May 23, 2019</last_update_submitted>
  <last_update_submitted_qc>May 23, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 24, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The Cleveland Clinic</investigator_affiliation>
    <investigator_full_name>Michael Rothberg</investigator_full_name>
    <investigator_title>Staff Physician</investigator_title>
  </responsible_party>
  <keyword>Venous Thromboembolism Risk Calculator</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Thromboembolism</mesh_term>
    <mesh_term>Venous Thromboembolism</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03243708
org study id: 17-396
nct id: NCT03243708
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Venous thromboembolism (VTE) is a serious source of hospital morbidity and mortality.
      Chemoprophylaxis with heparin has been shown to reduce the occurrence of VTE, but it
      increases the risk of bleeding and it is uncomfortable to receive. For that reason, VTE
      prophylaxis should be reserved for patients at moderate to high risk of VTE and low risk of
      bleeding. However, identifying patients at low risk for VTE can be difficult, because most
      patients have at least one risk factor for VTE and there are no validated risk prediction
      tools for use in US hospitals. Instead, many hospitals have opted for a one-size-fits-all
      approach with near-universal prophylaxis, putting many patients at unnecessary risk of
      bleeding. However, to provide care that is truly patient-centered, US physicians face several
      challenges. First, there is no accepted risk calculator that they can use to estimate an
      individual patient's risk. Second, risk calculators are not readily available at the point of
      care. As a result, prophylaxis rates have remained stubbornly low in some institutions, while
      in others the rate of prophylaxis is high, but the rate of inappropriate prophylaxis is also
      high. This study uses a risk prediction tool developed at the Cleveland Clinic to assess an
      individual patient's risk of VTE. The tool is incorporated into the electronic health record
      in the form of a smart order set. In this randomized trial, we will assess the effects of the
      order set on physician behavior and patient outcomes . Examining the effectiveness of an
      electronic decision aid embedded in an EHR in routine clinical practice will test whether a
      smart order set can improve patient care by incorporating patient-specific factors into a
      complex decision process.
Specific Aim:

      Assess the effects of a VTE risk calculator embedded in the admission order set vs. usual
      care on physician behavior and patient outcomes in a randomized trial

      Research Strategy:

      Utilizing a Step-Wedge design, this randomized controlled trial (RCT) will be conducted at 10
      Cleveland Clinic hospitals in efforts to assess the effects of a VTE (venous thromboembolism)
      risk calculator embedded in the admission order set vs. usual care on physician behavior and
      patient outcomes. Hospitals will be randomized to display the risk calculator to physicians
      admitting patients or to the usual order set that contains only a description of VTE risk
      factors. The risk calculator will produce a predicted risk of VTE together with a
      recommendation regarding the use of prophylaxis for an individual patient. Physicians will be
      free to ignore the calculator or override its results if they so choose.
allocation: Randomized
intervention model: Sequential Assignment
intervention model description: Step-Wedge Randomized controlled trial (RCT)
primary purpose: Prevention
masking: None (Open Label)
measure: Appropriate VTE prophylaxis
time frame: within 48 hours of index hospitalization admission
description: Proportion of patients at high risk of VTE who receive prophylaxis and the proportion of patients at low risk who do not receive prophylaxis
measure: Total patients receiving prophylaxis
time frame: 14 days
description: All patients who received any chemoprophylaxis during hospitalization, regardless of risk status.
measure: Rate of VTE among high risk patients
time frame: 14 days
description: Symptomatic VTE events not present on admission occurring among patients at high risk for VTE according to the risk calculator.
measure: Rate of VTE among high risk patients
time frame: 45 days
description: Symptomatic VTE events not present on admission occurring among patients at high risk for VTE according to the risk calculator.
measure: Rate of major bleeding among high risk patients
time frame: 14 days
description: Major bleeding events among patients with risk factors for bleeding.
measure: Average cost of prophylaxis
time frame: 14 days
description: Total cost of prophylaxis received during hospitalization
measure: Average cost of hospitalization
time frame: Up to 30 days
description: Cost of hospitalization as determined by the hospital cost accounting system
measure: Average length of stay
time frame: Up to 30 days
description: Total days in hospital
arm group label: Usual Care
arm group type: No Intervention
description: Control: Standard order set without risk calculator (usual care)
arm group label: Risk calculator
arm group type: Active Comparator
description: Intervention: VTE risk calculator embedded in the smart order set incorporated into the EHR and activated for all medical patients
intervention type: Behavioral
intervention name: Risk calculator
description: Venous thromboembolism (VTE) risk calculator embedded in the admission order set with personalized recommendation for prophylaxis
arm group label: Risk calculator
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Michael Rothberg
role: Principal Investigator
affiliation: The Cleveland Clinic
facility: 
country: United States
citation: Lederle FA, Zylla D, MacDonald R, Wilt TJ. Venous thromboembolism prophylaxis in hospitalized medical patients and those with stroke: a background review for an American College of Physicians Clinical Practice Guideline. Ann Intern Med. 2011 Nov 1;155(9):602-15. doi: 10.7326/0003-4819-155-9-201111010-00008.
PMID: 22041949
citation: Kakkar AK, Cimminiello C, Goldhaber SZ, Parakh R, Wang C, Bergmann JF; LIFENOX Investigators. Low-molecular-weight heparin and mortality in acutely ill medical patients. N Engl J Med. 2011 Dec 29;365(26):2463-72. doi: 10.1056/NEJMoa1111288.
PMID: 22204723
citation: Rothberg MB, Lahti M, Pekow PS, Lindenauer PK. Venous thromboembolism prophylaxis among medical patients at US hospitals. J Gen Intern Med. 2010 Jun;25(6):489-94. doi: 10.1007/s11606-010-1296-y. Epub 2010 Mar 30.
PMID: 20352366
citation: Cohen AT, Tapson VF, Bergmann JF, Goldhaber SZ, Kakkar AK, Deslandes B, Huang W, Zayaruzny M, Emery L, Anderson FA Jr; ENDORSE Investigators. Venous thromboembolism risk and prophylaxis in the acute hospital care setting (ENDORSE study): a multinational cross-sectional study. Lancet. 2008 Feb 2;371(9610):387-94. doi: 10.1016/S0140-6736(08)60202-0. Erratum In: Lancet. 2008 Jun 7;371(9628):1914.
PMID: 18242412
citation: Khanna R, Vittinghoff E, Maselli J, Auerbach A. Unintended consequences of a standard admission order set on venous thromboembolism prophylaxis and patient outcomes. J Gen Intern Med. 2012 Mar;27(3):318-24. doi: 10.1007/s11606-011-1871-x. Epub 2011 Sep 24.
PMID: 21948203
citation: Qaseem A, Chou R, Humphrey LL, Starkey M, Shekelle P; Clinical Guidelines Committee of the American College of Physicians. Venous thromboembolism prophylaxis in hospitalized patients: a clinical practice guideline from the American College of Physicians. Ann Intern Med. 2011 Nov 1;155(9):625-32. doi: 10.7326/0003-4819-155-9-201111010-00011.
PMID: 22041951
citation: Barbar S, Noventa F, Rossetto V, Ferrari A, Brandolin B, Perlati M, De Bon E, Tormene D, Pagnan A, Prandoni P. A risk assessment model for the identification of hospitalized medical patients at risk for venous thromboembolism: the Padua Prediction Score. J Thromb Haemost. 2010 Nov;8(11):2450-7. doi: 10.1111/j.1538-7836.2010.04044.x.
PMID: 20738765
citation: Kucher N, Koo S, Quiroz R, Cooper JM, Paterno MD, Soukonnikov B, Goldhaber SZ. Electronic alerts to prevent venous thromboembolism among hospitalized patients. N Engl J Med. 2005 Mar 10;352(10):969-77. doi: 10.1056/NEJMoa041533.
PMID: 15758007
citation: Dunn AS, Brenner A, Halm EA. The magnitude of an iatrogenic disorder: a systematic review of the incidence of venous thromboembolism for general medical inpatients. Thromb Haemost. 2006 May;95(5):758-62.
PMID: 16676063
citation: Bhalla R, Berger MA, Reissman SH, Yongue BG, Adelman JS, Jacobs LG, Billett H, Sinnett MJ, Kalkut G. Improving hospital venous thromboembolism prophylaxis with electronic decision support. J Hosp Med. 2013 Mar;8(3):115-20. doi: 10.1002/jhm.1993. Epub 2012 Nov 26.
PMID: 23184857
citation: Zeidan AM, Streiff MB, Lau BD, Ahmed SR, Kraus PS, Hobson DB, Carolan H, Lambrianidi C, Horn PB, Shermock KM, Tinoco G, Siddiqui S, Haut ER. Impact of a venous thromboembolism prophylaxis "smart order set": Improved compliance, fewer events. Am J Hematol. 2013 Jul;88(7):545-9. doi: 10.1002/ajh.23450. Epub 2013 Jun 12.
PMID: 23553743
citation: Baio G, Copas A, Ambler G, Hargreaves J, Beard E, Omar RZ. Sample size calculation for a stepped wedge trial. Trials. 2015 Aug 17;16:354. doi: 10.1186/s13063-015-0840-9.
PMID: 26282553
citation: Shekelle PG, Wachter RM, Pronovost PJ, Schoelles K, McDonald KM, Dy SM, Shojania K, Reston J, Berger Z, Johnsen B, Larkin JW, Lucas S, Martinez K, Motala A, Newberry SJ, Noble M, Pfoh E, Ranji SR, Rennke S, Schmidt E, Shanman R, Sullivan N, Sun F, Tipton K, Treadwell JR, Tsou A, Vaiana ME, Weaver SJ, Wilson R, Winters BD. Making health care safer II: an updated critical analysis of the evidence for patient safety practices. Evid Rep Technol Assess (Full Rep). 2013 Mar;(211):1-945.
PMID: 24423049
responsible party type: Principal Investigator
investigator affiliation: The Cleveland Clinic
investigator full name: Michael Rothberg
investigator title: Staff Physician
mesh term: Thromboembolism
mesh term: Venous Thromboembolism
sharing ipd: No