<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/NCT02217241</url>
  </required_header>
  <id_info>
    <org_study_id>101125</org_study_id>
    <nct_id>NCT02217241</nct_id>
  </id_info>
  <brief_title>Effect of Hand-off Skills Training for Students During the Medicine Clerkship</brief_title>
  <official_title>Effect of Hand-off Skills Training for Students During the Medicine Clerkship: A Randomized Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>George Washington University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>George Washington University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to assess the effectiveness of an educational intervention on&#xD;
      handoffs implemented during the third year of medical school. It also assesses whether these&#xD;
      skills are maintained over time into their fourth year of training and whether there is&#xD;
      transfer from the simulated setting into the clinical environment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2012</start_date>
  <primary_completion_date type="Actual">March 2013</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>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Evaluate workshop effectiveness of students undergoing the intervention, rated before and after the workshop utilizing standardized cases and a validated Handoff Rating Scale.</measure>
    <time_frame>up to 45 minutes post-intervention</time_frame>
  </primary_outcome>
  <other_outcome>
    <measure>Assess durability of the training by rating intervention and control group students on a third standardized case during their fourth year AI on internal medicine.</measure>
    <time_frame>up to 12 months after intervention</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Assess the transfer of handoff skills into the clinical setting by observing AI students in both the intervention and control groups providing real-time handoffs.</measure>
    <time_frame>Up to 12 months after the intervention</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">95</enrollment>
  <condition>Patient Handoff</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Students in the intervention group participated in a one-hour interactive, small-group handoff workshop facilitated by a study investigator. The workshop focused on the importance of specific handoff skills to patient safety.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Handoff Workshop</intervention_name>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Third Year Medicine Clerks&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  None&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>The George Washington University School of Medicine; The George Washington University Hospital</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20037</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Vidyarthi AR, Arora V, Schnipper JL, Wall SD, Wachter RM. Managing discontinuity in academic medical centers: strategies for a safe and effective resident sign-out. J Hosp Med. 2006 Jul;1(4):257-66. doi: 10.1002/jhm.103.</citation>
    <PMID>17219508</PMID>
  </reference>
  <reference>
    <citation>Laine C, Goldman L, Soukup JR, Hayes JG. The impact of a regulation restricting medical house staff working hours on the quality of patient care. JAMA. 1993 Jan 20;269(3):374-8.</citation>
    <PMID>8418344</PMID>
  </reference>
  <reference>
    <citation>Lofgren RP, Gottlieb D, Williams RA, Rich EC. Post-call transfer of resident responsibility: its effect on patient care. J Gen Intern Med. 1990 Nov-Dec;5(6):501-5. doi: 10.1007/BF02600880.</citation>
    <PMID>2266432</PMID>
  </reference>
  <reference>
    <citation>Horwitz LI, Krumholz HM, Green ML, Huot SJ. Transfers of patient care between house staff on internal medicine wards: a national survey. Arch Intern Med. 2006 Jun 12;166(11):1173-7. doi: 10.1001/archinte.166.11.1173.</citation>
    <PMID>16772243</PMID>
  </reference>
  <reference>
    <citation>Arora VM, Eastment MC, Bethea ED, Farnan JM, Friedman ES. Participation and experience of third-year medical students in handoffs: time to sign out? J Gen Intern Med. 2013 Aug;28(8):994-8. doi: 10.1007/s11606-012-2297-9.</citation>
    <PMID>23595921</PMID>
  </reference>
  <reference>
    <citation>Gordon M, Findley R. Educational interventions to improve handover in health care: a systematic review. Med Educ. 2011 Nov;45(11):1081-9. doi: 10.1111/j.1365-2923.2011.04049.x. Epub 2011 Sep 20.</citation>
    <PMID>21933243</PMID>
  </reference>
  <reference>
    <citation>Farnan JM, Paro JA, Rodriguez RM, Reddy ST, Horwitz LI, Johnson JK, Arora VM. Hand-off education and evaluation: piloting the observed simulated hand-off experience (OSHE). J Gen Intern Med. 2010 Feb;25(2):129-34. doi: 10.1007/s11606-009-1170-y.</citation>
    <PMID>19924489</PMID>
  </reference>
  <reference>
    <citation>Horwitz LI, Moin T, Green ML. Development and implementation of an oral sign-out skills curriculum. J Gen Intern Med. 2007 Oct;22(10):1470-4. doi: 10.1007/s11606-007-0331-0. Epub 2007 Aug 3.</citation>
    <PMID>17674110</PMID>
  </reference>
  <reference>
    <citation>Chu ES, Reid M, Schulz T, Burden M, Mancini D, Ambardekar AV, Keniston A, Albert RK. A structured handoff program for interns. Acad Med. 2009 Mar;84(3):347-52. doi: 10.1097/ACM.0b013e3181970829.</citation>
    <PMID>19240442</PMID>
  </reference>
  <reference>
    <citation>Gakhar B, Spencer AL. Using direct observation, formal evaluation, and an interactive curriculum to improve the sign-out practices of internal medicine interns. Acad Med. 2010 Jul;85(7):1182-8. doi: 10.1097/ACM.0b013e3181da8370.</citation>
    <PMID>20375830</PMID>
  </reference>
  <reference>
    <citation>Klamen DL, Reynolds KL, Yale B, Aiello M. Students learning handovers in a simulated in-patient unit. Med Educ. 2009 Nov;43(11):1097-8. doi: 10.1111/j.1365-2923.2009.03488.x. Epub 2009 Oct 3. No abstract available.</citation>
    <PMID>19799733</PMID>
  </reference>
  <reference>
    <citation>Darbyshire D, Gordon M, Baker P. Teaching handover of care to medical students. Clin Teach. 2013 Feb;10(1):32-7. doi: 10.1111/j.1743-498X.2012.00610.x.</citation>
    <PMID>23294741</PMID>
  </reference>
  <reference>
    <citation>Chu ES, Reid M, Burden M, Mancini D, Schulz T, Keniston A, Sarcone E, Albert RK. Effectiveness of a course designed to teach handoffs to medical students. J Hosp Med. 2010 Jul-Aug;5(6):344-8. doi: 10.1002/jhm.633.</citation>
    <PMID>20803673</PMID>
  </reference>
  <reference>
    <citation>Starmer AJ, Sectish TC, Simon DW, Keohane C, McSweeney ME, Chung EY, Yoon CS, Lipsitz SR, Wassner AJ, Harper MB, Landrigan CP. Rates of medical errors and preventable adverse events among hospitalized children following implementation of a resident handoff bundle. JAMA. 2013 Dec 4;310(21):2262-70. doi: 10.1001/jama.2013.281961.</citation>
    <PMID>24302089</PMID>
  </reference>
  <reference>
    <citation>Curtis JR, Back AL, Ford DW, Downey L, Shannon SE, Doorenbos AZ, Kross EK, Reinke LF, Feemster LC, Edlund B, Arnold RW, O'Connor K, Engelberg RA. Effect of communication skills training for residents and nurse practitioners on quality of communication with patients with serious illness: a randomized trial. JAMA. 2013 Dec 4;310(21):2271-81. doi: 10.1001/jama.2013.282081. Erratum In: JAMA. 2014 Apr 2;311(13):1360.</citation>
    <PMID>24302090</PMID>
  </reference>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 12, 2014</study_first_submitted>
  <study_first_submitted_qc>August 13, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 15, 2014</study_first_posted>
  <last_update_submitted>August 13, 2014</last_update_submitted>
  <last_update_submitted_qc>August 13, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 15, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>George Washington University</investigator_affiliation>
    <investigator_full_name>Juan Reyes</investigator_full_name>
    <investigator_title>Assistant Professor of Medicine</investigator_title>
  </responsible_party>
  <!-- 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/NCT02217241
org study id: 101125
nct id: NCT02217241
lead sponsor: 
has dmc: No
The purpose of this study is to assess the effectiveness of an educational intervention on
      handoffs implemented during the third year of medical school. It also assesses whether these
      skills are maintained over time into their fourth year of training and whether there is
      transfer from the simulated setting into the clinical environment.
allocation: Randomized
intervention model: Parallel Assignment
masking: Single (Outcomes Assessor)
measure: Evaluate workshop effectiveness of students undergoing the intervention, rated before and after the workshop utilizing standardized cases and a validated Handoff Rating Scale.
time frame: up to 45 minutes post-intervention
measure: Assess durability of the training by rating intervention and control group students on a third standardized case during their fourth year AI on internal medicine.
time frame: up to 12 months after intervention
measure: Assess the transfer of handoff skills into the clinical setting by observing AI students in both the intervention and control groups providing real-time handoffs.
time frame: Up to 12 months after the intervention
arm group label: Intervention
arm group type: Experimental
description: Students in the intervention group participated in a one-hour interactive, small-group handoff workshop facilitated by a study investigator. The workshop focused on the importance of specific handoff skills to patient safety.
arm group label: Control
arm group type: No Intervention
intervention type: Other
intervention name: Handoff Workshop
arm group label: Intervention
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
citation: Vidyarthi AR, Arora V, Schnipper JL, Wall SD, Wachter RM. Managing discontinuity in academic medical centers: strategies for a safe and effective resident sign-out. J Hosp Med. 2006 Jul;1(4):257-66. doi: 10.1002/jhm.103.
PMID: 17219508
citation: Laine C, Goldman L, Soukup JR, Hayes JG. The impact of a regulation restricting medical house staff working hours on the quality of patient care. JAMA. 1993 Jan 20;269(3):374-8.
PMID: 8418344
citation: Lofgren RP, Gottlieb D, Williams RA, Rich EC. Post-call transfer of resident responsibility: its effect on patient care. J Gen Intern Med. 1990 Nov-Dec;5(6):501-5. doi: 10.1007/BF02600880.
PMID: 2266432
citation: Horwitz LI, Krumholz HM, Green ML, Huot SJ. Transfers of patient care between house staff on internal medicine wards: a national survey. Arch Intern Med. 2006 Jun 12;166(11):1173-7. doi: 10.1001/archinte.166.11.1173.
PMID: 16772243
citation: Arora VM, Eastment MC, Bethea ED, Farnan JM, Friedman ES. Participation and experience of third-year medical students in handoffs: time to sign out? J Gen Intern Med. 2013 Aug;28(8):994-8. doi: 10.1007/s11606-012-2297-9.
PMID: 23595921
citation: Gordon M, Findley R. Educational interventions to improve handover in health care: a systematic review. Med Educ. 2011 Nov;45(11):1081-9. doi: 10.1111/j.1365-2923.2011.04049.x. Epub 2011 Sep 20.
PMID: 21933243
citation: Farnan JM, Paro JA, Rodriguez RM, Reddy ST, Horwitz LI, Johnson JK, Arora VM. Hand-off education and evaluation: piloting the observed simulated hand-off experience (OSHE). J Gen Intern Med. 2010 Feb;25(2):129-34. doi: 10.1007/s11606-009-1170-y.
PMID: 19924489
citation: Horwitz LI, Moin T, Green ML. Development and implementation of an oral sign-out skills curriculum. J Gen Intern Med. 2007 Oct;22(10):1470-4. doi: 10.1007/s11606-007-0331-0. Epub 2007 Aug 3.
PMID: 17674110
citation: Chu ES, Reid M, Schulz T, Burden M, Mancini D, Ambardekar AV, Keniston A, Albert RK. A structured handoff program for interns. Acad Med. 2009 Mar;84(3):347-52. doi: 10.1097/ACM.0b013e3181970829.
PMID: 19240442
citation: Gakhar B, Spencer AL. Using direct observation, formal evaluation, and an interactive curriculum to improve the sign-out practices of internal medicine interns. Acad Med. 2010 Jul;85(7):1182-8. doi: 10.1097/ACM.0b013e3181da8370.
PMID: 20375830
citation: Klamen DL, Reynolds KL, Yale B, Aiello M. Students learning handovers in a simulated in-patient unit. Med Educ. 2009 Nov;43(11):1097-8. doi: 10.1111/j.1365-2923.2009.03488.x. Epub 2009 Oct 3. No abstract available.
PMID: 19799733
citation: Darbyshire D, Gordon M, Baker P. Teaching handover of care to medical students. Clin Teach. 2013 Feb;10(1):32-7. doi: 10.1111/j.1743-498X.2012.00610.x.
PMID: 23294741
citation: Chu ES, Reid M, Burden M, Mancini D, Schulz T, Keniston A, Sarcone E, Albert RK. Effectiveness of a course designed to teach handoffs to medical students. J Hosp Med. 2010 Jul-Aug;5(6):344-8. doi: 10.1002/jhm.633.
PMID: 20803673
citation: Starmer AJ, Sectish TC, Simon DW, Keohane C, McSweeney ME, Chung EY, Yoon CS, Lipsitz SR, Wassner AJ, Harper MB, Landrigan CP. Rates of medical errors and preventable adverse events among hospitalized children following implementation of a resident handoff bundle. JAMA. 2013 Dec 4;310(21):2262-70. doi: 10.1001/jama.2013.281961.
PMID: 24302089
citation: Curtis JR, Back AL, Ford DW, Downey L, Shannon SE, Doorenbos AZ, Kross EK, Reinke LF, Feemster LC, Edlund B, Arnold RW, O'Connor K, Engelberg RA. Effect of communication skills training for residents and nurse practitioners on quality of communication with patients with serious illness: a randomized trial. JAMA. 2013 Dec 4;310(21):2271-81. doi: 10.1001/jama.2013.282081. Erratum In: JAMA. 2014 Apr 2;311(13):1360.
PMID: 24302090
responsible party type: Principal Investigator
investigator affiliation: George Washington University
investigator full name: Juan Reyes
investigator title: Assistant Professor of Medicine