<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/NCT03008863</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00069462</org_study_id>
    <nct_id>NCT03008863</nct_id>
  </id_info>
  <brief_title>Educating Anesthesia Residents to Improve Perioperative Care for the Elderly</brief_title>
  <official_title>Educating Anesthesia Residents to Improve Perioperative Care for the Elderly</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Duke University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Duke University</source>
  <brief_summary>
    <textblock>
      1. The investigators will design, test and implement a education curriculum for anesthesia&#xD;
           residents teaching geriatric anesthesiology.&#xD;
&#xD;
        2. The investigators will randomize 42 anesthesia residents so that half receive an&#xD;
           innovative, e-learning curriculum while the other half receives the current standard&#xD;
           curriculum. We will assess their medical knowledge, and the amount of anesthesia&#xD;
           delivered to patients after the curriculum is implemented.&#xD;
&#xD;
        3. The investigators will analyze any changes in clinical practice of residents in the care&#xD;
           of elderly patients. Enrollment will be voluntary for all residents. Also, the&#xD;
           investigators will not interfere with clinical management of any patients by residents&#xD;
           which are done under direct supervision of faculty.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>December 2016</start_date>
  <completion_date type="Actual">June 30, 2017</completion_date>
  <primary_completion_date type="Actual">June 30, 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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>average minimum alveolar concentration (MAC) fraction in patients over age 65 given general anesthesia by residents</measure>
    <time_frame>6 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>change in residents' geriatric anesthesia knowledge base to be measured using a pre- and post-test</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>mean bispectral index value in patients over age 65 given monitored sedation by residents</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>frequency of use of medications known to increase delirium risk given to patients over age 65 by residents</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>mean doses of medications known to increase delirium risk given to patients over age 65 by residents</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Anesthesia</condition>
  <arm_group>
    <arm_group_label>Education Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The investigators will use an electronic learning (E-learning) curriculum with an educational video and a user-centered checklist for anesthesia residents. This E-learning curriculum will cover how to care for geriatric patients in the preoperative, intraoperative and postoperative settings, and specific interventions that have been shown to improve postoperative outcomes in older patients.&#xD;
The checklist will be user-centered. It will remind providers of what they learned in the video and online curriculum, and how to apply these lessons in real-time while they are caring for older patients.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Residents randomized to this group will receive the current, standard education provided for all Duke Anesthesiology residents.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Education</intervention_name>
    <arm_group_label>Education Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Duke Anesthesiology Resident&#xD;
&#xD;
          -  Willing to comply with study activities and guidelines&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unable to comply with study activities and guidelines&#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>
  <overall_official>
    <last_name>Miles Berger, MD, Phd</last_name>
    <role>Principal Investigator</role>
    <affiliation>Duke University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Duke University Medical Center</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 28, 2016</study_first_submitted>
  <study_first_submitted_qc>December 30, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 4, 2017</study_first_posted>
  <last_update_submitted>December 21, 2018</last_update_submitted>
  <last_update_submitted_qc>December 21, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 24, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </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/NCT03008863
org study id: Pro00069462
nct id: NCT03008863
lead sponsor: 
1. The investigators will design, test and implement a education curriculum for anesthesia
           residents teaching geriatric anesthesiology.

        2. The investigators will randomize 42 anesthesia residents so that half receive an
           innovative, e-learning curriculum while the other half receives the current standard
           curriculum. We will assess their medical knowledge, and the amount of anesthesia
           delivered to patients after the curriculum is implemented.

        3. The investigators will analyze any changes in clinical practice of residents in the care
           of elderly patients. Enrollment will be voluntary for all residents. Also, the
           investigators will not interfere with clinical management of any patients by residents
           which are done under direct supervision of faculty.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: average minimum alveolar concentration (MAC) fraction in patients over age 65 given general anesthesia by residents
time frame: 6 months
measure: change in residents' geriatric anesthesia knowledge base to be measured using a pre- and post-test
time frame: 6 months
measure: mean bispectral index value in patients over age 65 given monitored sedation by residents
time frame: 6 months
measure: frequency of use of medications known to increase delirium risk given to patients over age 65 by residents
time frame: 6 months
measure: mean doses of medications known to increase delirium risk given to patients over age 65 by residents
time frame: 6 months
arm group label: Education Intervention
arm group type: Experimental
description: The investigators will use an electronic learning (E-learning) curriculum with an educational video and a user-centered checklist for anesthesia residents. This E-learning curriculum will cover how to care for geriatric patients in the preoperative, intraoperative and postoperative settings, and specific interventions that have been shown to improve postoperative outcomes in older patients.
The checklist will be user-centered. It will remind providers of what they learned in the video and online curriculum, and how to apply these lessons in real-time while they are caring for older patients.
arm group label: Control
arm group type: No Intervention
description: Residents randomized to this group will receive the current, standard education provided for all Duke Anesthesiology residents.
intervention type: Other
intervention name: Education
arm group label: Education Intervention
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Miles Berger, MD, Phd
role: Principal Investigator
affiliation: Duke University
facility: 
country: United States
responsible party type: Sponsor