<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/NCT02233153</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00047180</org_study_id>
    <nct_id>NCT02233153</nct_id>
  </id_info>
  <brief_title>Elder-friendly Approaches to the Surgical Environment (EASE) Study</brief_title>
  <acronym>EASE</acronym>
  <official_title>Elder-friendly Approaches to the Surgical Environment - Implementation of an Elder Friendly Surgical Unit</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Alberta</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Alberta Innovates Health Solutions</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Alberta</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>
      The aim of this study is to examine the impact implementing an elder-friendly surgical unit&#xD;
      has on post-operative complications, mortality and quality of life for patients ≥ 65 years&#xD;
      old who have undergone emergency surgical care.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators hypothesize that the elder-friendly surgical unit will reduce in-hospital&#xD;
      complications and mortality in a cost-effective manner, for this at risk population.&#xD;
&#xD;
      Specific elder-friendly interventions include:&#xD;
&#xD;
        1. Locate all elderly surgical patients on one nursing unit&#xD;
&#xD;
        2. Interdisciplinary team-based care&#xD;
&#xD;
        3. Elder-friendly evidence-informed practices including: comfort rounds with early&#xD;
           mobilization, delirium prevention/management, optimal nutrition and prevention of&#xD;
           post-operative complications&#xD;
&#xD;
        4. Early and interdisciplinary discharge management&#xD;
&#xD;
      This is a prospective, before-after study with a concurrent control group. Four senior&#xD;
      patient groups will be followed:&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 2014</start_date>
  <completion_date type="Actual">December 2017</completion_date>
  <primary_completion_date type="Actual">May 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Post-Operative complications</measure>
    <time_frame>During initial in-hospital stay (0-12 weeks on average)</time_frame>
    <description>Includes a) intensive care unit admission (includes respiratory failure, cardiac arrest or septic shock), b) vascular complications (myocardial infarction, stroke, deep venous thrombosis, pulmonary embolism), c) serious infections (pneumonia, intra-abdominal abscess, urinary tract infection, deep wound infection or infected decubitus ulcer) or d) protracted delirium (≥48 hours)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Death</measure>
    <time_frame>During initial in-hospital stay (0-12 weeks on average)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Post-discharge complications or health-events requiring re-admission</measure>
    <time_frame>Within 30 days post-discharge</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cost per quality-adjusted life year</measure>
    <time_frame>6 months post-discharge</time_frame>
    <description>Both direct and indirect study participant costs</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Health Related Quality of Life</measure>
    <time_frame>6 weeks and 6 months post-discharge</time_frame>
    <description>Including: EQ-5D questionnaire, SF-12 Questionnaire</description>
  </other_outcome>
  <other_outcome>
    <measure>Functional Status (Frailty)</measure>
    <time_frame>6 weeks post-discharge</time_frame>
    <description>Including: Edmonton Frail Scale, and Timed Up-and-Go Test</description>
  </other_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Actual">723</enrollment>
  <condition>General Surgery</condition>
  <arm_group>
    <arm_group_label>Pre-Elder Friendly Surgical Intervention Group</arm_group_label>
    <description>Elder Acute Care and Emergency Surgery patients</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Post-Elder Friendly Surgical Intervention Group</arm_group_label>
    <description>Elder Acute Care and Emergency Surgery patients</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Pre-Elder Friendly Surgical Control Group</arm_group_label>
    <description>Elder Acute Care and Emergency Surgery patients</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Post-Elder Friendly Surgical Control Group</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Elder-Friendly Surgical Unit</intervention_name>
    <arm_group_label>Post-Elder Friendly Surgical Intervention Group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All patients &gt; 65 years old admitted and received acute abdominal surgery&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients &gt; 65 years old admitted for Acute care and Emergency Surgery&#xD;
&#xD;
          -  Received acute abdominal surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Elective general surgery cases&#xD;
&#xD;
          -  Nursing home resident requiring full nursing care [dependency in 3 or more activities&#xD;
             of daily living ]&#xD;
&#xD;
          -  Palliative surgery [surgery with the primary intention of improving quality of life or&#xD;
             relieving symptoms caused by advancing non-curative disease]&#xD;
&#xD;
          -  Multi-system trauma&#xD;
&#xD;
          -  Patients from out of province or transferred from another inpatient service or&#xD;
             hospital&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rachel G Khadaroo, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Alberta</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Foothills Medical Center, Acute Care Emergency Surgical Services</name>
      <address>
        <city>Calgary</city>
        <state>Alberta</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Alberta Hospital, Acute Care and Emergency Surgery Service</name>
      <address>
        <city>Edmonton</city>
        <state>Alberta</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <reference>
    <citation>Hanson HM, Warkentin L, Wilson R, Sandhu N, Slaughter SE, Khadaroo RG. Facilitators and barriers of change toward an elder-friendly surgical environment: perspectives of clinician stakeholder groups. BMC Health Serv Res. 2017 Aug 24;17(1):596. doi: 10.1186/s12913-017-2481-z.</citation>
    <PMID>28836979</PMID>
  </reference>
  <reference>
    <citation>Khadaroo RG, Padwal RS, Wagg AS, Clement F, Warkentin LM, Holroyd-Leduc J. Optimizing senior's surgical care - Elder-friendly Approaches to the Surgical Environment (EASE) study: rationale and objectives. BMC Health Serv Res. 2015 Aug 21;15:338. doi: 10.1186/s12913-015-1001-2.</citation>
    <PMID>26293153</PMID>
  </reference>
  <results_reference>
    <citation>Li Y, Pederson JL, Churchill TA, Wagg AS, Holroyd-Leduc JM, Alagiakrishnan K, Padwal RS, Khadaroo RG. Impact of frailty on outcomes after discharge in older surgical patients: a prospective cohort study. CMAJ. 2018 Feb 20;190(7):E184-E190. doi: 10.1503/cmaj.161403.</citation>
    <PMID>29565018</PMID>
  </results_reference>
  <results_reference>
    <citation>Eamer GJ, Clement F, Pederson JL, Churchill TA, Khadaroo RG. Analysis of postdischarge costs following emergent general surgery in elderly patients. Can J Surg. 2018 Feb;61(1):19-27. doi: 10.1503/cjs.002617. Epub 2017 Dec 1.</citation>
    <PMID>29368673</PMID>
  </results_reference>
  <results_reference>
    <citation>McComb A, Warkentin LM, McNeely ML, Khadaroo RG. Development of a reconditioning program for elderly abdominal surgery patients: the Elder-friendly Approaches to the Surgical Environment-BEdside reconditioning for Functional ImprovemenTs (EASE-BE FIT) pilot study. World J Emerg Surg. 2018 May 21;13:21. doi: 10.1186/s13017-018-0180-7. eCollection 2018.</citation>
    <PMID>29942346</PMID>
  </results_reference>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>August 22, 2014</study_first_submitted>
  <study_first_submitted_qc>September 3, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 8, 2014</study_first_posted>
  <last_update_submitted>October 17, 2018</last_update_submitted>
  <last_update_submitted_qc>October 17, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 19, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Alberta</investigator_affiliation>
    <investigator_full_name>Rachel Khadaroo</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Senior</keyword>
  <keyword>Elderly</keyword>
  <keyword>Acute Care</keyword>
  <keyword>Emergency Surgery</keyword>
  <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/NCT02233153
org study id: Pro00047180
nct id: NCT02233153
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to examine the impact implementing an elder-friendly surgical unit
      has on post-operative complications, mortality and quality of life for patients ≥ 65 years
      old who have undergone emergency surgical care.
The investigators hypothesize that the elder-friendly surgical unit will reduce in-hospital
      complications and mortality in a cost-effective manner, for this at risk population.

      Specific elder-friendly interventions include:

        1. Locate all elderly surgical patients on one nursing unit

        2. Interdisciplinary team-based care

        3. Elder-friendly evidence-informed practices including: comfort rounds with early
           mobilization, delirium prevention/management, optimal nutrition and prevention of
           post-operative complications

        4. Early and interdisciplinary discharge management

      This is a prospective, before-after study with a concurrent control group. Four senior
      patient groups will be followed:
observational model: Other
time perspective: Prospective
measure: Post-Operative complications
time frame: During initial in-hospital stay (0-12 weeks on average)
description: Includes a) intensive care unit admission (includes respiratory failure, cardiac arrest or septic shock), b) vascular complications (myocardial infarction, stroke, deep venous thrombosis, pulmonary embolism), c) serious infections (pneumonia, intra-abdominal abscess, urinary tract infection, deep wound infection or infected decubitus ulcer) or d) protracted delirium (≥48 hours)
measure: Death
time frame: During initial in-hospital stay (0-12 weeks on average)
measure: Post-discharge complications or health-events requiring re-admission
time frame: Within 30 days post-discharge
measure: Cost per quality-adjusted life year
time frame: 6 months post-discharge
description: Both direct and indirect study participant costs
measure: Health Related Quality of Life
time frame: 6 weeks and 6 months post-discharge
description: Including: EQ-5D questionnaire, SF-12 Questionnaire
measure: Functional Status (Frailty)
time frame: 6 weeks post-discharge
description: Including: Edmonton Frail Scale, and Timed Up-and-Go Test
arm group label: Pre-Elder Friendly Surgical Intervention Group
description: Elder Acute Care and Emergency Surgery patients
arm group label: Post-Elder Friendly Surgical Intervention Group
description: Elder Acute Care and Emergency Surgery patients
arm group label: Pre-Elder Friendly Surgical Control Group
description: Elder Acute Care and Emergency Surgery patients
arm group label: Post-Elder Friendly Surgical Control Group
intervention type: Other
intervention name: Elder-Friendly Surgical Unit
arm group label: Post-Elder Friendly Surgical Intervention Group
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: No
last name: Rachel G Khadaroo, MD
role: Principal Investigator
affiliation: University of Alberta
facility: 
facility: 
country: Canada
citation: Hanson HM, Warkentin L, Wilson R, Sandhu N, Slaughter SE, Khadaroo RG. Facilitators and barriers of change toward an elder-friendly surgical environment: perspectives of clinician stakeholder groups. BMC Health Serv Res. 2017 Aug 24;17(1):596. doi: 10.1186/s12913-017-2481-z.
PMID: 28836979
citation: Khadaroo RG, Padwal RS, Wagg AS, Clement F, Warkentin LM, Holroyd-Leduc J. Optimizing senior's surgical care - Elder-friendly Approaches to the Surgical Environment (EASE) study: rationale and objectives. BMC Health Serv Res. 2015 Aug 21;15:338. doi: 10.1186/s12913-015-1001-2.
PMID: 26293153
citation: Li Y, Pederson JL, Churchill TA, Wagg AS, Holroyd-Leduc JM, Alagiakrishnan K, Padwal RS, Khadaroo RG. Impact of frailty on outcomes after discharge in older surgical patients: a prospective cohort study. CMAJ. 2018 Feb 20;190(7):E184-E190. doi: 10.1503/cmaj.161403.
PMID: 29565018
citation: Eamer GJ, Clement F, Pederson JL, Churchill TA, Khadaroo RG. Analysis of postdischarge costs following emergent general surgery in elderly patients. Can J Surg. 2018 Feb;61(1):19-27. doi: 10.1503/cjs.002617. Epub 2017 Dec 1.
PMID: 29368673
citation: McComb A, Warkentin LM, McNeely ML, Khadaroo RG. Development of a reconditioning program for elderly abdominal surgery patients: the Elder-friendly Approaches to the Surgical Environment-BEdside reconditioning for Functional ImprovemenTs (EASE-BE FIT) pilot study. World J Emerg Surg. 2018 May 21;13:21. doi: 10.1186/s13017-018-0180-7. eCollection 2018.
PMID: 29942346
responsible party type: Principal Investigator
investigator affiliation: University of Alberta
investigator full name: Rachel Khadaroo
investigator title: Assistant Professor
sharing ipd: No