<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/NCT02975375</url>
  </required_header>
  <id_info>
    <org_study_id>DM4</org_study_id>
    <nct_id>NCT02975375</nct_id>
  </id_info>
  <brief_title>The Impact of Perioperative Geriatric Care on Outcomes After Elective Noncardiac Surgery</brief_title>
  <official_title>The Impact of Perioperative Geriatric Care on Outcomes After Elective Noncardiac Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ottawa Hospital Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ottawa Hospital Research Institute</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators will conduct a population-based study using health administrative data to&#xD;
      evaluate the impact of preoperative geriatric consultation on postoperative outcomes in older&#xD;
      patients having elective, non-cardiac surgery&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators will use multilevel multivariable analyses to measure the association&#xD;
      between preoperative geriatric assessment or consultation and outcomes after major elective&#xD;
      non-cardiac surgery. Sensitivity analyses will be done to evaluate types and timing of&#xD;
      geriatric care around surgery, as well as for effect modification based on patient and&#xD;
      procedural factors.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2002</start_date>
  <completion_date type="Actual">November 2016</completion_date>
  <primary_completion_date type="Actual">March 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>90-day survival</measure>
    <time_frame>date of surgery to day of death or 365 days after surgery, whichever comes first</time_frame>
    <description>Death from any cause in the 90 days after surgery</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient safety event</measure>
    <time_frame>surgery to hospital discharge, or up to 365 days after surgery</time_frame>
    <description>Any Type 2 diagnostic code for a patient-safety event as described by Southern et al, Medical Care 2016</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital length of stay</measure>
    <time_frame>date of surgery to date of hospital discharge, or 365 days after surgery, whichever comes first</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Non-independent discharge location</measure>
    <time_frame>date of surgery to date of hospital discharge, or 365 days after surgery, whichever comes first</time_frame>
    <description>Discharge disposition from hospital record that is not a home discharge without support</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>30-day hospital readmission</measure>
    <time_frame>date of discharge to 30 days after discharge</time_frame>
    <description>New acute care hospitalization within 30-days of discharge from the index hospitalization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health Utility Index</measure>
    <time_frame>in the 365 days following surgery</time_frame>
    <description>A health utility index will be constructed, and used as an outcome if an adequate number of participants have required measures to support multivariable modelling</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">200000</enrollment>
  <condition>SURGICAL PROCEDURES, OPERATIVE</condition>
  <condition>Aged</condition>
  <condition>Epidemiology</condition>
  <condition>Mortality</condition>
  <arm_group>
    <arm_group_label>Preoperative geriatric consult or assessment</arm_group_label>
    <description>Patients who have a geriatric assessment of consult billed in the 4 months before surgery</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No Preoperative geriatric consult or assessment</arm_group_label>
    <description>Patients who do not have a geriatric assessment of consult billed in the 4 months before surgery</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Preoperative geriatric consult or assessment</intervention_name>
    <description>A preoperative geriatric consult or assessment will be considered to be present if such a consult or assessment is billed by a geriatrician for a patient in the cohort within 4 months preceding surgery. For the primary analysis we will collapse both geriatric consultations and comprehensive geriatric assessments into a single exposure level.</description>
    <arm_group_label>Preoperative geriatric consult or assessment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>No Preoperative geriatric consult or assessment</intervention_name>
    <description>No assessment or consult billed in the 4 months before surgery</description>
    <arm_group_label>No Preoperative geriatric consult or assessment</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Individuals &gt;65 years of age on the day of the potential participant's first elective&#xD;
        non-cardiac surgery in the study period&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  &gt;65&#xD;
&#xD;
          -  Resident of Ontario&#xD;
&#xD;
          -  Having elective non-cardiac surgery (inpatient admission)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Residing in a nursing home or long term care facility at baseline&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Ottawa Hospital Research Institute</name>
      <address>
        <city>Ottawa</city>
        <state>Ontario</state>
        <zip>K1Y 4E9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>November 17, 2016</study_first_submitted>
  <study_first_submitted_qc>November 28, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 29, 2016</study_first_posted>
  <last_update_submitted>December 6, 2016</last_update_submitted>
  <last_update_submitted_qc>December 6, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 8, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT02975375
org study id: DM4
nct id: NCT02975375
lead sponsor: 
has dmc: No
The investigators will conduct a population-based study using health administrative data to
      evaluate the impact of preoperative geriatric consultation on postoperative outcomes in older
      patients having elective, non-cardiac surgery
The investigators will use multilevel multivariable analyses to measure the association
      between preoperative geriatric assessment or consultation and outcomes after major elective
      non-cardiac surgery. Sensitivity analyses will be done to evaluate types and timing of
      geriatric care around surgery, as well as for effect modification based on patient and
      procedural factors.
observational model: Cohort
time perspective: Retrospective
measure: 90-day survival
time frame: date of surgery to day of death or 365 days after surgery, whichever comes first
description: Death from any cause in the 90 days after surgery
measure: Patient safety event
time frame: surgery to hospital discharge, or up to 365 days after surgery
description: Any Type 2 diagnostic code for a patient-safety event as described by Southern et al, Medical Care 2016
measure: Hospital length of stay
time frame: date of surgery to date of hospital discharge, or 365 days after surgery, whichever comes first
measure: Non-independent discharge location
time frame: date of surgery to date of hospital discharge, or 365 days after surgery, whichever comes first
description: Discharge disposition from hospital record that is not a home discharge without support
measure: 30-day hospital readmission
time frame: date of discharge to 30 days after discharge
description: New acute care hospitalization within 30-days of discharge from the index hospitalization
measure: Health Utility Index
time frame: in the 365 days following surgery
description: A health utility index will be constructed, and used as an outcome if an adequate number of participants have required measures to support multivariable modelling
arm group label: Preoperative geriatric consult or assessment
description: Patients who have a geriatric assessment of consult billed in the 4 months before surgery
arm group label: No Preoperative geriatric consult or assessment
description: Patients who do not have a geriatric assessment of consult billed in the 4 months before surgery
intervention type: Procedure
intervention name: Preoperative geriatric consult or assessment
description: A preoperative geriatric consult or assessment will be considered to be present if such a consult or assessment is billed by a geriatrician for a patient in the cohort within 4 months preceding surgery. For the primary analysis we will collapse both geriatric consultations and comprehensive geriatric assessments into a single exposure level.
arm group label: Preoperative geriatric consult or assessment
intervention type: Procedure
intervention name: No Preoperative geriatric consult or assessment
description: No assessment or consult billed in the 4 months before surgery
arm group label: No Preoperative geriatric consult or assessment
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Canada
responsible party type: Sponsor
sharing ipd: No