<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/NCT02225938</url>
  </required_header>
  <id_info>
    <org_study_id>SGS15-0104</org_study_id>
    <nct_id>NCT02225938</nct_id>
  </id_info>
  <brief_title>ICU Recovery in Australian Patients</brief_title>
  <acronym>ICU-RECOVERY</acronym>
  <official_title>ICU Recovery: A Multicentre Cohort Study in Critically Ill Patients to Determine Functional Recovery and Quality of Life</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Australian and New Zealand Intensive Care Research Centre</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Monash University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Australian and New Zealand Intensive Care Research Centre</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Increasingly patients with critical illness requiring life support in an intensive care unit&#xD;
      are surviving their hospital admission. Currently the investigators do not know what effect&#xD;
      the ICU admission, and the life support, has on their long-term quality of life and whether&#xD;
      they can return to their pre-illness level of function following ICU.&#xD;
&#xD;
      The investigators aim to test telephone follow-up of ICU survivors in assessing function and&#xD;
      quality of life six months after ICU admission. Additionally, the investigators will identify&#xD;
      if there are factors that lead to poor recovery. The investigators hope this can influence&#xD;
      and change current ICU practice to improve recovery and long-term outcomes for patients.&#xD;
&#xD;
      The investigators aim to select a total of 300 patients from ICU, 75 patients from each of&#xD;
      the four ICUs. If they survive to hospital discharge, patients and their relatives will&#xD;
      receive a telephone questionnaire at 6 months after the ICU admission that aims to assess&#xD;
      their long-term outcomes, including physical, cognitive and emotional function, quality of&#xD;
      life, and whether they have been able to return to work following ICU.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The ICU Recovery program will measure psychological, functional and cognitive function and&#xD;
      quality of life with health economic outcomes in critically ill patients 6 months after ICU&#xD;
      admission. The initial pilot study will determine feasibility of the patient outcomes and&#xD;
      measurement methods used. The study will consist of patients from three (3) Monash Partners&#xD;
      ICUs (2 public and 1 private) as well as The Austin Hospital ICU. 10,000 ICU patients are&#xD;
      managed by Monash Partners Academic Health Science Centre (MPAHSC) public and private&#xD;
      hospitals each year, of which in the region of 8,500 patients survive. These patients add to&#xD;
      the community burden and also influence community and rehabilitation costs. Ultimately, our&#xD;
      goal is to establish a national National Health &amp; Medical Research Council (NHMRC) -funded&#xD;
      interventional study, led by Monash Partners. Our aim is to improve long-term patient&#xD;
      outcomes through: improving sedation practices, delirium prevention, neurocognitive&#xD;
      stimulation, early mobilisation, post-ICU follow-up, and functional and psychological&#xD;
      rehabilitation. This study is required for the evaluation of hospital and post-ICU&#xD;
      rehabilitation practice as there is insufficient evidence to alter current clinical practice.&#xD;
&#xD;
      OBJECTIVES&#xD;
&#xD;
      Primary Aim:&#xD;
&#xD;
      To determine the feasibility of the multi-centre ICU Recovery study using telephone follow-up&#xD;
      to assess quality of life, global, psychological, cognitive and physical outcomes at six&#xD;
      months following ICU admission.&#xD;
&#xD;
      Secondary Aims&#xD;
&#xD;
        1. To determine the recovery of ICU patients ventilated &gt;24 hours at 6 months after ICU&#xD;
           admission&#xD;
&#xD;
        2. To identify risk factors for poor recovery in ICU patients&#xD;
&#xD;
      Tertiary Aims&#xD;
&#xD;
        1. To establish the likely recruitment rate for future studies of long-term outcomes&#xD;
&#xD;
        2. To establish the resource requirements for long term follow-up (including staff,&#xD;
           equipment and time taken for survey completion)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">December 2015</completion_date>
  <primary_completion_date type="Actual">December 2015</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>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Feasibility of telephone interview</measure>
    <time_frame>At completion of telephone interview, expected average of 6 months</time_frame>
    <description>Determine feasibility of using a telephone interview to ascertain the functional recovery and quality of life and critically ill ICU survivors.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Health related quality of life</measure>
    <time_frame>At telephone interview, conducted at an expected average of 6 months following discharge from the Intensive Care Unit</time_frame>
    <description>Health related quality of life (HRQOL) measured with EuroQol five dimensions questionnaire (EQ-5D) before ICU (retrospective survey) and at 6 months (prospective survey)</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Pre-ICU function</measure>
    <time_frame>At telephone interview, conducted at an expected average of 6 months following discharge from the Intensive Care Unit</time_frame>
    <description>Pre-ICU function measured with EuroQol five dimensions questionnaire (EQ-5D) and work details</description>
  </other_outcome>
  <other_outcome>
    <measure>Global function</measure>
    <time_frame>At telephone interview, conducted at an expected average of 6 months following discharge from the Intensive Care Unit</time_frame>
    <description>Global function at 6 months, assessed with World Health Organization Disability Assessment Schedule (WHODAS)</description>
  </other_outcome>
  <other_outcome>
    <measure>Physical activity</measure>
    <time_frame>At telephone interview, conducted at an expected average of 6 months following discharge from the Intensive Care Unit</time_frame>
    <description>Physical activity at 6 months, assessed with International Physical Activity Questionnaire (IPAQ).</description>
  </other_outcome>
  <other_outcome>
    <measure>Cognitive function</measure>
    <time_frame>At telephone interview, conducted at an expected average of 6 months following discharge from the Intensive Care Unit</time_frame>
    <description>Cognitive function at 6 months, assessed with Telephone Interview for Cognitive Status (TICS).</description>
  </other_outcome>
  <other_outcome>
    <measure>Anxiety and depression</measure>
    <time_frame>At telephone interview, conducted at an expected average of 6 months following discharge from the Intensive Care Unit</time_frame>
    <description>Anxiety and depression at 6 months will be assessed with the Hospital Anxiety and Depression Scale (HADS) and the Impact of Event Scale (IES-R)</description>
  </other_outcome>
  <other_outcome>
    <measure>Return to work</measure>
    <time_frame>At telephone interview, conducted at an expected average of 6 months following discharge from the Intensive Care Unit</time_frame>
    <description>Return to work at 6 months</description>
  </other_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">262</enrollment>
  <condition>Intensive Care Unit Syndrome</condition>
  <arm_group>
    <arm_group_label>Intensive care survivors</arm_group_label>
    <description>Patients surviving an admission to an intensive care unit</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        300 critically ill patients who were mechanically ventilated &gt;24 hours in an intensive care&#xD;
        unit who have survived to hospital discharge.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ICU patients who have been invasively mechanically ventilated for over 24 hours&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients aged less than 18 years old&#xD;
&#xD;
          -  A proven or suspected acute primary brain process that is likely to result in global&#xD;
             impairment of conscious level or cognition (e.g. traumatic brain injury, subarachnoid&#xD;
             haemorrhage, stroke or hypoxic brain injury after cardiac arrest)&#xD;
&#xD;
          -  Second or subsequent admission to ICU during a single hospital admission&#xD;
&#xD;
          -  Death is deemed imminent and inevitable&#xD;
&#xD;
          -  Participants who do not speak English&#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>Carol Hodgson, PhD MRes</last_name>
    <role>Principal Investigator</role>
    <affiliation>ANZIC-RC</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Monash Medical Centre</name>
      <address>
        <city>Clayton</city>
        <state>Victoria</state>
        <zip>3168</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Austin Hospital</name>
      <address>
        <city>Heidelberg</city>
        <state>Victoria</state>
        <zip>3084</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cabrini Hospital</name>
      <address>
        <city>Malvern</city>
        <state>Victoria</state>
        <zip>3144</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Alfred Hospital</name>
      <address>
        <city>Melbourne</city>
        <state>Victoria</state>
        <zip>3004</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Epworth Hospital</name>
      <address>
        <city>Richmond</city>
        <state>Victoria</state>
        <zip>3121</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
  </location_countries>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>August 6, 2014</study_first_submitted>
  <study_first_submitted_qc>August 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 26, 2014</study_first_posted>
  <last_update_submitted>August 20, 2018</last_update_submitted>
  <last_update_submitted_qc>August 20, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 22, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Intensive Care</keyword>
  <keyword>Recovery</keyword>
  <keyword>Long term outcome</keyword>
  <keyword>Function</keyword>
  <!-- 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/NCT02225938
org study id: SGS15-0104
nct id: NCT02225938
lead sponsor: 
collaborator: 
has dmc: No
Increasingly patients with critical illness requiring life support in an intensive care unit
      are surviving their hospital admission. Currently the investigators do not know what effect
      the ICU admission, and the life support, has on their long-term quality of life and whether
      they can return to their pre-illness level of function following ICU.

      The investigators aim to test telephone follow-up of ICU survivors in assessing function and
      quality of life six months after ICU admission. Additionally, the investigators will identify
      if there are factors that lead to poor recovery. The investigators hope this can influence
      and change current ICU practice to improve recovery and long-term outcomes for patients.

      The investigators aim to select a total of 300 patients from ICU, 75 patients from each of
      the four ICUs. If they survive to hospital discharge, patients and their relatives will
      receive a telephone questionnaire at 6 months after the ICU admission that aims to assess
      their long-term outcomes, including physical, cognitive and emotional function, quality of
      life, and whether they have been able to return to work following ICU.
The ICU Recovery program will measure psychological, functional and cognitive function and
      quality of life with health economic outcomes in critically ill patients 6 months after ICU
      admission. The initial pilot study will determine feasibility of the patient outcomes and
      measurement methods used. The study will consist of patients from three (3) Monash Partners
      ICUs (2 public and 1 private) as well as The Austin Hospital ICU. 10,000 ICU patients are
      managed by Monash Partners Academic Health Science Centre (MPAHSC) public and private
      hospitals each year, of which in the region of 8,500 patients survive. These patients add to
      the community burden and also influence community and rehabilitation costs. Ultimately, our
      goal is to establish a national National Health & Medical Research Council (NHMRC) -funded
      interventional study, led by Monash Partners. Our aim is to improve long-term patient
      outcomes through: improving sedation practices, delirium prevention, neurocognitive
      stimulation, early mobilisation, post-ICU follow-up, and functional and psychological
      rehabilitation. This study is required for the evaluation of hospital and post-ICU
      rehabilitation practice as there is insufficient evidence to alter current clinical practice.

      OBJECTIVES

      Primary Aim:

      To determine the feasibility of the multi-centre ICU Recovery study using telephone follow-up
      to assess quality of life, global, psychological, cognitive and physical outcomes at six
      months following ICU admission.

      Secondary Aims

        1. To determine the recovery of ICU patients ventilated >24 hours at 6 months after ICU
           admission

        2. To identify risk factors for poor recovery in ICU patients

      Tertiary Aims

        1. To establish the likely recruitment rate for future studies of long-term outcomes

        2. To establish the resource requirements for long term follow-up (including staff,
           equipment and time taken for survey completion)
observational model: Cohort
time perspective: Cross-Sectional
measure: Feasibility of telephone interview
time frame: At completion of telephone interview, expected average of 6 months
description: Determine feasibility of using a telephone interview to ascertain the functional recovery and quality of life and critically ill ICU survivors.
measure: Health related quality of life
time frame: At telephone interview, conducted at an expected average of 6 months following discharge from the Intensive Care Unit
description: Health related quality of life (HRQOL) measured with EuroQol five dimensions questionnaire (EQ-5D) before ICU (retrospective survey) and at 6 months (prospective survey)
measure: Pre-ICU function
time frame: At telephone interview, conducted at an expected average of 6 months following discharge from the Intensive Care Unit
description: Pre-ICU function measured with EuroQol five dimensions questionnaire (EQ-5D) and work details
measure: Global function
time frame: At telephone interview, conducted at an expected average of 6 months following discharge from the Intensive Care Unit
description: Global function at 6 months, assessed with World Health Organization Disability Assessment Schedule (WHODAS)
measure: Physical activity
time frame: At telephone interview, conducted at an expected average of 6 months following discharge from the Intensive Care Unit
description: Physical activity at 6 months, assessed with International Physical Activity Questionnaire (IPAQ).
measure: Cognitive function
time frame: At telephone interview, conducted at an expected average of 6 months following discharge from the Intensive Care Unit
description: Cognitive function at 6 months, assessed with Telephone Interview for Cognitive Status (TICS).
measure: Anxiety and depression
time frame: At telephone interview, conducted at an expected average of 6 months following discharge from the Intensive Care Unit
description: Anxiety and depression at 6 months will be assessed with the Hospital Anxiety and Depression Scale (HADS) and the Impact of Event Scale (IES-R)
measure: Return to work
time frame: At telephone interview, conducted at an expected average of 6 months following discharge from the Intensive Care Unit
description: Return to work at 6 months
arm group label: Intensive care survivors
description: Patients surviving an admission to an intensive care unit
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Carol Hodgson, PhD MRes
role: Principal Investigator
affiliation: ANZIC-RC
facility: 
facility: 
facility: 
facility: 
facility: 
country: Australia
responsible party type: Sponsor