<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/NCT03246334</url>
  </required_header>
  <id_info>
    <org_study_id>Radboudumc</org_study_id>
    <nct_id>NCT03246334</nct_id>
  </id_info>
  <brief_title>MONITOR-IC: Determining Long-term Consequences of ICU Care</brief_title>
  <acronym>MONITOR-IC</acronym>
  <official_title>MONITOR-IC: a Mixed Methods Multicenter Prospective Controlled Cohort Study Determining the Five-year Outcomes of ICU Survivors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Radboud University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Radboud University Medical Center</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>
      Due to advances in critical care medicine, more patients survive their critical illness.&#xD;
      However, intensive care unit (ICU) survivors often experience long-term physical, cognitive&#xD;
      and mental problems, summarized as post intensive care syndrome (PICS), impacting their&#xD;
      health related quality of life (HRQoL). In what frequency PICS occurs, and to what extent&#xD;
      this influences ICU survivors' HRQoL, is mostly unknown.&#xD;
&#xD;
      The aims of this study are therefore to study the: 1) five-year patient outcomes, 2)&#xD;
      predictors for PICS, 3) ratio between HRQoL of ICU-survivors and healthcare related costs,&#xD;
      and 4) care and support needs.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Specific research questions:&#xD;
&#xD;
        1. What are the post intensive care symptoms that patients experience during five years&#xD;
           after ICU admissions and what is their HRQoL?&#xD;
&#xD;
        2. What are important predictors for the various physical, cognitive and mental long-term&#xD;
           outcomes?&#xD;
&#xD;
        3. What is the ratio between HRQoL and healthcare related costs?&#xD;
&#xD;
        4. What are the care and support needs of ICU survivors during five years after ICU&#xD;
           admission?&#xD;
&#xD;
      Design:&#xD;
&#xD;
      The MONITOR-IC study is a multicenter prospective controlled cohort study in which long-term&#xD;
      outcomes of ICU patients are studied for a period of five year.&#xD;
&#xD;
      The study will be carried out in ICUs of four hospitals in the Netherlands; one academic&#xD;
      hospital, one teaching and two non-teaching hospitals. ICU patients will be recruited between&#xD;
      July 2016 and July 2021 with a subsequent follow-up for five years.&#xD;
&#xD;
      Inclusion:&#xD;
&#xD;
      For the MONITOR-IC study the investigators estimated to include 12.000 patients. This&#xD;
      estimation is based on: 1) the initial ICU admissions in the academic hospital and the three&#xD;
      other participating hospitals together (2,500 and 2,200 respectively per year), and 2) an&#xD;
      estimated response rate of 60%, which is based on previous conducted ICU studies. In the&#xD;
      control cohort, the investigators will include approximately 3000 patients during the next&#xD;
      four years.&#xD;
&#xD;
      Patient recruitment:&#xD;
&#xD;
      Patients scheduled for ICU admission after elective surgery, will be recruited at the&#xD;
      outpatient clinic (anaesthesiology or cardiac surgery) (Figure 1). Patients with a&#xD;
      non-scheduled admission will be recruited at the ICU. Patients will receive information by&#xD;
      ICU nurses and intensivists regarding the aim, content and relevance of the study, and will&#xD;
      be asked for participation. Informed consent is asked for the questionnaires, data from the&#xD;
      patients' individual medical record and data from their health insurance company. In case&#xD;
      patients are unable to give consent, their legal representative will be asked.&#xD;
&#xD;
      Methods:&#xD;
&#xD;
      Mixed methods will be used to collect data, including questionnaires, medical data from&#xD;
      patient records, cost data from health insurance companies and interviews with ICU survivors&#xD;
      and their family members.&#xD;
&#xD;
      All patients, or their relatives in case patients are not able to fill in the questionnaire&#xD;
      themselves, will be approached to fill in the self-administered paper based or online&#xD;
      questionnaire in total eight times:at ICU admission (T0), at hospital discharge (T1), after 3&#xD;
      months (T2), 12 months (T3), 24 months (T4), 36 months (T5), 48 months (T6) and 60 months&#xD;
      after ICU admission (T7). To get insight into the situation before the ICU admission, the&#xD;
      baseline questionnaire (T0) is provided when the patients is asked for informed consent. This&#xD;
      could be preoperatively for the planned admissions or after admission at the ICU. Then,&#xD;
      patients are asked to rate their situation before the ICU admission.&#xD;
&#xD;
      Items in questionnaire:&#xD;
&#xD;
        -  Patients' health status and HRQoL = SF-36 and the EQ-5D-5L.&#xD;
&#xD;
        -  Patients' level of frailty and vulnerability = Clinical Frailty Score (CFS)&#xD;
&#xD;
        -  The level of fatigue = CIS-8, a subscale of the Checklist Individual Strength&#xD;
&#xD;
        -  Cognitive impairment = abbreviated 14-item Cognitive Failure Questionnaire (CFQ-14).&#xD;
&#xD;
        -  Anxiety and depression = Hospital Anxiety and Depression Scale (HADS)&#xD;
&#xD;
        -  Subjective distress, caused by traumatic events = Impact of Event Scale Revised (IES-R)&#xD;
&#xD;
        -  Care needs and support from professionals and informal caregiver&#xD;
&#xD;
        -  Social consequences = novel question set for changes in family circumstances,&#xD;
           socio-economic stability and care requirements.&#xD;
&#xD;
      Medical data Patients' demographics and information regarding their diagnosis and treatment,&#xD;
      such as primary conditions, pre-existing co-morbidity, disease severity, sepsis,&#xD;
      (re)admission, length of mechanical ventilation, length of ICU stay, delirium (CAM-ICU), pain&#xD;
      (CPOT), expected mortality (based on the APACHE II, SAPS II, MPM II and APACHE III-IV models&#xD;
      and medication, will be extracted from their medical record and the Dutch National Intensive&#xD;
      Care Evaluation (NICE) registry.&#xD;
&#xD;
      Health Insurance data Healthcare use and related costs, covered by the Dutch healthcare&#xD;
      insurance, will be retrieved from Vektis; a Dutch organization which collects and manage&#xD;
      health insurance claimed data of all health insurance companies in the Netherlands.This data&#xD;
      is collected based on the Diagnosis Treatment Combination (DTC); a total set of activities&#xD;
      carried out by the hospital and medical specialists. Additionally, data is collected&#xD;
      regarding nursing days, visits at the outpatient clinic and emergency department, nursing&#xD;
      homes, ambulance transport, consultation with general practitioner, paramedical care&#xD;
      (including physiotherapist, occupational therapist, dietician and speech therapist),&#xD;
      prescribed medication, mental healthcare and revalidation. The Vektis database contains data&#xD;
      from all for healthcare insured citizens and covers 99% of the total Dutch population. Using&#xD;
      patient's unique insurance number the investigators are able to merge patient's insurance&#xD;
      data with the questionnaire data and medical data from the medical record at patient level.&#xD;
&#xD;
      Care delivered by community nurses and informal caregivers is not included in the Vektis&#xD;
      database and will be studied via the questionnaire.&#xD;
&#xD;
      Interviews To get insight into the experiences of ICU survivors during five years after ICU&#xD;
      admission and their need for support, face to face semi-structured interviews will be&#xD;
      conducted with ICU survivors and their family members. Interviews will take place at the&#xD;
      participants' preferred location (home or clinic). Interviews will be conducted until data&#xD;
      saturation is reached.&#xD;
&#xD;
      Patients will be purposively sampled based on various experienced outcomes, such as the&#xD;
      quality of life, daily functioning, anxiety, depression, and their experienced needs for more&#xD;
      information or emotional support. Experienced and trained researchers will conduct the&#xD;
      interviews using a topic guide. This guide will be developed using the current literature and&#xD;
      experience of the research team and will cover the following subjects: experiences with the&#xD;
      ICU admission and follow-up, experienced problems and needs for support. All interviews will&#xD;
      be audio recorded and transcribed verbatim.&#xD;
&#xD;
      Analysis Questionnaires, medical record and health insurance data During the data collection,&#xD;
      data are checked on a regular basis to identify out-of-range answers, inconsistent responses,&#xD;
      and missing data. Data from the questionnaires, medical record and healthcare insurance data&#xD;
      will be merged at patient level. Descriptive statistics will be used to describe baseline&#xD;
      characteristics and the incidence of long-term outcomes. Regression analysis will be used to&#xD;
      determine associations between patient characteristics, treatment, and long-term outcomes.&#xD;
      Subgroups will be identified based on their illness and condition (for example sepsis,&#xD;
      delirium, co morbidities, ARDS), treatment (for example length of ICU stay, duration of&#xD;
      mechanical ventilation, dialysis) and social demographics (age, gender, education, family&#xD;
      setting etc).&#xD;
&#xD;
      In order to predict the various physical, cognitive and mental long-term outcomes, multiple&#xD;
      prediction models will be developed. Multivariable linear (for continuous outcome variables)&#xD;
      and logistic (for dichotomous outcome variables) regression analysis will be performed.&#xD;
      Linear and logistic multilevel models will be used to compare long-term outcomes between the&#xD;
      study population (cohort) and control cohort group.&#xD;
&#xD;
      To determine the ratio between HRQoL and patient outcomes and the health related costs,&#xD;
      quality adjusted life years (QALYs) will be calculated. QALYs are a measure of the state of&#xD;
      health of a person or group in which the benefits, in terms of length of life, are adjusted&#xD;
      to reflect the quality of life. QALYs are calculated by estimating the years of life&#xD;
      remaining for particular treatment and weighting each year with a quality of life score.54&#xD;
      Software Package for the Social Sciences (SPSS) will be used for data analysis.&#xD;
&#xD;
      Interviews For the analysis of the interview data, the constant comparative method will be&#xD;
      used. Relevant data will be identified and structured by open, axial and selective coding.&#xD;
&#xD;
      Two researchers will independently code the transcripts to minimize subjectivity in findings.&#xD;
      The differences and similarities between the codes will be discussed together, and in case of&#xD;
      disagreement, a third researcher will be involved. In the meetings with the team, the&#xD;
      codebook will be refined and emerging categories and themes will be discussed.&#xD;
&#xD;
      Data analysis will be supported with the use of Atlas.ti, a qualitative data analysis&#xD;
      program.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 1, 2016</start_date>
  <completion_date type="Anticipated">August 2026</completion_date>
  <primary_completion_date type="Anticipated">August 2026</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Health related quality of life</measure>
    <time_frame>ICU discharge - 5 year follow up</time_frame>
    <description>SF-36</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Health related quality of life</measure>
    <time_frame>ICU admission- 5 year follow up</time_frame>
    <description>EQ5D-5L</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frailty as part of Physical-Cognitive-Mental impairments</measure>
    <time_frame>ICU admission- 5 year follow up</time_frame>
    <description>CFS (Clinical Frailty Score)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fatigue as part of Physical-Cognitive-Mental impairments</measure>
    <time_frame>ICU admission- 5 year follow up</time_frame>
    <description>CIS-8 (Checklist Individual Strength)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cognition as part of Physical-Cognitive-Mental impairments</measure>
    <time_frame>ICU admission- 5 year follow up</time_frame>
    <description>CFQ-14</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anxiety and depression as part of Physical-Cognitive-Mental impairments</measure>
    <time_frame>ICU admission- 5 year follow up</time_frame>
    <description>HADS (Hospital Anxiety and Depression Scale)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post traumatic stress disorder as part of Physical-Cognitive-Mental impairments</measure>
    <time_frame>ICU admission- 5 year follow up</time_frame>
    <description>IES-R (Impact of Event Scale Revised)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patients' care and support needs and social consequences</measure>
    <time_frame>ICU admission- 5 year follow up</time_frame>
    <description>Questionnaire regarding specific needs and supports and social impact post ICU</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patients' healthcare use and related costs</measure>
    <time_frame>ICU admission- 5 year follow up</time_frame>
    <description>Data of healthcare insurance</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">12000</enrollment>
  <condition>Post Intensive Care Syndrome (PICS)</condition>
  <arm_group>
    <arm_group_label>Cohort</arm_group_label>
    <description>Case group: critically ill patients admitted &gt;12 hours to the ICU. Control group: critically ill patients to the ICU &lt;12 hrs, or to Post Anaesthesia Care Unit (PACU), or Medium Care or High Dependency Unit.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        ICU patients admitted to one of the participating centers&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ICU patients age 16 years or older;&#xD;
&#xD;
          -  admitted at least 12 hours to a trauma, medical, neurosurgery or cardiac surgery ICU;&#xD;
&#xD;
          -  gave written informed consent (or by their legal representative).&#xD;
&#xD;
          -  for the control group: admitted either to the ICU &lt;12 hours, or to the Post&#xD;
             Anaesthesia Care Unit (PACU), the Medium Care or High Dependency Unit for instance for&#xD;
             monitoring during short interventions, such as bronchoalveolar lavage or insertion of&#xD;
             a central venous catheter.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with a life expectancy of &lt;48 hours;&#xD;
&#xD;
          -  receive palliative care;&#xD;
&#xD;
          -  are admitted for a donor procedure;&#xD;
&#xD;
          -  cannot read and speak the Dutch language;&#xD;
&#xD;
          -  or are not able to fill in the questionnaire and do not have family members/ legal&#xD;
             representatives either.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hans van der Hoeven, MD, PhD.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Radboud university medical center, head of dep. Intensive Care Medicine</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Mark van den Boogaard, RN, PhD</last_name>
    <phone>0031-243665009</phone>
    <email>Mark.vandenBoogaard@radboudumc.nl</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Marieke Zegers, PhD.</last_name>
    <phone>0031-243653881</phone>
    <email>Marieke.Zegers@radboudumc.nl</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Radboud university medical center</name>
      <address>
        <city>Nijmegen</city>
        <zip>6500 HB</zip>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mark van den Boogaard, RN, PhD.</last_name>
      <phone>0031-243665009</phone>
      <email>Mark.vandenBoogaard@radboudumc.nl</email>
    </contact>
    <contact_backup>
      <last_name>Marieke Zegers, PhD.</last_name>
      <phone>0031-243653881</phone>
      <email>Marieke.Zegers@radboudumc.nl</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>August 2, 2017</study_first_submitted>
  <study_first_submitted_qc>August 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 11, 2017</study_first_posted>
  <last_update_submitted>September 19, 2021</last_update_submitted>
  <last_update_submitted_qc>September 19, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 21, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Cohort study</keyword>
  <keyword>Critical Care</keyword>
  <keyword>Follow-up study</keyword>
  <keyword>Intensive care units</keyword>
  <keyword>Long-term outcome</keyword>
  <keyword>Outcome assessment</keyword>
  <keyword>Quality of life</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/NCT03246334
org study id: Radboudumc
nct id: NCT03246334
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Due to advances in critical care medicine, more patients survive their critical illness.
      However, intensive care unit (ICU) survivors often experience long-term physical, cognitive
      and mental problems, summarized as post intensive care syndrome (PICS), impacting their
      health related quality of life (HRQoL). In what frequency PICS occurs, and to what extent
      this influences ICU survivors' HRQoL, is mostly unknown.

      The aims of this study are therefore to study the: 1) five-year patient outcomes, 2)
      predictors for PICS, 3) ratio between HRQoL of ICU-survivors and healthcare related costs,
      and 4) care and support needs.
Specific research questions:

        1. What are the post intensive care symptoms that patients experience during five years
           after ICU admissions and what is their HRQoL?

        2. What are important predictors for the various physical, cognitive and mental long-term
           outcomes?

        3. What is the ratio between HRQoL and healthcare related costs?

        4. What are the care and support needs of ICU survivors during five years after ICU
           admission?

      Design:

      The MONITOR-IC study is a multicenter prospective controlled cohort study in which long-term
      outcomes of ICU patients are studied for a period of five year.

      The study will be carried out in ICUs of four hospitals in the Netherlands; one academic
      hospital, one teaching and two non-teaching hospitals. ICU patients will be recruited between
      July 2016 and July 2021 with a subsequent follow-up for five years.

      Inclusion:

      For the MONITOR-IC study the investigators estimated to include 12.000 patients. This
      estimation is based on: 1) the initial ICU admissions in the academic hospital and the three
      other participating hospitals together (2,500 and 2,200 respectively per year), and 2) an
      estimated response rate of 60%, which is based on previous conducted ICU studies. In the
      control cohort, the investigators will include approximately 3000 patients during the next
      four years.

      Patient recruitment:

      Patients scheduled for ICU admission after elective surgery, will be recruited at the
      outpatient clinic (anaesthesiology or cardiac surgery) (Figure 1). Patients with a
      non-scheduled admission will be recruited at the ICU. Patients will receive information by
      ICU nurses and intensivists regarding the aim, content and relevance of the study, and will
      be asked for participation. Informed consent is asked for the questionnaires, data from the
      patients' individual medical record and data from their health insurance company. In case
      patients are unable to give consent, their legal representative will be asked.

      Methods:

      Mixed methods will be used to collect data, including questionnaires, medical data from
      patient records, cost data from health insurance companies and interviews with ICU survivors
      and their family members.

      All patients, or their relatives in case patients are not able to fill in the questionnaire
      themselves, will be approached to fill in the self-administered paper based or online
      questionnaire in total eight times:at ICU admission (T0), at hospital discharge (T1), after 3
      months (T2), 12 months (T3), 24 months (T4), 36 months (T5), 48 months (T6) and 60 months
      after ICU admission (T7). To get insight into the situation before the ICU admission, the
      baseline questionnaire (T0) is provided when the patients is asked for informed consent. This
      could be preoperatively for the planned admissions or after admission at the ICU. Then,
      patients are asked to rate their situation before the ICU admission.

      Items in questionnaire:

        -  Patients' health status and HRQoL = SF-36 and the EQ-5D-5L.

        -  Patients' level of frailty and vulnerability = Clinical Frailty Score (CFS)

        -  The level of fatigue = CIS-8, a subscale of the Checklist Individual Strength

        -  Cognitive impairment = abbreviated 14-item Cognitive Failure Questionnaire (CFQ-14).

        -  Anxiety and depression = Hospital Anxiety and Depression Scale (HADS)

        -  Subjective distress, caused by traumatic events = Impact of Event Scale Revised (IES-R)

        -  Care needs and support from professionals and informal caregiver

        -  Social consequences = novel question set for changes in family circumstances,
           socio-economic stability and care requirements.

      Medical data Patients' demographics and information regarding their diagnosis and treatment,
      such as primary conditions, pre-existing co-morbidity, disease severity, sepsis,
      (re)admission, length of mechanical ventilation, length of ICU stay, delirium (CAM-ICU), pain
      (CPOT), expected mortality (based on the APACHE II, SAPS II, MPM II and APACHE III-IV models
      and medication, will be extracted from their medical record and the Dutch National Intensive
      Care Evaluation (NICE) registry.

      Health Insurance data Healthcare use and related costs, covered by the Dutch healthcare
      insurance, will be retrieved from Vektis; a Dutch organization which collects and manage
      health insurance claimed data of all health insurance companies in the Netherlands.This data
      is collected based on the Diagnosis Treatment Combination (DTC); a total set of activities
      carried out by the hospital and medical specialists. Additionally, data is collected
      regarding nursing days, visits at the outpatient clinic and emergency department, nursing
      homes, ambulance transport, consultation with general practitioner, paramedical care
      (including physiotherapist, occupational therapist, dietician and speech therapist),
      prescribed medication, mental healthcare and revalidation. The Vektis database contains data
      from all for healthcare insured citizens and covers 99% of the total Dutch population. Using
      patient's unique insurance number the investigators are able to merge patient's insurance
      data with the questionnaire data and medical data from the medical record at patient level.

      Care delivered by community nurses and informal caregivers is not included in the Vektis
      database and will be studied via the questionnaire.

      Interviews To get insight into the experiences of ICU survivors during five years after ICU
      admission and their need for support, face to face semi-structured interviews will be
      conducted with ICU survivors and their family members. Interviews will take place at the
      participants' preferred location (home or clinic). Interviews will be conducted until data
      saturation is reached.

      Patients will be purposively sampled based on various experienced outcomes, such as the
      quality of life, daily functioning, anxiety, depression, and their experienced needs for more
      information or emotional support. Experienced and trained researchers will conduct the
      interviews using a topic guide. This guide will be developed using the current literature and
      experience of the research team and will cover the following subjects: experiences with the
      ICU admission and follow-up, experienced problems and needs for support. All interviews will
      be audio recorded and transcribed verbatim.

      Analysis Questionnaires, medical record and health insurance data During the data collection,
      data are checked on a regular basis to identify out-of-range answers, inconsistent responses,
      and missing data. Data from the questionnaires, medical record and healthcare insurance data
      will be merged at patient level. Descriptive statistics will be used to describe baseline
      characteristics and the incidence of long-term outcomes. Regression analysis will be used to
      determine associations between patient characteristics, treatment, and long-term outcomes.
      Subgroups will be identified based on their illness and condition (for example sepsis,
      delirium, co morbidities, ARDS), treatment (for example length of ICU stay, duration of
      mechanical ventilation, dialysis) and social demographics (age, gender, education, family
      setting etc).

      In order to predict the various physical, cognitive and mental long-term outcomes, multiple
      prediction models will be developed. Multivariable linear (for continuous outcome variables)
      and logistic (for dichotomous outcome variables) regression analysis will be performed.
      Linear and logistic multilevel models will be used to compare long-term outcomes between the
      study population (cohort) and control cohort group.

      To determine the ratio between HRQoL and patient outcomes and the health related costs,
      quality adjusted life years (QALYs) will be calculated. QALYs are a measure of the state of
      health of a person or group in which the benefits, in terms of length of life, are adjusted
      to reflect the quality of life. QALYs are calculated by estimating the years of life
      remaining for particular treatment and weighting each year with a quality of life score.54
      Software Package for the Social Sciences (SPSS) will be used for data analysis.

      Interviews For the analysis of the interview data, the constant comparative method will be
      used. Relevant data will be identified and structured by open, axial and selective coding.

      Two researchers will independently code the transcripts to minimize subjectivity in findings.
      The differences and similarities between the codes will be discussed together, and in case of
      disagreement, a third researcher will be involved. In the meetings with the team, the
      codebook will be refined and emerging categories and themes will be discussed.

      Data analysis will be supported with the use of Atlas.ti, a qualitative data analysis
      program.
observational model: Cohort
time perspective: Prospective
measure: Health related quality of life
time frame: ICU discharge - 5 year follow up
description: SF-36
measure: Health related quality of life
time frame: ICU admission- 5 year follow up
description: EQ5D-5L
measure: Frailty as part of Physical-Cognitive-Mental impairments
time frame: ICU admission- 5 year follow up
description: CFS (Clinical Frailty Score)
measure: Fatigue as part of Physical-Cognitive-Mental impairments
time frame: ICU admission- 5 year follow up
description: CIS-8 (Checklist Individual Strength)
measure: Cognition as part of Physical-Cognitive-Mental impairments
time frame: ICU admission- 5 year follow up
description: CFQ-14
measure: Anxiety and depression as part of Physical-Cognitive-Mental impairments
time frame: ICU admission- 5 year follow up
description: HADS (Hospital Anxiety and Depression Scale)
measure: Post traumatic stress disorder as part of Physical-Cognitive-Mental impairments
time frame: ICU admission- 5 year follow up
description: IES-R (Impact of Event Scale Revised)
measure: Patients' care and support needs and social consequences
time frame: ICU admission- 5 year follow up
description: Questionnaire regarding specific needs and supports and social impact post ICU
measure: Patients' healthcare use and related costs
time frame: ICU admission- 5 year follow up
description: Data of healthcare insurance
arm group label: Cohort
description: Case group: critically ill patients admitted >12 hours to the ICU. Control group: critically ill patients to the ICU <12 hrs, or to Post Anaesthesia Care Unit (PACU), or Medium Care or High Dependency Unit.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 16 Years
maximum age: N/A
healthy volunteers: No
last name: Hans van der Hoeven, MD, PhD.
role: Principal Investigator
affiliation: Radboud university medical center, head of dep. Intensive Care Medicine
last name: Mark van den Boogaard, RN, PhD
phone: 0031-243665009
email: Mark.vandenBoogaard@radboudumc.nl
last name: Marieke Zegers, PhD.
phone: 0031-243653881
email: Marieke.Zegers@radboudumc.nl
facility: 
status: Recruiting
contact: 
contact backup: 
country: Netherlands
responsible party type: Sponsor
sharing ipd: No