<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/NCT03002701</url>
  </required_header>
  <id_info>
    <org_study_id>UNDERPIN-ICU</org_study_id>
    <nct_id>NCT03002701</nct_id>
  </id_info>
  <brief_title>The Impact of Nursing Delirium Preventive Interventions in the Intensive Care Unit</brief_title>
  <acronym>UNDERPIN-ICU</acronym>
  <official_title>The Impact of nUrsiNg DEliRium Preventive INterventions in the Intensive Care Unit (UNDERPIN-ICU): A Multi-centre, Stepped Wedge Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Radboud University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>ZonMw: The Netherlands Organisation for Health Research and Development</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Radboud University Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Delirium is a common disorder in Intensive Care Unit (ICU) patients and is associated with&#xD;
      serious short- and long-term consequences. This study focuses on a program of standardized&#xD;
      nursing and physical therapy interventions to prevent delirium in the ICU, and determines the&#xD;
      effect of the program on the number of delirium-coma-free days in 28 days and several&#xD;
      secondary outcomes in a multicenter randomized controlled trial.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Delirium is a common disorder in Intensive Care Unit (ICU) patients and is associated with&#xD;
      serious short- and long-term consequences, including re-intubations, ICU readmissions,&#xD;
      prolonged ICU and hospital stay, persistent cognitive problems, and higher mortality rates.&#xD;
      Considering the high incidence of delirium and its consequences, prevention of delirium is&#xD;
      imperative. This study focuses on a program of standardized nursing and physical therapy&#xD;
      interventions to prevent delirium in the ICU, called UNDERPIN-ICU (nUrsiNg DEliRium&#xD;
      Preventive INterventions in the ICU).&#xD;
&#xD;
      Objective: To determine the effect of the UNDERPIN-ICU program on the number of&#xD;
      delirium-coma-free days in 28 days and several secondary outcomes, such as delirium&#xD;
      incidence, the number of days of survival in 28 and 90 days and delirium-related outcomes.&#xD;
&#xD;
      Design and Setting: A multicenter stepped wedge cluster randomized controlled trial.&#xD;
&#xD;
      Methods: Eight to ten Dutch ICUs will implement the UNDERPIN-ICU program in a randomized&#xD;
      order. Every two months the UNDERPIN-ICU program will be implemented in an additional ICU&#xD;
      following a two months period of staff training. UNDERPIN-ICU consists of standardized&#xD;
      protocols focusing on several modifiable risk factors for delirium, including cognitive&#xD;
      impairment, sleep deprivation, immobility and visual and hearing impairment.&#xD;
&#xD;
      Participants: ICU patients aged ≥ 18 years (surgical, medical, or trauma) and at high risk&#xD;
      for delirium, E-PRE-DELIRIC ≥35%, will be included, unless delirium was detected prior ICU&#xD;
      admission, expected length of ICU stay is less then one day or when delirium assessment is&#xD;
      not possible.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 31, 2016</start_date>
  <completion_date type="Actual">May 31, 2020</completion_date>
  <primary_completion_date type="Actual">May 31, 2019</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>Crossover Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The number of delirium-coma-free days</measure>
    <time_frame>28 days</time_frame>
    <description>The number of days a patient is not delirious and not in coma in 28 days starting from the day of inclusion in the study after ICU admission.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Delirium incidence</measure>
    <time_frame>28 days</time_frame>
    <description>One or more episodes of positive delirium screening after ICU admission.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The number of days of survival</measure>
    <time_frame>28 days</time_frame>
    <description>The number of days survived since ICU admission.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The number of days of survival</measure>
    <time_frame>90 days</time_frame>
    <description>The number of days survived since ICU admission.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of mechanical ventilation</measure>
    <time_frame>28 days</time_frame>
    <description>The number of days a patient was mechanically ventilated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of re-intubation</measure>
    <time_frame>28 days</time_frame>
    <description>Patients who need to be intubated within 28 days after ICU admission, following a previous extubation, irrespectively the reason for re-intubation, will be counted as incident case for re-intubation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of ICU re-admission</measure>
    <time_frame>28 days</time_frame>
    <description>Patients who need to be readmitted to the ICU within 28 days, irrespectively the reason for readmission, will be counted as incident cases for ICU readmission.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of unplanned removal of tubes/catheters</measure>
    <time_frame>28 days</time_frame>
    <description>Incidents in which patients remove their tube or catheter themselves will be counted as incident cases for unplanned removal. The period in which this is measured is during patients' ICU stay or during the period when the patient is delirious (in case a patient is discharged to the ward) with a maximum of 28 days.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of physical restraints</measure>
    <time_frame>28 days</time_frame>
    <description>Patients who need physical restraints (fixation of their limbs to prevent them from removing tubes or lines) within 28 days, will be counted as incident cases for physical restraints.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ICU length of stay</measure>
    <time_frame>365 days</time_frame>
    <description>This is defined as the number of days a patient is admitted to the ICU. Hospital length of stay is defined as number of days a patient is admitted to the hospital.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital length of stay</measure>
    <time_frame>365 days</time_frame>
    <description>This is defined as the number of days a patient is admitted to the ICU. Hospital length of stay is defined as number of days a patient is admitted to the hospital.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health related quality of Life (HRQoL)</measure>
    <time_frame>90 days after ICU admission</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health related quality of Life (HRQoL)</measure>
    <time_frame>365 days after ICU admission</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-hoc analysis</measure>
    <time_frame>During admission</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cost-effectiveness</measure>
    <time_frame>During ICU admission</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1750</enrollment>
  <condition>Delirium</condition>
  <arm_group>
    <arm_group_label>Control - standard care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Prior to implementation of the intervention package the current standard of care will be maintained.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>After implementation the intervention package will be implemented as standard care.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>UNDERPIN-ICU program</intervention_name>
    <description>UNDERPIN-ICU consists of standardized protocols focusing on several modifiable risk factors for delirium, including cognitive impairment, sleep deprivation, immobility and visual and hearing impairment.</description>
    <arm_group_label>Intervention group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  aged ≥ 18 years&#xD;
&#xD;
          -  surgical, medical or trauma patients&#xD;
&#xD;
          -  admitted to one of the participating ICUs&#xD;
&#xD;
          -  at high risk for delirium (&gt;35% determined with the E-PRE-DELIRIC prediction tool)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  delirious before ICU admission&#xD;
&#xD;
          -  an ICU stay &lt; one day&#xD;
&#xD;
          -  reliable assessment for delirium is not possible due to: sustained coma; serious&#xD;
             auditory or visual disorders; inability to understand Dutch; severely mentally&#xD;
             disabled; serious receptive aphasia.&#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>Mark van den Boogaard, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Radboud University Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Radboud University Medical Center</name>
      <address>
        <city>Nijmegen</city>
        <state>Gelderland</state>
        <zip>6500HB</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Haaglanden Medical Center location Westeinde</name>
      <address>
        <city>Den Haag</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Gelderse Vallei</name>
      <address>
        <city>Ede</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical Spectrum Twente</name>
      <address>
        <city>Enschede</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital St. Jansdal</name>
      <address>
        <city>Harderwijk</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical Center Leeuwarden</name>
      <address>
        <city>Leeuwarden</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital ETZ location Elisabeth</name>
      <address>
        <city>Tilburg</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital ETZ location Tweesteden</name>
      <address>
        <city>Tilburg</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bernhoven Hospital</name>
      <address>
        <city>Uden</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Maxima Medical Center</name>
      <address>
        <city>Veldhoven</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ISALA clinics</name>
      <address>
        <city>Zwolle</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <link>
    <url>http://dx.doi.org/10.1016/j.ijnurstu.2016.11.018</url>
    <description>Related Info</description>
  </link>
  <results_reference>
    <citation>Wassenaar A, Rood P, Schoonhoven L, Teerenstra S, Zegers M, Pickkers P, van den Boogaard M. The impact of nUrsiNg DEliRium Preventive INnterventions in the Intensive Care Unit (UNDERPIN-ICU): A study protocol for a multi-centre, stepped wedge randomized controlled trial. Int J Nurs Stud. 2017 Mar;68:1-8. doi: 10.1016/j.ijnurstu.2016.11.018. Epub 2016 Dec 8.</citation>
    <PMID>28013104</PMID>
  </results_reference>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>November 25, 2016</study_first_submitted>
  <study_first_submitted_qc>December 21, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 26, 2016</study_first_posted>
  <last_update_submitted>October 8, 2020</last_update_submitted>
  <last_update_submitted_qc>October 8, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Prevention</keyword>
  <keyword>Critical care</keyword>
  <keyword>Delirium</keyword>
  <keyword>Nurse</keyword>
  <keyword>RCT</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Delirium</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03002701
org study id: UNDERPIN-ICU
nct id: NCT03002701
lead sponsor: 
collaborator: 
has dmc: No
Delirium is a common disorder in Intensive Care Unit (ICU) patients and is associated with
      serious short- and long-term consequences. This study focuses on a program of standardized
      nursing and physical therapy interventions to prevent delirium in the ICU, and determines the
      effect of the program on the number of delirium-coma-free days in 28 days and several
      secondary outcomes in a multicenter randomized controlled trial.
Delirium is a common disorder in Intensive Care Unit (ICU) patients and is associated with
      serious short- and long-term consequences, including re-intubations, ICU readmissions,
      prolonged ICU and hospital stay, persistent cognitive problems, and higher mortality rates.
      Considering the high incidence of delirium and its consequences, prevention of delirium is
      imperative. This study focuses on a program of standardized nursing and physical therapy
      interventions to prevent delirium in the ICU, called UNDERPIN-ICU (nUrsiNg DEliRium
      Preventive INterventions in the ICU).

      Objective: To determine the effect of the UNDERPIN-ICU program on the number of
      delirium-coma-free days in 28 days and several secondary outcomes, such as delirium
      incidence, the number of days of survival in 28 and 90 days and delirium-related outcomes.

      Design and Setting: A multicenter stepped wedge cluster randomized controlled trial.

      Methods: Eight to ten Dutch ICUs will implement the UNDERPIN-ICU program in a randomized
      order. Every two months the UNDERPIN-ICU program will be implemented in an additional ICU
      following a two months period of staff training. UNDERPIN-ICU consists of standardized
      protocols focusing on several modifiable risk factors for delirium, including cognitive
      impairment, sleep deprivation, immobility and visual and hearing impairment.

      Participants: ICU patients aged ≥ 18 years (surgical, medical, or trauma) and at high risk
      for delirium, E-PRE-DELIRIC ≥35%, will be included, unless delirium was detected prior ICU
      admission, expected length of ICU stay is less then one day or when delirium assessment is
      not possible.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: The number of delirium-coma-free days
time frame: 28 days
description: The number of days a patient is not delirious and not in coma in 28 days starting from the day of inclusion in the study after ICU admission.
measure: Delirium incidence
time frame: 28 days
description: One or more episodes of positive delirium screening after ICU admission.
measure: The number of days of survival
time frame: 28 days
description: The number of days survived since ICU admission.
measure: The number of days of survival
time frame: 90 days
description: The number of days survived since ICU admission.
measure: Duration of mechanical ventilation
time frame: 28 days
description: The number of days a patient was mechanically ventilated.
measure: Incidence of re-intubation
time frame: 28 days
description: Patients who need to be intubated within 28 days after ICU admission, following a previous extubation, irrespectively the reason for re-intubation, will be counted as incident case for re-intubation.
measure: Incidence of ICU re-admission
time frame: 28 days
description: Patients who need to be readmitted to the ICU within 28 days, irrespectively the reason for readmission, will be counted as incident cases for ICU readmission.
measure: Incidence of unplanned removal of tubes/catheters
time frame: 28 days
description: Incidents in which patients remove their tube or catheter themselves will be counted as incident cases for unplanned removal. The period in which this is measured is during patients' ICU stay or during the period when the patient is delirious (in case a patient is discharged to the ward) with a maximum of 28 days.
measure: Incidence of physical restraints
time frame: 28 days
description: Patients who need physical restraints (fixation of their limbs to prevent them from removing tubes or lines) within 28 days, will be counted as incident cases for physical restraints.
measure: ICU length of stay
time frame: 365 days
description: This is defined as the number of days a patient is admitted to the ICU. Hospital length of stay is defined as number of days a patient is admitted to the hospital.
measure: Hospital length of stay
time frame: 365 days
description: This is defined as the number of days a patient is admitted to the ICU. Hospital length of stay is defined as number of days a patient is admitted to the hospital.
measure: Health related quality of Life (HRQoL)
time frame: 90 days after ICU admission
measure: Health related quality of Life (HRQoL)
time frame: 365 days after ICU admission
measure: Post-hoc analysis
time frame: During admission
measure: Cost-effectiveness
time frame: During ICU admission
arm group label: Control - standard care
arm group type: No Intervention
description: Prior to implementation of the intervention package the current standard of care will be maintained.
arm group label: Intervention group
arm group type: Active Comparator
description: After implementation the intervention package will be implemented as standard care.
intervention type: Behavioral
intervention name: UNDERPIN-ICU program
description: UNDERPIN-ICU consists of standardized protocols focusing on several modifiable risk factors for delirium, including cognitive impairment, sleep deprivation, immobility and visual and hearing impairment.
arm group label: Intervention group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Mark van den Boogaard, PhD
role: Principal Investigator
affiliation: Radboud University Medical Center
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Netherlands
url: http://dx.doi.org/10.1016/j.ijnurstu.2016.11.018
description: Related Info
citation: Wassenaar A, Rood P, Schoonhoven L, Teerenstra S, Zegers M, Pickkers P, van den Boogaard M. The impact of nUrsiNg DEliRium Preventive INnterventions in the Intensive Care Unit (UNDERPIN-ICU): A study protocol for a multi-centre, stepped wedge randomized controlled trial. Int J Nurs Stud. 2017 Mar;68:1-8. doi: 10.1016/j.ijnurstu.2016.11.018. Epub 2016 Dec 8.
PMID: 28013104
responsible party type: Sponsor
mesh term: Delirium
sharing ipd: Undecided