<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/NCT01706744</url>
  </required_header>
  <id_info>
    <org_study_id>2009/1697</org_study_id>
    <nct_id>NCT01706744</nct_id>
  </id_info>
  <brief_title>Effect of Discharge Via an Intermediate Care Unit</brief_title>
  <official_title>Can Discharge Via an Intermediate Care Unit Prevent Aggravation of Disease and Loss of Functionality, Without Increasing the Level of Cost? A Controlled Observational Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Norwegian University of Science and Technology</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Norwegian University of Science and Technology</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The main goal is to investigate the following topics:&#xD;
&#xD;
        1. Can discharge via the Intermediate Care Unit in Stjørdal, compared to direct discharge&#xD;
           to Verdal Municipality, be equally effective in preventing aggravation of disease and&#xD;
           loss of function for patients over 60 years that have been hospitalized in Levanger&#xD;
           hospital?&#xD;
&#xD;
        2. Are the cost by discharge to the Intermediate Care Unit in Stjørdal, when the hospital&#xD;
           is not located in the same Municipality, comparable to the cost by direct discharge to&#xD;
           the Municipality of Verdal, for patients over 60 years that have been hospitalized in&#xD;
           Levanger hospital?&#xD;
&#xD;
        3. Which issues are considered important by patients and health personnel during discharge,&#xD;
           arrival and follow up in the Municipality, to ensure an optimal interaction between the&#xD;
           involved units.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>February 2010</start_date>
  <completion_date type="Actual">December 2013</completion_date>
  <primary_completion_date type="Actual">December 2013</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Hospital readmission</measure>
    <time_frame>30 days</time_frame>
    <description>Acute admission to hospital within 30 days from previous discharge</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Use of local health care services</measure>
    <time_frame>up to 1 year</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>death</measure>
    <time_frame>up to 1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>hospital admission</measure>
    <time_frame>up to 1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>functional assessment status</measure>
    <time_frame>up to 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health service cost</measure>
    <time_frame>up to 1 year</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">328</enrollment>
  <condition>Patients</condition>
  <condition>Aged</condition>
  <arm_group>
    <arm_group_label>Intermediate care unit</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Follow-up treatment and care in a intermediate care unit after discharge from hospital</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Local health care 1</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Discharge from hospital to usual care as provided by the local health and social care (Verdal)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Local health care 2</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Discharge from hospital to usual care as provided by the local health and social care (Stjørdal)</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Intermediate care unit</intervention_name>
    <arm_group_label>Intermediate care unit</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Local health care 1</intervention_name>
    <arm_group_label>Local health care 1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Local health care 2</intervention_name>
    <arm_group_label>Local health care 2</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patients 60 years old or older from Stjørdal- or Verdal municipality,&#xD;
&#xD;
          -  given consent,&#xD;
&#xD;
          -  admitted from their home,&#xD;
&#xD;
          -  diagnostics completed and necessary treatment started&#xD;
&#xD;
          -  the patient need not less than 3-4 days institutionalization for&#xD;
             treatment/rehabilitation/care&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with severe dementia&#xD;
&#xD;
          -  Patients with severe disease who cannot give consent&#xD;
&#xD;
          -  Patients with severe disease with short life expectancy (including severe cancer)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Roar Johnsen, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Norwegian University of Science and Technology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Sykehuset Levanger</name>
      <address>
        <city>Levanger</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Distriksmedisinsk Senter</name>
      <address>
        <city>Stjørdal</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Stjørdal Kommune</name>
      <address>
        <city>Stjørdal</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Verdal kommune</name>
      <address>
        <city>Verdal</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <results_reference>
    <citation>Dahl U, Johnsen R, Saetre R, Steinsbekk A. The influence of an intermediate care hospital on health care utilization among elderly patients--a retrospective comparative cohort study. BMC Health Serv Res. 2015 Feb 1;15:48. doi: 10.1186/s12913-015-0708-4.</citation>
    <PMID>25638151</PMID>
  </results_reference>
  <results_reference>
    <citation>Dahl U, Steinsbekk A, Jenssen S, Johnsen R. Hospital discharge of elderly patients to primary health care, with and without an intermediate care hospital - a qualitative study of health professionals' experiences. Int J Integr Care. 2014 Apr 30;14:e011. doi: 10.5334/ijic.1156. eCollection 2014 Apr.</citation>
    <PMID>24868194</PMID>
  </results_reference>
  <results_reference>
    <citation>Dahl U, Steinsbekk A, Johnsen R. Effectiveness of an intermediate care hospital on readmissions, mortality, activities of daily living and use of health care services among hospitalized adults aged 60 years and older--a controlled observational study. BMC Health Serv Res. 2015 Aug 28;15:351. doi: 10.1186/s12913-015-1022-x.</citation>
    <PMID>26315779</PMID>
  </results_reference>
  <verification_date>December 2015</verification_date>
  <study_first_submitted>October 11, 2012</study_first_submitted>
  <study_first_submitted_qc>October 12, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 15, 2012</study_first_posted>
  <last_update_submitted>December 7, 2015</last_update_submitted>
  <last_update_submitted_qc>December 7, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 8, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Hospital Readmissions</keyword>
  <keyword>Community Health Services</keyword>
  <keyword>Preventive Health Services</keyword>
  <keyword>Norway</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/NCT01706744
org study id: 2009/1697
nct id: NCT01706744
lead sponsor: 
has dmc: No
The main goal is to investigate the following topics:

        1. Can discharge via the Intermediate Care Unit in Stjørdal, compared to direct discharge
           to Verdal Municipality, be equally effective in preventing aggravation of disease and
           loss of function for patients over 60 years that have been hospitalized in Levanger
           hospital?

        2. Are the cost by discharge to the Intermediate Care Unit in Stjørdal, when the hospital
           is not located in the same Municipality, comparable to the cost by direct discharge to
           the Municipality of Verdal, for patients over 60 years that have been hospitalized in
           Levanger hospital?

        3. Which issues are considered important by patients and health personnel during discharge,
           arrival and follow up in the Municipality, to ensure an optimal interaction between the
           involved units.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Hospital readmission
time frame: 30 days
description: Acute admission to hospital within 30 days from previous discharge
measure: Use of local health care services
time frame: up to 1 year
measure: death
time frame: up to 1 year
measure: hospital admission
time frame: up to 1 year
measure: functional assessment status
time frame: up to 6 months
measure: Health service cost
time frame: up to 1 year
arm group label: Intermediate care unit
arm group type: Experimental
description: Follow-up treatment and care in a intermediate care unit after discharge from hospital
arm group label: Local health care 1
arm group type: Active Comparator
description: Discharge from hospital to usual care as provided by the local health and social care (Verdal)
arm group label: Local health care 2
arm group type: Active Comparator
description: Discharge from hospital to usual care as provided by the local health and social care (Stjørdal)
intervention type: Other
intervention name: Intermediate care unit
arm group label: Intermediate care unit
intervention type: Other
intervention name: Local health care 1
arm group label: Local health care 1
intervention type: Other
intervention name: Local health care 2
arm group label: Local health care 2
criteria: 
gender: All
minimum age: 60 Years
maximum age: 99 Years
healthy volunteers: No
last name: Roar Johnsen, PhD
role: Study Director
affiliation: Norwegian University of Science and Technology
facility: 
facility: 
facility: 
facility: 
country: Norway
citation: Dahl U, Johnsen R, Saetre R, Steinsbekk A. The influence of an intermediate care hospital on health care utilization among elderly patients--a retrospective comparative cohort study. BMC Health Serv Res. 2015 Feb 1;15:48. doi: 10.1186/s12913-015-0708-4.
PMID: 25638151
citation: Dahl U, Steinsbekk A, Jenssen S, Johnsen R. Hospital discharge of elderly patients to primary health care, with and without an intermediate care hospital - a qualitative study of health professionals' experiences. Int J Integr Care. 2014 Apr 30;14:e011. doi: 10.5334/ijic.1156. eCollection 2014 Apr.
PMID: 24868194
citation: Dahl U, Steinsbekk A, Johnsen R. Effectiveness of an intermediate care hospital on readmissions, mortality, activities of daily living and use of health care services among hospitalized adults aged 60 years and older--a controlled observational study. BMC Health Serv Res. 2015 Aug 28;15:351. doi: 10.1186/s12913-015-1022-x.
PMID: 26315779
responsible party type: Sponsor