<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/NCT02986399</url>
  </required_header>
  <id_info>
    <org_study_id>284907</org_study_id>
    <nct_id>NCT02986399</nct_id>
  </id_info>
  <brief_title>Fast Track Hip Fracture - an Optimized Pathway for Hip Fracture Patients</brief_title>
  <official_title>Influence of a Fast Track Pathway for Hip Fracture Patients on Mortality and Quality of Life</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Akershus</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Haukeland University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital, Akershus</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study examines if the introduction of a fast track pathway for hip fracture patients had&#xD;
      an influence on mortality and quality of life by comparing these outcomes between all hip&#xD;
      fracture patients operated at Akershus University Hospital two years before and two years&#xD;
      after this change in standard care.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The Norwegian hip fracture register prospectively collects data on all hip fracture patients&#xD;
      including, among others, time to surgery, type of fracture, type of surgery and American&#xD;
      Society of Anesthesiologists (ASA) score. The register also collects quality of life data 4&#xD;
      and 12 months after surgery. Using the unique Norwegian personal identification number the&#xD;
      data from the Norwegian hip fracture register will be connected with data from the electronic&#xD;
      patient record at Akershus University hospital (AHUS). Fast track surgery for hip fracture&#xD;
      patients was introduced at the end of 2013. Mortality and quality of life data will be&#xD;
      compared for all hip fracture patients operated at AHUS two years before and two years after&#xD;
      this change in standard care. The combined data from the register and the electronic patient&#xD;
      records will be used for regression analysis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2012</start_date>
  <completion_date type="Actual">September 14, 2017</completion_date>
  <primary_completion_date type="Actual">September 14, 2017</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>30 day mortality rate</measure>
    <time_frame>Within 30 days from surgery</time_frame>
    <description>Percentage of patients who die within 30 days from hip fracture surgery</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>1 year mortality rate</measure>
    <time_frame>Within 1 year from surgery</time_frame>
    <description>Percentage of patients who die within 1 year from hip fracture surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life</measure>
    <time_frame>4 and 12 months from surgery</time_frame>
    <description>Quality of life measured by EQ-5D</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Readmissions</measure>
    <time_frame>Within 30 days from discharge</time_frame>
    <description>Unscheduled, all-cause readmission within 30 days from discharge from the index admission</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative infection</measure>
    <time_frame>Within 1 year from surgery</time_frame>
    <description>Superficial and / or deep surgical site infection</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Re-operation</measure>
    <time_frame>Within 1 year from surgery</time_frame>
    <description>All-cause re-operation at the site of the index surgery</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">2495</enrollment>
  <condition>Hip Fractures</condition>
  <arm_group>
    <arm_group_label>Standard care</arm_group_label>
    <description>Hip fracture patients operated at Akershus University hospital in 2012 and 2013.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Fast track patient pathway</arm_group_label>
    <description>Hip fracture patients operated at Akershus University hospital in 2014 and 2015.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Fast track patient pathway</intervention_name>
    <description>Admittance: Ambulance - Radiology - Orthopaedic ward. Focus on preoperative information, stress reduction, pain relief, early mobilization and nutritional status.</description>
    <arm_group_label>Fast track patient pathway</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adult hip fracture patients operated at Akershus university hospital in 2012, 2013, 2014&#xD;
        and 2015.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Operated at Akershus university hospital for a hip fracture (neck of femur,&#xD;
             trochanteric, subtrochanteric) in 2012, 2013, 2014 or 2015&#xD;
&#xD;
          -  18 years or older&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  stress fracture&#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>Asbjorn Aaroen, Professor</last_name>
    <role>Study Director</role>
    <affiliation>Akershus University Hospital and Faculty of Medicine, University of Oslo</affiliation>
  </overall_official>
  <verification_date>February 2018</verification_date>
  <study_first_submitted>December 6, 2016</study_first_submitted>
  <study_first_submitted_qc>December 6, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 8, 2016</study_first_posted>
  <last_update_submitted>February 2, 2018</last_update_submitted>
  <last_update_submitted_qc>February 2, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 5, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Hospital, Akershus</investigator_affiliation>
    <investigator_full_name>Asbjorn Aroen</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>fast track</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fractures, Bone</mesh_term>
    <mesh_term>Hip Fractures</mesh_term>
  </condition_browse>
  <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/NCT02986399
org study id: 284907
nct id: NCT02986399
lead sponsor: 
collaborator: 
has dmc: No
The study examines if the introduction of a fast track pathway for hip fracture patients had
      an influence on mortality and quality of life by comparing these outcomes between all hip
      fracture patients operated at Akershus University Hospital two years before and two years
      after this change in standard care.
The Norwegian hip fracture register prospectively collects data on all hip fracture patients
      including, among others, time to surgery, type of fracture, type of surgery and American
      Society of Anesthesiologists (ASA) score. The register also collects quality of life data 4
      and 12 months after surgery. Using the unique Norwegian personal identification number the
      data from the Norwegian hip fracture register will be connected with data from the electronic
      patient record at Akershus University hospital (AHUS). Fast track surgery for hip fracture
      patients was introduced at the end of 2013. Mortality and quality of life data will be
      compared for all hip fracture patients operated at AHUS two years before and two years after
      this change in standard care. The combined data from the register and the electronic patient
      records will be used for regression analysis.
observational model: Cohort
time perspective: Retrospective
measure: 30 day mortality rate
time frame: Within 30 days from surgery
description: Percentage of patients who die within 30 days from hip fracture surgery
measure: 1 year mortality rate
time frame: Within 1 year from surgery
description: Percentage of patients who die within 1 year from hip fracture surgery
measure: Quality of life
time frame: 4 and 12 months from surgery
description: Quality of life measured by EQ-5D
measure: Readmissions
time frame: Within 30 days from discharge
description: Unscheduled, all-cause readmission within 30 days from discharge from the index admission
measure: Postoperative infection
time frame: Within 1 year from surgery
description: Superficial and / or deep surgical site infection
measure: Re-operation
time frame: Within 1 year from surgery
description: All-cause re-operation at the site of the index surgery
arm group label: Standard care
description: Hip fracture patients operated at Akershus University hospital in 2012 and 2013.
arm group label: Fast track patient pathway
description: Hip fracture patients operated at Akershus University hospital in 2014 and 2015.
intervention type: Other
intervention name: Fast track patient pathway
description: Admittance: Ambulance - Radiology - Orthopaedic ward. Focus on preoperative information, stress reduction, pain relief, early mobilization and nutritional status.
arm group label: Fast track patient pathway
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Asbjorn Aaroen, Professor
role: Study Director
affiliation: Akershus University Hospital and Faculty of Medicine, University of Oslo
responsible party type: Principal Investigator
investigator affiliation: University Hospital, Akershus
investigator full name: Asbjorn Aroen
investigator title: Professor
mesh term: Fractures, Bone
mesh term: Hip Fractures
sharing ipd: No