<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/NCT03265275</url>
  </required_header>
  <id_info>
    <org_study_id>2017/CP</org_study_id>
    <nct_id>NCT03265275</nct_id>
  </id_info>
  <brief_title>Why Still in Hospital After Hip Fracture Surgery?</brief_title>
  <official_title>Why Still in Hospital After Hip Fracture Surgery?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Akershus</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Oslo University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital, Akershus</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>
      At our institution, hip fracture patients are admitted and treated according to a fast track&#xD;
      patient pathway. The aim of this study is to identify areas of this patient pathway that can&#xD;
      be improved. To achieve this, the study will investigate the underlying reasons for the&#xD;
      continued need for hospitalization on the consecutive days after hip fracture surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study will be conducted at the orthopedic department, Akershus University Hospital, as a&#xD;
      prospective observational study and will include approximately 200 consecutive hip fracture&#xD;
      patients. The patients will be evaluated once daily for the fulfillment of predefined&#xD;
      discharge criteria. If the discharge criteria are not met or if the criteria are met but the&#xD;
      patient is not discharged in spite of this the underlying reason(s) are recorded.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 11, 2017</start_date>
  <completion_date type="Actual">March 31, 2020</completion_date>
  <primary_completion_date type="Actual">February 28, 2020</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>Factors necessitating hospitalization after hip fracture surgery</measure>
    <time_frame>Recorded using a check-list once daily from first day after hip fracture surgery until discharge from the orthopedic department, typically between 1 to 14 days after hip fracture surgery</time_frame>
    <description>Recorded as: acute anemia, delirium, medical complications, pain, dizziness, nausea/vomiting, logistical reasons, unwillingness to be discharged, other (specified as free text)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of patients discharged to their preoperative level of care</measure>
    <time_frame>At hospital discharge, typically between 1 to 14 days after hip fracture surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of hospital stay</measure>
    <time_frame>At hospital discharge, typically between 1 to 14 days after hip fracture surgery</time_frame>
    <description>Length of hospital stay in days, stratified after type of operation</description>
  </secondary_outcome>
  <enrollment type="Actual">182</enrollment>
  <condition>Hip Fractures</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Fast track patient pathway</intervention_name>
    <description>Prehospital services establish a working diagnosis of hip fracture and initiate first line treatment. In the emergency department a specially trained nurse triages the patient. Patients without signs of other acute disease or trauma and who have not previously been operated in the same hip are directly transported to the x-ray suite. The x-rays are reviewed by the radiographer and in case of an obvious fracture of the hip the patient is transported directly to the orthopedic ward where the patient is received by a nurse and seen by an orthopedic surgeon. The pathway includes standard procedures for blood sampling, pain relief, including a fascia iliaca compartment block, intravenous fluids, transfusion triggers, management of anticoagulants and premedication. The pathway puts focus on prevention of pressure sores, a short preoperative fasting period and early mobilization. Screening tools are used to assess for delirium, nutritional status and fall risk.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients over 18 years of age, who have been operated for a hip fracture at the orthopedic&#xD;
        department, Akershus University Hospital.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Operated at the orthopedic department, Akershus University Hospital, for a hip&#xD;
             fracture&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Lack of written informed consent&#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>University Hospital, Akershus</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Akershus University hospital</name>
      <address>
        <city>Lørenskog</city>
        <zip>1478</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>August 23, 2017</study_first_submitted>
  <study_first_submitted_qc>August 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 29, 2017</study_first_posted>
  <last_update_submitted>November 26, 2020</last_update_submitted>
  <last_update_submitted_qc>November 26, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 30, 2020</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/NCT03265275
org study id: 2017/CP
nct id: NCT03265275
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
At our institution, hip fracture patients are admitted and treated according to a fast track
      patient pathway. The aim of this study is to identify areas of this patient pathway that can
      be improved. To achieve this, the study will investigate the underlying reasons for the
      continued need for hospitalization on the consecutive days after hip fracture surgery.
The study will be conducted at the orthopedic department, Akershus University Hospital, as a
      prospective observational study and will include approximately 200 consecutive hip fracture
      patients. The patients will be evaluated once daily for the fulfillment of predefined
      discharge criteria. If the discharge criteria are not met or if the criteria are met but the
      patient is not discharged in spite of this the underlying reason(s) are recorded.
observational model: Cohort
time perspective: Prospective
measure: Factors necessitating hospitalization after hip fracture surgery
time frame: Recorded using a check-list once daily from first day after hip fracture surgery until discharge from the orthopedic department, typically between 1 to 14 days after hip fracture surgery
description: Recorded as: acute anemia, delirium, medical complications, pain, dizziness, nausea/vomiting, logistical reasons, unwillingness to be discharged, other (specified as free text)
measure: Percentage of patients discharged to their preoperative level of care
time frame: At hospital discharge, typically between 1 to 14 days after hip fracture surgery
measure: Length of hospital stay
time frame: At hospital discharge, typically between 1 to 14 days after hip fracture surgery
description: Length of hospital stay in days, stratified after type of operation
intervention type: Other
intervention name: Fast track patient pathway
description: Prehospital services establish a working diagnosis of hip fracture and initiate first line treatment. In the emergency department a specially trained nurse triages the patient. Patients without signs of other acute disease or trauma and who have not previously been operated in the same hip are directly transported to the x-ray suite. The x-rays are reviewed by the radiographer and in case of an obvious fracture of the hip the patient is transported directly to the orthopedic ward where the patient is received by a nurse and seen by an orthopedic surgeon. The pathway includes standard procedures for blood sampling, pain relief, including a fascia iliaca compartment block, intravenous fluids, transfusion triggers, management of anticoagulants and premedication. The pathway puts focus on prevention of pressure sores, a short preoperative fasting period and early mobilization. Screening tools are used to assess for delirium, nutritional status and fall risk.
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: University Hospital, Akershus
facility: 
country: Norway
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