<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/NCT03759314</url>
  </required_header>
  <id_info>
    <org_study_id>§50, 27.3.2018</org_study_id>
    <nct_id>NCT03759314</nct_id>
  </id_info>
  <brief_title>Identification of Risk Patients in Emergency Medical Services</brief_title>
  <official_title>Identification of Risk Patients in Emergency Medical Services</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Helsinki University Central Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Helsinki</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Helsinki University Central Hospital</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>
      Background: Inadequate nutrition has been associated with growing risk of falling and&#xD;
      impaired ability in elderly patients. Falling is a significant threat to the health of the&#xD;
      elderly. It is estimated that one third of people over the age of 65 experience at least one&#xD;
      falling each year. Over 60% of the falls cause serious injury or disability. Adequate&#xD;
      nutrition increases the muscle strength of the elderly. Therefore, determining and managing&#xD;
      the nutrition level is important for preventing falling. As far as we know emergency medical&#xD;
      services has never before reported being a part of prevention by performing risk&#xD;
      identification.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Aim: The purpose of the study is to assess whether it is possible to use a simple screening&#xD;
      tool to find out the risk of falling, the nutritional status and the level of cognitive&#xD;
      functioning activity when the EMS faces the elderly over the age of 70 years. In addition,&#xD;
      the flow of information between primary care and emergency services and nutritionists is&#xD;
      examined.&#xD;
&#xD;
      Material and method: Identification of poor nutrition is carried out in the Helsinki&#xD;
      University hospital area. All people over the age of 70 requiring ambulance transport will be&#xD;
      included in the study for 4 months during 2018. A structured electronic form is used to&#xD;
      identify the malnutrition, the level of cognitive functioning activity and the risk of&#xD;
      falling. The assessment is performed during the transport. The data is analyzed by the SPSS&#xD;
      statistical program both by descriptive and statistical significance by looking at the&#xD;
      methods suitable for the data.&#xD;
&#xD;
      Conclusion: The information produced by the research aims to develop (a) Identifying in the&#xD;
      ambulance those patients who are at risk; and (b) activating nursing staff and nutritionists&#xD;
      and, by means of these measures, increase the number of patients receiving effective&#xD;
      nutrition therapy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2018</start_date>
  <completion_date type="Actual">January 28, 2022</completion_date>
  <primary_completion_date type="Actual">January 28, 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Identifying in the ambulance those patients who are at risk (over 3 points in a single section)</measure>
    <time_frame>Through study completion an average of 12 months</time_frame>
    <description>to use a simple screening tool to find out the risk of falling, the nutritional status and the level of cognitive functioning activity when the EMS faces the elderly over the age of 70 The risk-screening tool is based on valid scales. RISK SCREENING TOOL;&#xD;
Risk of falling:&#xD;
Prediction of falls (4 items, 0-3 points) Self-reporting of falls over a 12-month period (3 items, 0-3 points)&#xD;
Malnutrition Risk:&#xD;
Home care and meal services (Yes, No) Nutritional status (4 items, 0-3 points) Effect of the diseases on nutrition (4 items, 0-3 points) Age (1 item, 1 point)&#xD;
Delirium and cognitive functioning:&#xD;
Alertness / memory / attention deficit / symptoms (4 items, 0-3 points)&#xD;
Complete when:&#xD;
&gt; 70 years patient The patient's physical state allows. Mostly completed during transport (no need to add actual time on scene). Possible risk points are reported at donation to the emergency department.</description>
  </primary_outcome>
  <other_outcome>
    <measure>Identifying in the ambulance those patients who are at risk (total scores over sections)</measure>
    <time_frame>Through study completion an average of 12 months</time_frame>
    <description>Subscales are combined to compute a total score, if more than three points in total, the patient is considered to be a risk patient.</description>
  </other_outcome>
  <enrollment type="Actual">500</enrollment>
  <condition>Malnutrition</condition>
  <condition>Falling</condition>
  <condition>Cognitive Impairment</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Observation</intervention_name>
    <description>to use a simple screening tool to find out the risk of falling, the nutritional status and the level of cognitive functioning activity</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All people over the age of 70 requiring ambulance transport will be included in the study&#xD;
        for 4 months during 2018 in the Helsinki University hospital area.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All people over the age of 70 requiring ambulance transport will be included in the&#xD;
             study for 4 months during 2018.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>70 Years</minimum_age>
    <maximum_age>104 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Department of Emergency Medicine and Services, Helsinki University Hospital and Helsinki University, Helsinki, Finland</name>
      <address>
        <city>Helsinki</city>
        <state>Helsinki Usimaa</state>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Finland</country>
  </location_countries>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>November 15, 2018</study_first_submitted>
  <study_first_submitted_qc>November 28, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 29, 2018</study_first_posted>
  <last_update_submitted>January 28, 2022</last_update_submitted>
  <last_update_submitted_qc>January 28, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 31, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Helsinki University Central Hospital</investigator_affiliation>
    <investigator_full_name>Marja Mäkinen</investigator_full_name>
    <investigator_title>Researcher</investigator_title>
  </responsible_party>
  <keyword>EMS</keyword>
  <keyword>elderly</keyword>
  <keyword>nutrition</keyword>
  <keyword>falling</keyword>
  <keyword>cognitive functioning</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Malnutrition</mesh_term>
    <mesh_term>Emergencies</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/NCT03759314
org study id: §50, 27.3.2018
nct id: NCT03759314
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Background: Inadequate nutrition has been associated with growing risk of falling and
      impaired ability in elderly patients. Falling is a significant threat to the health of the
      elderly. It is estimated that one third of people over the age of 65 experience at least one
      falling each year. Over 60% of the falls cause serious injury or disability. Adequate
      nutrition increases the muscle strength of the elderly. Therefore, determining and managing
      the nutrition level is important for preventing falling. As far as we know emergency medical
      services has never before reported being a part of prevention by performing risk
      identification.
Aim: The purpose of the study is to assess whether it is possible to use a simple screening
      tool to find out the risk of falling, the nutritional status and the level of cognitive
      functioning activity when the EMS faces the elderly over the age of 70 years. In addition,
      the flow of information between primary care and emergency services and nutritionists is
      examined.

      Material and method: Identification of poor nutrition is carried out in the Helsinki
      University hospital area. All people over the age of 70 requiring ambulance transport will be
      included in the study for 4 months during 2018. A structured electronic form is used to
      identify the malnutrition, the level of cognitive functioning activity and the risk of
      falling. The assessment is performed during the transport. The data is analyzed by the SPSS
      statistical program both by descriptive and statistical significance by looking at the
      methods suitable for the data.

      Conclusion: The information produced by the research aims to develop (a) Identifying in the
      ambulance those patients who are at risk; and (b) activating nursing staff and nutritionists
      and, by means of these measures, increase the number of patients receiving effective
      nutrition therapy.
observational model: Other
time perspective: Retrospective
measure: Identifying in the ambulance those patients who are at risk (over 3 points in a single section)
time frame: Through study completion an average of 12 months
description: to use a simple screening tool to find out the risk of falling, the nutritional status and the level of cognitive functioning activity when the EMS faces the elderly over the age of 70 The risk-screening tool is based on valid scales. RISK SCREENING TOOL;
Risk of falling:
Prediction of falls (4 items, 0-3 points) Self-reporting of falls over a 12-month period (3 items, 0-3 points)
Malnutrition Risk:
Home care and meal services (Yes, No) Nutritional status (4 items, 0-3 points) Effect of the diseases on nutrition (4 items, 0-3 points) Age (1 item, 1 point)
Delirium and cognitive functioning:
Alertness / memory / attention deficit / symptoms (4 items, 0-3 points)
Complete when:
> 70 years patient The patient's physical state allows. Mostly completed during transport (no need to add actual time on scene). Possible risk points are reported at donation to the emergency department.
measure: Identifying in the ambulance those patients who are at risk (total scores over sections)
time frame: Through study completion an average of 12 months
description: Subscales are combined to compute a total score, if more than three points in total, the patient is considered to be a risk patient.
intervention type: Other
intervention name: Observation
description: to use a simple screening tool to find out the risk of falling, the nutritional status and the level of cognitive functioning activity
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 70 Years
maximum age: 104 Years
healthy volunteers: No
facility: 
country: Finland
responsible party type: Principal Investigator
investigator affiliation: Helsinki University Central Hospital
investigator full name: Marja Mäkinen
investigator title: Researcher
mesh term: Malnutrition
mesh term: Emergencies
sharing ipd: Undecided