<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/NCT01706133</url>
  </required_header>
  <id_info>
    <org_study_id>R-201 l-785-056</org_study_id>
    <nct_id>NCT01706133</nct_id>
  </id_info>
  <brief_title>An Intervention for Elderly in Emergency Services</brief_title>
  <official_title>Elderly in Emergency Services: Effectiveness of an Intervention to Improve Health Outcomes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Coordinación de Investigación en Salud, Mexico</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Instituto Mexicano del Seguro Social</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Coordinación de Investigación en Salud, Mexico</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      -Can a scheme based on inter geriatricians visiting nurse consultants and reduce negative&#xD;
      impacts on the health of elderly over 70 years ?&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      - Usual care as the comparison group&#xD;
&#xD;
      Usual care or standard refers to those processes or services that the elderly claimant&#xD;
      receives the IMSS services network, after the acute phase of their illness has been&#xD;
      stabilized and is defined that can be discharged from the emergency department, following&#xD;
      clinical and therapeutic recommendations for improving their health.&#xD;
&#xD;
        -  Elders risk population for emergency&#xD;
&#xD;
      The aging population brings a major change in health conditions and social conditions around&#xD;
      the elderly, the analysis of the elderly population is considered according to functionality&#xD;
      and risks of old age, when it comes to care services emergency, care becomes more critical as&#xD;
      the elderly are older, have been identified adults of 70 and over as more vulnerable to&#xD;
      health services, especially for the emergency services as they do not exhibit classic&#xD;
      patterns to acute events of prevalent diseases.&#xD;
&#xD;
        -  Functionality and dependence&#xD;
&#xD;
      The commitment of the functionality in adults older than 65 may be present in 5% of cases,&#xD;
      while in over 70 years this figure rises to 50% or more. Functional impairment may be a&#xD;
      &quot;marker&quot; of the effect of systemic disease on the patient and is also an indicator of&#xD;
      severity of disease because it measures the ability of independence&#xD;
&#xD;
      The accumulation of normal aging characteristics define a threshold, which once pierced,&#xD;
      tends to increase the propensity for loss of functional abilities due to aging. However, not&#xD;
      everyone ages the same way, since factors such as inherited genetic capital, especially the&#xD;
      accumulation of risks associated with lifestyle and work activities, and the opportunity to&#xD;
      identify the disease in its period latency coupled with the accessibility and use of health&#xD;
      services, can delay or exacerbate the loss of functionality and increase the dependency of&#xD;
      the elderly.&#xD;
&#xD;
        -  Quality of life of older&#xD;
&#xD;
      Frailty in the elderly is a state of increased susceptibility due to less booking multiple&#xD;
      physiological systems resulting in lower resilience, negative energy balance, sarcopenia,&#xD;
      decreased strength and reduced exercise tolerance. Frailty is associated with adverse health&#xD;
      outcomes such as institutionalization, falls, reduced performance status and increased&#xD;
      mortality.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2013</start_date>
  <primary_completion_date type="Actual">March 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in hand grip strength (HS) as a physical performance test</measure>
    <time_frame>Basal and Six months</time_frame>
    <description>A standardized technique and digital dynamometers (Exacta TM) wil lbe used, and the best result of two tests in the dominant hand will be used for analysis. No cut-off points will be applied; instead the variable will be assessed as a continuous one with kilograms as the units of measure.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Evaluation of individual and institutional impact</measure>
    <time_frame>Six Months</time_frame>
    <description>Evaluate the impact of a scheme based on internal consultation geriatricians and home visiting nurses oriented elders 70 and over, in terms of individual outcomes and health services:&#xD;
a. Individual Impacts:&#xD;
a.1 Primary:&#xD;
• Fragility</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Quantify hospital readmissions</measure>
    <time_frame>One Year</time_frame>
    <description>Estimate the readmission to hospital adverse events in adults older than 70 years, underwent surgery and its comparison group from discharge from service</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">1400</enrollment>
  <condition>Stroke</condition>
  <condition>Ischemic Attack</condition>
  <condition>Diabetes Mellitus</condition>
  <condition>Hypertension</condition>
  <condition>Fragility</condition>
  <arm_group>
    <arm_group_label>Basal phase</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Integrated measurement of all variables involved impact and frequency of prior use of health services and specifically to the emergency room, service access, patient characteristics, features for the classification of frailty, cognitive impairment and depression, why consultation, triage scale level on admission to the service and to the service variables in terms of length of stay, diagnosis and medical management, and related services with internal consultants percentage of inpatients discharged or deceased, in further analysis the researchers undertake group estimating frequency of use and the identification of factors associated with the use of emergency departments and adverse events</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Factors associated with the use of emergency departments</intervention_name>
    <description>Participants who were assigned to the intervention will be evaluated jointly by the medical service by a medical specialist in geriatrics and a nurse trained in gerontology and geriatrics. The doctor will monitor the apparition and / or aggravation of any geriatric syndromes already established by the specialty in geriatrics, namely, polypharmacy, delirium, dementia, depression, risk of falls, etc.. The nurse will monitor and follow up in four areas I. medical issues (pressure ulcers, infusion, mobility); II. Mental and emotional state and coping strategies with hospitalization; III. functionality, and IV. Atmosphere (A. Service status, architectural difficulties for mobility, bathing etc. B. Support Network, caregiver, and C. hardship)</description>
    <arm_group_label>Basal phase</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults 70 and over.&#xD;
&#xD;
          -  Both sexes&#xD;
&#xD;
          -  Affiliation force in the IMSS&#xD;
&#xD;
          -  Attending spontaneously or referred to the emergency department of hospitals in the&#xD;
             study.&#xD;
&#xD;
          -  Agree to participate in the study phase in observational or intervention by signed&#xD;
             written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Adults 70 and older whose income is service by:&#xD;
&#xD;
             a. A very serious acute condition with imminent risk to life and requires immediate&#xD;
             emergency care, cataloged by the Triage system marked by the IMSS as Red or (state the&#xD;
             patient's functional impairment characterized by high and low, with imminent risk life&#xD;
             or the integrity and function of some of their organs and requires immediate medical&#xD;
             attention since his arrival to the emergency room) or require emergency care (patient&#xD;
             condition characterized by acute and severe functional impairment, life-threatening or&#xD;
             the integrity and function of some of their organs and requires medical attention&#xD;
             within the next 10 minutes after arrival at the emergency department).&#xD;
&#xD;
               -  An automobile accident&#xD;
&#xD;
               -  Burn-grade II or III&#xD;
&#xD;
               -  Partial or total unconsciousness&#xD;
&#xD;
               -  Severe cognitive impairment&#xD;
&#xD;
          2. Individuals who do not agree to participate in the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>70 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Carmen García-Peña, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Epidemiological Research Unit and Health Services. XXI Century National Medical Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Sergio Sánchez García, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Epidemiological Research Unit and Health Services. XXI Century National Medical Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Teresa Juarez Cedillo, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Epidemiological Research Unit and Health Services. XXI Century National Medical Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Rogelio Moncada Tobias, Doctor</last_name>
    <role>Study Chair</role>
    <affiliation>Emergency Service. General Hospital Zone No.2</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Nubia Franco Alvarez, Doctor</last_name>
    <role>Study Chair</role>
    <affiliation>Internal Medicine. General Hospital Zone No. 2</affiliation>
  </overall_official>
  <overall_official>
    <last_name>José García González, Master</last_name>
    <role>Study Chair</role>
    <affiliation>Department of Nephrology. Regional General Hospital No. 1</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ulises Pérez Zepeda, Master</last_name>
    <role>Study Chair</role>
    <affiliation>Institute of Geriatrics</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Leslie Viridiana Robles Jiménez, Doctor</last_name>
    <role>Study Chair</role>
    <affiliation>National Institute of Psychiatry</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>XXI Century National Medical</name>
      <address>
        <city>Mexico</city>
        <state>Distrito Federal</state>
        <zip>06725</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Mexico</country>
  </location_countries>
  <verification_date>February 2015</verification_date>
  <study_first_submitted>October 10, 2012</study_first_submitted>
  <study_first_submitted_qc>October 11, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 15, 2012</study_first_posted>
  <last_update_submitted>February 3, 2015</last_update_submitted>
  <last_update_submitted_qc>February 3, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 4, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Coordinación de Investigación en Salud, Mexico</investigator_affiliation>
    <investigator_full_name>Maria del Carmen Garcia-Pena</investigator_full_name>
    <investigator_title>Head, Research Unit on Aging</investigator_title>
  </responsible_party>
  <keyword>Frailty, emergency services, elderly</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Emergencies</mesh_term>
  </condition_browse>
  <!-- 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/NCT01706133
org study id: R-201 l-785-056
nct id: NCT01706133
lead sponsor: 
collaborator: 
has dmc: No
-Can a scheme based on inter geriatricians visiting nurse consultants and reduce negative
      impacts on the health of elderly over 70 years ?
- Usual care as the comparison group

      Usual care or standard refers to those processes or services that the elderly claimant
      receives the IMSS services network, after the acute phase of their illness has been
      stabilized and is defined that can be discharged from the emergency department, following
      clinical and therapeutic recommendations for improving their health.

        -  Elders risk population for emergency

      The aging population brings a major change in health conditions and social conditions around
      the elderly, the analysis of the elderly population is considered according to functionality
      and risks of old age, when it comes to care services emergency, care becomes more critical as
      the elderly are older, have been identified adults of 70 and over as more vulnerable to
      health services, especially for the emergency services as they do not exhibit classic
      patterns to acute events of prevalent diseases.

        -  Functionality and dependence

      The commitment of the functionality in adults older than 65 may be present in 5% of cases,
      while in over 70 years this figure rises to 50% or more. Functional impairment may be a
      "marker" of the effect of systemic disease on the patient and is also an indicator of
      severity of disease because it measures the ability of independence

      The accumulation of normal aging characteristics define a threshold, which once pierced,
      tends to increase the propensity for loss of functional abilities due to aging. However, not
      everyone ages the same way, since factors such as inherited genetic capital, especially the
      accumulation of risks associated with lifestyle and work activities, and the opportunity to
      identify the disease in its period latency coupled with the accessibility and use of health
      services, can delay or exacerbate the loss of functionality and increase the dependency of
      the elderly.

        -  Quality of life of older

      Frailty in the elderly is a state of increased susceptibility due to less booking multiple
      physiological systems resulting in lower resilience, negative energy balance, sarcopenia,
      decreased strength and reduced exercise tolerance. Frailty is associated with adverse health
      outcomes such as institutionalization, falls, reduced performance status and increased
      mortality.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Health Services Research
masking: Single (Outcomes Assessor)
measure: Change in hand grip strength (HS) as a physical performance test
time frame: Basal and Six months
description: A standardized technique and digital dynamometers (Exacta TM) wil lbe used, and the best result of two tests in the dominant hand will be used for analysis. No cut-off points will be applied; instead the variable will be assessed as a continuous one with kilograms as the units of measure.
measure: Evaluation of individual and institutional impact
time frame: Six Months
description: Evaluate the impact of a scheme based on internal consultation geriatricians and home visiting nurses oriented elders 70 and over, in terms of individual outcomes and health services:
a. Individual Impacts:
a.1 Primary:
• Fragility
measure: Quantify hospital readmissions
time frame: One Year
description: Estimate the readmission to hospital adverse events in adults older than 70 years, underwent surgery and its comparison group from discharge from service
arm group label: Basal phase
arm group type: No Intervention
description: Integrated measurement of all variables involved impact and frequency of prior use of health services and specifically to the emergency room, service access, patient characteristics, features for the classification of frailty, cognitive impairment and depression, why consultation, triage scale level on admission to the service and to the service variables in terms of length of stay, diagnosis and medical management, and related services with internal consultants percentage of inpatients discharged or deceased, in further analysis the researchers undertake group estimating frequency of use and the identification of factors associated with the use of emergency departments and adverse events
intervention type: Other
intervention name: Factors associated with the use of emergency departments
description: Participants who were assigned to the intervention will be evaluated jointly by the medical service by a medical specialist in geriatrics and a nurse trained in gerontology and geriatrics. The doctor will monitor the apparition and / or aggravation of any geriatric syndromes already established by the specialty in geriatrics, namely, polypharmacy, delirium, dementia, depression, risk of falls, etc.. The nurse will monitor and follow up in four areas I. medical issues (pressure ulcers, infusion, mobility); II. Mental and emotional state and coping strategies with hospitalization; III. functionality, and IV. Atmosphere (A. Service status, architectural difficulties for mobility, bathing etc. B. Support Network, caregiver, and C. hardship)
arm group label: Basal phase
criteria: 
gender: All
minimum age: 70 Years
maximum age: N/A
healthy volunteers: No
last name: Carmen García-Peña, PhD
role: Principal Investigator
affiliation: Epidemiological Research Unit and Health Services. XXI Century National Medical Center
last name: Sergio Sánchez García, PhD
role: Study Chair
affiliation: Epidemiological Research Unit and Health Services. XXI Century National Medical Center
last name: Teresa Juarez Cedillo, PhD
role: Study Chair
affiliation: Epidemiological Research Unit and Health Services. XXI Century National Medical Center
last name: Rogelio Moncada Tobias, Doctor
role: Study Chair
affiliation: Emergency Service. General Hospital Zone No.2
last name: Nubia Franco Alvarez, Doctor
role: Study Chair
affiliation: Internal Medicine. General Hospital Zone No. 2
last name: José García González, Master
role: Study Chair
affiliation: Department of Nephrology. Regional General Hospital No. 1
last name: Ulises Pérez Zepeda, Master
role: Study Chair
affiliation: Institute of Geriatrics
last name: Leslie Viridiana Robles Jiménez, Doctor
role: Study Chair
affiliation: National Institute of Psychiatry
facility: 
country: Mexico
responsible party type: Principal Investigator
investigator affiliation: Coordinación de Investigación en Salud, Mexico
investigator full name: Maria del Carmen Garcia-Pena
investigator title: Head, Research Unit on Aging
mesh term: Emergencies