<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/NCT03840759</url>
  </required_header>
  <id_info>
    <org_study_id>CMRPG8F1571</org_study_id>
    <nct_id>NCT03840759</nct_id>
  </id_info>
  <brief_title>Short-term Effects of an Inpatient Geriatric Consultation Team on Geriatric Syndrome Patients</brief_title>
  <official_title>A Pilot Study of the Short-term Effects of an Inpatient Geriatric Consultation Team on Geriatric Syndrome Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chang Gung Memorial Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chang Gung Memorial 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>
      Patients admitted to acute ordinary wards in a medical center in Southern Taiwan from an&#xD;
      elder-integrated outpatient department or emergency room from January 2017 to December 2017&#xD;
      were included if they met the following criteria: (i) age 65 years or older, (ii) Barthel&#xD;
      index score ≦60 and (iii) with at least one of the following geriatric syndromes: unsteady&#xD;
      gait or easy-to-fall ( falls ≧ 2 in last 1 year), malnutrition with Mini Nutritional&#xD;
      Assessment-Short Form screening score &lt; 12, urinary incontinence, pressure sores, dementia,&#xD;
      delirium, depression, polypharmacy (≧8 medications), and excessive utilization of healthcare&#xD;
      facilities (admission≧2, visit Emergency≧2, or visit outpatient department≧12 in one month).&#xD;
      Patients were excluded if they were in a vegetative state, under palliative care or&#xD;
      terminally ill and suffering from acute illness needing to be transferred to or cared for in&#xD;
      the Intensive Care Unit.&#xD;
&#xD;
      Human participant approval was obtained from the Chang Gung Medical Foundation Institutional&#xD;
      Review Board before data collection. Participants were recruited from the ordinary wards by&#xD;
      research assistants who screened the admission list every morning if they met the inclusion&#xD;
      criteria. Then, the detail of the research was explained to the patients and families. They&#xD;
      were allowed to choose to be in the control group or the intervention group. After the&#xD;
      participants and or family agreed, informed consent was signed. For those who were&#xD;
      cognitively impaired or suffered from dementia, informed consent was signed by their relative&#xD;
      or partner. For the intervention group, a geriatric physician was consulted and&#xD;
      recommendations were made by the geriatric consultant after a complete geriatric assessment.&#xD;
      Besides the geriatric physician, the investigator's multidisciplinary team included a social&#xD;
      worker, nutritionist and physical therapist. In the control group, the participants only&#xD;
      received routine hospital care and no geriatric physician was consulted.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Participants were recruited from the ordinary wards by research assistants who screened the&#xD;
      admission list every morning if they met the inclusion criteria. Then, the detail of the&#xD;
      research was explained to the patients and families. They were allowed to choose to be in the&#xD;
      control group or the intervention group. After the participants and or family agreed,&#xD;
      informed consent was signed. For those who were cognitively impaired or suffered from&#xD;
      dementia, informed consent was signed by their relative or partner. For the intervention&#xD;
      group, a geriatric physician was consulted and recommendations were made by the geriatric&#xD;
      consultant after a complete CGA. The CGA includes the assessment of depression, dementia,&#xD;
      physical performance of Activity of Daily Living (ADL) and nutrition using Geriatric&#xD;
      Depression Scale (GDC-15), Mini-Mental State Examination (MMSE), Barthel Index (BI), and Mini&#xD;
      Nutritional Assessment-Short Form (MNA®-SF) respectively. Besides the geriatric physician,&#xD;
      our multidisciplinary team included a social worker, nutritionist and physical therapist. In&#xD;
      the control group, the participants only received routine hospital care and no geriatric&#xD;
      physician was consulted. The case manager nurse filed the participant's baseline data and&#xD;
      clinical problems. After discharge, the participant's condition was assessed via telephone in&#xD;
      the first, third and six months after discharge.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2017</start_date>
  <completion_date type="Actual">December 31, 2017</completion_date>
  <primary_completion_date type="Actual">December 31, 2017</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>readmission rate</measure>
    <time_frame>readmission rate within one month after discharge</time_frame>
    <description>compare the differences of readmission rates between the intervention and control groups</description>
  </primary_outcome>
  <primary_outcome>
    <measure>readmission rate</measure>
    <time_frame>readmission rate within three months after discharge</time_frame>
    <description>compare the differences of readmission rates between the intervention and control groups</description>
  </primary_outcome>
  <primary_outcome>
    <measure>readmission rate</measure>
    <time_frame>readmission rate within six months after discharge</time_frame>
    <description>compare the differences of readmission rates between the intervention and control groups</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>mortality rate</measure>
    <time_frame>mortality rate within one month after discharge</time_frame>
    <description>compare the differences of mortality rates between the intervention and control groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>mortality rate</measure>
    <time_frame>mortality rate within three months after discharge</time_frame>
    <description>compare the differences of mortality rates between the intervention and control groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>mortality rate</measure>
    <time_frame>mortality rate within six months after discharge</time_frame>
    <description>compare the differences of mortality rates between the intervention and control groups</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">59</enrollment>
  <condition>Depression</condition>
  <condition>Senile Dementia</condition>
  <arm_group>
    <arm_group_label>usual care</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>For the intervention group, a geriatric physician was consulted and recommendations were made by the geriatric consultant and inpatient geriatric consultation team after a complete geriatric assessment (CGA). The CGA includes the assessment of depression, dementia, physical performance of Activity of Daily Living (ADL) and nutrition using Geriatric Depression Scale (GDC-15), Mini-Mental State Examination (MMSE), Barthel Index (BI), and Mini Nutritional Assessment-Short Form (MNA®-SF) respectively. Besides the geriatric physician, our multidisciplinary team included a social worker, nutritionist and physical therapist. In the control group, the participants only received routine hospital care and no geriatric physician was consulted.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>inpatient geriatric consultation team</intervention_name>
    <description>For the intervention group, a geriatric physician was consulted and recommendations were made by the geriatric consultant after a complete CGA.</description>
    <arm_group_label>usual care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        (i) age 65 years or older, (ii) Barthel index (BI) [18] score ≦60 and (iii) with at least&#xD;
        one of the following geriatric syndromes: unsteady gait or easy-to-fall ( falls ≧ 2 in last&#xD;
        1 year), malnutrition with Mini Nutritional Assessment-Short Form (MNA®-SF) screening score&#xD;
        &lt; 12, urinary incontinence, pressure sores, dementia, delirium, depression, polypharmacy&#xD;
        (≧8 medications), and excessive utilization of healthcare facilities (admission≧2, visit&#xD;
        Emergency≧2, or visit outpatient department≧12 in one month)-&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Patients were excluded if they were in a vegetative state, under palliative care or&#xD;
        terminally ill and suffering from acute illness needing to be transferred to or cared for&#xD;
        in the Intensive Care Unit.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Song-Seng Loke</last_name>
    <role>Study Director</role>
  </overall_official>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>January 30, 2019</study_first_submitted>
  <study_first_submitted_qc>February 13, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 15, 2019</study_first_posted>
  <last_update_submitted>February 13, 2019</last_update_submitted>
  <last_update_submitted_qc>February 13, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 15, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alzheimer Disease</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/NCT03840759
org study id: CMRPG8F1571
nct id: NCT03840759
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Patients admitted to acute ordinary wards in a medical center in Southern Taiwan from an
      elder-integrated outpatient department or emergency room from January 2017 to December 2017
      were included if they met the following criteria: (i) age 65 years or older, (ii) Barthel
      index score ≦60 and (iii) with at least one of the following geriatric syndromes: unsteady
      gait or easy-to-fall ( falls ≧ 2 in last 1 year), malnutrition with Mini Nutritional
      Assessment-Short Form screening score < 12, urinary incontinence, pressure sores, dementia,
      delirium, depression, polypharmacy (≧8 medications), and excessive utilization of healthcare
      facilities (admission≧2, visit Emergency≧2, or visit outpatient department≧12 in one month).
      Patients were excluded if they were in a vegetative state, under palliative care or
      terminally ill and suffering from acute illness needing to be transferred to or cared for in
      the Intensive Care Unit.

      Human participant approval was obtained from the Chang Gung Medical Foundation Institutional
      Review Board before data collection. Participants were recruited from the ordinary wards by
      research assistants who screened the admission list every morning if they met the inclusion
      criteria. Then, the detail of the research was explained to the patients and families. They
      were allowed to choose to be in the control group or the intervention group. After the
      participants and or family agreed, informed consent was signed. For those who were
      cognitively impaired or suffered from dementia, informed consent was signed by their relative
      or partner. For the intervention group, a geriatric physician was consulted and
      recommendations were made by the geriatric consultant after a complete geriatric assessment.
      Besides the geriatric physician, the investigator's multidisciplinary team included a social
      worker, nutritionist and physical therapist. In the control group, the participants only
      received routine hospital care and no geriatric physician was consulted.
Participants were recruited from the ordinary wards by research assistants who screened the
      admission list every morning if they met the inclusion criteria. Then, the detail of the
      research was explained to the patients and families. They were allowed to choose to be in the
      control group or the intervention group. After the participants and or family agreed,
      informed consent was signed. For those who were cognitively impaired or suffered from
      dementia, informed consent was signed by their relative or partner. For the intervention
      group, a geriatric physician was consulted and recommendations were made by the geriatric
      consultant after a complete CGA. The CGA includes the assessment of depression, dementia,
      physical performance of Activity of Daily Living (ADL) and nutrition using Geriatric
      Depression Scale (GDC-15), Mini-Mental State Examination (MMSE), Barthel Index (BI), and Mini
      Nutritional Assessment-Short Form (MNA®-SF) respectively. Besides the geriatric physician,
      our multidisciplinary team included a social worker, nutritionist and physical therapist. In
      the control group, the participants only received routine hospital care and no geriatric
      physician was consulted. The case manager nurse filed the participant's baseline data and
      clinical problems. After discharge, the participant's condition was assessed via telephone in
      the first, third and six months after discharge.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: readmission rate
time frame: readmission rate within one month after discharge
description: compare the differences of readmission rates between the intervention and control groups
measure: readmission rate
time frame: readmission rate within three months after discharge
description: compare the differences of readmission rates between the intervention and control groups
measure: readmission rate
time frame: readmission rate within six months after discharge
description: compare the differences of readmission rates between the intervention and control groups
measure: mortality rate
time frame: mortality rate within one month after discharge
description: compare the differences of mortality rates between the intervention and control groups
measure: mortality rate
time frame: mortality rate within three months after discharge
description: compare the differences of mortality rates between the intervention and control groups
measure: mortality rate
time frame: mortality rate within six months after discharge
description: compare the differences of mortality rates between the intervention and control groups
arm group label: usual care
arm group type: Experimental
description: For the intervention group, a geriatric physician was consulted and recommendations were made by the geriatric consultant and inpatient geriatric consultation team after a complete geriatric assessment (CGA). The CGA includes the assessment of depression, dementia, physical performance of Activity of Daily Living (ADL) and nutrition using Geriatric Depression Scale (GDC-15), Mini-Mental State Examination (MMSE), Barthel Index (BI), and Mini Nutritional Assessment-Short Form (MNA®-SF) respectively. Besides the geriatric physician, our multidisciplinary team included a social worker, nutritionist and physical therapist. In the control group, the participants only received routine hospital care and no geriatric physician was consulted.
intervention type: Other
intervention name: inpatient geriatric consultation team
description: For the intervention group, a geriatric physician was consulted and recommendations were made by the geriatric consultant after a complete CGA.
arm group label: usual care
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Song-Seng Loke
role: Study Director
responsible party type: Sponsor
mesh term: Alzheimer Disease
sharing ipd: No