xml: <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/NCT05963360</url>
    </required_header>
    <id_info>
      <org_study_id>71937</org_study_id>
      <nct_id>NCT05963360</nct_id>
    </id_info>
    <brief_title>Planning for Frailty: Optimal Health and Social Care Workforce Organisation Using Demand-led Simulation Modelling</brief_title>
    <acronym>FLOWS</acronym>
    <official_title>Planning for Frailty: Optimal Health and Social Care Workforce Organisation Using Demand-led Simulation Modelling (FLOWS)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Southampton</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Bournemouth University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Tameside Hospital NHS Foundation Trust</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Southern Health NHS Foundation Trust</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>University of Southampton</source>
    <oversight_info>
      <has_dmc>Yes</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>
        What is the present, and expected, size and composition of the health and social care&#xD;
        workforce required to provide care for the frail older population? As the population ages,&#xD;
        robust workforce planning to meet future demands for health and social care by older people&#xD;
        is needed. A lack of evidence in this areas has led to a mis-match between the health and&#xD;
        social care demand from the ageing population and the current workforce capacity. The&#xD;
        proposed study will use demand-led simulation modelling of the workforce required to address&#xD;
        the specific challenge of providing health and social care for the growing numbers of older&#xD;
        people living with frailty.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Research Question: What is the present, and expected, size and composition of the health and&#xD;
        social care workforce required to provide care for the frail older population? Background: As&#xD;
        the population ages, robust workforce planning to meet future demands for health and social&#xD;
        care by older people is needed. A lack of evidence in this area has led to a mis-match&#xD;
        between the health and social care demand from the ageing population and the current&#xD;
        workforce capacity. The proposed study will use demand-led simulation modelling of the&#xD;
        workforce required to address the specific challenge of providing health and social care for&#xD;
        the growing numbers of older people living with frailty.&#xD;
  &#xD;
        Aims &amp; Objectives: The aim of the study is to use simulation modelling to explore long-term&#xD;
        trends in frailty-related health and social care use in the ageing population and its&#xD;
        implications for future workforce size and competencies to support high quality care. The&#xD;
        primary objective of this study is the creation of a simulation model that will inform&#xD;
        service and workforce planning to meet health and social care needs associated with frailty.&#xD;
  &#xD;
        Methods: The study will use a System Dynamics design to develop and test the simulation&#xD;
        model.&#xD;
  &#xD;
        Work packages comprise a scoping review, gathering of public and professional perspectives on&#xD;
        service provision via a survey and stakeholder engagement activities, and analysis of linked&#xD;
        health and social care data, all of which inform the simulation modelling work package and&#xD;
        development of a workforce planning toolkit.&#xD;
  &#xD;
        Timelines for delivery: The scoping review will be completed in year 1. Routine health and&#xD;
        social care data specification and extraction will occur in year 1, as will service mapping&#xD;
        and classification and survey preparation. Survey data collection and analysis will occur in&#xD;
        year 2. Simulation modelling will commence in year 2, with validation, sensitivity analyses&#xD;
        and scenario modelling in year 3.&#xD;
  &#xD;
        Development of workforce guidelines and toolkit will occur in year 3 Stakeholder engagement,&#xD;
        including patient public involvement, will run throughout the study, reviewing study results&#xD;
        and informing development of the other work packages.&#xD;
  &#xD;
        Anticipated impact &amp; dissemination: This study will provide new, direct evidence about the&#xD;
        impact of frailty on health and social care workforce requirements within the ageing&#xD;
        population The improved understanding of workforce requirements offered by this study will&#xD;
        inform workforce planning for frailty services across health and social care, ensuring future&#xD;
        benefit for patients through provision of timely and appropriate care and a workforce&#xD;
        planning toolkit to support local decision-making.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">November 1, 2022</start_date>
    <completion_date type="Anticipated">October 31, 2025</completion_date>
    <primary_completion_date type="Anticipated">October 31, 2025</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>Service use (for cohort analysis)</measure>
      <time_frame>2015-2022</time_frame>
      <description>Use of primary, secondary, community, health and social care services</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Workforce provision of services to Adults living with Frailty</measure>
      <time_frame>2015-2022</time_frame>
      <description>Information from cohort analysis, health and social care professionals survey and scoping review.</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">50000</enrollment>
    <condition>Frailty in Aging</condition>
    <condition>Older People</condition>
    <arm_group>
      <arm_group_label>Frailty in Older people</arm_group_label>
      <description>Older people, 50 and above.</description>
    </arm_group>
    <eligibility>
      <study_pop>
        <textblock>
          Adults age 50 and above&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Eligibility:&#xD;
  &#xD;
            -  Age 50yrs and above,&#xD;
  &#xD;
            -  contributing data to the North West London NHS Integrated Care System database&#xD;
  &#xD;
          Exclusion:&#xD;
  &#xD;
          *Age below 50yrs&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>50 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Bronagh M Walsh/Professor, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Southampton</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>University of Southampton</name>
        <address>
          <city>Southampton</city>
          <country>United Kingdom</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United Kingdom</country>
    </location_countries>
    <link>
      <url>https://fundingawards.nihr.ac.uk/award/NIHR134305</url>
      <description>Funder website</description>
    </link>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 18, 2023</study_first_submitted>
    <study_first_submitted_qc>July 18, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 27, 2023</study_first_posted>
    <last_update_submitted>July 27, 2023</last_update_submitted>
    <last_update_submitted_qc>July 27, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Planning for Frailty</keyword>
    <keyword>Health and Social Care Workforce Organisation</keyword>
    <keyword>Social care Workforce</keyword>
    <keyword>Simulation Modelling</keyword>
    <keyword>Health Workforce</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Frailty</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>Data dictionary; variables; types of data</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
      <ipd_time_frame>Protocol - during study period Results and data - end of 2025</ipd_time_frame>
      <ipd_access_criteria>Research Report to funder Published Papers</ipd_access_criteria>
      <ipd_url>https://fundingawards.nihr.ac.uk/award/NIHR134305</ipd_url>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05963360
  org study id: 71937
  nct id: NCT05963360
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  What is the present, and expected, size and composition of the health and social care
        workforce required to provide care for the frail older population? As the population ages,
        robust workforce planning to meet future demands for health and social care by older people
        is needed. A lack of evidence in this areas has led to a mis-match between the health and
        social care demand from the ageing population and the current workforce capacity. The
        proposed study will use demand-led simulation modelling of the workforce required to address
        the specific challenge of providing health and social care for the growing numbers of older
        people living with frailty.
  Research Question: What is the present, and expected, size and composition of the health and
        social care workforce required to provide care for the frail older population? Background: As
        the population ages, robust workforce planning to meet future demands for health and social
        care by older people is needed. A lack of evidence in this area has led to a mis-match
        between the health and social care demand from the ageing population and the current
        workforce capacity. The proposed study will use demand-led simulation modelling of the
        workforce required to address the specific challenge of providing health and social care for
        the growing numbers of older people living with frailty.
  
        Aims & Objectives: The aim of the study is to use simulation modelling to explore long-term
        trends in frailty-related health and social care use in the ageing population and its
        implications for future workforce size and competencies to support high quality care. The
        primary objective of this study is the creation of a simulation model that will inform
        service and workforce planning to meet health and social care needs associated with frailty.
  
        Methods: The study will use a System Dynamics design to develop and test the simulation
        model.
  
        Work packages comprise a scoping review, gathering of public and professional perspectives on
        service provision via a survey and stakeholder engagement activities, and analysis of linked
        health and social care data, all of which inform the simulation modelling work package and
        development of a workforce planning toolkit.
  
        Timelines for delivery: The scoping review will be completed in year 1. Routine health and
        social care data specification and extraction will occur in year 1, as will service mapping
        and classification and survey preparation. Survey data collection and analysis will occur in
        year 2. Simulation modelling will commence in year 2, with validation, sensitivity analyses
        and scenario modelling in year 3.
  
        Development of workforce guidelines and toolkit will occur in year 3 Stakeholder engagement,
        including patient public involvement, will run throughout the study, reviewing study results
        and informing development of the other work packages.
  
        Anticipated impact & dissemination: This study will provide new, direct evidence about the
        impact of frailty on health and social care workforce requirements within the ageing
        population The improved understanding of workforce requirements offered by this study will
        inform workforce planning for frailty services across health and social care, ensuring future
        benefit for patients through provision of timely and appropriate care and a workforce
        planning toolkit to support local decision-making.
  observational model: Cohort
  time perspective: Retrospective
  measure: Service use (for cohort analysis)
  time frame: 2015-2022
  description: Use of primary, secondary, community, health and social care services
  measure: Workforce provision of services to Adults living with Frailty
  time frame: 2015-2022
  description: Information from cohort analysis, health and social care professionals survey and scoping review.
  arm group label: Frailty in Older people
  description: Older people, 50 and above.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 50 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Bronagh M Walsh/Professor, PhD
  role: Principal Investigator
  affiliation: University of Southampton
  facility: 
  country: United Kingdom
  url: https://fundingawards.nihr.ac.uk/award/NIHR134305
  description: Funder website
  responsible party type: Sponsor
  mesh term: Frailty
  sharing ipd: Yes
  ipd description: Data dictionary; variables; types of data
  ipd info type: Study Protocol
  ipd info type: Clinical Study Report (CSR)
  ipd time frame: Protocol - during study period Results and data - end of 2025
  ipd access criteria: Research Report to funder Published Papers
  ipd url: https://fundingawards.nihr.ac.uk/award/NIHR134305