<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/NCT03768050</url>
  </required_header>
  <id_info>
    <org_study_id>SELFIE-BSA</org_study_id>
    <nct_id>NCT03768050</nct_id>
  </id_info>
  <brief_title>Evaluation of Community-based Care for the Frail Elderly</brief_title>
  <official_title>Protocol for the Evaluation of Community-based Care for the Frail Elderly in Badalona Serveis Assistencials</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital Clinic of Barcelona</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital Clinic of Barcelona</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>
      The term frail chronic complex patient (CCP) is generally applied to subjects with&#xD;
      heterogeneous conditions that may represent at least one of the following three traits: (i)&#xD;
      the need for management by a number of specialists from different disciplines that often&#xD;
      leads to high use of healthcare resources; (ii) fragility, which requires additional support&#xD;
      either due to functional decline, social deficits and/or transient situations such as&#xD;
      hospital discharge or, (iii) the need for highly specialised care with home technological&#xD;
      support.&#xD;
&#xD;
      The current protocol deals with the second category of patients, frail CCP, and addresses&#xD;
      horizontal integration of community-based services. It is based in the city of Badalona (216K&#xD;
      inhabitants), within the metropolitan area of Barcelona. Badalona Serveis Assistencials (BSA)&#xD;
      is the service provider of integrated care services for this population.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study will assess three types of specific groups of patients: (i) Early discharge group&#xD;
      includes patients acutely admitted to the medical and/or surgical hospital wards and promptly&#xD;
      discharged to receive home-based post-acute care and/or rehabilitation; (ii) Home-based Case&#xD;
      Management group includes complex chronic patients or patients receiving long-term care by a&#xD;
      case management nurse; and (iii) Geriatric residences group will include patients receiving&#xD;
      acute support, post-acute or continued care for elderly people living in geriatric&#xD;
      residences.&#xD;
&#xD;
      It will be conducted by Badalona Serveis Assistencials (BSA), an integrated care service&#xD;
      provider located in the city of Badalona (420K inhabitants) in the North-Eastern part of the&#xD;
      Barcelona Metropolitan Area.&#xD;
&#xD;
      The current study protocol aims to assess cost-effectiveness of the three types of&#xD;
      interventions for frail patients, as well as to generate a roadmap for regional scalability&#xD;
      of the service. The study design will consist of a prospective quasi-experimental&#xD;
      case-control design wherein each intervention group will be compared with the corresponding&#xD;
      usual care group (controls, 1:1 ratio), using propensity score matching. Age, sex, GMA&#xD;
      (adjusted morbidity groups), socioeconomic status, number of hospitalisations during the&#xD;
      previous year and polypharmacy will be used as matching variables.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">April 1, 2018</start_date>
  <completion_date type="Anticipated">April 1, 2019</completion_date>
  <primary_completion_date type="Anticipated">March 1, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Costs</measure>
    <time_frame>30 days</time_frame>
    <description>Health Care Costs</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of hospital admissions</measure>
    <time_frame>30 days</time_frame>
    <description>Number of hospital admissions during the study period</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient centred healthcare provision</measure>
    <time_frame>30 days</time_frame>
    <description>Patient centred healthcare provision as measured by the Person Centred Coordinated Experience Questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Continuity of care within the healthcare system</measure>
    <time_frame>30 days</time_frame>
    <description>Continuity of care within the healthcare system as measured by the Nijmegen Continuity of Care Questionnaire</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">500</enrollment>
  <condition>Chronic Disease</condition>
  <condition>Frail Elderly Syndrome</condition>
  <arm_group>
    <arm_group_label>Advanced care for frail elderly</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Integrated care program for frail elderly covering Home Hospitalization/Early Discharge; geriatric residences and; home-based case management done by dedicated teams specialised in geriatric medicine</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Usual care at the community and geriatric residences by primary care physicians</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Advanced care for frail elderly</intervention_name>
    <description>Home-based case management group receives advanced nursing care meeting the health and social needs of patient and/or carer. It is carried out through a process of evaluation, planning&amp;coordination, facilitating the provision, monitoring and evaluation of the options and resources necessary for the resolution of the case. It is person-centred. The service also provides palliative care.&#xD;
Home hospitalisation/early discharge dispenses medical and nursing care at home on a transient basis after hospitalisation when patients still need surveillance and assistance. It is done in the acute, subacute or post-acute phase. In the last phase the focus is on functional recovery.&#xD;
The geriatric residences group is assisted by health care teams with expertise in geriatrics. They coordinate with primary care and health professionals of the residences to improve the attention. They are highly accessible, have high-resolutive capacity and can activate the resources of the healthcare network.</description>
    <arm_group_label>Advanced care for frail elderly</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
          -  Age ≥ 65 years.&#xD;
&#xD;
          -  Complexity: ≥ 2 chronic diseases&#xD;
&#xD;
          -  Polypharmacy: ≥ 4 drugs&#xD;
&#xD;
          -  Registered as complex chronic patient&#xD;
&#xD;
          -  ≥ 3 hospital or emergency room readmissions in the last year&#xD;
&#xD;
          -  Having suffered a recent acute illness requiring continuous clinical and/or&#xD;
             rehabilitative care by the Home Hospitalisation Unit or primary care.&#xD;
&#xD;
          -  To be admitted in one of the geriatric residences of the territory of Badalona,&#xD;
             Montgat and Tiana.&#xD;
&#xD;
        Exclusion criteria&#xD;
&#xD;
          -  Any neurological disease (e.g. severe-phase dementia with global deterioration scale&#xD;
             (GDS) ≥ 7) or psychiatrically severe enough not to allow the subject to respond to&#xD;
             questionnaires.&#xD;
&#xD;
          -  Subjects who do not agree to participate in the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Josep Roca, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital Clinic</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jordi Piera, PhD</last_name>
    <phone>+34932275747</phone>
    <email>jpiera@bsa.cat</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Josep Roca, MD</last_name>
    <phone>+34932275747</phone>
    <email>jroca@clinic.cat</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Hospital Clinic</name>
      <address>
        <city>Barcelona</city>
        <state>Catalonia</state>
        <zip>08036</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Josep Roca, MD</last_name>
      <phone>+34932275747</phone>
      <email>jroca@clinic.cat</email>
    </contact>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <link>
    <url>http://www.nextcarecat.cat</url>
    <description>NEXTCARE is an innovation project belonging to the Healthcare Ris3Cat community lead by Biocat which officially starts on October 2016</description>
  </link>
  <link>
    <url>http://www.selfie2020.eu/</url>
    <description>SELFIE (Sustainable intEgrated care modeLs for multi-morbidity: delivery, FInancing and performancE) is a Horizon2020 European Union project</description>
  </link>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>November 28, 2018</study_first_submitted>
  <study_first_submitted_qc>December 5, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 7, 2018</study_first_posted>
  <last_update_submitted>December 5, 2018</last_update_submitted>
  <last_update_submitted_qc>December 5, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 7, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hospital Clinic of Barcelona</investigator_affiliation>
    <investigator_full_name>Josep Roca</investigator_full_name>
    <investigator_title>Consultor Senior</investigator_title>
  </responsible_party>
  <keyword>integrated care</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chronic 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/NCT03768050
org study id: SELFIE-BSA
nct id: NCT03768050
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The term frail chronic complex patient (CCP) is generally applied to subjects with
      heterogeneous conditions that may represent at least one of the following three traits: (i)
      the need for management by a number of specialists from different disciplines that often
      leads to high use of healthcare resources; (ii) fragility, which requires additional support
      either due to functional decline, social deficits and/or transient situations such as
      hospital discharge or, (iii) the need for highly specialised care with home technological
      support.

      The current protocol deals with the second category of patients, frail CCP, and addresses
      horizontal integration of community-based services. It is based in the city of Badalona (216K
      inhabitants), within the metropolitan area of Barcelona. Badalona Serveis Assistencials (BSA)
      is the service provider of integrated care services for this population.
The study will assess three types of specific groups of patients: (i) Early discharge group
      includes patients acutely admitted to the medical and/or surgical hospital wards and promptly
      discharged to receive home-based post-acute care and/or rehabilitation; (ii) Home-based Case
      Management group includes complex chronic patients or patients receiving long-term care by a
      case management nurse; and (iii) Geriatric residences group will include patients receiving
      acute support, post-acute or continued care for elderly people living in geriatric
      residences.

      It will be conducted by Badalona Serveis Assistencials (BSA), an integrated care service
      provider located in the city of Badalona (420K inhabitants) in the North-Eastern part of the
      Barcelona Metropolitan Area.

      The current study protocol aims to assess cost-effectiveness of the three types of
      interventions for frail patients, as well as to generate a roadmap for regional scalability
      of the service. The study design will consist of a prospective quasi-experimental
      case-control design wherein each intervention group will be compared with the corresponding
      usual care group (controls, 1:1 ratio), using propensity score matching. Age, sex, GMA
      (adjusted morbidity groups), socioeconomic status, number of hospitalisations during the
      previous year and polypharmacy will be used as matching variables.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Costs
time frame: 30 days
description: Health Care Costs
measure: Number of hospital admissions
time frame: 30 days
description: Number of hospital admissions during the study period
measure: Patient centred healthcare provision
time frame: 30 days
description: Patient centred healthcare provision as measured by the Person Centred Coordinated Experience Questionnaire
measure: Continuity of care within the healthcare system
time frame: 30 days
description: Continuity of care within the healthcare system as measured by the Nijmegen Continuity of Care Questionnaire
arm group label: Advanced care for frail elderly
arm group type: Active Comparator
description: Integrated care program for frail elderly covering Home Hospitalization/Early Discharge; geriatric residences and; home-based case management done by dedicated teams specialised in geriatric medicine
arm group label: Standard care
arm group type: No Intervention
description: Usual care at the community and geriatric residences by primary care physicians
intervention type: Other
intervention name: Advanced care for frail elderly
description: Home-based case management group receives advanced nursing care meeting the health and social needs of patient and/or carer. It is carried out through a process of evaluation, planning&coordination, facilitating the provision, monitoring and evaluation of the options and resources necessary for the resolution of the case. It is person-centred. The service also provides palliative care.
Home hospitalisation/early discharge dispenses medical and nursing care at home on a transient basis after hospitalisation when patients still need surveillance and assistance. It is done in the acute, subacute or post-acute phase. In the last phase the focus is on functional recovery.
The geriatric residences group is assisted by health care teams with expertise in geriatrics. They coordinate with primary care and health professionals of the residences to improve the attention. They are highly accessible, have high-resolutive capacity and can activate the resources of the healthcare network.
arm group label: Advanced care for frail elderly
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: No
last name: Josep Roca, MD
role: Principal Investigator
affiliation: Hospital Clinic
last name: Jordi Piera, PhD
phone: +34932275747
email: jpiera@bsa.cat
last name: Josep Roca, MD
phone: +34932275747
email: jroca@clinic.cat
facility: 
status: Recruiting
contact: 
country: Spain
url: http://www.nextcarecat.cat
description: NEXTCARE is an innovation project belonging to the Healthcare Ris3Cat community lead by Biocat which officially starts on October 2016
url: http://www.selfie2020.eu/
description: SELFIE (Sustainable intEgrated care modeLs for multi-morbidity: delivery, FInancing and performancE) is a Horizon2020 European Union project
responsible party type: Principal Investigator
investigator affiliation: Hospital Clinic of Barcelona
investigator full name: Josep Roca
investigator title: Consultor Senior
mesh term: Chronic Disease
sharing ipd: No