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Evaluation of Community-based Care for the Frail Elderly

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03768050
Recruitment Status : Unknown
Verified December 2018 by Josep Roca, Hospital Clinic of Barcelona.
Recruitment status was:  Recruiting
First Posted : December 7, 2018
Last Update Posted : December 7, 2018
Information provided by (Responsible Party):
Josep Roca, Hospital Clinic of Barcelona

Tracking Information
First Submitted Date  ICMJE November 28, 2018
First Posted Date  ICMJE December 7, 2018
Last Update Posted Date December 7, 2018
Actual Study Start Date  ICMJE April 1, 2018
Estimated Primary Completion Date March 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 5, 2018)
Costs [ Time Frame: 30 days ]
Health Care Costs
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: December 5, 2018)
  • Number of hospital admissions [ Time Frame: 30 days ]
    Number of hospital admissions during the study period
  • Patient centred healthcare provision [ Time Frame: 30 days ]
    Patient centred healthcare provision as measured by the Person Centred Coordinated Experience Questionnaire
  • Continuity of care within the healthcare system [ Time Frame: 30 days ]
    Continuity of care within the healthcare system as measured by the Nijmegen Continuity of Care Questionnaire
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Evaluation of Community-based Care for the Frail Elderly
Official Title  ICMJE Protocol for the Evaluation of Community-based Care for the Frail Elderly in Badalona Serveis Assistencials
Brief Summary

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.

Detailed Description

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE
  • Chronic Disease
  • Frail Elderly Syndrome
Intervention  ICMJE Other: Advanced care for frail elderly

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.

Study Arms  ICMJE
  • Active Comparator: Advanced care for frail elderly
    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
    Intervention: Other: Advanced care for frail elderly
  • No Intervention: Standard care
    Usual care at the community and geriatric residences by primary care physicians
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: December 5, 2018)
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 1, 2019
Estimated Primary Completion Date March 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria

  • Age ≥ 65 years.
  • Complexity: ≥ 2 chronic diseases
  • Polypharmacy: ≥ 4 drugs
  • Registered as complex chronic patient
  • ≥ 3 hospital or emergency room readmissions in the last year
  • Having suffered a recent acute illness requiring continuous clinical and/or rehabilitative care by the Home Hospitalisation Unit or primary care.
  • To be admitted in one of the geriatric residences of the territory of Badalona, Montgat and Tiana.

Exclusion criteria

  • Any neurological disease (e.g. severe-phase dementia with global deterioration scale (GDS) ≥ 7) or psychiatrically severe enough not to allow the subject to respond to questionnaires.
  • Subjects who do not agree to participate in the study.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT03768050
Other Study ID Numbers  ICMJE SELFIE-BSA
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Josep Roca, Hospital Clinic of Barcelona
Study Sponsor  ICMJE Hospital Clinic of Barcelona
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Josep Roca, MD Hospital Clinic
PRS Account Hospital Clinic of Barcelona
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP