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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

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.

Condition or disease Intervention/treatment Phase
Chronic Disease Frail Elderly Syndrome Other: Advanced care for frail elderly Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Protocol for the Evaluation of Community-based Care for the Frail Elderly in Badalona Serveis Assistencials
Actual Study Start Date : April 1, 2018
Estimated Primary Completion Date : March 1, 2019
Estimated Study Completion Date : April 1, 2019

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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
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.

No Intervention: Standard care
Usual care at the community and geriatric residences by primary care physicians

Primary Outcome Measures :
  1. Costs [ Time Frame: 30 days ]
    Health Care Costs

Secondary Outcome Measures :
  1. Number of hospital admissions [ Time Frame: 30 days ]
    Number of hospital admissions during the study period

  2. Patient centred healthcare provision [ Time Frame: 30 days ]
    Patient centred healthcare provision as measured by the Person Centred Coordinated Experience Questionnaire

  3. 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03768050

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Contact: Jordi Piera, PhD +34932275747
Contact: Josep Roca, MD +34932275747

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Hospital Clinic Recruiting
Barcelona, Catalonia, Spain, 08036
Contact: Josep Roca, MD    +34932275747   
Sponsors and Collaborators
Hospital Clinic of Barcelona
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Principal Investigator: Josep Roca, MD Hospital Clinic
Additional Information:
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Responsible Party: Josep Roca, Consultor Senior, Hospital Clinic of Barcelona Identifier: NCT03768050    
Other Study ID Numbers: SELFIE-BSA
First Posted: December 7, 2018    Key Record Dates
Last Update Posted: December 7, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Josep Roca, Hospital Clinic of Barcelona:
integrated care
Additional relevant MeSH terms:
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Chronic Disease
Disease Attributes
Pathologic Processes