Evaluation of Community-based Care for the Frail Elderly

Chronic Disease Clinical Trial

Official title:

Protocol for the Evaluation of Community-based Care for the Frail Elderly in Badalona Serveis Assistencials

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03768050
• Other study ID #: SELFIE-BSA
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2018
• Est. completion date: April 1, 2019

Study information

• Verified date: December 2018
• Source: Hospital Clinic of Barcelona
• Contact: Jordi Piera, PhD
• Phone: +34932275747
• Email: jpiera[@]bsa.cat
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: April 1, 2019
• Est. primary completion date: March 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Disease
• Frail Elderly Syndrome

Intervention

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.

Locations

Country	Name	City	State
Spain	Hospital Clinic	Barcelona	Catalonia

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Clinic of Barcelona

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Costs	Health Care Costs	30 days
Secondary	Number of hospital admissions	Number of hospital admissions during the study period	30 days
Secondary	Patient centred healthcare provision	Patient centred healthcare provision as measured by the Person Centred Coordinated Experience Questionnaire	30 days
Secondary	Continuity of care within the healthcare system	Continuity of care within the healthcare system as measured by the Nijmegen Continuity of Care Questionnaire	30 days

External Links

•   NEXTCARE is an innovation project belonging to the Healthcare Ris3Cat community lead by Biocat which officially starts on October 2016
•   SELFIE (Sustainable intEgrated care modeLs for multi-morbidity: delivery, FInancing and performancE) is a Horizon2020 European Union project