Clinical trial NCT03768050: Evaluation of Community-based Care for the Frail Elderly
Official title: Protocol for the Evaluation of Community-based Care for the Frail Elderly in Badalona Serveis Assistencials
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Disease
Frail Elderly Syndrome
Keywords: integrated care
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
First posted: 2018-12-07
Enrollment: 500
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Costs
timeFrame: 30 days
Secondary outcomes:
measure: Number of hospital admissions
timeFrame: 30 days
measure: Patient centred healthcare provision
timeFrame: 30 days
measure: Continuity of care within the healthcare system
timeFrame: 30 days
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Clinic
state: Catalonia
Study officials:
affiliation: Hospital Clinic
name: Josep Roca, MD
role: PRINCIPAL_INVESTIGATOR
References: