Evaluation of Community-based Care for the Frail Elderly

NCT ID: NCT03768050

Last Updated: 2018-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-01

Study Completion Date

2019-04-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Disease Frail Elderly Syndrome

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

integrated care

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type ACTIVE_COMPARATOR

Advanced care for frail elderly

Intervention Type OTHER

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.

Standard care

Usual care at the community and geriatric residences by primary care physicians

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hospital Clinic of Barcelona

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Josep Roca

Consultor Senior

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Josep Roca, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Clinic

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hospital Clinic

Barcelona, Catalonia, Spain

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Spain

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Jordi Piera, PhD

Role: CONTACT

Phone: +34932275747

Email: [email protected]

Josep Roca, MD

Role: CONTACT

Phone: +34932275747

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Josep Roca, MD

Role: primary

Related Links

Access external resources that provide additional context or updates about the study.

http://www.nextcarecat.cat

NEXTCARE is an innovation project belonging to the Healthcare Ris3Cat community lead by Biocat which officially starts on October 2016

http://www.selfie2020.eu/

SELFIE (Sustainable intEgrated care modeLs for multi-morbidity: delivery, FInancing and performancE) is a Horizon2020 European Union project

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SELFIE-BSA

Identifier Type: -

Identifier Source: org_study_id