NCT03768050

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2018

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

November 28, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 7, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2019

Completed
Last Updated

December 7, 2018

Status Verified

December 1, 2018

Enrollment Period

11 months

First QC Date

November 28, 2018

Last Update Submit

December 5, 2018

Conditions

Keywords

integrated care

Outcome Measures

Primary Outcomes (1)

  • Costs

    Health Care Costs

    30 days

Secondary Outcomes (3)

  • Number of hospital admissions

    30 days

  • Patient centred healthcare provision

    30 days

  • Continuity of care within the healthcare system

    30 days

Study Arms (2)

Advanced care for frail elderly

ACTIVE COMPARATOR

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

Standard care

NO INTERVENTION

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

Interventions

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.

Advanced care for frail elderly

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Clinic

Barcelona, Catalonia, 08036, Spain

RECRUITING

Related Links

MeSH Terms

Conditions

Chronic Disease

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Josep Roca, MD

    Hospital Clinic

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jordi Piera, PhD

CONTACT

Josep Roca, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultor Senior

Study Record Dates

First Submitted

November 28, 2018

First Posted

December 7, 2018

Study Start

April 1, 2018

Primary Completion

March 1, 2019

Study Completion

April 1, 2019

Last Updated

December 7, 2018

Record last verified: 2018-12

Data Sharing

IPD Sharing
Will not share

Locations