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Evaluation of Community-based Care for the Frail Elderly

Primary Purpose

Chronic Disease, Frail Elderly Syndrome

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Advanced care for frail elderly
Sponsored by
Hospital Clinic of Barcelona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Chronic Disease focused on measuring integrated care

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital ClinicRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Advanced care for frail elderly

Standard care

Arm Description

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

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

Outcomes

Primary Outcome Measures

Costs
Health Care Costs

Secondary Outcome Measures

Number of hospital admissions
Number of hospital admissions during the study period
Patient centred healthcare provision
Patient centred healthcare provision as measured by the Person Centred Coordinated Experience Questionnaire
Continuity of care within the healthcare system
Continuity of care within the healthcare system as measured by the Nijmegen Continuity of Care Questionnaire

Full Information

First Posted
November 28, 2018
Last Updated
December 5, 2018
Sponsor
Hospital Clinic of Barcelona
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1. Study Identification

Unique Protocol Identification Number
NCT03768050
Brief Title
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

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2018 (Actual)
Primary Completion Date
March 1, 2019 (Anticipated)
Study Completion Date
April 1, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Clinic of Barcelona

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Disease, Frail Elderly Syndrome
Keywords
integrated care

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Advanced care for frail elderly
Arm Type
Active Comparator
Arm Description
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
Arm Title
Standard care
Arm Type
No Intervention
Arm Description
Usual care at the community and geriatric residences by primary care physicians
Intervention Type
Other
Intervention Name(s)
Advanced care for frail elderly
Intervention Description
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.
Primary Outcome Measure Information:
Title
Costs
Description
Health Care Costs
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Number of hospital admissions
Description
Number of hospital admissions during the study period
Time Frame
30 days
Title
Patient centred healthcare provision
Description
Patient centred healthcare provision as measured by the Person Centred Coordinated Experience Questionnaire
Time Frame
30 days
Title
Continuity of care within the healthcare system
Description
Continuity of care within the healthcare system as measured by the Nijmegen Continuity of Care Questionnaire
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jordi Piera, PhD
Phone
+34932275747
Email
jpiera@bsa.cat
First Name & Middle Initial & Last Name or Official Title & Degree
Josep Roca, MD
Phone
+34932275747
Email
jroca@clinic.cat
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Josep Roca, MD
Organizational Affiliation
Hospital Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Clinic
City
Barcelona
State/Province
Catalonia
ZIP/Postal Code
08036
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Josep Roca, MD
Phone
+34932275747
Email
jroca@clinic.cat

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://www.nextcarecat.cat
Description
NEXTCARE is an innovation project belonging to the Healthcare Ris3Cat community lead by Biocat which officially starts on October 2016
URL
http://www.selfie2020.eu/
Description
SELFIE (Sustainable intEgrated care modeLs for multi-morbidity: delivery, FInancing and performancE) is a Horizon2020 European Union project

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Evaluation of Community-based Care for the Frail Elderly

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