Evaluation of Community-based Care for the Frail Elderly

• ClinicalTrials.gov Identifier: NCT03768050
• Recruitment Status: Recruiting
• First Posted: December 7, 2018
• Last Update Posted: December 7, 2018
• Sponsor: Hospital Clinic of Barcelona
• Information provided by (Responsible Party): Josep Roca, Hospital Clinic of Barcelona

Tracking Information

• First Submitted Date: November 28, 2018
• First Posted Date: December 7, 2018
• Last Update Posted Date: December 7, 2018
• Actual Study Start Date: April 1, 2018
• Estimated Primary Completion Date: March 1, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: December 5, 2018)

Costs [ Time Frame: 30 days ]

Health Care Costs

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: December 5, 2018)

• Number of hospital admissions [ Time Frame: 30 days ]
  Number of hospital admissions during the study period
• Patient centred healthcare provision [ Time Frame: 30 days ]
  Patient centred healthcare provision as measured by the Person Centred Coordinated Experience Questionnaire
• Continuity of care within the healthcare system [ Time Frame: 30 days ]
  Continuity of care within the healthcare system as measured by the Nijmegen Continuity of Care Questionnaire

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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

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.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Health Services Research

Condition

• 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.

Study Arms

• Active Comparator: 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
  Intervention: Other: Advanced care for frail elderly
• No Intervention: Standard care
  Usual care at the community and geriatric residences by primary care physicians

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: December 5, 2018): 500
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: April 1, 2019
• Estimated Primary Completion Date: March 1, 2019 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 65 Years and older (Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Jordi Piera, PhD; +34932275747; jpiera@bsa.cat

Contact: Josep Roca, MD; +34932275747; jroca@clinic.cat

• Listed Location Countries: Spain

Administrative Information

• NCT Number: NCT03768050
• Other Study ID Numbers: SELFIE-BSA
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Josep Roca, Hospital Clinic of Barcelona
• Study Sponsor: Hospital Clinic of Barcelona
• Collaborators: Not Provided

Investigators

• Principal Investigator: Josep Roca, MD; Hospital Clinic

• PRS Account: Hospital Clinic of Barcelona
• Verification Date: December 2018