Chronic DiseaseNCT03768050
Evaluation of Community-based Care for the Frail Elderly
A study testing Advanced care for frail elderly in people with Chronic Disease and Frail Elderly Syndrome, run by Hospital Clinic of Barcelona at 1 site in Spain.
Trial 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)… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Chronic Disease, Frail Elderly Syndrome
- What is being tested?
- Advanced care for frail elderly
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteSpain
- Study dates
- 1 Apr 2018to 1 Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Clinic
Barcelona, Catalonia, 08036
Josep Roca, MD, +34932275747, jroca@clinic.cat
About this study
Official title: Protocol for the Evaluation of Community-based Care for the Frail Elderly in Badalona Serveis Assistencials
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.
Read the 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.
- Conditions
- Chronic Disease, Frail Elderly Syndrome
- Being tested
- Advanced care for frail elderly
- Keywords
- integrated care
- Medical subject headings
- Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Advanced care for frail elderlyOther
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 group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Advanced care for frail elderly |
| Standard care | No intervention | Usual care at the community and geriatric residences by primary care physicians |
What is being measured
The primary outcome is the main question the study is designed to answer.
Costs
Health Care Costs
Measured: 30 days
Secondary outcomes (3)
Number of hospital admissions
Number of hospital admissions during the study period
Measured: 30 days
Patient centred healthcare provision
Patient centred healthcare provision as measured by the Person Centred Coordinated Experience Questionnaire
Measured: 30 days
Continuity of care within the healthcare system
Continuity of care within the healthcare system as measured by the Nijmegen Continuity of Care Questionnaire
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2018
- Study start1 Apr 2018
- Primary completion1 Mar 2019 (estimated)
- Study completion1 Apr 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic DiseaseStudies of the same condition, open and under way.
- More trials run by Hospital Clinic of BarcelonaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Josep Roca, Hospital Clinic of Barcelona
- Investigators
- Josep Roca, MD, Principal investigator, Hospital Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03768050
- Sponsor's protocol ID
- SELFIE-BSA
- Status last verified
- Dec 2018
- First submitted
- 28 Nov 2018
- Last updated
- 7 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protocol for the Evaluation of Community-based Care for the Frail Elderly in Badalona Serveis Assistencials
- ClinicalTrials.gov ID
- NCT03768050
- Acronym / sponsor ID
- SELFIE-BSA
- Conditions
- Chronic Disease, Frail Elderly Syndrome
- Keywords
- integrated care
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 1 Mar 2019 (estimated)
- Study completion
- 1 Apr 2019 (estimated)
- First posted
- 7 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Advanced care for frail elderly | Active comparator | Other: Advanced care for frail elderlyIntegrated 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 |
| Standard care | No intervention | –Usual care at the community and geriatric residences by primary care physicians |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Advanced care for frail elderlyHome-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. | Other | Advanced care for frail elderly |
Primary outcome
Costs
Time frame: 30 days
Health Care Costs
3 secondary outcomes
Number of hospital admissions
Time frame: 30 days
Patient centred healthcare provision
Time frame: 30 days
Continuity of care within the healthcare system
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2018.
- NEXTCARE is an innovation project belonging to the Healthcare Ris3Cat community lead by Biocat which officially starts on October 2016Link provided by the sponsor.
- SELFIE (Sustainable intEgrated care modeLs for multi-morbidity: delivery, FInancing and performancE) is a Horizon2020 European Union projectLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Josep Roca, MD principal investigator
Hospital Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Advanced care for frail elderly in people with Chronic Disease and Frail Elderly Syndrome, run by Hospital Clinic of Barcelona at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jordi Piera, PhD (+34932275747, jpiera@bsa.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Costs (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2018.