Randomized Clinical Trial: Assessment of a Multidisciplinary Intervention by a Cardiologist and Geriatrician After Hospital Admission Due to Heart Failure in Elderly Patients.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 150
- Locations
- 2
- Primary Endpoint
- Number of participants with all-cause hospitalization within the defined time points
Study Overview
Brief Summary
Randomized clinical trial in which patients with a recent admission for heart failure in the cardiology department of the Hospital de Mar will be randomized to usual follow-up (cardiologist of the Heart Failure Unit) or follow-up by cardiologist and intervention by the geriatrician. This visit will be done at the same time. The main gial of this study is to evaluate whether the combined intervention of a cardiologist and a geriatrician reduces hospital all-cause rehospitalizations at 1 year.
Detailed Description
Patients will be invited to participate on the day of hospital discharge. Once the informed consent has been signed, patients will be randomized with a 1: 1 ratio to conventional follow-up (cardiologist) or combined follow-up (ambulatory visit with cardiologist and geriatrics on the same day). Randomization will be stratified according to the presence or absence of criteria of frailty and ventricular function (cut-off 50%) to ensure that both groups are balanced. This stratification will be achieved by generating 4 different randomization lists. Frailty will be assessed using the Canadian Study of Health and Aging (CSHA) Clinical Frailty Scale. Randomization will be carried out by administrative staff independent of the study following a computer generated randomization scheme.The first visit will be made in less than 10 days after discharge from the hospital. Lawton and Barthel index and Pfeiffer test and quality of life test will be done in both groups.
The cost associated with care in the hospital is collected in each patient and therefore the total cost of the admissions, ambulatory visits and emergencies of each patient will be retrospectively evaluated.
In patients in the intervention arm the following areas will be evaluated: social sphere (Social and family evaluation scale of Gijón (abbreviated and modified) (Barcelona version), functional capacity (Barthel index and Lawton index), cognitive sphere (Pfeiffer test), emotional sphere (Geriatric Depression Scale Yesavage), nutritional status (Mini-Nutritional Assessment Short Form, plasma albumin), comorbidity (Charlson index) and the presence of geriatric syndromes (falls, polypharmacy, ulcers pressure, constipation, incontinence, insomnia.) Interdisciplinary interventions will be carried out in each of the areas evaluated.
Follow-up will be carried out at the heart failure clinic of the Cardiology Department at 3, 6 and 12 months. A clinical event evaluation committee will be appointed, consisting of 2 independent cardiologists, who will blindly adjudicate the events that occurred during the duration of the study.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 75 Years to — (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients older than 75 years with a recent admission for heart failure (within the previous 10 days).
Exclusion Criteria
- •Patients in palliative care.
- •Patients with chronic pathologies with expected life expectancy <1 year.
- •Patients discharged to a skilled nursing facility
- •Patients with heart valve replacement during index admission
Outcomes
Primary Outcomes
Number of participants with all-cause hospitalization within the defined time points
Time Frame: 1 year
Number of participants with an all-cause hospitalization at 1 year follow-up
Secondary Outcomes
- Number of participants with heart failure hospitalization within the defined time points(1 year)
- Differences in total number of outpatient visits, emergency room visits and hospitalizations (resource use) within the defined time points(1 year)
- Change in functional capacity measured with the Barthel index within the defined time points(1 year)
- Change in quality of life measured with the Kansas City Cardiomyopathy Questionnaire (KCCQ) within the defined time points(1 year)
- Number of participants dead within the defined time points(1 year)
- Change in the number of participants with more than 5 medications (polypharmacy) within the defined time points(1 year)