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| [ Print-friendly version ] |
| Cost-effectiveness of a management program after hospital discharge in older patients with heart failure |
| ISRCTN | ISRCTN10823032 |
| ClinicalTrials.gov identifier | |
| Public title | Cost-effectiveness of a management program after hospital discharge in older patients with heart failure |
| Scientific title | Cost-effectiveness of a disease management program after hospital discharge in older patients with heart failure delivered by geriatric day hospital versus usual care |
| Acronym | N/A |
| Serial number at source | N/A |
| Study hypothesis |
1. A disease management program delivered by geriatric day hospital improves event free survival (defined as any cause readmissions or death) in older patients with heart failure after hospital discharge
2. A disease management program for older patients with heart failure after hospital discharge delivered by geriatric day-hospital is cost-effective 3. An intervention program improves health related quality of life and functional status for elderly patients with heart failure |
| Lay summary | Lay summary under review 1 |
| Ethics approval | Clinical Research Ethics Committee, Caceres, 23 February 2006, ref: CE 23022006 |
| Study design | Randomized controlled trial |
| Countries of recruitment | Spain |
| Disease/condition/study domain | Heart failure in the elderly |
| Participants - inclusion criteria |
1. Patients aged older 65 years
2. Discharged home or nursing home without medical staff after a hospitalization due to heart failure of at least 48 hours of hospital stay (determined according to the European Society of Cardiology guidelines) |
| Participants - exclusion criteria |
1. Planned discharge to a long-term-care facility or nursing home with medical staff
2. Severe dementia or other serious psychiatric illness 3. Confined to bed 4. Anticipated survival of less than six months 5. Foreseeable follow up problems such as residence outside the hospital catchment area 6. Refusal to participate |
| Anticipated start date | 02/03/2007 |
| Anticipated end date | 30/11/2010 |
| Status of trial | Completed |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 56 patients had to be included in each group to detect at least a 30% relative reduction at 12 months in the outcome of events in the intervention group |
| Interventions |
Intervention group:
The disease management program (DMP) had four main components: 1. Educational intervention on management of heart failure to improve patient and caregiver's knowledge of the disease and self-management skills 2. Monitoring and improvement of therapy according to international guidelines 3. Monitoring of clinical status and comorbidity 4. Monitoring changes in functional and mental status, and social network The intervention program consisted of two phases. In the first phase, prior to discharge the multidisciplinary team (which was formed for a geriatrician (case manager), a nurse and a social worker) assessed and had an in-depth interview with the patient and caregiver or family members. Later the patients and their families received formal education session about the disease by the nurse using a teaching manual. During the second phase, regular follow-up were scheduled. The first contact with the patient was by telephone in the second day after hospital discharge. The first visit occurred in the geriatric day-hospital 10 days after discharge. Future visits were agreed according to the patient’s clinical and treatment needs, but minimum controls were established at months 1, 3, and 6 after hospital discharge. The case manager was available for consultation during working hours by phone contact number. Patients were instructed to contact in case of doubts or signs of worsening. Control group: Patients assigned to usual care received the preexisting routine of post-discharge care. After hospital discharge, the patients were managed in accordance with current clinical practice. In general, this meant that the patient was treated and followed by their primary care physician. An outpatient visit by the geriatrician was planned at 12 months after discharge. Follow-up began with the index admission and ended 12 months after discharge or in case of the patient’s death. |
| Primary outcome measure(s) |
1. Estimate event-free survival, defined on the basis of time to first event (any cause readmission or death) at 1 year. Kaplan–Meier survival curves will be constructed to assess differences in deaths or readmissions between groups and compared using the log rank test. Data for all event-free patients will be censored on study day 365. Event-free survivals will be tested with the Cox proportional hazards method.
2. Cost-effectiveness analysis. We will estimate costs from a societal perspective and will be included medical and nonmedical costs. The effectiveness will be expressed in Quality-Adjusted Life Years (QALY) and will be calculated from the data of the Health Related Quality of Life (HRQL) obtained from the generic EuroQol-5D questionnaire. |
| Secondary outcome measure(s) |
1. Evaluate health related quality of life:
For health-related quality of life, the Minnesota Living With Heart Failure Questionnaire (MLWHFQ) score at baseline and 12 months will be calculated for each group in the trial. The effect of the DMP on quality of life will be estimated as the difference between groups in the change in MLWHFQ scores during the study. 2. Functional status: Assessed as ability to perform basic activities of daily living, the Barthel index (BI) score at baseline and 12 months will be calculated for each group in the trial. The effect of the DMP on functional status will be estimated as the difference between groups in the change in BI scores during the study. |
| Sources of funding |
1. Regional Government of Extremadura (Spain) ref: GR10127
2. European Regional Development Fund [Fonds Européen de Développement Régional (FEDER)] |
| Trial website | |
| Publications | |
| Contact name | Dr José Luis González Guerrero |
| Address |
Hospital Nuestra Señora de la Montaña
Avda. España, 2 |
| City/town | Cáceres |
| Zip/Postcode | 10004 |
| Country | Spain |
| Tel | +34 927 256 886 |
| Fax | +34 927 256 816 |
| jlglezg@terra.es | |
| Sponsor | Our Lady of the Mountain Hospital, Caceres [Hospital Nuestra Señora de la Montaña] (Spain) |
| Address | Avda España, 2 |
| City/town | Cáceres |
| Zip/Postcode | 10004 |
| Country | Spain |
| Tel | +34 927 256 800 |
| Fax | +34 927 256 816 |
| jlglezg@terra.es | |
| Sponsor website: | http://www.areasaludcaceres.es/ |
| Date applied | 19/12/2011 |
| Last edited | 27/01/2012 |
| Date ISRCTN assigned | 27/01/2012 |
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| © 2012 ISRCTN unless otherwise stated. | |
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