Heart Failure
Conditions
Keywords
Heart failure, pharmacist, multidisciplinary team, readmission
Brief summary
This is a controlled, randomized, open-label, multicentric study evaluating the value of coordinated medico-pharmaceutical management compared to standard management in patients with heart failure. The aim of this study is to evaluate the impact of these optimized activities on the re-hospitalization of the patient with cardiac insufficiency for a disease-related event within three months of the initial hospitalization.
Detailed description
Heart failure (FH) is a public health problem with an estimated prevalence of about 1.5% in developed countries. In 2013, the number of patients hospitalized in France for heart failure amounted to 165 231 and 20% of them were re-hospitalized at least once for the same reason during this year. Several factors contribute to the occurrence of cardiac decompensation (DC) : some modifiable (age, severity of IC, etiology ...) and others modifiable, such as therapeutics. Various elements could reduce the frequency of re-hospitalizations and the mortality due to this disease : * a better knowledge of treatments by patients and consequently a better therapeutic compliance * a better knowledge of the factors and signs of DC (low-sodium diet, weighing...) * a better implementation of prescribing recommendations : less than 50% of patients have optimal treatment compared to ESC recommendations * a better communication at the transition points of the patient pathway. The creation of a binomial cardiologist-clinical pharmacist during hospitalization and the maintenance of this optimized multidisciplinary follow-up within 3 months post-hospitalization is a proposal to intervene on these factors. Indeed, the clinical pharmacist (present in the care unit) works in collaboration with the medical and paramedical teams and can improve the care of patients. In the experimental group, a specific multidisciplinary consultation is planned for one month after the end of the hospitalization. A 3-month follow-up visit will be carried out by phone call to meet the criteria for readmission, mortality, quality of life, adherence and persistence of treatments.
Interventions
OTHERReinforced multidisciplinary follow-up
Reinforced multidisciplinary follow-up
Sponsors
University Hospital, Montpellier
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient aged more than 18 years * Adult patient admitted in cardiology department (full hospitalisation or intensive care) for heart failure no matter the type and the stage of the disease * Person affiliated or beneficiary of a social security system * Collection of a free, informed, express and written consent
Exclusion criteria
* Non autonomous drug management patients and not disposing * a present caregiver during hospitalisation * Patients living in an institution * Person participating in another clinical trial with an exclusion period still ongoing * Person whose physical and/or psychological health is severely altered, and which, in the opinion of the investigator, may affect the participation's to the study * Person deprived of his rights, person under tutorship or guardianship * Refusal to sign the consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rehospitalisation for heart failure | Call at 3 months after hospitalisation discharge | At least one rehospitalisation with heart failure related cause |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Prescriptions conformity rates compared to heart failure recommendations edited by the European Society of Cardiology in 2016 | At hospitalisation discharge (Day 0) | Evaluated by a pharmacist |
| Compliance level | At hospitalisation discharge (Day 0) | Evaluated by the " Girerd medication adherence questionnaire " The " Girerd medication adherence questionnaire " contains 6 questions which answers are " yes " or " no ". The number of " yes " responses permits to evaluate the level of the patient medication adherence as following : 0 yes : good compliance 1 or 2 yes : minor non compliance 3 or more yes : non compliance |
| Treatment persistence rates | Call at 3 months after hospitalisation discharge | Evaluated by a pharmacist |
| Death rate | Call at 3 months after hospitalisation discharge | Evaluated by a pharmacist |
| Time before death | Call at 3 months after hospitalisation discharge | Evaluated by a pharmacist |
| Time of occurrence of a potential rehospitalisation related to the disease | Call at 3 months after hospitalisation discharge | Evaluated by a pharmacist |
| Quality of life score | Call at 3 months after hospitalisation discharge | Evaluated by the Minnesota Living with Heart Failure Questionnaire the Minnesota Living with Heart Failure Questionnaire contains 21 questions. Each of the 21 questions ask the patients to indicate how much a possible effect of heart failure have affected their ability to live as wanted during the past month using a scale from 0 (not present or no effect), 1 (very little), 2, 3, 4, or 5 (very much).The measurement of heart failure severity is assessed by summing the responses that ranges from 0 to 105. |
| Satisfaction of the patient | Call at 3 months after hospitalisation discharge | Evaluated by Likert scale This questionnaire indicates the degree of patient satisfaction using 9 questions which explore the improvement of patient behavior concerning disease and treatment. The measurement of satisfaction is assessed by summing the responses that range from 9 (unsatisfied) to 36 (very satisfied) |
| Satisfaction of health professionals | online questionnaire at 3 months after hospitalisation discharge | Evaluated by Likert scale (only for interventional arm) This questionnaire indicates the degree of health professional satisfaction using 6 questions which explore the improvement of transition between hospital to community and comprehension of therapeutic optimization. The measurement of satisfaction is assessed by summing the responses that range from 6 (unsatisfied) to 24 (very satisfied) |
| Incremental cost-effectiveness ratio | 3 months after hospitalisation discharge | — |
Countries
France
Outcome results
None listed