Optimized Medico-pharmaceutical Collaboration in the Drug Management of Patients With Heart Failure

Study Overview
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Brief Summary
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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
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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.

Official Title
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Interest of an Optimized Medico-pharmaceutical Collaboration in the Drug Management of Patients With Heart Failure: Controlled, Randomized, Multicentric Study

Conditions
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Heart Failure

Intervention / Treatment
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* Other: Reinforced multidisciplinary follow-up


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Reinforced multidisciplinary follow-up<br>Entrance medication reconciliation performed by a pharmacist Patient compliance evaluation Patient quality of life evaluation Pharmaceutical analysis with focus on medication optimization with a specific check-list (according to ESC 2016 recommendations) Hospitalisation discharge medication reconciliation Patient pharmaceutic interview at the hospitalisation discharge Transmission of informations to the general practitioner and the pharmacist's patient Multidisciplinary consult at 1 month after hospitalisation discharge | Other: Reinforced multidisciplinary follow-up<br>* Reinforced multidisciplinary follow-up<br>|
| No Intervention: Standard care<br>Drug review by a paramedic or a pharmacist Pharmaceutical analysis Therapeutic optimisation based on the usual practices care of the cardiologic department Writing of the prescription given on leaving hospital based on the usual care of the department Treatments explanations and support to the patient on the usual care Transmission of the hospitalisation report to the patient general practitioner as the usual practice Medical consult in usual time frames (an average of 1 month after hospitalisation discharge) at the patient location of choice | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rehospitalisation for heart failure | At least one rehospitalisation with heart failure related cause | Call at 3 months after hospitalisation discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prescriptions conformity rates compared to heart failure recommendations edited by the European Society of Cardiology in 2016 | Evaluated by a pharmacist | At hospitalisation discharge (Day 0) | 
| Prescriptions conformity rates compared to heart failure recommendations edited by the European Society of Cardiology in 2016 | Evaluated by a pharmacist | Call at 3 months after hospitalisation discharge | 
| Compliance level | 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 | At hospitalisation discharge (Day 0) | 
| Compliance level | Evaluated by the Girerd medication adherence questionnaire 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 | At 1 month after hospitalisation discharge for the experimental group only | 
| Compliance level | Evaluated by the Girerd medication adherence questionnaire 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 | Call at 3 months after hospitalisation discharge | 
| Treatment persistence rates | Evaluated by a pharmacist | Call at 3 months after hospitalisation discharge | 
| Death rate | Evaluated by a pharmacist | Call at 3 months after hospitalisation discharge | 
| Time before death | Evaluated by a pharmacist | Call at 3 months after hospitalisation discharge | 
| Time of occurrence of a potential rehospitalisation related to the disease | Evaluated by a pharmacist | Call at 3 months after hospitalisation discharge | 
| Quality of life score | 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. | Call at 3 months after hospitalisation discharge | 
| Satisfaction of the patient | 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) | Call at 3 months after hospitalisation discharge | 
| Satisfaction of health professionals | 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) | online questionnaire at 3 months after hospitalisation discharge | 
| Incremental cost-effectiveness ratio |  | 3 months after hospitalisation discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart failure, pharmacist, multidisciplinary team, readmission