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

University Hospital Center (CHU)

Status: Unknown

Conditions: Heart Failure

Treatments: Other: Reinforced multidisciplinary follow-up

Study type: Interventional

Funder types: Other

Identifiers

NCT03902028

RECHMPL18_0040

Details and patient eligibility

About

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.

Full 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.

Enrollment: 248 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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248 participants in 2 patient groups

Reinforced multidisciplinary follow-up

Experimental group

Description:

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

Treatment:

Other: Reinforced multidisciplinary follow-up

Standard care

No Intervention group

Description:

* 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