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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03902028
Recruitment Status : Recruiting
First Posted : April 3, 2019
Last Update Posted : March 31, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier

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.

Condition or disease Intervention/treatment Phase
Heart Failure Other: Reinforced multidisciplinary follow-up Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 248 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Interest of an Optimized Medico-pharmaceutical Collaboration in the Drug Management of Patients With Heart Failure: Controlled, Randomized, Multicentric Study
Actual Study Start Date : August 2, 2019
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : August 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Experimental: Reinforced multidisciplinary follow-up

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
Reinforced multidisciplinary follow-up

No Intervention: Standard care
  • 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



Primary Outcome Measures :
  1. Rehospitalisation for heart failure [ Time Frame: Call at 3 months after hospitalisation discharge ]
    At least one rehospitalisation with heart failure related cause


Secondary Outcome Measures :
  1. Prescriptions conformity rates compared to heart failure recommendations edited by the European Society of Cardiology in 2016 [ Time Frame: At hospitalisation discharge (Day 0) ]
    Evaluated by a pharmacist

  2. Prescriptions conformity rates compared to heart failure recommendations edited by the European Society of Cardiology in 2016 [ Time Frame: Call at 3 months after hospitalisation discharge ]
    Evaluated by a pharmacist

  3. Compliance level [ Time Frame: 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


  4. Compliance level [ Time Frame: At 1 month after hospitalisation discharge for the experimental group only ]

    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


  5. Compliance level [ Time Frame: Call at 3 months after hospitalisation discharge ]

    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


  6. Treatment persistence rates [ Time Frame: Call at 3 months after hospitalisation discharge ]
    Evaluated by a pharmacist

  7. Death rate [ Time Frame: Call at 3 months after hospitalisation discharge ]
    Evaluated by a pharmacist

  8. Time before death [ Time Frame: Call at 3 months after hospitalisation discharge ]
    Evaluated by a pharmacist

  9. Time of occurrence of a potential rehospitalisation related to the disease [ Time Frame: Call at 3 months after hospitalisation discharge ]
    Evaluated by a pharmacist

  10. Quality of life score [ Time Frame: 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.

  11. Satisfaction of the patient [ Time Frame: 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)

  12. Satisfaction of health professionals [ Time Frame: 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)

  13. Incremental cost-effectiveness ratio [ Time Frame: 3 months after hospitalisation discharge ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03902028


Contacts
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Contact: Audrey CASTET-NICOLAS, MCU-PH, Pharm D, PhD (0)467338564 ext +33 audrey-castet@chu-montpellier.fr
Contact: Nicolas CHAPET, Pharm D, PhD (0)467338562 n-chapet@chu-montpellier.fr

Locations
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France
University Hospital of Montpellier Cardiology departments oh the Montpellier, Nîmes and Toulouse University Hospitals Recruiting
Montpellier, Occitanie, France, 34295
Contact: Audrey CASTET-NICOLAS, MCU-PH, Pharm D, PhD    (0)467338564    audrey-castet@chu-montpellier.fr   
Contact: Nicolas CHAPET, Pharm D    (0)467338562    n-chapet@chu-montpellier.fr   
Sponsors and Collaborators
University Hospital, Montpellier
Publications of Results:
Available at: https://academic.oup.com/eurheartj/article/37/27/2129/1748921/2016-ESC-Guidelines-for-the-diagnosis-and. (Accessed: 12th September 2017).

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Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT03902028    
Other Study ID Numbers: RECHMPL18_0040
First Posted: April 3, 2019    Key Record Dates
Last Update Posted: March 31, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Montpellier:
Heart failure
pharmacist
multidisciplinary team
readmission
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases