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

Heart Failure Clinical Trial

— COMPIC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03902028
• Other study ID #: RECHMPL18_0040
• Status: Recruiting
• Phase: N/A
• Start date: August 2, 2019
• Est. completion date: August 2022

Study information

• Verified date: December 2021
• Source: University Hospital, Montpellier
• Contact: Audrey CASTET-NICOLAS, MCU-PH, Pharm D, PhD
• Phone: (0)467338564
• Email: audrey-castet[@]chu-montpellier.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 248
• Est. completion date: August 2022
• Est. primary completion date: February 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

Other:
• Reinforced multidisciplinary follow-up
Reinforced multidisciplinary follow-up

Locations

Country	Name	City	State
France	University Hospital of Montpellier Cardiology departments oh the Montpellier, Nîmes and Toulouse University Hospitals	Montpellier	Occitanie

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

References & Publications (10)

Available at: https://academic.oup.com/eurheartj/article/37/27/2129/1748921/2016-ESC-Guidelines-for-the-diagnosis-and. (Accessed: 12th September 2017).

Buckley MS, Harinstein LM, Clark KB, Smithburger PL, Eckhardt DJ, Alexander E, Devabhakthuni S, Westley CA, David B, Kane-Gill SL. Impact of a clinical pharmacy admission medication reconciliation program on medication errors in "high-risk" patients. Ann — View Citation

Jackevicius CA, de Leon NK, Lu L, Chang DS, Warner AL, Mody FV. Impact of a Multidisciplinary Heart Failure Post-hospitalization Program on Heart Failure Readmission Rates. Ann Pharmacother. 2015 Nov;49(11):1189-96. doi: 10.1177/1060028015599637. Epub 201 — View Citation

López Cabezas C, Falces Salvador C, Cubí Quadrada D, Arnau Bartés A, Ylla Boré M, Muro Perea N, Homs Peipoch E. Randomized clinical trial of a postdischarge pharmaceutical care program vs regular follow-up in patients with heart failure. Farm Hosp. 2006 N — View Citation

Masters J, Morton G, Anton I, Szymanski J, Greenwood E, Grogono J, Flett AS, Cleland JG, Cowburn PJ. Specialist intervention is associated with improved patient outcomes in patients with decompensated heart failure: evaluation of the impact of a multidisc — View Citation

Parajuli DR, Franzon J, McKinnon RA, Shakib S, Clark RA. Role of the Pharmacist for Improving Self-care and Outcomes in Heart Failure. Curr Heart Fail Rep. 2017 Apr;14(2):78-86. doi: 10.1007/s11897-017-0323-2. Review. — View Citation

Ponikowski P, Voors AA, Anker SD, Bueno H, Cleland JGF, Coats AJS, Falk V, González-Juanatey JR, Harjola VP, Jankowska EA, Jessup M, Linde C, Nihoyannopoulos P, Parissis JT, Pieske B, Riley JP, Rosano GMC, Ruilope LM, Ruschitzka F, Rutten FH, van der Meer — View Citation

Van Spall HGC, Rahman T, Mytton O, Ramasundarahettige C, Ibrahim Q, Kabali C, Coppens M, Brian Haynes R, Connolly S. Comparative effectiveness of transitional care services in patients discharged from the hospital with heart failure: a systematic review a — View Citation

Wan TTH, Terry A, Cobb E, McKee B, Tregerman R, Barbaro SDS. Strategies to Modify the Risk of Heart Failure Readmission: A Systematic Review and Meta-Analysis. Health Serv Res Manag Epidemiol. 2017 Apr 18;4:2333392817701050. doi: 10.1177/2333392817701050. — View Citation

Warden BA, Freels JP, Furuno JP, Mackay J. Pharmacy-managed program for providing education and discharge instructions for patients with heart failure. Am J Health Syst Pharm. 2014 Jan 15;71(2):134-9. doi: 10.2146/ajhp130103. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rehospitalisation for heart failure	At least one rehospitalisation with heart failure related cause	Call at 3 months after hospitalisation discharge
Secondary	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)
Secondary	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
Secondary	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)
Secondary	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
Secondary	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
Secondary	Treatment persistence rates	Evaluated by a pharmacist	Call at 3 months after hospitalisation discharge
Secondary	Death rate	Evaluated by a pharmacist	Call at 3 months after hospitalisation discharge
Secondary	Time before death	Evaluated by a pharmacist	Call at 3 months after hospitalisation discharge
Secondary	Time of occurrence of a potential rehospitalisation related to the disease	Evaluated by a pharmacist	Call at 3 months after hospitalisation discharge
Secondary	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
Secondary	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
Secondary	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
Secondary	Incremental cost-effectiveness ratio		3 months after hospitalisation discharge