Heart Failure Clinical Trial
— COMPICOfficial title:
Interest of an Optimized Medico-pharmaceutical Collaboration in the Drug Management of Patients With Heart Failure: Controlled, Randomized, Multicentric Study
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.
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 |
Country | Name | City | State |
---|---|---|---|
France | University Hospital of Montpellier Cardiology departments oh the Montpellier, Nîmes and Toulouse University Hospitals | Montpellier | Occitanie |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Montpellier |
France,
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
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 |
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