Clinical trial NCT03902028: Optimized Medico-pharmaceutical Collaboration in the Drug Management of Patients With Heart Failure
Official title: Interest of an Optimized Medico-pharmaceutical Collaboration in the Drug Management of Patients With Heart Failure: Controlled, Randomized, Multicentric Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Heart Failure
Keywords: Heart failure
pharmacist
multidisciplinary team
readmission
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2019-04-03
Enrollment: 248
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Eligibility 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

Primary outcomes:
measure: Rehospitalisation for heart failure
timeFrame: Call at 3 months after hospitalisation discharge
Secondary outcomes:
measure: Prescriptions conformity rates compared to heart failure recommendations edited by the European Society of Cardiology in 2016
timeFrame: At hospitalisation discharge (Day 0)
measure: Prescriptions conformity rates compared to heart failure recommendations edited by the European Society of Cardiology in 2016
timeFrame: Call at 3 months after hospitalisation discharge
measure: Compliance level
timeFrame: At hospitalisation discharge (Day 0)
measure: Compliance level
timeFrame: At 1 month after hospitalisation discharge for the experimental group only
measure: Compliance level
timeFrame: Call at 3 months after hospitalisation discharge
measure: Treatment persistence rates
timeFrame: Call at 3 months after hospitalisation discharge
measure: Death rate
timeFrame: Call at 3 months after hospitalisation discharge
measure: Time before death
timeFrame: Call at 3 months after hospitalisation discharge
measure: Time of occurrence of a potential rehospitalisation related to the disease
timeFrame: Call at 3 months after hospitalisation discharge
measure: Quality of life score
timeFrame: Call at 3 months after hospitalisation discharge
measure: Satisfaction of the patient
timeFrame: Call at 3 months after hospitalisation discharge
measure: Satisfaction of health professionals
timeFrame: online questionnaire at 3 months after hospitalisation discharge
measure: Incremental cost-effectiveness ratio
timeFrame: 3 months after hospitalisation discharge
Other outcomes:
Locations:
city: Montpellier
country: France
facility: University Hospital of Montpellier Cardiology departments oh the Montpellier, Nîmes and Toulouse University Hospitals
state: Occitanie
Study officials:
References:
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 2015 Aug 10.
citation: Ponikowski P, Voors AA, Anker SD, Bueno H, Cleland JGF, Coats AJS, Falk V, Gonzalez-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 P; ESC Scientific Document Group. 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: The Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC)Developed with the special contribution of the Heart Failure Association (HFA) of the ESC. Eur Heart J. 2016 Jul 14;37(27):2129-2200. doi: 10.1093/eurheartj/ehw128. Epub 2016 May 20. No abstract available.
citation: Available at: https://academic.oup.com/eurheartj/article/37/27/2129/1748921/2016-ESC-Guidelines-for-the-diagnosis-and. (Accessed: 12th September 2017).
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 multidisciplinary inpatient heart failure team. Open Heart. 2017 Mar 8;4(1):e000547. doi: 10.1136/openhrt-2016-000547. eCollection 2017.
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 and network meta-analysis. Eur J Heart Fail. 2017 Nov;19(11):1427-1443. doi: 10.1002/ejhf.765. Epub 2017 Feb 24.
citation: Lopez Cabezas C, Falces Salvador C, Cubi Quadrada D, Arnau Bartes A, Ylla Bore 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 Nov-Dec;30(6):328-42. doi: 10.1016/s1130-6343(06)74004-1. English, Spanish.
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.
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. eCollection 2017 Jan-Dec.
citation: 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 Pharmacother. 2013 Dec;47(12):1599-610. doi: 10.1177/1060028013507428. Epub 2013 Oct 15.
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.