Optimized Medico-pharmaceutical Collaboration in the Drug Management of Patients With Heart Failure
NCT ID: NCT03902028
Last Updated: 2022-01-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
248 participants
INTERVENTIONAL
2019-08-02
2022-08-31
Brief Summary
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Detailed Description
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* 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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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
Reinforced multidisciplinary follow-up
Reinforced multidisciplinary follow-up
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
No interventions assigned to this group
Interventions
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Reinforced multidisciplinary follow-up
Reinforced multidisciplinary follow-up
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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University Hospital, Montpellier
OTHER
Responsible Party
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Locations
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University Hospital of Montpellier Cardiology departments oh the Montpellier, Nîmes and Toulouse University Hospitals
Montpellier, Occitanie, France
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
Available at: https://academic.oup.com/eurheartj/article/37/27/2129/1748921/2016-ESC-Guidelines-for-the-diagnosis-and. (Accessed: 12th September 2017).
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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RECHMPL18_0040
Identifier Type: -
Identifier Source: org_study_id
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