Establishment of a Personalized Pharmaceutical Plan in Renal or Hepatic Transplant Patients
NCT ID: NCT04295928
Last Updated: 2022-11-03
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
1716 participants
INTERVENTIONAL
2020-10-12
2025-09-11
Brief Summary
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Detailed Description
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In 2016, 1,322 liver transplantations (LT) were performed in France. Indications for LT are mainly acute or chronic hepatic insufficiency and liver tumors. LT is the only therapeutic solution for these patients because there is no such alternative as dialysis in nephrology. According to the DRG (Diagnosis Related Group) tariff, the average cost of a LT is about 35,000€ (excluding preparation for transplantation, drugs and post-transplantation follow-up).
If kidney and liver transplantations allow the patient to return to a life close to normal, with graft survival at one year of 84% for the liver and 91% for the kidney, these is constrained by taking immunosuppressive treatments (IS). In the last few years, progress has been made both in surgery and in immediate post-transplantation management. Therefore, now, the challenges of transplantation lie in the long-term transplant patients management, that is to say in prevention of transplant organ rejection and of anti-rejection drugs side effects (cardiovascular diseases, cancers, infections). This prevention requires optimal adherence of the patients both to the drug treatment and to the hygieno-dietetic rules. The scarcity of grafts in France makes it necessary to maximize graft survival so as to limit the need for a new transplantation.
In the literature, drug adherence of IS is between 45% and 85%. Among the non-adherence factors identified, there is a lack of a therapeutic education program and the delay with respect to the transplantation (with the spacing of the consultations at the hospital).
The investigators hypothesize that the combination of pharmaceutical follow-up during hospitalization, coupled with a strengthened hospital-community link, is central to patient adherence, and therefore to patient and graft survival.
The French Society of Clinical Pharmacy (SFPC) established in 2017 a new model of clinical pharmacy. The latter is based (apart from the regulatory activity of prescriptions analysis), on the implementation of a Personalized Pharmaceutical Plan (PPP) corresponding to a management adapted to the patient's path by proposing best possible medication history, pharmaceutical interviews, dedicated pharmaceutical outpatient consultations and therapeutic education. These actions must be carried out both at the hospital and at the local pharmacy.
Most often, the post-transplantation follow-up is done by the transplant center or for some cases (especially for the liver) by expert centers closer to the patient's home but often quite far from the transplant team. Primary care teams have little or no integration into the care of these patients. This is why the community pharmacist, in collaboration with the transplant team, could be a relay close to the patient ensuring continuity, repetition of messages and follow-up as soon as the post-transplantation consultations spread out.
Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
SUPPORTIVE_CARE
NONE
Study Groups
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Intervention
Implementation of a personalized pharmaceutical plan with a view to increasing the patient's therapeutic education in the hospital and in the community (entrance and discharge reconciliation, 3 pharmaceutical interviews in the hospital, strengthening of the community-hospital link , 3 outpatient pharmaceutical consultations)
PPP
Personalized Pharmaceutical Plan on therapeutic adherence to immunosuppressive treatments after the transplantation
Usual care period
No changes to usual center practices
No interventions assigned to this group
Interventions
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PPP
Personalized Pharmaceutical Plan on therapeutic adherence to immunosuppressive treatments after the transplantation
Eligibility Criteria
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Inclusion Criteria
* Patient having given his free, informed and express consent
* Patient with a kidney or liver transplantation performed in the 10 participating university hospital centers
* Patient speaking french
* Patient whose main residence is in France and has no project of moving during the study period
* Patient declaring to attend the same pharmacy
* Social insured patient
Exclusion Criteria
* Patient having a double liver / kidney transplantation with a center not participating in the study
* Patients with a double organ transplantation kidney /hart
* Patient already transplanted regardless of the organ
18 Years
ALL
No
Sponsors
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Unité d'Epidémiologie des Données cliniques en Centre-Val de Loire (EpiDcliC)
UNKNOWN
Unité d'Evaluation Médico-Economique (UEME)
UNKNOWN
University Hospital, Tours
OTHER
Responsible Party
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Principal Investigators
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Xavier POURRAT, PhD
Role: STUDY_DIRECTOR
University Hospital of TOURS
Locations
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CHU-BREST - Pharmacie clinique La Cavale Blanche
Brest, , France
APHM - Service de Pharmacie Clinique; Hôpital de la Timone
Marseille, , France
APHM Service Pharmacie- Hôpital de la Conception
Marseille, , France
CHU-Montpellier Service Pharmacie Lapeyronie
Montpellier, , France
CHU-NANTES Service de Pharmacie
Nantes, , France
CHU-POITIERS Service de Pharmacie
Poitiers, , France
CHU-REIMS Service de Pharmacie -Robert Debré
Reims, , France
CHU-RENNES Pôle Pharmacie, Unité de pharmacie clinique
Rennes, , France
CHU-STRASBOURG Service Pharmacie, Hôpital Hautepierre
Strasbourg, , France
CHU-TOULOUSE Pôle Pharmacie PURPAN
Toulouse, , France
CHU-TOURS Hôpital Bretonneau
Tours, , France
CHU-TOURS-Hôpital TROUSSEAU
Tours, , France
Countries
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References
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Pourrat X, Berthy E, Dupuis A, Barbier L, Buchler M, Guillon LG, Monmousseau F, Ruspini E, Salame E, Houdard SB, Giraudeau B. Implementing a personalized pharmaceutical plan in kidney or liver transplant patients: study protocol for a stepped-wedge cluster randomized trial (GRePH). Trials. 2021 Nov 8;22(1):782. doi: 10.1186/s13063-021-05749-w.
Other Identifiers
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2019-A01723-54
Identifier Type: REGISTRY
Identifier Source: secondary_id
920070
Identifier Type: REGISTRY
Identifier Source: secondary_id
DR190061-GREPH
Identifier Type: -
Identifier Source: org_study_id
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