Clinical trial NCT04295928: Establishment of a Personalized Pharmaceutical Plan in Renal or Hepatic Transplant Patients
Official title: Mise en Place d'un Plan Pharmaceutique Personnalisé Chez Les Patients transplantés rénaux ou hépatiques : Essai randomisé en Cluster de Type Stepped-wedge.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Personalized Pharmaceutical Plan After Transpantation
Keywords: Therapeutic adherence
Immunosuppressive treatments
Transplantation
Liver
Kidney
Personalized Pharmaceutical Plan
Community-hospital link
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
Collaborators: name: Unité d'Epidémiologie des Données cliniques en Centre-Val de Loire (EpiDcliC)
name: Unité d'Evaluation Médico-Economique (UEME)
First posted: 2020-03-05
Enrollment: 1716
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Cluster Stepped-wedge; Inclusions per cluster: Control period-\>Leeadin period-\>Interventionnal period
Primary purpose: SUPPORTIVE_CARE

Brief summary: The main objective of the study is to evaluate the impact of the Personalized Pharmaceutical Plan on the therapeutic adherence to immunosuppressive treatments one year after liver or kidney transplantation.

Detailed description: In 2016, 3,615 renal transplantations (RT) were performed in France. RT is indicated for end-stage renal failure, especially in dialysis patients. The average cost of a year of dialysis is 60,000 €, and that of a kidney transplantation according to the GHS tariff of 20,000 € (excluding preparation of the patient for the transplantation, drugs and post-transplantation follow-up).

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.

Eligibility criteria: Inclusion Criteria:

* Patient ≥ 18 years old
* 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 protected: safeguard of justice, curatorship, tutelage
* 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

Primary outcomes:
measure: Therapeutic adhesion
timeFrame: 1 year after transplantation
Secondary outcomes:
measure: Drug adherence of all chronic treatments prescribed to the patient (except immunosuppression (IS) drug)
timeFrame: 1 year after transplantation
measure: Knowledge of hygienic-dietetic rules and drug intake modalities
timeFrame: 1 year after transplantation
measure: Occurrence of adverse effects
timeFrame: At month 1,month 3, and 12 months after transplantation
measure: Fate of the graft
timeFrame: 1 year and 3 years after transplantation
measure: Assessing patient, medical, and community pharmacist satisfaction
timeFrame: 1 year after transplantation
measure: Assessment of potential release risk by measuring the coefficient of variation (CV) of anticalcineurin doses
timeFrame: 3 years after transplantation
measure: For kidney transplantation : testing for anti-HLA antibodies
timeFrame: 1 year and 3 years after transplantation
measure: Determining the efficiency of the implementation of the PPP
timeFrame: 1 year after transplantation
Other outcomes:
Locations:
city: Brest
country: France
facility: CHU-BREST - Pharmacie clinique La Cavale Blanche
city: Marseille
country: France
facility: APHM - Service de Pharmacie Clinique; Hôpital de la Timone
city: Marseille
country: France
facility: APHM Service Pharmacie- Hôpital de la Conception
city: Montpellier
country: France
facility: CHU-Montpellier Service Pharmacie Lapeyronie
city: Nantes
country: France
facility: CHU-NANTES Service de Pharmacie
city: Poitiers
country: France
facility: CHU-POITIERS Service de Pharmacie
city: Reims
country: France
facility: CHU-REIMS Service de Pharmacie -Robert Debré
city: Rennes
country: France
facility: CHU-RENNES Pôle Pharmacie, Unité de pharmacie clinique
city: Strasbourg
country: France
facility: CHU-STRASBOURG Service Pharmacie, Hôpital Hautepierre
city: Toulouse
country: France
facility: CHU-TOULOUSE Pôle Pharmacie PURPAN
city: Tours
country: France
facility: CHU-TOURS Hôpital Bretonneau
city: Tours
country: France
facility: CHU-TOURS-Hôpital TROUSSEAU
Study officials:
affiliation: University Hospital of TOURS
name: Xavier POURRAT, PhD
role: STUDY_DIRECTOR
References:
citation: 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.