Ignite Creation Date:
2025-12-26 @ 11:11 AM
Ignite Modification Date:
2025-12-31 @ 7:22 PM
Study NCT ID:
NCT04295928
Status:
UNKNOWN
Last Update Posted:
2022-11-03
First Post:
2020-03-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Establishment of a Personalized Pharmaceutical Plan in Renal or Hepatic Transplant Patients
Sponsor:
University Hospital, Tours
Organization:
Study Overview
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.
Status:
UNKNOWN
Status Verified Date:
2022-11
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GREPH
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: