Mise en Place d'un Plan Pharmaceutique Personnalisé Chez Les Patients transplantés rénaux ou hépatiques : Essai randomisé en Cluster de Type Stepped-wedge.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- University Hospital, Tours
- Enrollment
- 1,716
- Locations
- 12
- Primary Endpoint
- Therapeutic adhesion
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Usual care period
No changes to usual center practices
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)
Intervention: PPP (Behavioral)
Outcomes
Primary Outcomes
Therapeutic adhesion
Time Frame: 1 year after transplantation
The Investigator will consider that a patient is in therapeutic adhesion thanks to two methods : use of the BAASIS® questionnaire (if answer \<1 for at least one of the 4 questions in the score, the patient will be considered as a non-adherent) and use of the health insurance data from the national health data system (checking that 100% of the days are covered by possession of immunosuppressive drugs)
Secondary Outcomes
- Knowledge of hygienic-dietetic rules and drug intake modalities(1 year after transplantation)
- Assessing patient, medical, and community pharmacist satisfaction(1 year after transplantation)
- Assessment of potential release risk by measuring the coefficient of variation (CV) of anticalcineurin doses(3 years after transplantation)
- Fate of the graft(1 year and 3 years after transplantation)
- Drug adherence of all chronic treatments prescribed to the patient (except immunosuppression (IS) drug)(1 year after transplantation)
- Occurrence of adverse effects(At month 1,month 3, and 12 months after transplantation)
- For kidney transplantation : testing for anti-HLA antibodies(1 year and 3 years after transplantation)
- Determining the efficiency of the implementation of the PPP(1 year after transplantation)