Implementing a personalized pharmaceutical plan in kidney or liver transplant patients: study protocol for a stepped-wedge cluster randomized trial (GRePH)

Xavier Pourrat, Elise Berthy, Antoine Dupuis, Louise Barbier, Matthias Buchler, Leslie Grammatico Guillon, Fanny Monmousseau, Eric Ruspini, Ephrem Salamé, Solène Brunet Houdard, Bruno Giraudeau, Xavier Pourrat, Elise Berthy, Antoine Dupuis, Louise Barbier, Matthias Buchler, Leslie Grammatico Guillon, Fanny Monmousseau, Eric Ruspini, Ephrem Salamé, Solène Brunet Houdard, Bruno Giraudeau

Abstract

Background: Nowadays, the main challenge of transplantation is the improvement of long-term care, aiming at reducing treatment-related complications and at decreasing rejection rates. Patients' adherence to both treatment and hygienic-dietary measures is mandatory to achieve these objectives. Adherence to immunosuppressive drugs is estimated to be only 70%. We hypothesized that the implementation of a personalized pharmaceutical plan (PPP) would increase adherence and therefore graft survival.

Methods/design: This study is a stepped-wedge cluster randomized trial with transplantation units defining clusters. Twelve clusters from 10 university hospitals were recruited. All centres started on the same day in the control phase. Every 7 weeks, one centre will switch to the intervention phase and remain there until the end of inclusions. We plan to recruit 1716 kidney and/or liver transplant patients. The intervention phase consists in setting up the PPP: development of the patient's hospital and community pharmaceutical follow-up. In the hospital, the pharmacist will carry out drug reconciliation upon admission, daily pharmaceutical follow-up of prescriptions and pharmaceutical interviews with the patient in order to explain the modalities of taking immunosuppressive drugs and hygienic-dietary measures. After hospitalization, during the post-transplantation year, pharmaceutical meetings will take place, prior to medical consultations in order to check the patient's understanding of the prescription, his adherence, to remind them of hygienic-dietary measures and to look for adverse effects. The hospital pharmacist will also be in charge of establishing a close link with the community pharmacist (CP) and general practitioner, especially providing discharge medication reconciliation, an e-learning and a checklist. Moreover, prior to each pharmaceutical consultation, the hospital pharmacist will contact the CP to discuss patient adherence. The primary outcome is adherence to immunosuppressive treatments 1 year post-transplantation assessed by using the BAASIS questionnaire and the health insurance data from the national health data system. A medico-economic study will measure the efficiency of this plan.

Discussion: GRePH aims to increase adherence of liver and/or kidney transplant patients to their immunosuppressive therapies in order to reduce transplant rejections. To this end, a new clinical pharmacy model, the PPP, will be set up in 10 university hospitals.

Trial registration: ClinicalTrials.gov NCT04295928 . Registered on 5 March 2020.

Keywords: Clinical pharmacy; Community-hospital link; Immunosuppressive drugs; Medico-economic study; Personalized pharmaceutical plan; Stepped-wedge cluster randomized trial; Therapeutic adherence; Transplantation.

Conflict of interest statement

The authors declare that they have no competing interests.

© 2021. The Author(s).

Figures

Fig. 1
Fig. 1
Schematic representation of the stepped-wedge study
Fig. 2
Fig. 2
Diagram showing the course of the study

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Source: PubMed

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