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

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...

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Autores principales:	Xavier Pourrat, Elise Berthy, Antoine Dupuis, Louise Barbier, Matthias Buchler, Leslie Grammatico Guillon, Fanny Monmousseau, Eric Ruspini, Ephrem Salamé, Solène Brunet Houdard, Bruno Giraudeau
Formato:	article
Lenguaje:	EN
Publicado:	BMC 2021
Materias:	Personalized pharmaceutical plan Therapeutic adherence Immunosuppressive drugs Clinical pharmacy Community-hospital link Transplantation Medicine (General) R5-920
Acceso en línea:	https://doaj.org/article/764f405dcaf04d969fcb343e2ec3b94f
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spelling	oai:doaj.org-article:764f405dcaf04d969fcb343e2ec3b94f2021-11-14T12:31:11ZImplementing a personalized pharmaceutical plan in kidney or liver transplant patients: study protocol for a stepped-wedge cluster randomized trial (GRePH)10.1186/s13063-021-05749-w1745-6215https://doaj.org/article/764f405dcaf04d969fcb343e2ec3b94f2021-11-01T00:00:00Zhttps://doi.org/10.1186/s13063-021-05749-whttps://doaj.org/toc/1745-6215Abstract 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 2020Xavier PourratElise BerthyAntoine DupuisLouise BarbierMatthias BuchlerLeslie Grammatico GuillonFanny MonmousseauEric RuspiniEphrem SalaméSolène Brunet HoudardBruno GiraudeauBMCarticlePersonalized pharmaceutical planTherapeutic adherenceImmunosuppressive drugsClinical pharmacyCommunity-hospital linkTransplantationMedicine (General)R5-920ENTrials, Vol 22, Iss 1, Pp 1-9 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Personalized pharmaceutical plan Therapeutic adherence Immunosuppressive drugs Clinical pharmacy Community-hospital link Transplantation Medicine (General) R5-920
spellingShingle	Personalized pharmaceutical plan Therapeutic adherence Immunosuppressive drugs Clinical pharmacy Community-hospital link Transplantation Medicine (General) R5-920 Xavier Pourrat Elise Berthy Antoine Dupuis Louise Barbier Matthias Buchler Leslie Grammatico Guillon Fanny Monmousseau Eric Ruspini Ephrem Salamé Solène Brunet Houdard Bruno Giraudeau Implementing a personalized pharmaceutical plan in kidney or liver transplant patients: study protocol for a stepped-wedge cluster randomized trial (GRePH)
description	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
format	article
author	Xavier Pourrat Elise Berthy Antoine Dupuis Louise Barbier Matthias Buchler Leslie Grammatico Guillon Fanny Monmousseau Eric Ruspini Ephrem Salamé Solène Brunet Houdard Bruno Giraudeau
author_facet	Xavier Pourrat Elise Berthy Antoine Dupuis Louise Barbier Matthias Buchler Leslie Grammatico Guillon Fanny Monmousseau Eric Ruspini Ephrem Salamé Solène Brunet Houdard Bruno Giraudeau
author_sort	Xavier Pourrat
title	Implementing a personalized pharmaceutical plan in kidney or liver transplant patients: study protocol for a stepped-wedge cluster randomized trial (GRePH)
title_short	Implementing a personalized pharmaceutical plan in kidney or liver transplant patients: study protocol for a stepped-wedge cluster randomized trial (GRePH)
title_full	Implementing a personalized pharmaceutical plan in kidney or liver transplant patients: study protocol for a stepped-wedge cluster randomized trial (GRePH)
title_fullStr	Implementing a personalized pharmaceutical plan in kidney or liver transplant patients: study protocol for a stepped-wedge cluster randomized trial (GRePH)
title_full_unstemmed	Implementing a personalized pharmaceutical plan in kidney or liver transplant patients: study protocol for a stepped-wedge cluster randomized trial (GRePH)
title_sort	implementing a personalized pharmaceutical plan in kidney or liver transplant patients: study protocol for a stepped-wedge cluster randomized trial (greph)
publisher	BMC
publishDate	2021
url	https://doaj.org/article/764f405dcaf04d969fcb343e2ec3b94f
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Implementing a personalized pharmaceutical plan in kidney or liver transplant patients: study protocol for a stepped-wedge cluster randomized trial (GRePH)

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