Pharmacy Department, Pharm D, Tours University Hospital, 2 boulevard Tonnelle, 37044, 09, Tours Cedex, France.
Biology-Pharmacy-Public Health Department, University Hospital of Poitiers, 2 rue de la 9 Milétrie, 86021, Poitiers Cedex, France.
Trials. 2021 Nov 8;22(1):782. doi: 10.1186/s13063-021-05749-w.
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.
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.
ClinicalTrials.gov NCT04295928 . Registered on 5 March 2020.
如今，移植的主要挑战是改善长期护理，旨在减少与治疗相关的并发症，并降低排斥率。患者必须遵守治疗和卫生饮食措施，以实现这些目标。免疫抑制药物的依从性估计只有 70%。我们假设实施个性化药物方案（PPP）将提高依从性，从而提高移植物存活率。
方法/设计：这是一项采用移植单位定义群组的阶梯式楔形集群随机试验。从 10 家大学医院中招募了 12 个群组。所有中心都在对照阶段的同一天开始。每 7 周，一个中心将切换到干预阶段，并一直保持到纳入结束。我们计划招募 1716 名肾和/或肝移植患者。干预阶段包括建立 PPP：制定患者的医院和社区药物随访计划。在医院，药剂师将在入院时进行药物调整，每天对处方进行药物随访，并与患者进行药物访谈，以解释免疫抑制药物和卫生饮食措施的服用方式。住院后，在移植后的一年内，将在医疗咨询之前进行药物会议，以检查患者对处方的理解、他的依从性、提醒他们卫生饮食措施，并寻找不良反应。医院药剂师还将负责与社区药剂师（CP）和全科医生建立密切联系，特别是提供出院药物调整、电子学习和检查表。此外，在每次药物咨询之前，医院药剂师都会与 CP 联系，讨论患者的依从性。主要结果是使用 BAASIS 问卷和国家健康数据系统的健康保险数据评估移植后 1 年的免疫抑制治疗依从性。一项医疗经济学研究将衡量该计划的效率。
GRePH 旨在提高肝和/或肾移植患者对免疫抑制治疗的依从性，以降低移植排斥率。为此，将在 10 家大学医院建立新的临床药学模式 PPP。
ClinicalTrials.gov NCT04295928。于 2020 年 3 月 5 日注册。
