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Personalized Pharmaceutical Plan After TranspantationGREPHNCT04295928

Establishment of a Personalized Pharmaceutical Plan in Renal or Hepatic Transplant Patients

A study testing PPP in people with Personalized Pharmaceutical Plan After Transpantation, run by University Hospital, Tours at 12 sites in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
PPP
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,716 participants
Where
12 sitesFrance
Study dates
12 Oct 2020to 11 Sep 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

France12 sites
  • CHU-BREST - Pharmacie clinique La Cavale Blanche

    Brest, 29609

  • APHM - Service de Pharmacie Clinique; Hôpital de la Timone

    Marseille, 13385

  • APHM Service Pharmacie- Hôpital de la Conception

    Marseille, 13385

  • CHU-Montpellier Service Pharmacie Lapeyronie

    Montpellier, 34000

  • CHU-NANTES Service de Pharmacie

    Nantes, 44000

  • CHU-POITIERS Service de Pharmacie

    Poitiers, 86021

  • CHU-REIMS Service de Pharmacie -Robert Debré

    Reims, 51092

  • CHU-RENNES Pôle Pharmacie, Unité de pharmacie clinique

    Rennes, 35000

  • CHU-STRASBOURG Service Pharmacie, Hôpital Hautepierre

    Strasbourg, 67200

  • CHU-TOULOUSE Pôle Pharmacie PURPAN

    Toulouse, 31059

  • CHU-TOURS Hôpital Bretonneau

    Tours, 37044

  • CHU-TOURS-Hôpital TROUSSEAU

    Tours, 37044

Other trials in France

About this study

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.

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.

Read the 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.

Being tested
PPP
Keywords
Therapeutic adherence, Immunosuppressive treatments, Transplantation, Liver, Kidney, Personalized Pharmaceutical Plan, Community-hospital link
Medical subject headings
Treatment Adherence and Compliance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PPPBehavioural

    Personalized Pharmaceutical Plan on therapeutic adherence to immunosuppressive treatments after the transplantation

Study groups in NCT04295928
Study groupRoleWhat they receive
InterventionExperimentalImplementation 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)
Receives: Behavioral: PPP
Usual care periodNo interventionNo changes to usual center practices

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Therapeutic adhesion

    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)

    Measured: 1 year after transplantation

Secondary outcomes (8)
  1. Drug adherence of all chronic treatments prescribed to the patient (except immunosuppression (IS) drug)

    Drug adherence of all chronic treatments prescribed to the patient (except immunosuppression (IS) drug) measured by the EvalObs® scale (graduation from 0 to 15)

    Measured: 1 year after transplantation

  2. Knowledge of hygienic-dietetic rules and drug intake modalities

    Knowledge of hygienic-dietetic rules and drug intake modalities assessed using an questionnaire ( scale from 1-9)

    Measured: 1 year after transplantation

  3. Occurrence of adverse effects

    Search for the occurrence of adverse events related to IS (diabetes, hypertension, weight gain, tremor, leukopenia, thrombocytopenia,...) during medical and pharmaceutical consultations.

    Measured: At month 1,month 3, and 12 months after transplantation

  4. Fate of the graft

    Study of the fate of the graft (rejection, rejection episodes)

    Measured: 1 year and 3 years after transplantation

  5. Assessing patient, medical, and community pharmacist satisfaction

    Assessing patient, medical, community pharmacist and trial satisfaction (thanks to a 5-level Likert scale) with the system implemented

    Measured: 1 year after transplantation

  6. Assessment of potential release risk by measuring the coefficient of variation (CV) of anticalcineurin doses

    A patient with a CV greater than 30% will be considered to be at higher risk of rejection

    Measured: 3 years after transplantation

  7. For kidney transplantation : testing for anti-HLA antibodies

    Anti-HLA antibodies are known to be responsible for rejection in kidney transplants: search for anti-HLA antibodies directed against the donor one and three years after the transplant by Elisa technique

    Measured: 1 year and 3 years after transplantation

  8. Determining the efficiency of the implementation of the PPP

    Determining the efficiency of the implementation of this PPP in 3 different ways: by determining the cost per QALY gained at 1 year, the cost per additional patient adherent at 1 year and the cost per first functional graft in additional living patient (living patient, carrying their first graft and functional graft) at 1 year

    Measured: 1 year after transplantation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Mar 2020
  2. Study start12 Oct 2020
  3. Primary completion11 Sep 2022
  4. Study completion11 Sep 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Non-randomised
Intervention model
Sequential
Model description
Cluster Stepped-wedge; Inclusions per cluster: Control period-\>Leeadin period-\>Interventionnal period
Masking
None (open label)
Enrolment
1,716 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04295928
Sponsor's protocol ID
DR190061-GREPH
Other IDs
2019-A01723-54, 920070
Acronym
GREPH
Status last verified
Nov 2022
First submitted
2 Mar 2020
Last updated
3 Nov 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Pourrat X, Berthy E, Dupuis A, Barbier L, Buchler M, Guillon LG, Monmousseau F, Ruspini E, Salame E, Houdard SB, Giraudeau B. Implementing a personalized pharmaceutical plan in kidney or liver transplant patients: study protocol for a stepped-wedge cluster randomized trial (GRePH). Trials. 2021 Nov 8;22(1):782. doi: 10.1186/s13063-021-05749-w.

    PubMed 34749777

Questions about this trial

What is this clinical trial studying?

A study testing PPP in people with Personalized Pharmaceutical Plan After Transpantation, run by University Hospital, Tours at 12 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 3 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Therapeutic adhesion (time frame: 1 year after transplantation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04295928, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2022.

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