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Open Access Study protocol

Impact of drug reconciliation at discharge and communication between hospital and community pharmacists on drug-related problems: study protocol for a randomized controlled trial

Xavier Pourrat1*, Clarisse Roux2, Brigitte Bouzige3, Valérie Garnier4, Armelle Develay2, Benoit Allenet59, Martial Fraysse6, Jean-Michel Halimi107, Jacqueline Grassin1 and Bruno Giraudeau118

Author Affiliations

1 Pharmacy Department, Pharm D, Tours University Hospital, 2 boulevard Tonnelle, 37044 Tours cedex 09, France

2 Pharmacy Department, Pharm D, Nîmes University Hospital, 4 Rue du Professeur Robert Debré, 30029 Nîmes, France

3 Pharm D, Pharmacie Bouzige, 32 Rue Pont, 30110 Les Salles du Gardon, France

4 Pharm D, Pharmacien, Pharmacie Garnier, 1 Chemin des Prés, 30840 Meynes, France

5 Pharmacy Department, Pharm D, CHU de Grenoble, Boulevard de la Chantourne, 38700 La Tronche, France

6 Pharm D, 52 Rue du Commandant Jean Duhail, 94120 Fontenay-sous-Bois, France

7 Nephrology Department, Tours University Hospital, 2 boulevard Tonnelle, 37044 Tours cedex 09, France

8 INSERM CIC 1415, CHRU de Tours, Hôpital Bretonneau, 2 Boulevard Tonnellé, 37044 Tours Cedex 09, France

9 ThEMAS TIMC-IMAG (UMR CNRS 5525), School of Medicine and Pharmacy, J Fourier University, Grenoble, 621 Avenue Centrale, 38041 Saint-Martin-d'Hères, France

10 Therapeutic Department, School of Medicine, François Rabelais University, 10 Boulevard Tonnellé, 37000 Tours, France

11 INSERM CIC 1415, François Rabelais University, 10 Boulevard Tonnellé, 37000 Tours, France

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Trials 2014, 15:260  doi:10.1186/1745-6215-15-260

Published: 30 June 2014

Abstract

Background

Patients are at risk of drug-related problems (DRPs) at transition points during hospitalization. The community pharmacist (CP) is often the first healthcare professional patients visit after discharge. CPs lack sufficient information about the patient and so they may be unable to identify problems in medications, which may lead to dispensing the wrong drugs or dosage, and/or giving wrong information. We aim to assess the impact of a complex intervention comprising of medication reconciliation performed at discharge by a hospital pharmacist (HP) with communication between the HP and CP on DRPs during the seven days following discharge.

Methods/Design

The study is a cluster randomized crossover trial involving 46 care units (each unit corresponding to a cluster) in 22 French hospitals during two consecutive 14-day periods, randomly assigned as ‘experimental’ or ‘control’ (usual care) periods. We will recruit patients older than 18 years of age and visiting the same CP for at least three months. We will exclude patients with a hospital length of stay of more than 21 days, who do not return home or those in palliative care. During the experimental period, the HP will perform a medications reconciliation that will be communicated to the patient. The HP will inform the patient’s CP about the patient’s drug therapy (modification in home medication, acute drugs prescribed, nonprescription treatments, and/or lab results). The primary outcome will be a composite outcome of any kind of drug misuse during the seven days following discharge assessed at day seven (±2) post-discharge by a pharmacist in charge of the study who will contact both patients and CPs by phone. The secondary outcome will be unplanned hospitalizations assessed by phone contact at day 35 (±5) after discharge. We plan to recruit 1,176 patients.

Discussion

This study will assess the impact of a reconciliation of medications performed at patient discharge followed by communication between the HP and the patient’s CP. It will allow for identifying the type of patients in France for which the intervention is most relevant.

Trial registration

This study was registered with ClinicalTrials.gov (number: NCT02006797) on 5 December 2013.

Keywords:
Community pharmacist; hospital pharmacist; drug-related problem; communication; cluster randomized crossover trial; hospital discharge; drug reconciliation