Impact of collaborative pharmaceutical care on in-patients’ medication safety: study protocol for a stepped wedge cluster randomized trial (MEDREV study)

Trials

MEDREV Working Group¹  Rémy Collomp²  Jean-Marie Kinowski³  Géraldine Leguelinel-Blache³  Clarisse Roux-Marson³  Sandrine Andrieu⁴  Philippe Cestac⁴  Rémi Varin⁵  Bertrice Loulière⁶  Christelle Mouchoux⁷  Benoit Allenet⁸  Pierrick Bedouch⁸  Christel Castelli⁹  Sophie Bouvet⁹  Paul Landais⁹ 

[1] ;Department of Pharmacy, Nice University Hospital;Department of Pharmacy, Nîmes University Hospital;Epidemiology and Public Health Research Unit, INSERM 1027;INSERM U1234, PANTHER unit, Faculty of Medicine and Pharmacy, University of Rouen;Observatory of Medicine, Medical Devices and Therapeutic Innovation, Regional Health Agency;Research Clinic Centre (CRC) - VCF (Aging – Brain - Frailty), Charpennes Hospital, University Hospital of Lyon;TIMC-IMAG UMR CNRS 5525, Grenoble Alpes University;UPRES EA 2415, Laboratory of Biostatistics, Epidemiology, Clinical Research and Health Economics, Clinical Research University Institute, Montpellier University;

关键词: Stepped wedge study;    Medication reconciliation;    Medication review;    Pharmaceutical care;    Hospital pharmacist;    Drug-related problem;   

DOI  :  10.1186/s13063-017-2412-7

来源: DOAJ

【 摘 要 】

Abstract Background Clinical pharmaceutical care has long played an important role in the improvement of healthcare safety. Pharmaceutical care is a collaborative care approach, implicating all the actors of the medication circuit in order to prevent and correct drug-related problems that can lead to adverse drug events. The collaborative pharmaceutical care performed during patients’ hospitalization requires two mutually reinforcing activities: medication reconciliation and medication review. Until now, the impact of the association of these two activities has not been clearly studied. Methods This is a multicentric stepped wedge randomized study involving six care units from six French University Hospitals (each unit corresponding to a cluster) over seven consecutive 14-day periods. Each hospital unit will start with a control period and switch to an experimental period after a randomized number of 14-day periods. Patients aged at least 65 years hospitalized in one of the participating care units and having given their consent to be called for a 30-day and 90-day follow-up can be enrolled. For each 14-day period, 15 patients will be recruited in each care unit to obtain a total of 630 patients enrolled in all centers. Patients with a hospital stay of more than 21 days will be excluded. During the control period, there will be no clinical pharmacist in the care unit, whereas during the experimental period a clinical pharmacist will perform medication reconciliation and review with the healthcare team. The primary outcome will assess the impact of collaborative pharmaceutical care on preventable medication error rate. The secondary outcomes will evaluate the clinical impact of the strategy, the acceptance rate of pharmaceutical interventions, the induced and avoided costs of the strategy (cost-consequence analysis), and the healthcare team’s satisfaction. Discussion This study will assess the impact of collaborative pharmaceutical care associating medication reconciliation and review at patient admission to hospital in terms of preventable medication error rate and costs. This activity will prevent and correct medication errors arising earlier in the hospitalization. Trial registration ClinicalTrials.gov, NCT02598115 . Registered on 4 November 2015.

【 授权许可】

Unknown