Granados 2020.

Study name	Effect and associated factors of a clinical pharmacy model in the incidence of medication errors (EACPharModel) in the Hospital Pablo Tobón Uribe: study protocol for a stepped wedge randomized controlled trial
Methods	A prospective, stepped‐wedge, cluster‐randomised, controlled trial with a duration of 14 months will be performed to compare the effect of a clinical pharmacy practice model (CPPM) along with the usual care process of patients in the Pablo Tobón Uribe Hospital (Medellin, Colombia). The study is designed as a cluster‐randomised controlled trial, involving five hospital wards (clusters) and 720 patients. Medical wards are allocated to interventions using a stepped‐wedge design. Clusters are initially assigned to the control group. After a 2‐month observation period, hospital clusters were randomly allocated to the intervention group. Study outcomes will be assessed at baseline and at 2, 4, 6, 8, 10, and 12 months after randomisation. Statistical analyses will be performed using a mixed model, with the treatment group and time as fixed effects and the clustering structure as a random effect. Statistical analysis will be performed using Pearson Chi2 tests and Student’s t‐tests, and a P value.
Participants	720 patients admitted to five hospital wards (clusters) of the Pablo Tobón Uribe Hospital (Medellin, Colombia) A pharmacist will evaluate whether each patient meets all the inclusion criteria. The inclusion criteria will be the following: patients at least 18 years old; hospitalised patients in the Pablo Tobón Uribe Hospital; patients receive at least five drugs in their pharmacological therapy The exclusion criterion is a ward stay of less than 24 h.
Interventions	Intervention: clinical pharmacy practice model (CPPM) Comparator / control treatment (active): the hospital sites are their own controls.
Outcomes	The primary outcome will be to assess the effect of a CPPM on the incidence of medication errors associated with the medication use process. Drug‐related problems and factors that contribute to the occurrence of MEs will be assessed as secondary outcomes.
Starting date	01 February 2018
Contact information	Correspondence: elkyn.granados@udea.edu.co +573185864419 Grupo Promoción y Prevención Farmacéutica, Facultad de Ciencias Farmacéuticas y Alimentarias, Universidad de Antioquia, Calle 70 No 52‐21, Medellín, Colombia Pedro Amariles pedro.amariles@udea.edu.co
Notes	NCT03338725