Clinical trial NCT03338725: Effect and Associated Factors of the Clinical Pharmacy Model in the Incidence of Medical Errors
Official title: Effect and Associated Factors of the Clinical Pharmacy Model in the Incidence of Medical Errors in the Hospital Pablo Tobon Uribe- Colombia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pharmaceutical Services
Medication Errors
Drug-Related Side Effects and Adverse Reactions
Outcome Assessment (Health Care)
Lead sponsor: Universidad de Antioquia
Sponsor class: OTHER
Collaborators: name: Hospital Pablo Tobón Uribe
First posted: 2017-11-09
Enrollment: 720
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Cluster Randomized Trials and The Stepped Wedge (Cluster Analysis Mesh Terms)
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Medication errors are considered by WHO to be a subject that requires attention at all levels of care, in order to reduce the serious and preventable damage related to medication.

These strategies are aimed at the patient's safety policy. In Colombia, at the regulatory level there is no standardized clinical pharmacy model where the role of the clinical pharmacist is described extensively and in detail, and in addition, data are unknown of the scope or direct effect of the incorporation of this model in the assistance in the results of health care.

The Hospital Pablo Tobón Uribe, it is a highly complex institution in Medellin (Colombia), certified by Join Comission International (JCI), which requires the continuous interaction of the pharmacist in patient care, in order to avoid medication errors and contribute to patient safety indicators. In this sense, the hospital structured and implemented a clinical pharmacy model that establishes the activities of the pharmacist incorporated into the care team in the patient attention. Today this model is applied in the institution, however, it is necessary to know the effect of its application in the solution of drug-related problems (DRPs) or a negative outcome related to medicine. The objective of this study is to know the effect on patient safety of a clinical pharmacy model in a hospital of high complexity and framed in the WHO initiative to reduce these errors of medication.

Detailed description: A randomized controlled clinical trial of stepped wedge will be performed. Patients will be admitted according to the inclusion criteria. Randomization will be done at the cluster level (group) and the result measured in the participants within the cluster.

Eligibility criteria: Inclusion Criteria:

* To be hospitalized in the Hospital Pablo Tobón Uribe a minimum of 24 hours.
* Patient with at least 5 drugs in their pharmacological therapy

Exclusion Criteria:

* Patients with only surgical procedures.

Primary outcomes:
measure: The probability of developing medication errors over a certain period of time and recommendations to avoid such errors.
timeFrame: 2 months
Secondary outcomes:
measure: Problems related with the pharmacotherapy
timeFrame: 2 months
measure: Factors that contribute to the occurrence of process and outcomes problems
timeFrame: 2 months
measure: To classify according to the clinical severity the results problems detected
timeFrame: 2 months
measure: Estimate adjusted survival distribution curves determined by Cox proportional hazards method, in order to estimate the probability that a subject re-mains free of an error medication and its resolution over the time
timeFrame: 14 months
Other outcomes:
Locations:
city: Medellin
country: Colombia
facility: Hospital Pablo Tobon Uribe
state: Antioquia
Study officials:
affiliation: Hospital Pablo Tobon Uribe
name: Johann Granados, Msc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Granados J, Amariles P, Botero-Aguirre JP, Ortiz-Cano NA, Valencia-Quintero AF, Salazar-Ospina A. Effect and associated factors of a clinical pharmacy model in the incidence of medication errors in the hospital Pablo Tobon Uribe eacpharmodel study: stepped wedge randomized controlled Trial (NCT03338725). Int J Clin Pharm. 2022 Apr;44(2):439-447. doi: 10.1007/s11096-021-01361-9. Epub 2022 Jan 3.
citation: Granados J, Salazar-Ospina A, Botero-Aguirre JP, Valencia-Quintero AF, Ortiz N, Amariles P. Effect and associated factors of a clinical pharmacy model in the incidence of medication errors (EACPharModel) in the Hospital Pablo Tobon Uribe: study protocol for a stepped wedge randomized controlled trial (NCT03338725). Trials. 2020 Jan 6;21(1):26. doi: 10.1186/s13063-019-3945-8.