Effect and Associated Factors of the Clinical Pharmacy Model in the Incidence of Medical Errors

Not Applicable

Completed

• Conditions: Medication Errors; Pharmaceutical Services; Outcome Assessment (Health Care); Drug-Related Side Effects and Adverse Reactions
• Interventions: Other: Clinical pharmacy model

• Registration Number: NCT03338725
• Lead Sponsor: Universidad de Antioquia

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.

Study Timeline

• Study First Submitted: 2017-10-09
• Study First Submitted QC: 2017-11-07
• Study First Posted: 2017-11-09
• Study Start: 2018-02-01
• Status Verified: 2018-10
• Primary Completion: 2019-05-30
• Study Completion: 2020-11-10
• Last Update Submitted: 2020-11-10
• Last Update Posted: 2020-11-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 720

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Patients with intervention	Clinical pharmacy model	Patients who are being monitored by a clinical pharmacy model
Patients without intervention	Clinical pharmacy model	Patients without follow-up by clinical pharmacy model

Primary Outcome Measures

Name	Time	Method
The probability of developing medication errors over a certain period of time and recommendations to avoid such errors.	2 months	Identify and analyze the types of medication errors

Secondary Outcome Measures

Name	Time	Method
Factors that contribute to the occurrence of process and outcomes problems	2 months	The factors that influence the occurrence of errors will be estimated through logistic regression
Problems related with the pharmacotherapy	2 months	Identify, quantify and classify problems related with the pharmacotherapy: If any prescription in a patient have at least on of: Incorrect dosage, Incorrect frequency, Incorrect route of administration, Incorrect duration of therapy, drug not indicated, Contraindicated drug, Lack of treatment, Drug-drug interaction, Drug-food Interaction, Therapeutic duplicity. it is considered as problem related with the pharmacotherapy; According whit the oficial FDA label of each drug.
To classify according to the clinical severity the results problems detected	2 months	To classify according to the clinical severity the results problems detected: A-Circumstances or incidents that are capable of causing error B-The error occurred but did not reach the patient C-The error reached the patient, but did not cause harm D-The error reached the patient and did not cause damage, but needed follow-up to check it E-The error contributed or caused temporary damage to the patient and required intervention F-The error contributed or caused temporary damage and specified or prolonged hospitalization G-The error contributed or caused permanent damage to the patient H-The error affected the life of the patient I-The error contributed or caused the death of the patient
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	14 months	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

Trial Locations

Locations (1)

Hospital Pablo Tobon Uribe; 🇨🇴 Medellin, Antioquia, Colombia