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

Drug-Related Side Effects and Adverse Reactions Clinical Trial

— EACPharModel  

Official title:

Effect and Associated Factors of the Clinical Pharmacy Model in the Incidence of Medical Errors in the Hospital Pablo Tobon Uribe- Colombia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03338725
• Other study ID #: 0016052017JG
• Status: Completed
• Phase: N/A
• Start date: February 1, 2018
• Est. completion date: November 10, 2020

Study information

• Verified date: October 2018
• Source: Universidad de Antioquia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 720
• Est. completion date: November 10, 2020
• Est. primary completion date: May 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Drug-Related Side Effects and Adverse Reactions
• Medication Errors
• Outcome Assessment (Health Care)
• Pharmaceutical Services

Intervention

Other:
• Clinical pharmacy model
Patients who are being monitored by a clinical pharmacy model

Locations

Country	Name	City	State
Colombia	Hospital Pablo Tobon Uribe	Medellin	Antioquia

Sponsors (2)

Lead Sponsor	Collaborator
Universidad de Antioquia	Hospital Pablo Tobón Uribe

Country where clinical trial is conducted

Colombia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The probability of developing medication errors over a certain period of time and recommendations to avoid such errors.	Identify and analyze the types of medication errors	2 months
Secondary	Problems related with the pharmacotherapy	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.	2 months
Secondary	Factors that contribute to the occurrence of process and outcomes problems	The factors that influence the occurrence of errors will be estimated through logistic regression	2 months
Secondary	To classify according to the clinical severity the results problems detected	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	2 months
Secondary	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	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