Skip to main content
OpenTrials
Completed

NCT Number: NCT03338725

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Pablo Tobon Uribe

Medellín, Antioquia, 05001000, Colombia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Clinical pharmacy model

Other

Patients who are being monitored by a clinical pharmacy model

Primary outcomes

  1. The probability of developing medication errors over a certain period of time and recommendations to avoid such errors.

    Time frame: 2 months

    Identify and analyze the types of medication errors

Secondary outcomes

  1. Problems related with the pharmacotherapy

    Time frame: 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.

  2. Factors that contribute to the occurrence of process and outcomes problems

    Time frame: 2 months

    The factors that influence the occurrence of errors will be estimated through logistic regression

  3. To classify according to the clinical severity the results problems detected

    Time frame: 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

  4. 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

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Universidad de Antioquia

Other

Collaborators

  • Hospital Pablo Tobón Uribe

Registry information

Official study title

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

Acronym: EACPharModel

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Nov 9, 2017
Registry last updated
Nov 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.