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

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

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Actual): 720
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Colombia
  • Antioquia
    • Medellin, Antioquia, Colombia, 05001000
      • Hospital Pablo Tobon Uribe

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Patients without intervention; Patients without follow-up by clinical pharmacy model	Other: Clinical pharmacy model; Patients who are being monitored by a clinical pharmacy model
Experimental: Patients with intervention; Patients who are being monitored by a clinical pharmacy model	Other: Clinical pharmacy model; Patients who are being monitored by a clinical pharmacy model

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: Universidad de Antioquia
• Collaborators: Hospital Pablo Tobón Uribe
• Investigators: Principal Investigator: Johann Granados, Msc, Hospital Pablo Tobon Uribe

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2018
• Primary Completion (Actual): May 30, 2019
• Study Completion (Actual): November 10, 2020

Study Registration Dates

• First Submitted: October 9, 2017
• First Submitted That Met QC Criteria: November 7, 2017
• First Posted (Actual): November 9, 2017

Study Record Updates

• Last Update Posted (Actual): November 12, 2020
• Last Update Submitted That Met QC Criteria: November 10, 2020
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Drug-Related Side Effects and Adverse Reactions
• Other Study ID Numbers: 0016052017JG

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No