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

NCT03338725 | Completed DMC

• 1 other identifier: 0016052017JG
• Study Type: interventional
• Target: 720
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Problems related with the pharmacotherapy

  2 months

• Factors that contribute to the occurrence of process and outcomes problems

  2 months

• To classify according to the clinical severity the results problems detected

  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

  14 months

Study Arms (2)

Patients without intervention

ACTIVE COMPARATOR

Patients without follow-up by clinical pharmacy model

Other: Clinical pharmacy model

Patients with intervention

EXPERIMENTAL

Patients who are being monitored by a clinical pharmacy model

Other: Clinical pharmacy model

Interventions

Clinical pharmacy model OTHER

Patients who are being monitored by a clinical pharmacy model

Patients with intervention; Patients without intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Patients with only surgical procedures.

Sponsors & Collaborators

• Universidad de Antioquia: lead
• Hospital Pablo Tobón Uribe: collaborator

Study Sites (1)

Hospital Pablo Tobon Uribe

Medellín, Antioquia, 05001000, Colombia

Location

Related Publications (2)

• 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.

  PMID: 34977994 DERIVED

• 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.

  PMID: 31907009 DERIVED

MeSH Terms

Conditions

Drug-Related Side Effects and Adverse Reactions

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders

Study Officials

• Johann Granados, Msc

  Hospital Pablo Tobon Uribe

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Cluster Randomized Trials and The Stepped Wedge (Cluster Analysis Mesh Terms)

Study Record Dates

• First Submitted: October 9, 2017
• First Posted: November 9, 2017
• Study Start: February 1, 2018
• Primary Completion: May 30, 2019
• Study Completion: November 10, 2020
• Last Updated: November 12, 2020

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)