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

NCT ID: NCT03338725

Last Updated: 2020-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

720 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-01

Study Completion Date

2020-11-10

Brief Summary

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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

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Cluster Randomized Trials and The Stepped Wedge (Cluster Analysis Mesh Terms)
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Patients without intervention

Patients without follow-up by clinical pharmacy model

Group Type ACTIVE_COMPARATOR

Clinical pharmacy model

Intervention Type OTHER

Patients who are being monitored by a clinical pharmacy model

Patients with intervention

Patients who are being monitored by a clinical pharmacy model

Group Type EXPERIMENTAL

Clinical pharmacy model

Intervention Type OTHER

Patients who are being monitored by a clinical pharmacy model

Interventions

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Clinical pharmacy model

Patients who are being monitored by a clinical pharmacy model

Intervention Type OTHER

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Pablo Tobón Uribe

OTHER

Sponsor Role collaborator

Universidad de Antioquia

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Johann Granados, Msc

Role: PRINCIPAL_INVESTIGATOR

Hospital Pablo Tobon Uribe

Locations

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Hospital Pablo Tobon Uribe

Medellín, Antioquia, Colombia

Site Status

Countries

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Colombia

References

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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.

Reference Type DERIVED
PMID: 34977994 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31907009 (View on PubMed)

Other Identifiers

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0016052017JG

Identifier Type: -

Identifier Source: org_study_id