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

Study Overview
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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.

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

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

Intervention / Treatment
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* Other: Clinical pharmacy model


Participation Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: Cluster Randomized Trials and The Stepped Wedge (Cluster Analysis Mesh Terms)
Masking: Single


Arms and Interventions

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

What is the study measuring?
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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 |