An interventional study of Clinical pharmacy model in Pharmaceutical Services, Medication Errors and Drug-Related Side Effects and Adverse Reactions, sponsored by Universidad de Antioquia. Completed at 1 site in Colombia. Per ClinicalTrials.gov, last updated 2020-11-12.
Sponsored by Universidad de Antioquia · Not applicable, Interventional, and Health services research
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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.
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.
449 studies on the registry are indexed under Drug-Related Side Effects and Adverse Reactions; 77 are open to participants now.
This study's enrollment of 720 is above the median of 108 across 262 interventional studies indexed under Drug-Related Side Effects and Adverse Reactions.
Browse Drug-Related Side Effects and Adverse Reactions studies →Universidad de Antioquia is the lead sponsor of 80 studies on the registry; 9 are open to participants now.
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Exclusion Criteria:
Patients without follow-up by clinical pharmacy model
Other: Clinical pharmacy model
Patients who are being monitored by a clinical pharmacy model
Other: Clinical pharmacy model
Patients who are being monitored by a clinical pharmacy model
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
Time frame: 2 months
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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 14 months
Plan to share: No
Ran from Feb 2018 to primary completion in May 2019, 15 months.
Of 71 non-industry interventional studies with no phase under Drug-Related Side Effects and Adverse Reactions, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 43. This study's 15 months is below that.
Counting every sponsor, half of 73 studies reached it within 26 months; a quarter within 12 and three quarters within 43.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.
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Universidad de Antioquia