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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03338725
Recruitment Status : Recruiting
First Posted : November 9, 2017
Last Update Posted : September 6, 2019
Sponsor:
Collaborator:
Hospital Pablo Tobón Uribe
Information provided by (Responsible Party):
Universidad de Antioquia

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.


Condition or disease Intervention/treatment Phase
Pharmaceutical Services Medication Errors Drug-Related Side Effects and Adverse Reactions Outcome Assessment (Health Care) Other: Clinical pharmacy model Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 720 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Cluster Randomized Trials and The Stepped Wedge (Cluster Analysis Mesh Terms)
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Effect and Associated Factors of the Clinical Pharmacy Model in the Incidence of Medical Errors in the Hospital Pablo Tobon Uribe- Colombia
Actual Study Start Date : February 1, 2018
Actual Primary Completion Date : May 30, 2019
Estimated Study Completion Date : December 1, 2019

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. The probability of developing medication errors over a certain period of time and recommendations to avoid such errors. [ Time Frame: 2 months ]
    Identify and analyze the types of medication errors


Secondary Outcome Measures :
  1. Problems related with the pharmacotherapy [ Time Frame: 2 months ]

    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. Factors that contribute to the occurrence of process and outcomes problems [ Time Frame: 2 months ]
    The factors that influence the occurrence of errors will be estimated through logistic regression

  3. To classify according to the clinical severity the results problems detected [ Time Frame: 2 months ]

    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


  4. 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 ]
    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



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03338725


Contacts
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Contact: Johann Granados, Msc +573185864419 elkyn.granados@udea.edu.co
Contact: Pedro Amariles, PhD +57(4) 2195476 pedro.amariles@udea.edu.co

Locations
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Colombia
Hospital Pablo Tobon Uribe Recruiting
Medellin, Antioquia, Colombia, 05001000
Contact: Elkyn Johan Granados Vega         
Sponsors and Collaborators
Universidad de Antioquia
Hospital Pablo Tobón Uribe
Investigators
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Principal Investigator: Johann Granados, Msc Hospital Pablo Tobon Uribe
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Universidad de Antioquia
ClinicalTrials.gov Identifier: NCT03338725    
Other Study ID Numbers: 0016052017JG
First Posted: November 9, 2017    Key Record Dates
Last Update Posted: September 6, 2019
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders