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Clinical Trials/NCT03901820
NCT03901820
Completed
N/A

Evaluation of a Drug Interactions Software to Limit Polypharmacy (Evaluación de un Programa de Interacciones Medicamentosas Para Limitar la Polifarmacia)

University of Buenos Aires1 site in 1 country1,053 target enrollmentMarch 26, 2019

Overview

Phase
N/A
Intervention
Not specified
Conditions
Polypharmacy
Sponsor
University of Buenos Aires
Enrollment
1053
Locations
1
Primary Endpoint
Prevalence of polypharmacy cases detected in two internal medicine hospitalization units of a University Hospital
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

Multiple morbidity is increasing, especially in elderly people, with a corresponding increase in polypharmacy and inappropriate prescriptions. According to different evaluations, between 25 and 75% of patients aged 75 or older are exposed to 5 or more drugs. There is increasing evidence that polypharmacy can cause more harm than good, especially in elderly people, due to factors such as drug-drug and drug-disease interactions.

Many strategies were proposed to reduce polypharmacy and inappropriate prescribing, but there is little evidence to show benefit. There is an urgent need to implement effective strategies. The application methodology must be simple so that it does not fail in daily practice.

For the current plan, an electronic medical record, named "DrApp", will be used, which will include a drug interaction program, SIMDA, which will automatically indicate the medication prescriptions that involve a risk for the patient.

The first indication of each patient admitted to two rooms of the Internal Medicine Department of the Hospital de Clínicas José de San Martín will be registered. The indications will be compared in the 4 months prior to the incorporation of the SIMDA program with the 4 months after the incorporation of the program. Between both stages a period of 2 weeks will be established in which the data will not be recorded. The minimum number of patients that will be included in each stage is 100.

The primary end point is to compare the total number of indications per inpatient, before the availability of the SIMDA program and after the application of this program.

The objective is to evaluate if the computer program of detection of drug interactions allows to limit the polypharmacy in hospitalized patients.

Detailed Description

Multiple morbidity is increasing, especially in elderly people, with a corresponding increase in polypharmacy and inappropriate prescriptions. According to different evaluations, between 25 and 75% of patients aged 75 or older are exposed to 5 or more drugs. There is increasing evidence that polypharmacy can cause more harm than good, especially in elderly people, due to factors such as drug-drug and drug-disease interactions. Many strategies were proposed to reduce polypharmacy and inappropriate prescribing, but there is little evidence to show benefit. There is an urgent need to implement effective strategies. The application methodology must be simple so that it does not fail in daily practice. For the current plan, an electronic medical record, named "DrApp", will be used, which will include a drug interaction program, SIMDA, which will automatically indicate the medication prescriptions that involve a risk for the patient. The first indication of each patient admitted to two rooms of the Internal Medicine Department of the Hospital de Clínicas José de San Martín will be registered. The indications will be compared in the 4 months prior to the incorporation of the SIMDA program with the 4 months after the incorporation of the program. Between both stages a period of 2 weeks will be established in which the data will not be recorded. The minimum number of patients that will be included in each stage is 100. The primary end point is to compare the total number of indications per inpatient, before the availability of the SIMDA program and after the application of this program. The objective is to evaluate if the computer program of detection of drug interactions allows to limit the polypharmacy in hospitalized patients.

Registry
clinicaltrials.gov
Start Date
March 26, 2019
End Date
November 30, 2021
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University of Buenos Aires
Responsible Party
Principal Investigator
Principal Investigator

Guillermo Alberto Keller

Head of Pharmacovigilance Program

University of Buenos Aires

Eligibility Criteria

Inclusion Criteria

  • Patients interned in the medical clinic room of the Hospital de Clínicas José de San Martín

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Prevalence of polypharmacy cases detected in two internal medicine hospitalization units of a University Hospital

Time Frame: 1 year

Through the electronic medical record called DrApp, the quantity of medicines prescribed to each patient is quantified and used for calculation of polypharmacy prevalence in tha basal period (pre-introduction of SIMDA) and late period (Post introduction of SIMDA).

Secondary Outcomes

  • Number of total drug interactions per patient and subclassification by severity (in post-SIMDA period).(1 year)
  • difference between Number of total drug interactions per patient in the local environment with those reported in the literature at the international level(1 year)
  • SIMDA associated change in the number of total prescribed drug per patient(1 year)

Study Sites (1)

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