Viewing Study NCT03901820


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Study NCT ID: NCT03901820
Status: COMPLETED
Last Update Posted: 2022-05-20
First Post: 2019-03-27
Is NOT Gene Therapy: False
Has Adverse Events: False

Brief Title: Evaluation of a Drug Interactions Software to Limit Polypharmacy
Sponsor: University of Buenos Aires
Organization:

Study Overview

Official Title: Evaluation of a Drug Interactions Software to Limit Polypharmacy (Evaluación de un Programa de Interacciones Medicamentosas Para Limitar la Polifarmacia)
Status: COMPLETED
Status Verified Date: 2022-05
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: SIMDA
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.

Study Oversight

Has Oversight DMC: True
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: