Drug Interactions in Outpatients.

NCT ID: NCT03943524

Last Updated: 2022-05-25

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-01
• Study Completion Date: 2022-12-01

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, (Interax-AI), which will automatically indicate the medication prescriptions that involve a risk for the patient.

All outpatient indications followed by physicians using the DrApp electronic history will be registered. The indications will be compared in the 4 months prior to the incorporation of the Interax-AI 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 & maximum number of patients that will be included in each stage are 100 & 200.

The primary end point is to compare the total number of indications per inpatient, before the availability of the Interax-AI 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 outpatients.

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, (Interax-AI), which will automatically indicate the medication prescriptions that involve a risk for the patient.

All outpatient indications followed by physicians using the DrApp electronic history will be registered. The indications will be compared in the 4 months prior to the incorporation of the Interax-AI 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 & maximum number of patients that will be included in each stage are 100 & 200.

The primary end point is to compare the total number of indications per inpatient, before the availability of the Interax-AI 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 outpatients.

Conditions

Polypharmacy; Outpatient; Drug Interaction; Adverse Drug Reaction

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

DrApp Without Interax-AI

There are approximately 100 outpatients in whom the indications were registered through the use of DrApp, before the implementation of the drug interactions detection module.

Group Type: NO_INTERVENTION

No interventions assigned to this group

DrApp With Interax-AI

There are approximately 100 outpatients in whom the indications were registered through the use of DrApp, AFTER the implementation of the drug interactions detection module (Interax-AI).

Intervention: Device: Medication Interaction System of Dr App (Interax-AI)

Group Type: EXPERIMENTAL

Interax-AI

Intervention Type: DEVICE

Interax-AI is a drug interactions detection module for the electronic clinical history software DrApp

Interventions

Interax-AI

Interax-AI is a drug interactions detection module for the electronic clinical history software DrApp

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Outpatients followed in outpatient clinics of doctors using the electronic medical record application DrApp

Exclusion Criteria

• Lack of registration of medications used by the patient in the DrApp application

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

DrApp S.A.

UNKNOWN

Sponsor Role: collaborator

University of Buenos Aires

OTHER

Sponsor Role: lead

Responsible Party

Guillermo Alberto Keller

Head of Pharmacovigilance Program

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hospital de Clínicas José de San Martín

Buenos Aires, Buenos Aires F.D., Argentina

Centro de Vigilancia y Seguridad de Medicamentos

Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., Argentina

Instituto de Investigaciones Cardiológicas Prof. Dr. Alberto C. Taquini

Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., Argentina

Countries

Argentina

Other Identifiers

RB-002

Identifier Type: -

Identifier Source: org_study_id