Drug Interactions in Outpatients.

NCT03943524 | Suspended DMC

• 1 other identifier: RB-002
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 3

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.

Conditions

Polypharmacy; Outpatient; Drug Interaction; Adverse Drug Reaction

Keywords

Polypharmacy; Outpatient; Drug Interaction; Adverse Drug Reaction; DrApp; Interax-AI

Outcome Measures

Primary Outcomes (1)

• Prevalence of polypharmacy cases detected in outpatients of outpatient clinics of doctors using the electronic medical record application DrApp

  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 Interax-AI) and late period (Post introduction of Interax-AI).

  1 year

Secondary Outcomes (3)

• Interax-AI associated change in the number of total prescribed drug per patient

  1 year

• Number of total drug interactions per patient and subclassification by severity (in post-Interax-AI 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

Study Arms (2)

DrApp Without Interax-AI

NO INTERVENTION

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.

DrApp With Interax-AI

EXPERIMENTAL

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)

Device: Interax-AI

Interventions

Interax-AI DEVICE

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

DrApp With Interax-AI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Buenos Aires: lead
• DrApp S.A.: collaborator

Study Sites (3)

Hospital de Clínicas José de San Martín

Buenos Aires, Buenos Aires F.D., 1121, Argentina

Location

Centro de Vigilancia y Seguridad de Medicamentos

Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., C1121ABG, Argentina

Location

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

Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., C1121, Argentina

Location

MeSH Terms

Conditions

Drug-Related Side Effects and Adverse Reactions

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Pharmacovigilance Program

Model Details: Allocation: Non-Randomized An electronic medical record, 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 indications of each outpatient 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 number of patients that will be included in each stage is 100 and the maximum 200. Masking: Triple (Participant, Care Provider, Investigator) Primary Purpose: Prevention

Study Record Dates

• First Submitted: May 7, 2019
• First Posted: May 9, 2019
• Study Start: August 1, 2019
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2022
• Last Updated: May 25, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: 1 Year

Locations

AR (3)