NCT03943524

Drug Interactions in Outpatients.

Suspended NA Last updated 25 May 2022

What this trial tests

NA trial testing Interax-AI in Polypharmacy in 200 participants. Suspended.

Timeline

1 August 2019

Primary endpoint
1 December 2021

1 December 2022

Quick facts

Lead sponsor	University of Buenos Aires
Phase	NA
Status	Suspended
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	quadruple
Primary purpose	prevention
Enrollment	200
Start date	1 August 2019
Primary completion	1 December 2021
Estimated completion	1 December 2022
Sites	3 locations across Argentina

Drugs / interventions tested

• Interax-AI

Conditions studied

• Polypharmacy — all drugs for Polypharmacy →
• Outpatient — all drugs for Outpatient →
• Drug Interaction — all drugs for Drug Interaction →
• Adverse Drug Reaction — all drugs for Adverse Drug Reaction →

Sponsor

University of Buenos Aires

Who can join

18 and older, any sex, with Polypharmacy or Outpatient. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own 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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.