Clinical trial NCT03943524: Drug Interactions in Outpatients.
Official title: Evaluation of a Drug Interactions Software (Interax-AI) in Outpatients.
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Polypharmacy
Outpatient
Drug Interaction
Adverse Drug Reaction
Keywords: Polypharmacy
Outpatient
Drug Interaction
Adverse Drug Reaction
DrApp
Interax-AI
Lead sponsor: University of Buenos Aires
Sponsor class: OTHER
Collaborators: name: DrApp S.A.
First posted: 2019-05-09
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: 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
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Prevalence of polypharmacy cases detected in outpatients of outpatient clinics of doctors using the electronic medical record application DrApp
timeFrame: 1 year
Secondary outcomes:
measure: Interax-AI associated change in the number of total prescribed drug per patient
timeFrame: 1 year
measure: Number of total drug interactions per patient and subclassification by severity (in post-Interax-AI period).
timeFrame: 1 year
measure: Difference between Number of total drug interactions per patient in the local environment with those reported in the literature at the international level.
timeFrame: 1 year
Other outcomes:
Locations:
city: Ciudad Autonoma de Buenos Aire
country: Argentina
facility: Centro de Vigilancia y Seguridad de Medicamentos
state: Capital Federal
city: Ciudad Autonoma de Buenos Aire
country: Argentina
facility: Instituto de Investigaciones Cardiológicas Prof. Dr. Alberto C. Taquini
state: Capital Federal
city: Ciudad autónoma de Buenos Aires
country: Argentina
facility: Hospital de Clínicas José de San Martín
state: Capital Federal
Study officials:
References: