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Drug Interactions in Outpatients.

Primary Purpose

Polypharmacy, Outpatient, Drug Interaction

Status
Suspended
Phase
Not Applicable
Locations
Argentina
Study Type
Interventional
Intervention
Interax-AI
Sponsored by
University of Buenos Aires
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Polypharmacy focused on measuring Polypharmacy, Outpatient, Drug Interaction, Adverse Drug Reaction, DrApp, Interax-AI

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centro de Vigilancia y Seguridad de Medicamentos
  • Instituto de Investigaciones Cardiológicas Prof. Dr. Alberto C. Taquini
  • Hospital de Clínicas José de San Martín

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

DrApp Without Interax-AI

DrApp With Interax-AI

Arm Description

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.

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)

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Interax-AI associated change in the number of total prescribed drug per patient
Change in total prescribed drug per patient will be calculated as the differene between basal total prescribed drug per patient (Pre-Interax-AI) minus resulting total prescribed drug per patient (Post-Interax-AI)
Number of total drug interactions per patient and subclassification by severity (in post-Interax-AI period).
The addition of the application called Interax-AI, will allow detecting the presence of drug interactions and their severity in the second phase. These will be reported as the total number of interactions reported per patient, and subclassificated into number of mild (no need to take action), moderate (require patient monitoring), and severe (possible contraindication) interactions detected per patient.
Difference between Number of total drug interactions per patient in the local environment with those reported in the literature at the international level.
The difference will be calculated as the number of total drug interactions per patient minus the value (number of drug interaction per patient) reported in the bibliography at international level in similar populations.

Full Information

First Posted
May 7, 2019
Last Updated
May 18, 2022
Sponsor
University of Buenos Aires
Collaborators
DrApp S.A.
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1. Study Identification

Unique Protocol Identification Number
NCT03943524
Brief Title
Drug Interactions in Outpatients.
Official Title
Evaluation of a Drug Interactions Software (Interax-AI) in Outpatients.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Suspended
Why Stopped
Enrollment difficulties during the COVID pandemic
Study Start Date
August 1, 2019 (Actual)
Primary Completion Date
December 1, 2021 (Actual)
Study Completion Date
December 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Buenos Aires
Collaborators
DrApp S.A.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polypharmacy, Outpatient, Drug Interaction, Adverse Drug Reaction
Keywords
Polypharmacy, Outpatient, Drug Interaction, Adverse Drug Reaction, DrApp, Interax-AI

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
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
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Non-Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
DrApp Without Interax-AI
Arm Type
No Intervention
Arm Description
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.
Arm Title
DrApp With Interax-AI
Arm Type
Experimental
Arm Description
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)
Intervention Type
Device
Intervention Name(s)
Interax-AI
Intervention Description
Interax-AI is a drug interactions detection module for the electronic clinical history software DrApp
Primary Outcome Measure Information:
Title
Prevalence of polypharmacy cases detected in outpatients of outpatient clinics of doctors using the electronic medical record application DrApp
Description
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).
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Interax-AI associated change in the number of total prescribed drug per patient
Description
Change in total prescribed drug per patient will be calculated as the differene between basal total prescribed drug per patient (Pre-Interax-AI) minus resulting total prescribed drug per patient (Post-Interax-AI)
Time Frame
1 year
Title
Number of total drug interactions per patient and subclassification by severity (in post-Interax-AI period).
Description
The addition of the application called Interax-AI, will allow detecting the presence of drug interactions and their severity in the second phase. These will be reported as the total number of interactions reported per patient, and subclassificated into number of mild (no need to take action), moderate (require patient monitoring), and severe (possible contraindication) interactions detected per patient.
Time Frame
1 year
Title
Difference between Number of total drug interactions per patient in the local environment with those reported in the literature at the international level.
Description
The difference will be calculated as the number of total drug interactions per patient minus the value (number of drug interaction per patient) reported in the bibliography at international level in similar populations.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Centro de Vigilancia y Seguridad de Medicamentos
City
Ciudad Autonoma de Buenos Aire
State/Province
Capital Federal
ZIP/Postal Code
C1121ABG
Country
Argentina
Facility Name
Instituto de Investigaciones Cardiológicas Prof. Dr. Alberto C. Taquini
City
Ciudad Autonoma de Buenos Aire
State/Province
Capital Federal
ZIP/Postal Code
C1121
Country
Argentina
Facility Name
Hospital de Clínicas José de San Martín
City
Ciudad autónoma de Buenos Aires
State/Province
Capital Federal
ZIP/Postal Code
1121
Country
Argentina

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
There is an intention to publish all the results obtained and share them with other researchers.
IPD Sharing Time Frame
1 Year

Learn more about this trial

Drug Interactions in Outpatients.

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