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Drug Interactions in Outpatients.

  • Clinicaltrials.gov identifier

    NCT03943524

  • Recruitment Status

    Enrolling by invitation

  • First Posted

    May 9, 2019

  • Last update posted

    April 27, 2021

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.

  • Condition or Disease:Polypharmacy
    Outpatient
    Drug Interaction
    Adverse Drug Reaction
  • Intervention/Treatment: Device: Interax-AI
  • Phase: N/A

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.

Study Design

  • Study Type: Interventional
  • Estimated Enrollment: 200 participants
  • Allocation: Non-Randomized
  • Intervention Model: Sequential Assignment
  • 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
  • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Primary Purpose: Prevention
  • Official Title: Evaluation of a Drug Interactions Software (Interax-AI) in Outpatients.
  • Actual Study Start Date: August 2019
  • Estimated Primary Completion Date: December 2021
  • Estimated Study Completion Date: December 2021

Arms and interventions

Arm Intervention/treatment
Experimental: 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)
Device: Interax-AI
Interax-AI is a drug interactions detection module for the electronic clinical history software DrApp

Outcome Measures

  • Primary Outcome Measures: 1. Prevalence of polypharmacy cases detected in outpatients of outpatient clinics of doctors using the electronic medical record application DrApp [ Time Frame: 1 year ]
    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: 1. Interax-AI associated change in the number of total prescribed drug per patient [ Time Frame: 1 year ]
    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)
  • 2. Number of total drug interactions per patient and subclassification by severity (in post-Interax-AI period). [ Time Frame: 1 year ]
    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.
  • 3. Difference between Number of total drug interactions per patient in the local environment with those reported in the literature at the international level. [ Time Frame: 1 year ]
    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.

Eligibility Criteria

  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No

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

Contacts and Locations

Contacts

Locations

Argentina, Capital Federal
Centro de Vigilancia y Seguridad de Medicamentos
Ciudad Autonoma de Buenos Aire

Argentina, Capital Federal
Instituto de Investigaciones Cardiológicas Prof. Dr. Alberto C. Taquini
Ciudad Autonoma de Buenos Aire

Argentina, Capital Federal
Hospital de Clínicas José de San Martín
Ciudad autónoma de Buenos Aires

Sponsors and Collaborators

University of Buenos Aires

DrApp S.A.

More Information

  • Responsible Party: University of Buenos Aires
  • ClinicalTrials.gov Identifier: NCT03943524 History of Changes
  • Other Study ID Numbers: RB-002
  • First Posted: May 9, 2019 Key Record Dates
  • Last Update Posted: April 27, 2021
  • Last Verified: November 2020
  • Individual Participant
    Data (IPD) Sharing
    Statement:

  • Plan to Share IPD: Yes
  • Plan Description: There is an intention to publish all the results obtained and share them with other researchers.
  • Supporting Materials: Study Protocol, Informed Consent Form (ICF)
  • Time Frame: 1 Year
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by University of Buenos Aires: Polypharmacy
    Outpatient
    Drug Interaction
    Adverse Drug Reaction
    DrApp
    Interax-AI
  • Additional relevant MeSH terms: Drug-Related Side Effects and Adverse Reactions