PolypharmacyNCT03943524
Drug Interactions in Outpatients.
A study testing Interax-AI in people with Polypharmacy and Outpatient, run by University of Buenos Aires at 3 sites in Argentina.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Polypharmacy, Outpatient, Drug Interaction
- What is being tested?
- Interax-AI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 3 sitesArgentina
- Study dates
- 1 Aug 2019to 1 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Outpatients followed in outpatient clinics of doctors using the electronic medical record application DrApp
Who cannot join
- Lack of registration of medications used by the patient in the DrApp application
Trial locations and contacts
3 sites in 1 country.
Argentina3 sites
Hospital de Clínicas José de San Martín
Buenos Aires, Buenos Aires F.D., 1121
Centro de Vigilancia y Seguridad de Medicamentos
Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., C1121ABG
Instituto de Investigaciones Cardiológicas Prof. Dr. Alberto C. Taquini
Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., C1121
About this study
Official title: Evaluation of a Drug Interactions Software (Interax-AI) in Outpatients.
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.
Read more
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.
Read the 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.
- Conditions
- Polypharmacy, Outpatient, Drug Interaction, Adverse Drug Reaction
- Being tested
- Interax-AI
- Keywords
- Polypharmacy, Outpatient, Drug Interaction, Adverse Drug Reaction, DrApp, Interax-AI
- Medical subject headings
- Drug-Related Side Effects and Adverse Reactions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interax-AIDevice
Interax-AI is a drug interactions detection module for the electronic clinical history software DrApp
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Device: Interax-AI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 1 year
Secondary outcomes (3)
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)
Measured: 1 year
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.
Measured: 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.
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2019
- Study start1 Aug 2019
- Primary completion1 Dec 2021
- Study completion1 Dec 2022 (estimated)
Why it stopped: Enrollment difficulties during the COVID pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PolypharmacyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- 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 blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Buenos Aires
- Sponsor type
- University, hospital or other
- Collaborators
- DrApp S.A.
- Responsible party
- Principal investigator, Guillermo Alberto Keller, University of Buenos Aires
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03943524
- Sponsor's protocol ID
- RB-002
- Status last verified
- May 2022
- First submitted
- 7 May 2019
- Last updated
- 25 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: There is an intention to publish all the results obtained and share them with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Drug Interactions Software (Interax-AI) in Outpatients.
- ClinicalTrials.gov ID
- NCT03943524
- Acronym / sponsor ID
- RB-002
- Conditions
- Polypharmacy, Outpatient, Drug Interaction, Adverse Drug Reaction
- Keywords
- Polypharmacy, Outpatient, Drug Interaction, Adverse Drug Reaction, DrApp, Interax-AI
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Enrollment difficulties during the COVID pandemic
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of Buenos AiresUniversity, hospital or other
- Collaborators
- DrApp S.A.
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 9 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| 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 | Device: Interax-AIThere 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Outpatients followed in outpatient clinics of doctors using the electronic medical record application DrApp
Key exclusion criteria (1 listed)
- Lack of registration of medications used by the patient in the DrApp application
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interax-AIInterax-AI is a drug interactions detection module for the electronic clinical history software DrApp | Device | DrApp With Interax-AI |
Primary outcome
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).
3 secondary outcomes
Interax-AI associated change in the number of total prescribed drug per patient
Time frame: 1 year
Number of total drug interactions per patient and subclassification by severity (in post-Interax-AI period).
Time frame: 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.
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2022.
- Individual participant dataSharing planned: Yes. There is an intention to publish all the results obtained and share them with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interax-AI in people with Polypharmacy and Outpatient, run by University of Buenos Aires at 3 sites in Argentina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 25 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of polypharmacy cases detected in outpatients of outpatient clinics of doctors using the electronic medical record application DrApp (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2022.