Evaluation of a Drug Interactions Software to Limit Polypharmacy
NCT ID: NCT03901820
Last Updated: 2022-05-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
1053 participants
INTERVENTIONAL
2019-03-26
2021-11-30
Brief Summary
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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, SIMDA, which will automatically indicate the medication prescriptions that involve a risk for the patient.
The first indication of each patient admitted to two rooms of the Internal Medicine Department of the Hospital de Clínicas José de San Martín will be registered. The indications will be compared in the 4 months prior to the incorporation of the SIMDA 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.
The primary end point is to compare the total number of indications per inpatient, before the availability of the SIMDA 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 hospitalized patients.
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Detailed Description
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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, SIMDA, which will automatically indicate the medication prescriptions that involve a risk for the patient.
The first indication of each patient admitted to two rooms of the Internal Medicine Department of the Hospital de Clínicas José de San Martín will be registered. The indications will be compared in the 4 months prior to the incorporation of the SIMDA 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.
The primary end point is to compare the total number of indications per inpatient, before the availability of the SIMDA 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 hospitalized patients.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
The first indication of each patient admitted to two rooms of the Internal Medicine Department of the Hospital de Clínicas José de San Martín will be registered. The indications will be compared in the 4 months prior to the incorporation of the SIMDA 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.
PREVENTION
TRIPLE
Study Groups
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DrApp Without SIMDA
There are approximately 100 inpatients in whom the indications were registered through the use of DrApp, before the implementation of the drug interactions detection module.
No interventions assigned to this group
DrApp With SIMDA
There are approximately 100 inpatients in whom the indications were registered through the use of DrApp, AFTER the implementation of the drug interactions detection module (SIMDA).
Medication Interaction System of Dr App (SIMDA)
A module for the electronic clinical records allowing detection of the potential drug interactions
Interventions
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Medication Interaction System of Dr App (SIMDA)
A module for the electronic clinical records allowing detection of the potential drug interactions
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
18 Years
ALL
No
Sponsors
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University of Buenos Aires
OTHER
Responsible Party
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Guillermo Alberto Keller
Head of Pharmacovigilance Program
Principal Investigators
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Ricardo Barcia, MD
Role: PRINCIPAL_INVESTIGATOR
Universidad de Buenos Aires, Hospital de Clínicas José de San Martín
Francisco Azzato, MD PhD
Role: STUDY_DIRECTOR
Universidad de Buenos Aires, Hospital de Clínicas José de San Martín
Roberto A Diez, MD PhD
Role: STUDY_DIRECTOR
Universidad de Buenos Aires, Facultad de Medicina, Centro de Vigilancia y Seguridad de Medicamentos
Guillermo A Keller, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Universidad de Buenos Aires, Facultad de Medicina, Centro de Vigilancia y Seguridad de Medicamentos
Locations
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Hospital de Clínicas José de San Martín
Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., Argentina
Countries
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References
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Sonnichsen A, Trampisch US, Rieckert A, Piccoliori G, Vogele A, Flamm M, Johansson T, Esmail A, Reeves D, Loffler C, Hock J, Klaassen-Mielke R, Trampisch HJ, Kunnamo I. Polypharmacy in chronic diseases-Reduction of Inappropriate Medication and Adverse drug events in older populations by electronic Decision Support (PRIMA-eDS): study protocol for a randomized controlled trial. Trials. 2016 Jan 29;17:57. doi: 10.1186/s13063-016-1177-8.
Rieckert A, Sommerauer C, Krumeich A, Sonnichsen A. Reduction of inappropriate medication in older populations by electronic decision support (the PRIMA-eDS study): a qualitative study of practical implementation in primary care. BMC Fam Pract. 2018 Jul 9;19(1):110. doi: 10.1186/s12875-018-0789-3.
Clyne B, Bradley MC, Hughes CM, Clear D, McDonnell R, Williams D, Fahey T, Smith SM; OPTI-SCRIPT study team. Addressing potentially inappropriate prescribing in older patients: development and pilot study of an intervention in primary care (the OPTI-SCRIPT study). BMC Health Serv Res. 2013 Aug 14;13:307. doi: 10.1186/1472-6963-13-307.
Clyne B, Cooper JA, Hughes CM, Fahey T, Smith SM; OPTI-SCRIPT study team. A process evaluation of a cluster randomised trial to reduce potentially inappropriate prescribing in older people in primary care (OPTI-SCRIPT study). Trials. 2016 Aug 3;17(1):386. doi: 10.1186/s13063-016-1513-z.
Bril F, Castro V, Centurion IG, Espinosa J, Keller GA, Gonzalez CD, Riera MC, Saubidet CL, Di Girolamo G, Pujol GS, Alvarez PA. A Systematic Approach to Assess the Burden of Drug Interactions in Adult Kidney Transplant Patients. Curr Drug Saf. 2016;11(2):156-63. doi: 10.2174/157488631102160429003742.
Alvarez PA, Bril F, Castro V, Meiville I, Gonzalez CD, Centurion IG, Parejas G, Riera CS, Saubidet CL, Di Girolamo G, Keller GA. Adverse drug reactions as a reason for admission to an internal medicine ward in Argentina. Int J Risk Saf Med. 2013;25(3):185-92. doi: 10.3233/JRS-130596.
Barcia RE, Keller GA, Azzato F, Diez RA, Sielecki M, Kleine RS, Lescano JA, Giunti G. Development and Implementation of the Hdc.DrApp.la and SIMDA Programs to Reduce Polypharmacy and Drug-drug Interactions in Patients Hospitalized in Internal Medicine. Rev Recent Clin Trials. 2023;18(2):156-166. doi: 10.2174/1574887118666230208124744.
Other Identifiers
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RB-001
Identifier Type: -
Identifier Source: org_study_id
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