Evaluation of a Drug Interactions Software to Limit Polypharmacy (SIMDA)

Evaluation of a Drug Interactions Software to Limit Polypharmacy (Evaluación de un Programa de Interacciones Medicamentosas Para Limitar la Polifarmacia)

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, 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.

Study Overview

• Status: Completed
• Conditions: Elderly; Polypharmacy; Inpatient; Drug Interaction
• Intervention / Treatment: Device: Medication Interaction System of Dr App (SIMDA)

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, 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.

• Study Type: Interventional
• Enrollment (Actual): 1053
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Argentina
  • Capital Federal
    • Ciudad Autonoma de Buenos Aire, Capital Federal, Argentina, 1121
      • HOSPITAL DE CLINICAS JOSE DE SAN MARTIN

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Patients interned in the medical clinic room of the Hospital de Clínicas José de San Martín

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: 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.
Experimental: 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).	Device: Medication Interaction System of Dr App (SIMDA); A module for the electronic clinical records allowing detection of the potential drug interactions; Other Names: SIMDA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of polypharmacy cases detected in two internal medicine hospitalization units of a University Hospital	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 SIMDA) and late period (Post introduction of SIMDA).	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SIMDA 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-SIMDA) minus resulting total prescribed drug per patient (Post-SIMDA)	1 year
Number of total drug interactions per patient and subclassification by severity (in post-SIMDA period).	The addition of the application called SIMDA, 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.	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.	1 year

Collaborators and Investigators

• Sponsor: University of Buenos Aires
• Investigators: Principal Investigator: Ricardo Barcia, MD, Universidad de Buenos Aires, Hospital de Clínicas José de San Martín; Study Director: Francisco Azzato, MD PhD, Universidad de Buenos Aires, Hospital de Clínicas José de San Martín; Study Director: Roberto A Diez, MD PhD, Universidad de Buenos Aires, Facultad de Medicina, Centro de Vigilancia y Seguridad de Medicamentos; Principal Investigator: Guillermo A Keller, MD PhD, Universidad de Buenos Aires, Facultad de Medicina, Centro de Vigilancia y Seguridad de Medicamentos

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 26, 2019
• Primary Completion (Actual): November 30, 2021
• Study Completion (Actual): November 30, 2021

Study Registration Dates

• First Submitted: March 27, 2019
• First Submitted That Met QC Criteria: April 1, 2019
• First Posted (Actual): April 3, 2019

Study Record Updates

• Last Update Posted (Actual): May 20, 2022
• Last Update Submitted That Met QC Criteria: May 18, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Elderly; Polypharmacy; Drug interaction; Electronic Record; Adverse Drug reaction
• Other Study ID Numbers: RB-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: There is an intention to publish all the results obtained and share them with other researchers.
• IPD Sharing Time Frame: 1 year after study termination
• IPD Sharing Supporting Information Type: Study Protocol; Informed Consent Form (ICF)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No