Evaluation of a Drug Interactions Software to Limit Polypharmacy

NCT03901820 | Completed DMC

• 1 other identifier: RB-001
• Study Type: interventional
• Target: 1,053
• Locations: 1 country
• Sites: 1

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, 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

Polypharmacy; Elderly; Inpatient; Drug Interaction

Keywords

Electronic Record; Drug interaction; Polypharmacy; Elderly; Adverse Drug reaction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• SIMDA associated change in the number of total prescribed drug per patient

  1 year

• Number of total drug interactions per patient and subclassification by severity (in post-SIMDA period).

  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

  1 year

Study Arms (2)

DrApp Without SIMDA

NO INTERVENTION

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.

DrApp With SIMDA

EXPERIMENTAL

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)

Interventions

Medication Interaction System of Dr App (SIMDA) DEVICE

A module for the electronic clinical records allowing detection of the potential drug interactions

Also known as: SIMDA

DrApp With SIMDA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• University of Buenos Aires: lead

Study Sites (1)

Hospital de Clínicas José de San Martín

Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., 1121, Argentina

Location

Related Publications (7)

• 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.

  PMID: 26822311 BACKGROUND

• 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.

  PMID: 29986668 BACKGROUND

• 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.

  PMID: 23941110 BACKGROUND

• 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.

  PMID: 27488272 BACKGROUND

• 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.

  PMID: 27194037 BACKGROUND

• 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.

  PMID: 24047689 BACKGROUND

• 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.

  PMID: 36752290 DERIVED

MeSH Terms

Conditions

Drug-Related Side Effects and Adverse Reactions

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders

Study Officials

• Ricardo Barcia, MD

  Universidad de Buenos Aires, Hospital de Clínicas José de San Martín

  PRINCIPAL INVESTIGATOR

• 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

  STUDY DIRECTOR

• Guillermo A Keller, MD PhD

  Universidad de Buenos Aires, Facultad de Medicina, Centro de Vigilancia y Seguridad de Medicamentos

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Pharmacovigilance Program

Model Details: An electronic medical record, 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.

Study Record Dates

• First Submitted: March 27, 2019
• First Posted: April 3, 2019
• Study Start: March 26, 2019
• Primary Completion: November 30, 2021
• Study Completion: November 30, 2021
• Last Updated: May 20, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: 1 year after study termination

Locations

AR (1)