Clinical trial NCT03901820: Evaluation of a Drug Interactions Software to Limit Polypharmacy
Official title: Evaluation of a Drug Interactions Software to Limit Polypharmacy (Evaluación de un Programa de Interacciones Medicamentosas Para Limitar la Polifarmacia)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Polypharmacy
Elderly
Inpatient
Drug Interaction
Keywords: Electronic Record
Drug interaction
Polypharmacy
Elderly
Adverse Drug reaction
Lead sponsor: University of Buenos Aires
Sponsor class: OTHER
First posted: 2019-04-03
Enrollment: 1053
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: Inclusion Criteria:

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

Primary outcomes:
measure: Prevalence of polypharmacy cases detected in two internal medicine hospitalization units of a University Hospital
timeFrame: 1 year
Secondary outcomes:
measure: SIMDA associated change in the number of total prescribed drug per patient
timeFrame: 1 year
measure: Number of total drug interactions per patient and subclassification by severity (in post-SIMDA period).
timeFrame: 1 year
measure: difference between Number of total drug interactions per patient in the local environment with those reported in the literature at the international level
timeFrame: 1 year
Other outcomes:
Locations:
city: Ciudad Autonoma de Buenos Aire
country: Argentina
facility: Hospital de Clínicas José de San Martín
state: Capital Federal
Study officials:
affiliation: Universidad de Buenos Aires, Hospital de Clínicas José de San Martín
name: Ricardo Barcia, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidad de Buenos Aires, Hospital de Clínicas José de San Martín
name: Francisco Azzato, MD PhD
role: STUDY_DIRECTOR
affiliation: Universidad de Buenos Aires, Facultad de Medicina, Centro de Vigilancia y Seguridad de Medicamentos
name: Roberto A Diez, MD PhD
role: STUDY_DIRECTOR
affiliation: Universidad de Buenos Aires, Facultad de Medicina, Centro de Vigilancia y Seguridad de Medicamentos
name: Guillermo A Keller, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.