Clinical trial NCT05336565: PIM Incidence in Older Cardiovascular Patients During COVID-19 Pandemics
Official title: Incidence of Prescribing Potentially Inappropriate Medications to Older Cardiovascular Patients During COVID-19 Pandemics According to Medical Information System BARS
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Potentially Inappropriate Medications
Keywords: Potentially inappropriate medication
Drug-drug-interaction
Polypharmacy
Cardiovascular
Electronic medical record
Medical information system
Prevention
Lead sponsor: Tomsk National Research Medical Center of the Russian Academy of Sciences
Sponsor class: OTHER
First posted: 2022-04-20
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cardiovascular patients enrolled in the reimbursement program in Tomsk Region who have electronic medical records stored in medical information system BARS.

Brief summary: The aim of the study is to assess the incidence of potentially inappropriate medication (PIM) administration, polypharmacy, and potential drug-drug-interactions (PDDIs) in cardiovascular patients enrolled in the reimbursement program in the time of coronavirus disease (COVID-19) pandemic. Medical information system (MIS) "BARS" will be used for inclusion and retrieval of relevant data of cardiovascular patients enrolled in the reimbursement programs in the Tomsk Region. The incidence rates of PIM prescriptions will be assessed in patients aged 75 years and older. Potentially inappropriate medications will be defined according to 2015 Beers criteria. Polypharmacy will be defined as being administered five or more medications at the same time. PDDIs will be checked with Medscape Drug Interaction Checker and rated as 'Contraindicated', 'Serious', and 'Requiring Monitoring'. Combined analysis of retrospective and prospective occurrences of study parameters will be performed. PIM-BARS will evaluate the incidence rates and patterns of PIM prescriptions, polypharmacy, and PDDIs in elderly cardiovascular patients enrolled in the reimbursement program in the time of COVID-19 pandemic.

Detailed description: Objective: It is essential to improve patient safety by determining an individual's exposure to potentially inappropriate drugs.

This study will be performed to find out the incidence of potentially inappropriate medication (PIM) administration, polypharmacy, and potential drug-drug-interactions (PDDIs) in cardiovascular patients enrolled in the reimbursement program in the time of COVID-19 pandemic.

Method: Medical information system (MIS) "BARS" will be used for inclusion and retrieval of relevant data of cardiovascular patients enrolled in the reimbursement programs in the Tomsk Region. Incidence of PIM administration, polypharmacy, and PDDIs in the time of COVID-19 pandemic will be studied. Brief characteristics of MIS "BARS" implemented in the Diagnostic and Consultation Center of Cardiology Research Institute, Tomsk National Research Medical Center, Russian Academy of Sciences (NRMC) are as follows: MIS "BARS" is a universal solution for automatization of activities of medical institutions of various specializations and scale ranging from small highly specialized clinics to multi-specialty hospitals and medical centers. The system is the united information space for administrative, treatment-and-diagnostic, and financial-and-economic processes of medical institution. MIS "BARS" is a cloud-based solution, and the deployment of the system in cloud allows getting the remote access to working places from any location. The system is built based on module principle. The system implements automatic control over provision of medical services allowing for feedback with practical healthcare workers. The system is integrated with other information systems and medical equipment. The advantage of the system consists in a capability to assess economic element of study parameters. Technical characteristics of MIS "BARS": The system has a centralized data base with provision of protected remote access for users. The system is organized based on principle of three-tiered architecture: Web browser, Web-server, and database server. ORACLE is used as a database server, which provides the highest data security, scalability, fall-over protection, and the greatest capabilities for integration. Built-in mechanisms of functional system expansion allow to perform advanced customization.

Expected Results: Patient demographics, clinical data, instrumental examination data, and medication prescriptions will be collected using electronic medical records stored in medical information system (MIS) "BARS". The incidence rates of PIM prescriptions will be assessed. Potentially inappropriate medications will be defined according to 2015 Beers criteria. Polypharmacy will be defined as being administered five or more medications at the same time. PDDIs will be checked with Medscape Drug Interaction Checker and rated as 'Contraindicated', 'Serious', and 'Requiring Monitoring'. Combined analysis of retrospective and prospective occurrences of study parameters will be performed.

Conclusion: PIM-BARS will evaluate the incidence rates and patterns of PIM prescriptions, polypharmacy, and PDDIs in elderly cardiovascular patients enrolled in the reimbursement program in the time of COVID-19 pandemic. This effort will contribute to prevention of medication errors by inappropriate prescribing.

Eligibility criteria: Inclusion Criteria:

* established diagnosis of cardiovascular disease
* age of 18 years and older
* enrollment in the reimbursement program in Tomsk Region

Exclusion Criteria:

* age of 17 years and younger

Primary outcomes:
measure: Incidence of potentially inappropriate medication prescription
timeFrame: Five years
Secondary outcomes:
measure: Potential drug-drug interactions (PDDIs)
timeFrame: Five years
measure: Polypharmacy rate
timeFrame: Five years
Other outcomes:
Locations:
city: Tomsk
country: Russian Federation
facility: Tomsk NRMC
Study officials:
affiliation: Cardiology Research Institute, Tomsk National Research Medical Center, Russian Academy of Sciences
name: Nina D Anfinogenova, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cardiology Research Institute, Tomsk National Research Medical Center, Russian Academy of Sciences
name: Alexey N Repin, MD, PhD
role: STUDY_DIRECTOR
References: