PIM Incidence in Older Cardiovascular Patients During COVID-19 Pandemics (PIM-BARS)

Incidence of Prescribing Potentially Inappropriate Medications to Older Cardiovascular Patients During COVID-19 Pandemics According to Medical Information System BARS

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.

Study Overview

• Status: Recruiting
• Conditions: Potentially Inappropriate Medications
• Intervention / Treatment: Other: Electronic medical record analysis

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.

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Nina D Anfinogenova, PhD; Phone Number: +79095390220; Email: cardio.intl@gmail.com
• Study Contact Backup: Name: Nadezhda I Ryumshina, MD, PhD; Email: n.rumshina@list.ru

Study Locations

• Russia
  • Tomsk, Russia, 634012
    • Recruiting
    • Tomsk NRMC
    • Contact: Nina D Anfinogenova; Phone Number: 89962052183; Email: cardio.intl@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 75 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of potentially inappropriate medication prescription	Incidence rate of potentially inappropriate medication prescriptions (PIM) will be assessed as annual percentage (%) of patient visits to medical doctors resulting in PIM prescription registered in medical information system BARS.	Five years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Potential drug-drug interactions (PDDIs)	Potential drug-drug interactions (PDDIs) will be checked with Medscape Drug Interaction Checker, rated as 'Contraindicated', 'Serious', and 'Requiring Monitoring', and assessed as percentage (%) of patients exposed to them based on data of medical information system BARS.	Five years
Polypharmacy rate	Polypharmacy is defined as being prescribed five or more medications at the same time and assessed as percentage (%) of patients exposed to it based on data of medical information system BARS.	Five years
Incidence of pharmacogenetic drug administration (percentage)	Pharmacogenetics (PGx) drugs are identified using ClinPGx data base at www.clinPGx.org. Incidence of PGx drugs is assessed as a percentage.	Five years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of pharmacogenes (counts)	Number of pharmacogenes that are involved in the effects of drug(s) in each pharmacotherapy case is identified using data derived from www.clinPGx.org.	Five years

Collaborators and Investigators

• Sponsor: Tomsk National Research Medical Center of the Russian Academy of Sciences
• Investigators: Principal Investigator: Nina D Anfinogenova, MD, PhD, Cardiology Research Institute, Tomsk National Research Medical Center, Russian Academy of Sciences; Study Director: Alexey N Repin, MD, PhD, Cardiology Research Institute, Tomsk National Research Medical Center, Russian Academy of Sciences

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2022
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: April 19, 2022
• First Submitted That Met QC Criteria: April 19, 2022
• First Posted (Actual): April 20, 2022

Study Record Updates

• Last Update Posted (Actual): March 17, 2026
• Last Update Submitted That Met QC Criteria: March 13, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Polypharmacy; Prevention; Cardiovascular; Electronic medical record; Drug-drug-interaction; Potentially inappropriate medication; Medical information system
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: PIM-BARS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Deidentified individual participant data (text, tables, figures, and appendices), underlying the results of the trial, will be shared with researchers to achieve the aims in the approved proposal.
• IPD Sharing Time Frame: Proposals may be submitted up to 36 months following publication of the results of the trial. After 36 months, the data will be available in the Center's data ware house but without investigator support other than deposited metadata.
• IPD Sharing Access Criteria: Information regarding submitting proposals and accessing data may be requested from the principal investigator by e-mail.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

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