Potentially Inappropriate MedicationsPIM-BARSNCT05336565
PIM Incidence in Older Cardiovascular Patients During COVID-19 Pandemics
An observational study of Potentially Inappropriate Medications, run by Tomsk National Research Medical Center of the Russian Academy of Sciences at 1 site in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Potentially Inappropriate Medications
- What is being tested?
- Electronic medical record analysis
- How many people
- 1,000 participants
- Where
- 1 siteRussia
- Study dates
- 1 Jul 2022to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Cardiovascular patients enrolled in the reimbursement program in Tomsk Region who have electronic medical records stored in medical information system BARS.
Who may be able to join
- established diagnosis of cardiovascular disease
- age of 18 years and older
- enrollment in the reimbursement program in Tomsk Region
Who cannot join
- age of 17 years and younger
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Nadezhda I Ryumshina, MD, PhD contact
Russia1 site, 1 recruiting
- Recruiting
Tomsk NRMC
Tomsk, 634012
Nina D Anfinogenova, 89962052183, cardio.intl@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Potentially Inappropriate Medications
- Being tested
- Electronic medical record analysis
- Keywords
- Potentially inappropriate medication, Drug-drug-interaction, Polypharmacy, Cardiovascular, Electronic medical record, Medical information system, Prevention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electronic medical record analysisOther
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 rates and patterns of PIM prescription, polypharmacy, and PDDIs in the time of COVID-19 pandemic will be studied.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Five years
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Five years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2022
- Study start1 Jul 2022
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Potentially Inappropriate MedicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tomsk National Research Medical Center of the Russian Academy of Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nina D. Anfinogenova, Tomsk National Research Medical Center of the Russian Academy of Sciences
- Investigators
- Nina D Anfinogenova, MD, PhD, Principal investigator, Cardiology Research Institute, Tomsk National Research Medical Center, Russian Academy of SciencesAlexey N Repin, MD, PhD, Study director, Cardiology Research Institute, Tomsk National Research Medical Center, Russian Academy of Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05336565
- Sponsor's protocol ID
- CRI-230
- Acronym
- PIM-BARS
- Status last verified
- Jun 2026
- First submitted
- 19 Apr 2022
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Prescribing Potentially Inappropriate Medications to Older Cardiovascular Patients During COVID-19 Pandemics According to Medical Information System BARS
- ClinicalTrials.gov ID
- NCT05336565
- Acronym / sponsor ID
- PIM-BARS / CRI-230
- Conditions
- Potentially Inappropriate Medications
- Keywords
- Potentially inappropriate medication, Drug-drug-interaction, Polypharmacy, Cardiovascular, Electronic medical record, Medical information system, Prevention
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Tomsk National Research Medical Center of the Russian Academy of SciencesUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 20 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cardiovascular patients enrolled in the reimbursement program in Tomsk Region who have electronic medical records stored in medical information system BARS.
Key inclusion criteria (3 listed)
- established diagnosis of cardiovascular disease
- age of 18 years and older
- enrollment in the reimbursement program in Tomsk Region
Key exclusion criteria (1 listed)
- age of 17 years and younger
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electronic medical record analysisMedical 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 rates and patterns of PIM prescription, polypharmacy, and PDDIs in the time of COVID-19 pandemic will be studied. | Other | – |
Primary outcome
Incidence of potentially inappropriate medication prescription
Time frame: Five years
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.
3 secondary outcomes
Potential drug-drug interactions (PDDIs)
Time frame: Five years
Polypharmacy rate
Time frame: Five years
Incidence of pharmacogenetic drug administration (percentage)
Time frame: Five years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nadezhda I Ryumshina, MD, PhD contact
Nina D Anfinogenova, MD, PhD principal investigator
Cardiology Research Institute, Tomsk National Research Medical Center, Russian Academy of Sciences
Alexey N Repin, MD, PhD study director
Cardiology Research Institute, Tomsk National Research Medical Center, Russian Academy of Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Potentially Inappropriate Medications, run by Tomsk National Research Medical Center of the Russian Academy of Sciences at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nina D Anfinogenova, PhD (+79095390220, cardio.intl@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of potentially inappropriate medication prescription (time frame: Five years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026.