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

Sponsor
Tomsk National Research Medical Center of the Russian Academy of Sciences (Other)
Overall Status
Recruiting
CT.gov ID
NCT05336565
Collaborator
(none)
1,000
1
28.5
35.1

Study Details

Study Description

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 aged 75 years and older enrolled in the reimbursement programs in the Tomsk Region. 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. 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.

Condition or Disease Intervention/Treatment Phase
  • 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 aged 75 years and older 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

Study Type:
Observational
Anticipated Enrollment :
1000 participants
Observational Model:
Cohort
Time Perspective:
Other
Official Title:
Incidence of Prescribing Potentially Inappropriate Medications to Older Cardiovascular Patients During COVID-19 Pandemics According to Medical Information System BARS
Actual Study Start Date :
Jul 1, 2022
Anticipated Primary Completion Date :
Aug 31, 2024
Anticipated Study Completion Date :
Nov 15, 2024

Outcome Measures

Primary Outcome Measures

  1. Incidence of potentially inappropriate medication prescription [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.

Secondary Outcome Measures

  1. Potential drug-drug interactions (PDDIs) [Five years]

    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.

  2. Polypharmacy rate [Five years]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
75 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • established diagnosis of cardiovascular disease

  • age of 75 years and older

  • enrollment in the reimbursement program in Tomsk Region

Exclusion Criteria:
  • age of 74 years and younger

Contacts and Locations

Locations

Site City State Country Postal Code
1 Tomsk NRMC Tomsk Russian Federation 634012

Sponsors and Collaborators

  • 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Nina D. Anfinogenova, Leading Research Scientist, Tomsk National Research Medical Center of the Russian Academy of Sciences
ClinicalTrials.gov Identifier:
NCT05336565
Other Study ID Numbers:
  • PIM-BARS
First Posted:
Apr 20, 2022
Last Update Posted:
Jul 7, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Nina D. Anfinogenova, Leading Research Scientist, Tomsk National Research Medical Center of the Russian Academy of Sciences
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 7, 2022