Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05336565 |
| Other study ID # |
PIM-BARS |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
July 1, 2022 |
| Est. completion date |
November 15, 2024 |
Study information
| Verified date |
December 2023 |
| Source |
Tomsk National Research Medical Center of the Russian Academy of Sciences |
| Contact |
Nina D Anfinogenova, PhD |
| Phone |
+79095390220 |
| Email |
cardio.intl[@]gmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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. 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.
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.
