PIM Incidence in Older Cardiovascular Patients During COVID-19 Pandemics

NCT05336565 | Recruiting

• 1 other identifier: PIM-BARS
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Potentially Inappropriate Medications

Keywords

Potentially inappropriate medication; Drug-drug-interaction; Polypharmacy; Cardiovascular; Electronic medical record; Medical information system; Prevention

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Potential drug-drug interactions (PDDIs)

  Five years

• Polypharmacy rate

  Five years

• Incidence of pharmacogenetic drug administration (percentage)

  Five years

Other Outcomes (1)

• Number of pharmacogenes (counts)

  Five years

Interventions

Electronic medical record analysis OTHER

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• age of 17 years and younger

Sponsors & Collaborators

• Tomsk National Research Medical Center of the Russian Academy of Sciences: lead

Study Sites (1)

Tomsk NRMC

Tomsk, 634012, Russia

RECRUITING

Study Officials

• Nina D Anfinogenova, MD, PhD

  Cardiology Research Institute, Tomsk National Research Medical Center, Russian Academy of Sciences

  PRINCIPAL INVESTIGATOR

• Alexey N Repin, MD, PhD

  Cardiology Research Institute, Tomsk National Research Medical Center, Russian Academy of Sciences

  STUDY DIRECTOR

Central Study Contacts

Nina D Anfinogenova, PhD

CONTACT

+79095390220; cardio.intl@gmail.com

Nadezhda I Ryumshina, MD, PhD

CONTACT

n.rumshina@list.ru

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Leading Research Scientist

Study Record Dates

• First Submitted: April 19, 2022
• First Posted: April 20, 2022
• Study Start: July 1, 2022
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 17, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• 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.
• Access Criteria: Information regarding submitting proposals and accessing data may be requested from the principal investigator by e-mail.

Locations

RU (1)