PIM Incidence in Older Cardiovascular Patients During COVID-19 Pandemics
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorTomsk National Research Medical Center of the Russian Academy of Sciences
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
established diagnosis of cardiovascular disease
age of 18 years and older
enrollment in the reimbursement program in Tomsk Region
Disqualifiers
age of 17 years and younger
Trial population
Cardiovascular patients enrolled in the reimbursement program in Tomsk Region who have electronic medical records stored in medical information system BARS.
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
Electronic medical record analysis
Other interventionMedical 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.
Treatment groups
No treatment groups listed
Trial outcomes
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.
Time frame
Five yearsSecondary outcomes
1
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.
Time frame
Five years2
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.
Time frame
Five years3
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.
Time frame
Five yearsOther outcomes
1
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.
Time frame
Five yearsSponsors and contacts
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Source ClinicalTrials.gov