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Assessment of a Novel Algorithm System for Polypharmacy Patient Medication Safety and Consultation

NCT05589870 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 91

Last updated 2023-10-23

No results posted yet for this study

Summary

The aim of this study is to determine if insights based on the analysis of historical data of multidrug patients' electronic health records, by a novel system and algorithm, is noninferior to a clinical pharmacist analysis and insights.

Multidrug patients, also known as polypharmacy patients often suffer from adverse drug reactions (ADRs). In routine practice the clinical pharmacist helps prevent ADRs by comprehensive medication review, identifying drug related risks and problems and providing recommendations. The analysis of multidrug patients is highly complex and time consuming due to the large amount of multifactorial data of chronic multidrug patients' medications, symptoms, comorbidities and age-related issues. The MDI system is a tool for analyzing and providing insights on polypharmacy data \[including electronic health records (EHRs) and claims data\] to help clinicians evaluate complex medical records and ensure optimal and personal treatment recommendations.

After initial training of the MDI system on historical real-life patient EHRs, the MDI system and the clinical pharmacist reviewed patient EHR data from another patient cohort according to five categories: 1) duplication of therapy, 2) age-related issues, 3) incorrect dose, 4) current side effects and 5) future side effects risks. The insights of this assessment were recorded on patient conclusion sheets and adjudicated by an external judging committee, comprised of two senior academic clinical pharmacists. The judging committee were blinded to the source of the conclusion sheets.

Diagnostic accuracy parameters: agreement, sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of the MDI system and the clinical pharmacist were assessed. The gold standard of the diagnostic accuracy analysis was the judging committee.

Assuming that the total agreement is 5% higher for the MDI System, with a non-inferiority margin of 5%, α level of 5%, statistical power of 90%, and an expected standard deviation of 15%, the minimum sample size is about 20 cases. The achieved recruitment level was more than twice as much in the actual clinical trial.

Conditions

  • Polypharmacy Patients

Interventions

OTHER

Multi-drug analysis of polypharmacy treatment

Multi-drug analysis to assess and provide insights for lowering the risk of ADRs and increasing the benefit of polypharmacy treatment

Sponsors & Collaborators

  • Hadassah Medical Organization

    collaborator OTHER

  • MDI Health

    lead INDUSTRY

Principal Investigators

  • Sigal Shafran, Dr. · Hadassah Medical Organization

Eligibility

Min Age
45 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-13
Primary Completion
2021-07-07
Completion
2021-07-07

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05589870 on ClinicalTrials.gov