NCT05589870

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

Completed Last updated 23 October 2023

What this trial tests

trial testing Multi-drug analysis of polypharmacy treatment in Polypharmacy Patients in 91 participants. Completed in 7 July 2021.

Timeline

13 February 2021

Primary endpoint
7 July 2021

7 July 2021

Quick facts

Lead sponsor	MDI Health
Status	Completed
Study type	OBSERVATIONAL
Enrollment	91
Start date	13 February 2021
Primary completion	7 July 2021
Estimated completion	7 July 2021
Sites	1 location across Israel

Drugs / interventions tested

• Multi-drug analysis of polypharmacy treatment

Conditions studied

• Polypharmacy Patients — all drugs for Polypharmacy Patients →

Sponsor

MDI Health

Who can join

Adults 45 to 100, any sex, with Polypharmacy Patients. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.