Simulation of Risk of Adverse Drug Events Associated With the Initiation of Drugs Repurposed for the Treatment of COVID-19 in Frail Elderly Adults With Polypharmacy

Study Overview
=================
Brief Summary
-----------------
This retrospective study aims to perform a medication risk stratification using drug claims data and to simulate the impact of the addition of various repurposed drugs on the Medication Risk Score (MRS) in elderly people enrolled in PACE organizations. Our clinical tool would enable to identify potential multi-drug interactions and potentially reduce the risk of adverse drug events (ADE) developing in elderly patients infected with COVID-19.

Detailed Description
-----------------
Certain investigational agents have been described in observational series or are being used anecdotally based on in vitro or extrapolated evidence. It is important to acknowledge that there are no controlled data supporting the use of any of these agents, and their efficacy for COVID-19 is unknown. FDA-approved drugs such as chloroquine/hydroxychloroquine, lopinavir/ritonavir, monoclonal IL-6 antibodies, JAK inhibitors, thalidomide and the new investigational drug, remdesivir have been proposed for repurposing to fight COVID-19 and its complications. A medication risk stratification strategy will be used to simulate the impacts of different potential repurposed drugs for COVID-19 on the Medication Risk Score (MRS) which is used as a predictive tool for ADEs. A retrospective study will be conducted using de-identified drug claims data of elderly patients with polypharmacy. Patients meeting all the following criteria will be included: Patient enrolled in a PACE organization during the implementation period; PACE organization contractually receiving pharmacy services from CareKinesis; Exclusion Criteria a) No drug claims data available for the period of 2019-2020 This retrospective cohort will utilize 178,867 drug claims from approximately 12,123 patients enrolled in PACE. MRS will be calculated using the last available 3-month period of drug claims in 2019. The data elements required for the calculation of the full set of risk scores are: prescribed drugs, dose, age, gender. Medication risk stratification using 5 factors will be performed to obtain the MRS. Various repurposed drugs (drugs associated with the highest probability or efficacy or shown interest as per their inclusion in current clinical trials will be prioritized) will be added to the patient drug regimen except for the patients that are currently taking the repurposed drug. A new MRS will be generated for all stratified patients.

Official Title
-----------------
Simulation of Risk of Adverse Drug Events Associated With the Initiation of Drugs Repurposed for the Treatment of COVID-19 in Frail Elderly Adults With Polypharmacy

Conditions
-----------------
COVID, Drug Effect, Drug Interaction, Adverse Drug Event

Intervention / Treatment
-----------------
* Other: Simulation of Repurposed Drugs for COVID-19


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient enrolled in a PACE organization during the implementation period; PACE organization contractually receiving pharmacy services from CareKinesis; Exclusion Criteria: No drug claims data available for the period of 2019-2020

Ages Eligible for Study
-----------------
Minimum Age: 55 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Program of All-Inclusive Care for the Elderly<br>The Program of All-Inclusive Care for the Elderly (PACE) provides comprehensive medical and supportive services for community-dwelling persons, mostly older adults (>55 years), as an alternative to institutionalization. Medical services are provided by an interdisciplinary team of healthcare professionals, Tabula Rasa HealthCare being the pharmacy care provider for several PACE organizations. | Other: Simulation of Repurposed Drugs for COVID-19<br>* This study is a simulation of adding repurposed drugs for COVID-19. We are using drug claims, and will not intervene with patient care.<br>* Other names: Simulation using proprietary risk stratification software;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the Medication Risk Score of de-identified PACE's participants using their current drug regimen. | Quantitative | Three months | 
| To simulate the Medication Risk Score following the addition of different repurposed drugs against COVID-19 to their current drug regimen. | Quantitative | Three months | 
| To compare the impact on Medication Risk Score before and after the addition of repurposed drugs for COVID-19. | Quantitative | Three months | 
| To assess and compare the effects of various repurposed drugs for COVID-19 on each of the 5 factors computed by algorithms to derive the Medication Risk Score. | Quantitative | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To investigate the effects of various covariables on the Medication Risk Score in the presence of repurposed drugs for COVID-19. | Qualitative | 6 months | 
| To explore the effects on Medication Risk Score of various repurposed drugs for COVID-19 within subgroups of patients classified by specific diseases or drugs used. | Qualitative | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COVID-19, Elderly, Adverse Drug Event, Repurposed Drug, Drug Interaction, LQTS