An observational study in COVID, Drug Effect and Drug Interaction, sponsored by Tabula Rasa HealthCare. Completed at 1 site in United States. Open to participants aged 55 Years and older. Per ClinicalTrials.gov, last updated 2023-01-31.
Sponsored by Tabula Rasa HealthCare · Observational
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.
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:
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.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's enrollment of 12,873 is above the median of 261 across 3,136 observational studies indexed under COVID-19.
Browse COVID-19 studies →Tabula Rasa HealthCare is the lead sponsor of 13 studies on the registry; none are open to participants now.
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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.
Exclusion Criteria:
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
This study is a simulation of adding repurposed drugs for COVID-19. We are using drug claims, and will not intervene with patient care.
Also known as: Simulation using proprietary risk stratification software
To determine the Medication Risk Score of de-identified PACE's participants using their current drug regimen.
Quantitative
Time frame: Three months
To simulate the Medication Risk Score following the addition of different repurposed drugs against COVID-19 to their current drug regimen.
Quantitative
Time frame: Three months
To compare the impact on Medication Risk Score before and after the addition of repurposed drugs for COVID-19.
Quantitative
Time frame: 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
Time frame: 3 months
To investigate the effects of various covariables on the Medication Risk Score in the presence of repurposed drugs for COVID-19.
Qualitative
Time frame: 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
Time frame: 1 year
Plan to share: No
This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
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Tabula Rasa HealthCare