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
1 other identifier
observational
12,873
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2020
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 2, 2020
CompletedFirst Submitted
Initial submission to the registry
April 7, 2020
CompletedFirst Posted
Study publicly available on registry
April 9, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
January 30, 2023
CompletedJanuary 31, 2023
January 1, 2023
2.8 years
April 7, 2020
January 30, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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 Outcomes (2)
To investigate the effects of various covariables on the Medication Risk Score in the presence of repurposed drugs for COVID-19.
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.
1 year
Study Arms (1)
Program of All-Inclusive Care for the Elderly
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.
Interventions
This study is a simulation of adding repurposed drugs for COVID-19. We are using drug claims, and will not intervene with patient care.
Eligibility 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.
You may qualify if:
- Patient enrolled in a PACE organization during the implementation period;
- PACE organization contractually receiving pharmacy services from CareKinesis;
You may not qualify if:
- No drug claims data available for the period of 2019-2020
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Tabula Rasa HealthCare Precision Pharmacotherapy Research and Development Institute
Orlando, Florida, 32827, United States
Related Publications (5)
Epidemiology Working Group for NCIP Epidemic Response, Chinese Center for Disease Control and Prevention. [The epidemiological characteristics of an outbreak of 2019 novel coronavirus diseases (COVID-19) in China]. Zhonghua Liu Xing Bing Xue Za Zhi. 2020 Feb 10;41(2):145-151. doi: 10.3760/cma.j.issn.0254-6450.2020.02.003. Chinese.
PMID: 32064853BACKGROUNDHajjar ER, Cafiero AC, Hanlon JT. Polypharmacy in elderly patients. Am J Geriatr Pharmacother. 2007 Dec;5(4):345-51. doi: 10.1016/j.amjopharm.2007.12.002.
PMID: 18179993BACKGROUNDMehta P, McAuley DF, Brown M, Sanchez E, Tattersall RS, Manson JJ; HLH Across Speciality Collaboration, UK. COVID-19: consider cytokine storm syndromes and immunosuppression. Lancet. 2020 Mar 28;395(10229):1033-1034. doi: 10.1016/S0140-6736(20)30628-0. Epub 2020 Mar 16. No abstract available.
PMID: 32192578BACKGROUNDStabler T, Piette JC, Chevalier X, Marini-Portugal A, Kraus VB. Serum cytokine profiles in relapsing polychondritis suggest monocyte/macrophage activation. Arthritis Rheum. 2004 Nov;50(11):3663-7. doi: 10.1002/art.20613.
PMID: 15529362BACKGROUNDVouri SM, Crist SM, Sutcliffe S, Austin S. Changes in Mood in New Enrollees at a Program of All-Inclusive Care for the Elderly. Consult Pharm. 2015 Aug;30(8):463-71. doi: 10.4140/TCP.n.2015.463.
PMID: 26260643BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Veronique Michaud, PhD
Tabula Rasa HealthCare
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 7, 2020
First Posted
April 9, 2020
Study Start
April 2, 2020
Primary Completion
January 30, 2023
Study Completion
January 30, 2023
Last Updated
January 31, 2023
Record last verified: 2023-01
Data Sharing
- IPD Sharing
- Will not share