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
NCT ID: NCT04339634
Last Updated: 2023-01-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
12873 participants
OBSERVATIONAL
2020-04-02
2023-01-30
Brief Summary
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Detailed Description
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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:
1. Patient enrolled in a PACE organization during the implementation period;
2. 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.
Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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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.
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* PACE organization contractually receiving pharmacy services from CareKinesis;
Exclusion Criteria
55 Years
ALL
No
Sponsors
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Tabula Rasa HealthCare
INDUSTRY
Responsible Party
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Principal Investigators
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Veronique Michaud, PhD
Role: PRINCIPAL_INVESTIGATOR
Tabula Rasa HealthCare
Locations
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Tabula Rasa HealthCare Precision Pharmacotherapy Research and Development Institute
Orlando, Florida, United States
Countries
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References
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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.
Hajjar 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.
Mehta 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.
Stabler 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.
Vouri 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.
Related Links
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World Health Organization: COVID-19
Application of a Novel Medication-Related Risk Stratification
Other Identifiers
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COVID-PACE-2020-001
Identifier Type: -
Identifier Source: org_study_id
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