The Use of Antipsychotics in the Program of All-inclusive Care for the Elderly (PACE)
9. september 2019 opdateret af: Tabula Rasa HealthCare
Antipsychotic Use Within the Program of All-inclusive Care for the Elderly (PACE)
The aim of this study is to retrospectively evaluate and describe the use of antipsychotics among participants enrolled in the Program of All-inclusive Care for the Elderly (PACE), a community-based practice setting.
Studieoversigt
Status
Afsluttet
Detaljeret beskrivelse
Much national attention has been given to assessing and reducing the use of antipsychotics among nursing home residents, yet comparatively little attention has focused on antipsychotic use among older adults receiving care in community-based settings.
The primary objective of this study is to determine the prevalence of antipsychotic use among a nationally representative sample of nursing home-eligible older adults in a community-based practice setting known as Program of All-inclusive Care for the Elderly (PACE).
The secondary objectives are focused on characterizing antipsychotic use within PACE and for these participants.
Specifically, the investigator's secondary objectives are to describe patterns of other drugs concomitantly used with antipsychotics (e.g., benzodiazepines, opioids) and to identify clinically relevant drug-drug interactions involving antipsychotics.
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
10000
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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New Jersey
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Moorestown, New Jersey, Forenede Stater, 08057
- Tabula Rasa HealthCare
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
55 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Program of All-inclusive Care for the Elderly (PACE) is a Medicare-Medicaid program that provides comprehensive medical and supportive services to individuals >55 years of age who are certified by their state as needing nursing home care but are able to live safely in the community through PACE, as an alternative to institutionalization.
Beskrivelse
Inclusion Criteria:
- Participant enrolled in PACE contractually receiving pharmacy services from Tabula Rasa Healthcare CareKinesis Pharmacy (Tabula Rasa HealthCare) during the project time period (January 2017 through December 2017).
Exclusion Criteria:
- Participant with a diagnosis of bipolar disorder and/or schizophrenia, according to pharmacy records.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: Kohorte
- Tidsperspektiver: Tilbagevirkende kraft
Kohorter og interventioner
Gruppe / kohorte |
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Study group
Participants enrolled in PACE who received an antipsychotic medication.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Prevalence of Antipsychotic Use
Tidsramme: 12 months
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Quantitative description of antipsychotic use as assessed by pharmacy records
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12 months
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Concomitant Drug Use with Antipsychotics
Tidsramme: 12 months
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Qualitative and quantitative description of patterns of other drugs concomitantly used with antipsychotics as assessed by pharmacy records
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12 months
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Drug-Drug Interactions
Tidsramme: 12 months
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Qualitative and quantitative description of drug-drug interactions involving antipsychotics as assessed by proprietary clinical decision support system (CDSS)
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12 months
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Kevin T Bain, PharmD, MPH, Tabula Rasa HealthCare
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Bain KT, Schwartz EJ, Chan-Ting R. Reducing Off-Label Antipsychotic Use in Older Community-Dwelling Adults With Dementia: A Narrative Review. J Am Osteopath Assoc. 2017 Jul 1;117(7):441-450. doi: 10.7556/jaoa.2017.090.
- Pimentel CB, Donovan JL, Field TS, Gurwitz JH, Harrold LR, Kanaan AO, Lemay CA, Mazor KM, Tjia J, Briesacher BA. Use of atypical antipsychotics in nursing homes and pharmaceutical marketing. J Am Geriatr Soc. 2015 Feb;63(2):297-301. doi: 10.1111/jgs.13180.
- Liperoti R, Pedone C, Corsonello A. Antipsychotics for the treatment of behavioral and psychological symptoms of dementia (BPSD). Curr Neuropharmacol. 2008 Jun;6(2):117-24. doi: 10.2174/157015908784533860.
- Schneider LS, Dagerman KS, Insel P. Risk of death with atypical antipsychotic drug treatment for dementia: meta-analysis of randomized placebo-controlled trials. JAMA. 2005 Oct 19;294(15):1934-43. doi: 10.1001/jama.294.15.1934.
- Salvo F, Pariente A, Shakir S, Robinson P, Arnaud M, Thomas S, Raschi E, Fourrier-Reglat A, Moore N, Sturkenboom M, Hazell On Behalf Of Investigators Of The Aritmo Consortium L; Investigators of the ARITMO Consortium. Sudden cardiac and sudden unexpected death related to antipsychotics: A meta-analysis of observational studies. Clin Pharmacol Ther. 2016 Mar;99(3):306-14. doi: 10.1002/cpt.250. Epub 2015 Nov 20.
- Gareri P, De Fazio P, Manfredi VG, De Sarro G. Use and safety of antipsychotics in behavioral disorders in elderly people with dementia. J Clin Psychopharmacol. 2014 Feb;34(1):109-23. doi: 10.1097/JCP.0b013e3182a6096e.
- Mehta S, Johnson ML, Chen H, Aparasu RR. Risk of cerebrovascular adverse events in older adults using antipsychotic agents: a propensity-matched retrospective cohort study. J Clin Psychiatry. 2010 Jun;71(6):689-98. doi: 10.4088/JCP.09m05817yel.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. januar 2017
Primær færdiggørelse (Faktiske)
1. december 2017
Studieafslutning (Faktiske)
1. marts 2019
Datoer for studieregistrering
Først indsendt
25. september 2018
Først indsendt, der opfyldte QC-kriterier
28. september 2018
Først opslået (Faktiske)
2. oktober 2018
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
10. september 2019
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
9. september 2019
Sidst verificeret
1. september 2019
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- AP-BPSD-001
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Ingen
IPD-planbeskrivelse
There will be no disclosure of participant information and no details of participant identity will be part of any presentation or publication of the research.
Participant confidentiality will be held in strict trust by the project investigators.
The project data or other information generated will be held in strict confidence.
No information concerning the project or the data will be released to any unauthorized third party without prior written consent.
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
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