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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study group | Participants enrolled in PACE who received an antipsychotic medication. |
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| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of Antipsychotic Use | Quantitative description of antipsychotic use as assessed by pharmacy records | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Concomitant Drug Use with Antipsychotics | Qualitative and quantitative description of patterns of other drugs concomitantly used with antipsychotics as assessed by pharmacy records | 12 months |
| Drug-Drug Interactions |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Kevin T Bain, PharmD, MPH | Tabula Rasa HealthCare | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tabula Rasa HealthCare | Moorestown | New Jersey | 08057 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28662557 | Background | 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. | |
| 25688605 | Background | 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. |
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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.
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| ID | Term |
|---|---|
| D001519 | Behavior |
| D003704 | Dementia |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D019965 | Neurocognitive Disorders |
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Qualitative and quantitative description of drug-drug interactions involving antipsychotics as assessed by proprietary clinical decision support system (CDSS)
| 12 months |
| 19305792 | Background | 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. |
| 16234500 | Background | 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. |
| 26272741 | Background | 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. |
| 24158020 | Background | 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. |
| 20573328 | Background | 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. |
| D001523 | Mental Disorders |