The Use of Antipsychotics in the Program of All-inclusive Care for the Elderly (PACE)

Behavioral and Psychiatric Symptoms of Dementia Clinical Trial

Official title:

Antipsychotic Use Within the Program of All-inclusive Care for the Elderly (PACE)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03692182
• Other study ID #: AP-BPSD-001
• Status: Completed
• Start date: January 2017
• Est. completion date: March 2019

Study information

• Verified date: September 2019
• Source: Tabula Rasa HealthCare
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10000
• Est. completion date: March 2019
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Behavioral and Psychiatric Symptoms of Dementia
• Dementia

Locations

Country	Name	City	State
United States	Tabula Rasa HealthCare	Moorestown	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Tabula Rasa HealthCare

Country where clinical trial is conducted

United States, 

References & Publications (7)

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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Salvo F, Pariente A, Shakir S, Robinson P, Arnaud M, Thomas S, Raschi E, Fourrier-Réglat 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of Antipsychotic Use	Quantitative description of antipsychotic use as assessed by pharmacy records	12 months
Secondary	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
Secondary	Drug-Drug Interactions	Qualitative and quantitative description of drug-drug interactions involving antipsychotics as assessed by proprietary clinical decision support system (CDSS)	12 months