Expired Study
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Moorestown, New Jersey 08057


Purpose:

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.


Study summary:

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.


Criteria:

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.


Study is Available At:


Original ID:

AP-BPSD-001


NCT ID:

NCT03692182


Secondary ID:


Study Acronym:


Brief Title:

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


Official Title:

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


Overall Status:

Active, not recruiting


Study Phase:

N/A


Genders:

N/A


Minimum Age:

55 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Tabula Rasa HealthCare


Oversight Authority:

There was an error processing this request


Reasons Why Stopped:


Study Type:

Observational


Study Design:


Number of Arms:

0


Number of Groups:

1


Total Enrollment:

10000


Enrollment Type:

Actual


Overall Contact Information

Official Name:Kevin T Bain, PharmD, MPH
Principal Investigator
Tabula Rasa HealthCare

Study Dates

Start Date:January 2017
Completion Date:March 2019
Completion Type:Anticipated
Primary Completion Date:December 2017
Primary Completion Type:Actual
Verification Date:January 2019
Last Changed Date:January 31, 2019
First Received Date:September 25, 2018

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Drug-Drug Interactions
Time Frame:12 months
Safety Issues:False
Description:Qualitative and quantitative description of drug-drug interactions involving antipsychotics as assessed by proprietary clinical decision support system (CDSS)
Outcome Type:Secondary Outcome
Measure:Concomitant Drug Use with Antipsychotics
Time Frame:12 months
Safety Issues:False
Description:Qualitative and quantitative description of patterns of other drugs concomitantly used with antipsychotics as assessed by pharmacy records
Outcome Type:Primary Outcome
Measure:Prevalence of Antipsychotic Use
Time Frame:12 months
Safety Issues:False
Description:Quantitative description of antipsychotic use as assessed by pharmacy records

Study Interventions

There are no available Study Interventions

Study Arms

Study Arm Type:Other
Arm Name:Study group
Description:Participants enrolled in PACE who received an antipsychotic medication.

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Tabula Rasa HealthCare

Samples and Retentions

Study Population: 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.
Sample Method:Non-Probability Sample

Study References

Reference Type:Reference
Citation: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.
PMID:28662557
Reference Type:Reference
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.
PMID:25688605
Reference Type:Reference
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.
PMID:19305792
Reference Type:Reference
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.
PMID:16234500
Reference Type:Reference
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.
PMID:26272741
Reference Type:Reference
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.
PMID:24158020
Reference Type:Reference
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.
PMID:20573328

Data Source: ClinicalTrials.gov

Date Processed: August 31, 2019

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