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

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ClinicalTrials.gov Identifier: NCT03692182
Recruitment Status : Active, not recruiting
First Posted : October 2, 2018
Last Update Posted : February 4, 2019
Sponsor:
Information provided by (Responsible Party):
Tabula Rasa HealthCare

Brief 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.

Condition or disease
Behavioral and Psychiatric Symptoms of Dementia

Detailed 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.

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Study Type : Observational
Actual Enrollment : 10000 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Antipsychotic Use Within the Program of All-inclusive Care for the Elderly (PACE)
Actual Study Start Date : January 2017
Actual Primary Completion Date : December 2017
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dementia

Group/Cohort
Study group
Participants enrolled in PACE who received an antipsychotic medication.



Primary Outcome Measures :
  1. Prevalence of Antipsychotic Use [ Time Frame: 12 months ]
    Quantitative description of antipsychotic use as assessed by pharmacy records


Secondary Outcome Measures :
  1. Concomitant Drug Use with Antipsychotics [ Time Frame: 12 months ]
    Qualitative and quantitative description of patterns of other drugs concomitantly used with antipsychotics as assessed by pharmacy records

  2. Drug-Drug Interactions [ Time Frame: 12 months ]
    Qualitative and quantitative description of drug-drug interactions involving antipsychotics as assessed by proprietary clinical decision support system (CDSS)



Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03692182


Locations
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United States, New Jersey
Tabula Rasa HealthCare
Moorestown, New Jersey, United States, 08057
Sponsors and Collaborators
Tabula Rasa HealthCare
Investigators
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Principal Investigator: Kevin T Bain, PharmD, MPH Tabula Rasa HealthCare

Publications:

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Responsible Party: Tabula Rasa HealthCare
ClinicalTrials.gov Identifier: NCT03692182     History of Changes
Other Study ID Numbers: AP-BPSD-001
First Posted: October 2, 2018    Key Record Dates
Last Update Posted: February 4, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: 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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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Tabula Rasa HealthCare:
Antipsychotic
Dementia

Additional relevant MeSH terms:
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Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs