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

September 9, 2019 updated by: 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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

10000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Moorestown, New Jersey, United States, 08057
        • Tabula Rasa HealthCare

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of Antipsychotic Use
Time Frame: 12 months
Quantitative description of antipsychotic use as assessed by pharmacy records
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 months
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)
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tabula Rasa HealthCare

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

March 1, 2019

Study Registration Dates

First Submitted

September 25, 2018

First Submitted That Met QC Criteria

September 28, 2018

First Posted (Actual)

October 2, 2018

Study Record Updates

Last Update Posted (Actual)

September 10, 2019

Last Update Submitted That Met QC Criteria

September 9, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AP-BPSD-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD 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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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