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

Sponsor:

Collaborators:

Information provided by (Responsible Party):

，

Tracking Information

First Submitted Date ^ICMJE

September 25, 2018

First Posted Date ^ICMJE

October 2, 2018

Last Update Posted Date

October 2, 2018

Actual Study Start Date ^ICMJE

January 2017

Estimated Primary Completion Date

December 2017 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Prevalence of Antipsychotic Use[ Time Frame: 12 months ]

Quantitative description of antipsychotic use as assessed by pharmacy records

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

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
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)

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

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 ^ICMJE

Observational

Study Phase

Study Design ^ICMJE

Allocation:
Intervention Model:
Intervention Model Description:
Masking: Observational
Masking Description:
Primary Purpose:

Condition ^ICMJE

Intervention ^ICMJE

Study Arms

: Study group
Participants enrolled in PACE who received an antipsychotic medication.

Recruitment Information

Recruitment Status ^ICMJE

Enrolling by invitation

Estimated Enrollment ^ICMJE

10000

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

October 2018

Estimated Primary Completion Date

December 2017 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Sex/Gender

Sexes Eligible for Study:

All

Ages

55 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Responsible Party

，

Study Sponsor ^ICMJE

Tabula Rasa HealthCare

Collaborators ^ICMJE

Investigators ^ICMJE

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

PRS Account

Verification Date

September 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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