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Implementation of a Pharmacist-Driven Antipsychotic Deprescribing Initiative in the PACE Setting: A Pilot Study

Implementation of a Pharmacist-Driven Antipsychotic Deprescribing Initiative in the Program of All-inclusive Care for the Elderly (PACE) Setting: A Pilot Study

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04288193
Enrollment
0
Registered
2020-02-28
Start date
2021-05-19
Completion date
2022-05-18
Last updated
2022-05-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Behavioral and Psychiatric Symptoms of Dementia, Insomnia

Keywords

sleep, antipsychotic, bpsd, deprescribing

Brief summary

The aim of this pilot study is to determine the feasibility of implementing an antipsychotic deprescribing initiative that is driven by pharmacists working collaboratively with the Program of All-inclusive Care for the Elderly (PACE) interdisciplinary team.

Detailed description

No individual antipsychotic has been approved by the U.S. Food and Drug Administration (FDA) for treating insomnia or behavioral and psychological symptoms of dementia (BPSD). Despite these medications being associated with significant harms, a considerable portion of older adults are prescribed antipsychotics for treatment of insomnia or BPSD. The aim of this study is to determine the feasibility of a pharmacist-driven antipsychotic deprescribing initiative in a community-based practice setting known as Program of All-inclusive Care for the Elderly (PACE). Our primary objective is to assess and describe the implementation process, including barriers and enablers to implementation. Our secondary objectives are to quantify and describe changes in antipsychotic prescribing following implementation; evaluate and report on antipsychotic re-initiations or changes in dosing; and evaluate and report on adverse drug withdrawal events (ADWEs) following antipsychotic deprescribing.

Interventions

Recommendation to Deprescribe

Sponsors

Tabula Rasa HealthCare
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Participant enrolled in a PACE organization during the implementation time period; * PACE organization contractually receiving pharmacy services from CareKinesis during the implementation time period; and, * Participant's prescriber determines that the participant could potentially benefit from deprescribing the antipsychotic.

Exclusion criteria

* A diagnosis of bipolar disorder, schizophrenia, schizo-affective disorder, acute delirium, Tourette's syndrome, tic disorders, autism, intellectual disability, developmental delay, obsessive-compulsive disorder, alcoholism, cocaine abuse, Parkinson's disease psychosis, or major depressive disorder for which the antipsychotic is specifically prescribed as adjunctive treatment; * Participant's prescriber determines that the participant would likely not benefit or could be harmed from deprescribing the antipsychotic; and, * Participant, or healthcare decision-maker on behalf of the participant (e.g., caregiver) refuses to participate in the deprescribing initiative.

Design outcomes

Primary

MeasureTime frameDescription
Identify barriers and enablers to implementation of antipsychotic deprescribing initiative.Three monthsQualitative

Secondary

MeasureTime frameDescription
Implement changes in antipsychotic prescribing to patients in the PACE population.Three monthsQuantitative and Qualitative
Measure the number of antipsychotic re-initiations in the PACE population.Three monthsQuantitative
Measure changes in antipsychotic dosing for the PACE population.Three monthsQuantitative
Identify the number of adverse drug withdrawal events (ADWEs) in the PACE population.Three monthsQuantitative and Qualitative

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026