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

Withdrawn

• Conditions: Behavioral and Psychiatric Symptoms of Dementia; Insomnia
• Interventions: Drug: Recommendation to Deprescribe

• Registration Number: NCT04288193
• Lead Sponsor: Tabula Rasa HealthCare

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.

Study Timeline

• Study First Submitted: 2020-02-25
• Study First Submitted QC: 2020-02-25
• Study First Posted: 2020-02-28
• Study Start: 2021-05-19
• Status Verified: 2022-05
• Primary Completion: 2022-05-18
• Study Completion: 2022-05-18
• Last Update Submitted: 2022-05-18
• Last Update Posted: 2022-05-25

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Trinity Health LIFE New Jersey PACE	Recommendation to Deprescribe	Participants enrolled in Trinity Health LIFE New Jersey PACE facility who received an antipsychotic medication for the treatment of BPSD or insomnia

Primary Outcome Measures

Name	Time	Method
Identify barriers and enablers to implementation of antipsychotic deprescribing initiative.	Three months	Qualitative

Secondary Outcome Measures

Name	Time	Method
Implement changes in antipsychotic prescribing to patients in the PACE population.	Three months	Quantitative and Qualitative
Measure the number of antipsychotic re-initiations in the PACE population.	Three months	Quantitative
Measure changes in antipsychotic dosing for the PACE population.	Three months	Quantitative
Identify the number of adverse drug withdrawal events (ADWEs) in the PACE population.	Three months	Quantitative and Qualitative

Trial Locations

Locations (1)

Trinity Health LIFE, New Jersey; 🇺🇸 Pennsauken, New Jersey, United States