跳至主要内容
临床试验/NCT04288193
NCT04288193撤回不适用

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

Tabula Rasa HealthCare1 个研究点 分布在 1 个国家开始时间: 2021年5月19日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
撤回
发起方
试验地点
1
主要终点
Identify barriers and enablers to implementation of antipsychotic deprescribing initiative.

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
55 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

Trinity Health LIFE New Jersey PACE

Participants enrolled in Trinity Health LIFE New Jersey PACE facility who received an antipsychotic medication for the treatment of BPSD or insomnia

干预措施: Recommendation to Deprescribe (Drug)

结局指标

主要结局

Identify barriers and enablers to implementation of antipsychotic deprescribing initiative.

时间窗: Three months

Qualitative

次要结局

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

研究者

发起方
Tabula Rasa HealthCare
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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