Clinical trial NCT04288193: Implementation of a Pharmacist-Driven Antipsychotic Deprescribing Initiative in the PACE Setting: A Pilot Study
Official title: Implementation of a Pharmacist-Driven Antipsychotic Deprescribing Initiative in the Program of All-inclusive Care for the Elderly (PACE) Setting: A Pilot Study
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Behavioral and Psychiatric Symptoms of Dementia
Insomnia
Keywords: sleep
antipsychotic
bpsd
deprescribing
Lead sponsor: Tabula Rasa HealthCare
Sponsor class: INDUSTRY
First posted: 2020-02-28
Enrollment: 0
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Identify barriers and enablers to implementation of antipsychotic deprescribing initiative.
timeFrame: Three months
Secondary outcomes:
measure: Implement changes in antipsychotic prescribing to patients in the PACE population.
timeFrame: Three months
measure: Measure the number of antipsychotic re-initiations in the PACE population.
timeFrame: Three months
measure: Measure changes in antipsychotic dosing for the PACE population.
timeFrame: Three months
measure: Identify the number of adverse drug withdrawal events (ADWEs) in the PACE population.
timeFrame: Three months
Other outcomes:
Locations:
city: Pennsauken
country: United States
facility: Trinity Health LIFE, New Jersey
state: New Jersey
Study officials:
affiliation: Tabula Rasa HealthCare
name: Veronique Michaud, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Tabula Rasa HealthCare
name: Anna Furman, PharmD
role: PRINCIPAL_INVESTIGATOR
affiliation: Tabula Rasa HealthCare
name: Adriana Matos, PharmD
role: PRINCIPAL_INVESTIGATOR
affiliation: Tabula Rasa HealthCare
name: Nishita Amin, PharmD
role: PRINCIPAL_INVESTIGATOR
affiliation: Tabula Rasa HealthCare
name: Briana Skalski, PharmD
role: PRINCIPAL_INVESTIGATOR
affiliation: Tabula Rasa HealthCare
name: Sweilem Al Rihani, PhD, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Jeste DV, Blazer D, Casey D, Meeks T, Salzman C, Schneider L, Tariot P, Yaffe K. ACNP White Paper: update on use of antipsychotic drugs in elderly persons with dementia. Neuropsychopharmacology. 2008 Apr;33(5):957-70. doi: 10.1038/sj.npp.1301492. Epub 2007 Jul 18.
citation: Feng Z, Hirdes JP, Smith TF, Finne-Soveri H, Chi I, Du Pasquier JN, Gilgen R, Ikegami N, Mor V. Use of physical restraints and antipsychotic medications in nursing homes: a cross-national study. Int J Geriatr Psychiatry. 2009 Oct;24(10):1110-8. doi: 10.1002/gps.2232.
citation: Yan J. FDA extends black-box warning to all antipsychotics. Psychiatric News. 2008;43:1-27.
citation: US Government Accountability Office. Antipsychotic drug use: HHS has initiatives to reduce use among older adults in nursing homes, but should expand efforts to other settings. Washington, DC: US Government Accountability Office; 2015.
citation: U.S. Food and Drug Administration. Information for healthcare professionals: conventional antipsychotics. Silver Spring, MD: Center for Drug Evaluation and Research. 2008.
citation: Wetzels RB, Zuidema SU, de Jonghe JF, Verhey FR, Koopmans RT. Prescribing pattern of psychotropic drugs in nursing home residents with dementia. Int Psychogeriatr. 2011 Oct;23(8):1249-59. doi: 10.1017/S1041610211000755. Epub 2011 Jun 20.
citation: U.S. Food and Drug Administration. Public health advisory:deaths with antipsychotics in elderly patients with behavioral disturbances. Silver Spring, MD: Center for Drug Evaluation and Research. 2005.