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

Overview

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.

Full Title of Study: “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

  • Study Type: Observational [Patient Registry]
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: May 2021

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

  • Drug: Recommendation to Deprescribe
    • Recommendation to Deprescribe

Arms, Groups and Cohorts

  • 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

Clinical Trial Outcome Measures

Primary Measures

  • Identify barriers and enablers to implementation of antipsychotic deprescribing initiative.
    • Time Frame: Three months
    • Qualitative

Secondary Measures

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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 55 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Tabula Rasa HealthCare
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Veronique Michaud, PhD, Principal Investigator, Tabula Rasa HealthCare
    • Anna Furman, PharmD, Principal Investigator, Tabula Rasa HealthCare
    • Adriana Matos, PharmD, Principal Investigator, Tabula Rasa HealthCare
    • Nishita Amin, PharmD, Principal Investigator, Tabula Rasa HealthCare
    • Briana Skalski, PharmD, Principal Investigator, Tabula Rasa HealthCare
    • Sweilem Al Rihani, PhD, PharmD, Principal Investigator, Tabula Rasa HealthCare
  • Overall Contact(s)
    • Veronique Michaud, PhD, 4074549933, vmichaud@trhc.com

References

Bain KT, Holmes HM, Beers MH, Maio V, Handler SM, Pauker SG. Discontinuing medications: a novel approach for revising the prescribing stage of the medication-use process. J Am Geriatr Soc. 2008 Oct;56(10):1946-52. doi: 10.1111/j.1532-5415.2008.01916.x. Epub 2008 Sep 2.

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. Epub 2007 Jul 18. Review.

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.

Yan J. FDA extends black-box warning to all antipsychotics. Psychiatric News. 2008;43:1-27.

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.

U.S. Food and Drug Administration. Information for healthcare professionals: conventional antipsychotics. Silver Spring, MD: Center for Drug Evaluation and Research. 2008.

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.

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.

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