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

NCT ID: NCT04288193

Last Updated: 2022-05-25

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-05-19
• Study Completion Date: 2022-05-18

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.

Conditions

Behavioral and Psychiatric Symptoms of Dementia; Insomnia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

Recommendation to Deprescribe

Intervention Type: DRUG

Recommendation to Deprescribe

Interventions

Recommendation to Deprescribe

Recommendation to Deprescribe

Intervention Type: DRUG

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.

• Minimum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tabula Rasa HealthCare

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Veronique Michaud, PhD

Role: PRINCIPAL_INVESTIGATOR

Tabula Rasa HealthCare

Anna Furman, PharmD

Role: PRINCIPAL_INVESTIGATOR

Tabula Rasa HealthCare

Adriana Matos, PharmD

Role: PRINCIPAL_INVESTIGATOR

Tabula Rasa HealthCare

Nishita Amin, PharmD

Role: PRINCIPAL_INVESTIGATOR

Tabula Rasa HealthCare

Briana Skalski, PharmD

Role: PRINCIPAL_INVESTIGATOR

Tabula Rasa HealthCare

Sweilem Al Rihani, PhD, PharmD

Role: PRINCIPAL_INVESTIGATOR

Tabula Rasa HealthCare

Locations

Trinity Health LIFE, New Jersey

Pennsauken, New Jersey, United States

Countries

United States

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.

Reference Type: BACKGROUND

PMID: 18771457 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17637610 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19280680 (View on PubMed)

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

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

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

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

PMID: 21682938 (View on PubMed)

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.

Reference Type: BACKGROUND

Other Identifiers

RPH-APDP-001

Identifier Type: -

Identifier Source: org_study_id