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

Insomnia Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04288193
• Other study ID #: RPH-APDP-001
• Status: Withdrawn
• Start date: May 19, 2021
• Est. completion date: May 18, 2022

Study information

• Verified date: May 2022
• Source: Tabula Rasa HealthCare
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 18, 2022
• Est. primary completion date: May 18, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Behavioral and Psychiatric Symptoms of Dementia
• Dementia
• Insomnia

Intervention

Drug:
• Recommendation to Deprescribe
Recommendation to Deprescribe

Locations

Country	Name	City	State
United States	Trinity Health LIFE, New Jersey	Pennsauken	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Tabula Rasa HealthCare

Country where clinical trial is conducted

United States, 

References & Publications (8)

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. — View 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. — View 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. Epub 2007 Jul 18. Review. — View Citation

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

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.

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.

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. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identify barriers and enablers to implementation of antipsychotic deprescribing initiative.	Qualitative	Three months
Secondary	Implement changes in antipsychotic prescribing to patients in the PACE population.	Quantitative and Qualitative	Three months
Secondary	Measure the number of antipsychotic re-initiations in the PACE population.	Quantitative	Three months
Secondary	Measure changes in antipsychotic dosing for the PACE population.	Quantitative	Three months
Secondary	Identify the number of adverse drug withdrawal events (ADWEs) in the PACE population.	Quantitative and Qualitative	Three months