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

NCT04288193 | Withdrawn

• 1 other identifier: RPH-APDP-001
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Behavioral and Psychiatric Symptoms of Dementia; Insomnia

Keywords

sleep; antipsychotic; bpsd; deprescribing

Outcome Measures

Primary Outcomes (1)

• Identify barriers and enablers to implementation of antipsychotic deprescribing initiative.

  Qualitative

  Three months

Secondary Outcomes (4)

• 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

Study Arms (1)

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

Drug: Recommendation to Deprescribe

Interventions

Recommendation to Deprescribe DRUG

Recommendation to Deprescribe

Trinity Health LIFE New Jersey PACE

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tabula Rasa HealthCare: lead

Study Sites (1)

Trinity Health LIFE, New Jersey

Pennsauken, New Jersey, 08109, United States

Location

Related 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.

  PMID: 18771457 BACKGROUND

• 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.

  PMID: 17637610 BACKGROUND

• 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.

  PMID: 19280680 BACKGROUND

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

  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.

  BACKGROUND

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

  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.

  PMID: 21682938 BACKGROUND

• 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.

  BACKGROUND

MeSH Terms

Conditions

Behavior; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Veronique Michaud, PhD

  Tabula Rasa HealthCare

  PRINCIPAL INVESTIGATOR

• Anna Furman, PharmD

  Tabula Rasa HealthCare

  PRINCIPAL INVESTIGATOR

• Adriana Matos, PharmD

  Tabula Rasa HealthCare

  PRINCIPAL INVESTIGATOR

• Nishita Amin, PharmD

  Tabula Rasa HealthCare

  PRINCIPAL INVESTIGATOR

• Briana Skalski, PharmD

  Tabula Rasa HealthCare

  PRINCIPAL INVESTIGATOR

• Sweilem Al Rihani, PhD, PharmD

  Tabula Rasa HealthCare

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2020
• First Posted: February 28, 2020
• Study Start: May 19, 2021
• Primary Completion: May 18, 2022
• Study Completion: May 18, 2022
• Last Updated: May 25, 2022

Record last verified: 2022-05

Locations

US (1)