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Change in personnel, unable to begin project.
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Recommendation to Deprescribe | Drug | Recommendation to Deprescribe |
|
| Measure | Description | Time Frame |
|---|---|---|
| Identify barriers and enablers to implementation of antipsychotic deprescribing initiative. | Qualitative | Three months |
| Measure | Description | Time Frame |
|---|---|---|
| Implement changes in antipsychotic prescribing to patients in the PACE population. | Quantitative and Qualitative | Three months |
| Measure the number of antipsychotic re-initiations in the PACE population. |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Trinity Health LIFE, New Jersey | Pennsauken | New Jersey | 08109 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18771457 | Background | 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. | |
| 17637610 | 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. |
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| ID | Term |
|---|---|
| D001519 | Behavior |
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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Quantitative
| Three months |
| Measure changes in antipsychotic dosing for the PACE population. | Quantitative | Three months |
| Identify the number of adverse drug withdrawal events (ADWEs) in the PACE population. | Quantitative and Qualitative | Three months |
| 19280680 | 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. |
| 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. |
| 21682938 | 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. |
| 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. |
| D001523 |
| Mental Disorders |