- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04288193
Implementation of a Pharmacist-Driven Antipsychotic Deprescribing Initiative in the PACE Setting: A Pilot Study
May 18, 2022 updated by: Tabula Rasa HealthCare
Implementation of a Pharmacist-Driven Antipsychotic Deprescribing Initiative in the Program of All-inclusive Care for the Elderly (PACE) Setting: A Pilot Study
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.
Study Overview
Status
Withdrawn
Intervention / Treatment
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.
Study Type
Observational
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New Jersey
-
Pennsauken, New Jersey, United States, 08109
- Trinity Health LIFE, New Jersey
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
55 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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.
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Identify barriers and enablers to implementation of antipsychotic deprescribing initiative.
Time Frame: Three months
|
Qualitative
|
Three months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Implement changes in antipsychotic prescribing to patients in the PACE population.
Time Frame: Three months
|
Quantitative and Qualitative
|
Three months
|
Measure the number of antipsychotic re-initiations in the PACE population.
Time Frame: Three months
|
Quantitative
|
Three months
|
Measure changes in antipsychotic dosing for the PACE population.
Time Frame: Three months
|
Quantitative
|
Three months
|
Identify the number of adverse drug withdrawal events (ADWEs) in the PACE population.
Time Frame: Three months
|
Quantitative and Qualitative
|
Three months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: 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
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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. doi: 10.1038/sj.npp.1301492. Epub 2007 Jul 18.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 19, 2021
Primary Completion (Anticipated)
May 18, 2022
Study Completion (Anticipated)
May 18, 2022
Study Registration Dates
First Submitted
February 25, 2020
First Submitted That Met QC Criteria
February 25, 2020
First Posted (Actual)
February 28, 2020
Study Record Updates
Last Update Posted (Actual)
May 25, 2022
Last Update Submitted That Met QC Criteria
May 18, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RPH-APDP-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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