Behavioral and Psychiatric Symptoms of DementiaNCT04288193
Implementation of a Pharmacist-Driven Antipsychotic Deprescribing Initiative in the PACE Setting: A Pilot Study
An observational study of Behavioral and Psychiatric Symptoms of Dementia and Insomnia, run by Tabula Rasa HealthCare at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Behavioral and Psychiatric Symptoms of Dementia, Insomnia
- What is being tested?
- Recommendation to Deprescribe
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 19 May 2021to 18 May 2022
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Trinity Health LIFE, New Jersey
Pennsauken, New Jersey, 08109
About this study
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
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.
Read the 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.
- Being tested
- Recommendation to Deprescribe
- Keywords
- sleep, antipsychotic, bpsd, deprescribing
- Medical subject headings
- Behavior, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recommendation to DeprescribeDrug
Recommendation to Deprescribe
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Recommendation to Deprescribe |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identify barriers and enablers to implementation of antipsychotic deprescribing initiative.
Qualitative
Measured: Three months
Secondary outcomes (4)
Implement changes in antipsychotic prescribing to patients in the PACE population.
Quantitative and Qualitative
Measured: Three months
Measure the number of antipsychotic re-initiations in the PACE population.
Quantitative
Measured: Three months
Measure changes in antipsychotic dosing for the PACE population.
Quantitative
Measured: Three months
Identify the number of adverse drug withdrawal events (ADWEs) in the PACE population.
Quantitative and Qualitative
Measured: Three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2020
- Study start19 May 2021
- Primary completion18 May 2022 (estimated)
- Study completion18 May 2022 (estimated)
Why it stopped: Change in personnel, unable to begin project.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Behavioral and Psychiatric Symptoms of DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Tabula Rasa HealthCare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Veronique Michaud, PhD, Principal investigator, Tabula Rasa HealthCareAnna Furman, PharmD, Principal investigator, Tabula Rasa HealthCareAdriana Matos, PharmD, Principal investigator, Tabula Rasa HealthCareNishita Amin, PharmD, Principal investigator, Tabula Rasa HealthCareBriana Skalski, PharmD, Principal investigator, Tabula Rasa HealthCareSweilem Al Rihani, PhD, PharmD, Principal investigator, Tabula Rasa HealthCare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04288193
- Sponsor's protocol ID
- RPH-APDP-001
- Status last verified
- May 2022
- First submitted
- 25 Feb 2020
- Last updated
- 25 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 18771457Jeste 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.
PubMed 17637610Feng 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.
PubMed 19280680Yan 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.
PubMed 21682938U.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 at a glance
From the registry record, last updated by the sponsor on 25 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04288193
- Acronym / sponsor ID
- RPH-APDP-001
- Keywords
- sleep, antipsychotic, bpsd, deprescribing
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Change in personnel, unable to begin project.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Tabula Rasa HealthCareIndustry (pharma, biotech, devices)
- Study start
- 19 May 2021 (actual)
- Primary completion
- 18 May 2022 (estimated)
- Study completion
- 18 May 2022 (estimated)
- First posted
- 28 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Trinity Health LIFE New Jersey PACE | – | Drug: Recommendation to DeprescribeParticipants enrolled in Trinity Health LIFE New Jersey PACE facility who received an antipsychotic medication for the treatment of BPSD or insomnia |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Recommendation to DeprescribeRecommendation to Deprescribe | Drug | Trinity Health LIFE New Jersey PACE |
Primary outcome
Identify barriers and enablers to implementation of antipsychotic deprescribing initiative.
Time frame: Three months
Qualitative
4 secondary outcomes
Implement changes in antipsychotic prescribing to patients in the PACE population.
Time frame: Three months
Measure the number of antipsychotic re-initiations in the PACE population.
Time frame: Three months
Measure changes in antipsychotic dosing for the PACE population.
Time frame: Three months
Identify the number of adverse drug withdrawal events (ADWEs) in the PACE population.
Time frame: Three months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2022.
- Background: PubMed 18771457Bain 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.
- Background: PubMed 17637610Jeste 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.
- Background: PubMed 19280680Feng 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.
- BackgroundYan J. FDA extends black-box warning to all antipsychotics. Psychiatric News. 2008;43:1-27.
- BackgroundUS 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.
- BackgroundU.S. Food and Drug Administration. Information for healthcare professionals: conventional antipsychotics. Silver Spring, MD: Center for Drug Evaluation and Research. 2008.
- Background: PubMed 21682938Wetzels 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.
- BackgroundU.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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Veronique Michaud, PhD principal investigator
Tabula Rasa HealthCare
Anna Furman, PharmD principal investigator
Tabula Rasa HealthCare
Adriana Matos, PharmD principal investigator
Tabula Rasa HealthCare
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Behavioral and Psychiatric Symptoms of Dementia and Insomnia, run by Tabula Rasa HealthCare at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 25 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identify barriers and enablers to implementation of antipsychotic deprescribing initiative. (time frame: Three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04288193, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2022.