Clinical trial NCT06722352: Palliative Care Education in Assisted Living for Dementia Care Providers (PCEAL-DCP)
Official title: Preparing Assisted Living Staff to Provider Palliative Care to Residents With Dementia: Palliative Care Education in Assisted Living for Dementia Care Providers (PCEAL-DCP)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Alzheimer Disease
End of Life
Caregiver Burden
Caregiver Burnout
Patient Participation
Self Efficacy
Keywords: end of life
palliative care
education
staff training
assisted living
dementia
dementia care
Alzheimer's
Lead sponsor: University of South Florida
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2024-12-09
Enrollment: 792
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The palliative care education in assisted living for dementia care providers (PCEAL-DCP) is a 4-week intervention (once a week for 1.5 hours, a total of 6 hours) for licensed nurses, administrators and dementia care coordinators to improve quality of dementia care outcomes

Detailed description: This is a five-year cluster randomized trial (CRT) among 30 assisted living (AL) communities (k=30) and residents (N=450), staff (N=72) and family members (N=270) with a baseline, 3, and 6 months post-intervention follow-ups for residents, a baseline and 6-month follow-up for family and a pre- and post-test (one month), 3- and 6-month follow-up for staff and baseline AL facility information from administrators to examine dementia care outcomes.

Eligibility criteria: Inclusion Criteria:

The AL community eligibility criteria include a minimum of 40+ beds and provide memory care services to at least 35% of their residents, and access to hospice services from Lifepath or Suncoast Hospice. The AL size of 40+ beds is selected so we will be able to recruit a minimum of 14 residents per site, based on the power analysis for the sample size of 450 for the primary study outcome of documentation of ACP discussions.

Residents are eligible if 1) they have a dementia diagnosis confirmed by the resident's physician (physician's signature required by University of South Florida (USF) Institutional Reiew Board (IRB) in prior clinical trial) regardless of dementia severity (mild, moderate, or severe), 2) if they have been admitted to the AL in the last month, and 3) if they have a legally responsible representative who understands English.

Staff are eligible if they are currently employed with the participating study AL as a registered/licensed practical nurse, administrator, or dementia care coordinator of a memory care unit and English speaking and 21 years of age or older.

Family members are eligible if 1) they are listed as the legally responsible party in the chart records for the resident with ADRD, 2) they understand English, and 3) are at least 21 years of age or older. This could include someone related to the person, a close friend or a legal guardian who oversees the person's care and is responsible for decisions about their care.

Exclusion Criteria:

AL sites will be ineligible if 1) the are not a licensed Florida assisted living facility; 2) they have previously participated in a PCEAL-DCP clinical trial (2018-2021) to avoid possible experimental contamination effects, and 3) if no staff employed at the AL are willing to participate in the study.

Residents are ineligible if they: 1) are currently receiving hospice services because residents who receive hospice are already engaged in ACP discussions upon admission; 2) if they are discharged from assisted living to another setting (nursing home or hospital) or are admitted to hospice or have died before baseline data is collected.

Staff will be ineligible if they are not licensed nurses, administrators or dementia care coordinators of a dementia care unit or terminated/resign before baseline data is collected.

Family are ineligible if: 1) they are under 21 years of age and do not understand spoken or written English and if there is already a legal authorized representative for a resident participating in the study (one family member per resident).

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Primary outcomes:
measure: Documentation of Advance Care Planning (ACP) Discussions
timeFrame: Baseline, 3, and 6 months
Secondary outcomes:
measure: Hospice Use
timeFrame: Baseline, 3, and 6 months
Other outcomes:
measure: Palliative Care Staff Knowledge
timeFrame: Baseline, 3, and 6 months
measure: Staff Self-Efficacy
timeFrame: Baseline, 3, and 6 months
measure: Staff commitment
timeFrame: Baseline, 3, and 6 months
measure: Staff satisfaction with org. support.
timeFrame: Baseline, 3, and 6 months
Locations:
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Tampa
country: United States
facility: University of South Florida
state: Florida
Study officials:
affiliation: University of South Florida
name: Debra Dobbs, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dobbs D, Yauk J, Vogel CE, Fanfan D, Buck H, Haley WE, Meng H. Feasibility of the Palliative Care Education in Assisted Living Intervention for Dementia Care Providers: A Cluster Randomized Trial. Gerontologist. 2024 Jan 1;64(1):gnad018. doi: 10.1093/geront/gnad018.
citation: Bureau Y, Rodat G, Barriere H, Litoux P, Bureau B. [Cutaneous mastocytosis in adults with hepatic mastocytosis and blood monocytosis]. Bull Soc Fr Dermatol Syphiligr. 1965 Nov-Dec;72(6):850-3. No abstract available. French.