Palliative Care Education in Assisted Living for Dementia Care Providers (PCEAL-DCP)

Not Applicable

Not yet recruiting

• Conditions: Alzheimer Disease; End of Life; Caregiver Burden; Caregiver Burnout; Patient Participation; Self Efficacy

• Registration Number: NCT06722352
• Lead Sponsor: University of South Florida

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.

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-03
• Study First Submitted QC: 2024-12-03
• Last Update Submitted: 2024-12-03
• Study First Posted: 2024-12-09
• Last Update Posted: 2024-12-09
• Study Start: 2025-02-01
• Primary Completion: 2028-12-01
• Study Completion: 2029-08-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 792

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.

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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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Documentation of Advance Care Planning (ACP) Discussions	Baseline, 3, and 6 months	Resident Chart: Percent of residents in sample with documentation in chart of any discussion of ACP with residents or family, last 90 days.; Resident Chart: Percent of residents in sample with living will, health care surrogate, durable power of attorney and do not resuscitate (DNR)s in chart. (yes/no).

Secondary Outcome Measures

Name	Time	Method
Hospice Use	Baseline, 3, and 6 months	Hospice use (Secondary Outcome) Resident Chart: Percent of residents in sample admitted to hospice: Calculated based on # of residents admitted to hospice in last three months. Resident Resident Resident; Hospice use (Secondary Outcome) Resident Chart: Percent of residents in sample admitted to hospice: Calculated based on # of residents admitted to hospice in last three months. Resident Resident Resident Percent of residents in sample admitted to hospice: Calculated based on # of residents admitted to hospice in last three months.

Trial Locations

Locations (1)

University of South Florida; 🇺🇸 Tampa, Florida, United States