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

NCT ID: NCT06722352

Last Updated: 2025-04-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

792 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-28

Study Completion Date

2029-08-01

Brief Summary

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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

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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.

Conditions

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Alzheimer Disease End of Life Caregiver Burden Caregiver Burnout Patient Participation Self Efficacy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors
Two research study nurses blinded to the intervention will be trained and a rating manual provided to assist in gaining a 90% IRR.

Study Groups

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Intervention -

Hospice nurses or social workers selected from LifePath and Suncoast Hospice organizations will train the AL interventionists on the PCEAL-DCP intervention. All hospice nurses and social workers who are facilitators will be licensed practical nurses, registered nurses or master's in social work. Prior to the intervention, the hospice facilitators will complete a four-hour workshop about the topics to cover and be trained on the protocol to follow for facilitation of the four-week PCEAL sessions so each cluster in the treatment group is trained in the same manner.

Group Type EXPERIMENTAL

Palliative Care Training

Intervention Type BEHAVIORAL

Teaching about caring for individuals with

Control

Wait-listed group will receive the PCEAL-DCP curriculum after completion of the study.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Palliative Care Training

Teaching about caring for individuals with

Intervention Type BEHAVIORAL

Eligibility Criteria

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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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Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

University of South Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Debra Dobbs, PhD

Role: PRINCIPAL_INVESTIGATOR

University of South Florida

Locations

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University of South Florida

Tampa, Florida, United States

Site Status RECRUITING

University of South Florida

Tampa, Florida, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Debra Dobbs, PhD

Role: CONTACT

813-974-5767

Facility Contacts

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Debra Dobbs, PhD

Role: primary

Debra Dobbs, PhD.

Role: primary

813-974-5767

Jonathan Clapp, PhD

Role: backup

References

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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.

Reference Type BACKGROUND
PMID: 36842068 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 5881970 (View on PubMed)

Other Identifiers

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1RF1AG087325-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

007811

Identifier Type: -

Identifier Source: org_study_id

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