NCT06722352

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
792

participants targeted

Target at P75+ for not_applicable alzheimer-disease

Timeline
40mo left

Started Jan 2025

Longer than P75 for not_applicable alzheimer-disease

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress28%
Jan 2025Aug 2029

First Submitted

Initial submission to the registry

December 3, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 9, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

January 28, 2025

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2028

Expected
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2029

Last Updated

April 29, 2026

Status Verified

April 1, 2026

Enrollment Period

3.8 years

First QC Date

December 3, 2024

Last Update Submit

April 27, 2026

Conditions

Keywords

end of lifepalliative careeducationstaff trainingassisted livingdementiadementia careAlzheimer's

Outcome Measures

Primary Outcomes (1)

  • Documentation of Advance Care Planning (ACP) Discussions

    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).

    Baseline, 3, and 6 months

Secondary Outcomes (1)

  • Hospice Use

    Baseline, 3, and 6 months

Other Outcomes (4)

  • Palliative Care Staff Knowledge

    Baseline, 3, and 6 months

  • Staff Self-Efficacy

    Baseline, 3, and 6 months

  • Staff commitment

    Baseline, 3, and 6 months

  • +1 more other outcomes

Study Arms (2)

Intervention -

EXPERIMENTAL

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.

Behavioral: Palliative Care Training

Control

NO INTERVENTION

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

Interventions

Teaching about caring for individuals with

Intervention -

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of South Florida

Tampa, Florida, 33612, United States

RECRUITING

University of South Florida

Tampa, Florida, 33620, United States

RECRUITING

Related Publications (2)

  • 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.

    PMID: 36842068BACKGROUND
  • 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.

    PMID: 5881970BACKGROUND

MeSH Terms

Conditions

Alzheimer DiseaseDeathCaregiver BurdenPatient ParticipationDementia

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental DisordersPathologic ProcessesPathological Conditions, Signs and SymptomsStress, PsychologicalBehavioral SymptomsBehaviorPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth Behavior

Study Officials

  • Debra Dobbs, PhD

    University of South Florida

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Debra Dobbs, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Two research study nurses blinded to the intervention will be trained and a rating manual provided to assist in gaining a 90% IRR.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 3, 2024

First Posted

December 9, 2024

Study Start

January 28, 2025

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

August 1, 2029

Last Updated

April 29, 2026

Record last verified: 2026-04

Locations