跳至主要内容
临床试验/NCT06722352
NCT06722352招募中不适用

Preparing Assisted Living Staff to Provider Palliative Care to Residents With Dementia: Palliative Care Education in Assisted Living for Dementia Care Providers (PCEAL-DCP)

University of South Florida2 个研究点 分布在 1 个国家目标入组 792 人开始时间: 2025年1月28日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
792
试验地点
2
主要终点
Documentation of Advance Care Planning (ACP) Discussions

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

盲法说明

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

入排标准

年龄范围
21 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •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.

排除标准

  • •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).

研究组 & 干预措施

Control

No Intervention

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

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.

干预措施: Palliative Care Training (Behavioral)

结局指标

主要结局

Documentation of Advance Care Planning (ACP) Discussions

时间窗: 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).

次要结局

  • Hospice Use(Baseline, 3, and 6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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