Clinical trial NCT05719077: Pilot Testing Dementia-Enhanced Training and Tool for Home Hospice Clinicians
Official title: Study 3. Pilot Testing Feasibility, Acceptability, and Preliminary Efficacy of a Dementia-Enhanced Training and Tool for Home Hospice Clinicians in a Clinical Setting.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Alzheimer's Disease and Related Dementias
Keywords: Dementia
End of life
Hospice
Caregiver Burden
Caregiving
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2023-02-08
Enrollment: 120
Sex: ALL
Minimum age (years): 19
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Nurses and social workers are organized into interdisciplinary teams (IDTs) based on geographic location. Patients and families in those geographic are assigned to clinicians' individual caseloads. The investigators will randomize up to 14 IDTs of 6-8 clinicians each to the intervention and control groups. Six teams will be randomized at the beginning of the study. The remaining 8 teams will be adaptively randomized as they enter the study to maintain balance between the number of Black and White family caregiver participants in each arm. Family caregivers will be assigned to the same group (intervention or control) as the clinician they are assigned to. IDT assignment to intervention and control groups will be balanced based on characteristics including patients' racial/ethnic group membership and neighborhood socioeconomic status.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to pilot test the feasibility, acceptability, and preliminary efficacy of a clinically useful, inclusive dementia-enhanced training and tool for use by home hospice clinicians to improve care and support for Black and White patients with dementia and their family caregivers. The investigators expect family caregivers of clinicians in the intervention group will report less caregiver burden (primary outcome) than caregivers of clinicians in the control group. The investigators expect that, compared to clinicians in the control group (usual care), clinicians in the intervention group (receive the training and use the tool) will demonstrate more knowledge of dementia-related caregiving issues (secondary outcomes). In exploratory analyses, the investigators expect family caregivers will report greater self-efficacy and preparedness, and that patients of clinicians in the intervention group will experience fewer live discharges than family caregivers of patients of clinicians in the control group.

Detailed description: For this aim, the investigators will conduct a randomized pilot study to determine the feasibility and acceptability of implementing the training and tool in clinical practice compared to usual care with 40 clinicians (20 intervention, 20 control) and 160 Black and white FCG (80 intervention, 80 control). The investigators will also determine preliminary efficacy of the training and tool. Outcomes include feasibility and acceptability of the intervention, reducing FCG burden (primary outcome), improving clinician knowledge and confidence (secondary outcomes) and increasing FCG preparedness and self-efficacy.

Eligibility criteria: Inclusion Criteria:

* Individuals are not excluded from this study based on gender.
* Based on proportion of hospice workforce and family caregivers that are female, we expect 70%-80% of participants will be female.
* Nurse, social worker, or family member who provides care to persons(s) living with dementia enrolled in home hospice care.
* 19-90 years old.
* Can complete data collection in English.
* Family Caregivers: identify as White or Black/African American.

Exclusion Criteria:

* Participant is less than 19 years old or older than 90 years old.
* Does not provide care to person(s) living with dementia enrolled in home hospice.
* Cannot complete data collection in English.
* Family Caregiver does not identify as White or Black/African American.

Primary outcomes:
measure: Family Caregiver Burden
timeFrame: Baseline and through intervention completion, an average of 8 weeks
Secondary outcomes:
measure: Clinician knowledge of dementia-related issues at end of life
timeFrame: Baseline and through training completion, an average of 4 weeks
Other outcomes:
measure: Family caregiver self-efficacy (exploratory)
timeFrame: Baseline and through intervetion completion, an average of 8 weeks
measure: Family caregiver preparedness (exploratory)
timeFrame: Baseline and through intervention completion, an average of 8 weeks
measure: Patient hospice discharge status (exploratory)
timeFrame: 3 months post-intervention, 6 months post-intervention
Locations:
city: New Brunswick
country: United States
facility: Rutgers Univeristy
state: New Jersey
Study officials:
affiliation: Rutgers University
name: Elizabeth Luth, PhD
role: PRINCIPAL_INVESTIGATOR
References: