Clinical trial NCT04520698: Utilizing Palliative Leaders In Facilities to Transform Care for Alzheimer's Disease
Official title: Utilizing Palliative Leaders In Facilities to Transform Care for Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Alzheimer Disease
Keywords: Alzheimer Disease
Palliative Care
Dementia
Nursing Home
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: University of Maryland, Baltimore
name: National Institute on Aging (NIA)
First posted: 2020-08-20
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: The study will use a stepped-wedge non-randomized trial design with 16 sites in two states (Indiana and Maryland). The study team will compare process and outcomes of the UPLIFT-AD intervention vs. usual care. The intervention will be implemented consecutively over 36 months, with staggered roll-out at 4 sites (2 per state) approximately every 6 months.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to evaluate a comprehensive model for integrating both primary and specialty Palliative Care for older adults with dementia into nursing facilities. Palliative Care is a supportive care approach that aims to improve the quality of life of patients and their families facing serious or life-threatening illnesses, through the prevention and relief of suffering through the treatment of pain and other problems, using physical, psychosocial and spiritual approaches. Palliative care is specialized medical care for people who are living with a serious illness. This type of care is focused on providing relief from the symptoms and from the stress of the illness. The goal is to improve quality of life for both patient and family.

The UPLIFT-AD model will include providing education on primary Palliative Care for residents with dementia to nursing facility staff, training nursing facility staff in providing primary Palliative Care, and providing access to specialty Palliative Care consultations for residents. To help understand the impact of these interventions, this study will also collect information about resident health, the care they receive, and perceptions of their quality of life according to both family members and nursing facility staff.

Detailed description: The objective of this proposal is to evaluate the effectiveness of the UPLIFT-AD (Utilizing Palliative Leaders In Facilities to Transform care for Alzheimer's Disease) intervention and to assess the implementation context of the intervention using a hybrid 1 trial design. The UPLIFT-AD intervention includes 1) in-house PC champions trained to facilitate goals of care conversations with residents with Alzheimer's Disease and Related Dementias (ADRD) and their surrogate decision-makers, screen residents for symptoms and other PC needs, provide symptom management and serve as a liaison to external PC consultants; 2) specialty PC consultants who provide consults for complex residents and families; and 3) primary PC education for nursing home (NH) staff. The study will use a randomized, stepped wedge design involving 16 diverse NHs in Indiana and Maryland and 640 residents, 640 family members and/or surrogate decision-makers, and 320 nursing facility staff.

Eligibility criteria: Inclusion Criteria:

-

NURSING HOME RESIDENTS:

* Long-stay resident in an enrolled nursing home defined as not paying through Medicare Part A at the enrolled facility.
* Has a diagnosis of moderate to severe ADRD, as measured on the Minimum Data Set (MDS)
* Length of stay \>30 days

FAMILY MEMBERS/SURROGATE DECISION MAKERS:

* Family member and/or surrogate decision maker for an eligible resident in an enrolled nursing home
* English-speaking

NURSING HOME STAFF:

* Staff, nurse, or nurse assistant in an enrolled nursing facility
* English-speaking

Exclusion Criteria:

-

NURSING HOME RESIDENTS:

• Short-stay resident, defined as paying through Medicare Part A at the enrolled facility and/or receiving respite care

FAMILY MEMBERS/SURROGATE DECISION MAKERS:

• Non-English-speaking

NURSING FACILITY STAFF:

• Non-English-speaking

Primary outcomes:
measure: Change in End-of-Life Dementia - Comfort Assessment In Dying scale (EOLD-CAD)
timeFrame: 1, 6, 12, and 18 months
Secondary outcomes:
measure: Change in End of Life Dementia - Satisfaction with Care (EOLD-SWC) scale
timeFrame: 6, 12, and 18 months
measure: Change in Single item quality-of-life (QOL) measure
timeFrame: 1, 6, 12, and 18 months
measure: Change in staff perceptions survey
timeFrame: 6, 12, and 18 months
measure: Change in Palliative Care outcomes
timeFrame: 1, 3, 6, 9, 12, 15, and 18 months
measure: Change in staff palliative care knowledge
timeFrame: 5 and 7 months
measure: Quality of Dying in Long Term Care (QOD-LTC)
timeFrame: 18 months
measure: Fidelity to intervention
timeFrame: 1, 6, 12, and 18 months
measure: Change in Family Distress in Advanced Dementia Scale.
timeFrame: 6, 12, and 18 months
measure: Change in End of Life Dementia - Symptom Management Scale.
timeFrame: 1, 6, 12, and 18 months
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: American Senior Communities
state: Indiana
Study officials:
affiliation: Indiana University
name: Kathleen T Unroe, MD, MHA
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Maryland, Baltimore
name: John Cagle, PhD, MSW
role: PRINCIPAL_INVESTIGATOR
References: