Utilizing Palliative Leaders In Facilities to Transform Care for Alzheimer's Disease

NCT04520698 | Completed

• 2 other identifiers: 2005967061R01AG066922
• Study Type: interventional
• Target: 1,322
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer Disease

Keywords

Alzheimer Disease; Palliative Care; Dementia; Nursing Home

Outcome Measures

Primary Outcomes (1)

• Change in End-of-Life Dementia - Comfort Assessment In Dying scale (EOLD-CAD)

  Nursing home staff and family members reported symptom frequency and intensity for 18 symptoms in the past 30 days. Symptom assessment was derived from the End-of-Life in Dementia Comfort Assessment in Dying (EOLD-CAD) and End-of-Life in Dementia Symptom Management (EOLD-SM) instruments. These symptoms included pain, discomfort, shortness of breath, choking, gurgling, difficulty swallowing, skin breakdown, restlessness, agitation, anxiety, depression, fear, crying, moaning, resistiveness to care, calm, serenity, peace. If the symptom did occur, respondents were asked if it had occurred once a month, 2-3 days a month, once a week, several days a week, or every day (ranging 0-5) and asked if the symptom was not at all intense, somewhat intense or very intense (ranging 1-3). Frequency and intensity were multiplied together for a score of 0-15 per symptom. A total score was derived by calculating the sum score and dividing by number of items. Higher scores indicate greater symptom burden.

  Baseline (prior to intervention) and12 months (post intervention implementation)

Secondary Outcomes (5)

• Change in End of Life Dementia - Satisfaction with Care (EOLD-SWC) scale

  Baseline (prior to intervention) and 12 months (post intervention implementation)

• Change in Quality-of-life (QOL)

  Baseline (prior to intervention) and 12 months (post intervention implementation)

• Change in staff palliative care knowledge

  Baseline and 6 months (post intervention implementation)

• Quality of Dying in Long-Term Care (QOD-LTC)

  Collected post-death

• Change in Family Distress in Advanced Dementia Scale (Modified)

  Baseline (prior to intervention) and 12 months (post intervention implementation)

Study Arms (2)

Nursing Home-level UPLIFT-AD intervention

EXPERIMENTAL

The UPLIFT-AD intervention consists of three major components delivered at the level of the nursing home: 1) in-house PC champions trained to a) facilitate advance care planning conversations with residents with Alzheimer's Disease and Related Dementias and their surrogate decision-makers, b) screen and follow up on residents' Palliative Care needs and c) serve as a liaison to Palliative Care consultants; 2) specialty Palliative Care consultant support providing individual consults for residents with complex Palliative Care needs; and 3) education on primary Palliative Care offered to all clinical NH staff.

Behavioral: UPLIFT-AD

Usual Care

NO INTERVENTION

Usual nursing home care.

Interventions

UPLIFT-AD BEHAVIORAL

Access to palliative care needs screening, advance care planning conversations, palliative care consultations

Nursing Home-level UPLIFT-AD intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Indiana University: lead
• University of Maryland, Baltimore: collaborator
• National Institute on Aging (NIA): collaborator

Study Sites (1)

American Senior Communities

Indianapolis, Indiana, 46201, United States

Location

Related Publications (3)

• Unroe KT, Ersek M, Stump TE, Floyd A, Nesvet M, Block LVD, Tu W, Cagle JG. Discordance in Ratings of Symptoms Experienced by Nursing Home Residents With Cognitive Impairment. J Pain Symptom Manage. 2025 Nov 28:S0885-3924(25)00976-5. doi: 10.1016/j.jpainsymman.2025.11.022. Online ahead of print.

  PMID: 41319818 DERIVED

• Cagle JG, Stump TE, Tu W, Ersek M, Floyd A, Van den Block L, Zhang P, Becker TD, Unroe KT. A Psychometric Evaluation of the Staff-Reported EOLD-CAD Measure Among Nursing Home Residents With Cognitive Impairment. Int J Geriatr Psychiatry. 2025 Jan;40(1):e70037. doi: 10.1002/gps.70037.

  PMID: 39743326 DERIVED

• Unroe KT, Ersek M, Tu W, Floyd A, Becker T, Trimmer J, Lamie J, Cagle J. Using Palliative Leaders in Facilities to Transform Care for People with Alzheimer's Disease (UPLIFT-AD): protocol of a palliative care clinical trial in nursing homes. BMC Palliat Care. 2023 Jul 26;22(1):105. doi: 10.1186/s12904-023-01226-0.

  PMID: 37496001 DERIVED

MeSH Terms

Conditions

Alzheimer Disease; Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Kathleen T Unroe, MD, MHA

  Indiana University

  PRINCIPAL INVESTIGATOR

• John Cagle, PhD, MSW

  University of Maryland, Baltimore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Model Details: 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.

Study Record Dates

• First Submitted: August 17, 2020
• First Posted: August 20, 2020
• Study Start: September 8, 2021
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: October 23, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR, ANALYTIC CODE
• Time Frame: The final de-identified dataset will be available to qualified investigators who meet the above criteria upon the on-line publication date of the final results of the trial.
• Access Criteria: Individuals requesting access to the data must provide the following: (1) Executed DUAs with all NH partners; (2) documentation of Institutional Review Board approval; (3) a written commitment that the data will be used only for scholarly research purposes; (4) a written commitment that the user will not attempt to identify any individual patient or NH; (5) confirmation that the data will be secured using appropriate computer technology; and (6) a written commitment that data will be destroyed or returned after analyses are completed.

Locations

US (1)