Palliative Care for Persons With ADRD and CI in SNF

NCT05308004 | Completed Results DMC

• 3 other identifiers: HP-001003483K23NR017663-02S11K23NR017663-01A1
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

Alzheimer's disease and related dementias (ADRD) are serious, life limiting illnesses with no known cure. Dementia is the fifth-leading cause of death in older adults and the majority of people with advanced dementia die in nursing homes (NHs). Miller et al reported that 40% of U.S. NH residents dying with advanced dementia received Skilled Nursing Facility (SNF) care in the last 90 days of life, and receipt of this care was associated significantly with poorer end-of-life outcomes, including a higher risk of dying in a hospital, compared to decedents with no SNF care. SNF care is a Medicare post-acute rehabilitation service delivered in NHs focused on intense rehabilitation and/or aggressive, disease-modifying therapies. Regardless of life expectancy, use of SNF care precludes access to Hospice services. Palliative care (PC) offers an evidence-based alternative.

Conditions

Advance Care Planning; Palliative Care; Skilled Nursing Facility; Cognitive Impairment

Outcome Measures

Primary Outcomes (1)

• Number of Participants That Completed Patient Quality of Life Survey

  12-item survey that measures quality of life in five dimensions: 1) physical; 2) emotional; 3) psychological; 4) spiritual needs, and 5) provision of information and support. Items scored on a 5 point Likert Scale (0=not at all, 4= overwhelmingly) based on symptom/need in the past week. Overall profile score is calculated by summing responses (range 0-40). Source: patient or family caregiver; Time to complete: 5-7 minutes

  Collected upon admission to the nursing home (Baseline) and again 21 days post-admission to the nursing home (Follow up)

Secondary Outcomes (2)

• Number of Participants That Completed Satisfaction With Care Survey (SWC-EOLD)

  Collected upon admission to the nursing home and again 21 days post-admission to the nursing home

• Number of Participants That Completed the Symptom Management Survey (SM-EOLD)

  Collected upon admission to the nursing home and again 21 days post-admission to the nursing home

Study Arms (2)

Standard Care

NO INTERVENTION

Participants will receive the standard Medicare Skilled Nursing Facility care.

Palliative Care Consult

EXPERIMENTAL

Participants will receive the standard Medicare Skilled Nursing Facility care plus a Palliative Care Consultation with a trained provider.

Other: Palliative Care Consultation

Interventions

Palliative Care Consultation OTHER

Trained provider will discuss illness trajectories, establish and communicate patient-directed goals that guide health care decisions, identify and treat illness-related symptoms, and identify psycho-spiritual needs and approaches to mitigate suffering

Palliative Care Consult

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients:
• Admitted for SNF post-acute care at a participating NHs following a recent hospitalization
• Age ≥ 60 years old
• Speaks English (if verbal)
• If non-verbal/unable to participate in a conversation and/or unable to make decisions, a legally authorized representative (LAR)/surrogate decision maker who can make decisions for the patient as determined by ACTs staff
• Documented ADRD diagnosis in the medical record or history of cognitive impairment (defined as BIMS score ≤ 12)
• At least one global indicator for PC at SNF admission (provider would not be surprised if patient died within 1 year, believes the patient would benefit from advance care planning or symptom management; frequent hospital or NH SNF admissions; complex care requirements; decline in function; feeding intolerance; unintended decline in weight; or previous hospice assessment or enrollment and subsequent discharge)
• Surrogate/LAR:
• ≥18 years old
• Family member or friend of an eligible patient as determined by ACTs staff
• Speaks English

You may not qualify if:

• Patients:
• Who have previously received or are referred for PC by their primary care team
• With a discharge plan within 48 hours of screening
• Currently receiving hospice care
• Who do not have one global indicator of need
• No documented ADRD diagnosis or history of cognitive impairment in the medical record
• That are non-English speaking, (if verbal)
• If unable to make decisions, do not have an LAR/surrogate decision maker.
• Surrogate/LAR:
• \< 18 years of age
• Not a family Member or friend of an eligible patient
• Non-English speaking

Sponsors & Collaborators

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

Study Sites (1)

Acts Continuing Care Retirement Communities

Philadelphia, Pennsylvania, 19014, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Results Point of Contact

• Title: Dr. Joan Carpenter
• Organization: University of Maryland School of Nursing

joan.carpenter@umaryland.edu

443-880-1430

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Pre-post design where control data will be collected prior to intervention being implemented

Study Record Dates

• First Submitted: March 24, 2022
• First Posted: April 1, 2022
• Study Start: June 15, 2022
• Primary Completion: April 24, 2023
• Study Completion: December 14, 2023
• Last Updated: December 27, 2024
• Results First Posted: August 14, 2024

Record last verified: 2024-12

Locations

US (1)