Translating Data Science to Palliative Care

NCT05942040 | Completed Results

• 2 other identifiers: Pro2023000794P30AG064105
• Study Type: interventional
• Target: 301
• Locations: 1 country
• Sites: 1

Brief Summary

This research study is intended to 1) better understand seriously ill adults' and their family care partners' (FCP), particularly for persons living with dementia (PLwD), barriers to accepting community-based palliative care (CBPC); 2) develop an intervention to address barriers; and 3) pilot test whether the intervention has an impact on CBPC uptake. The intervention will consist of 1) a set of informational material describing the benefits of CBPC for the CBPC team to use when presenting CBPC to members of a Medicare Advantage plan and their FCP; and 2) processes for tailoring information delivery so that eligible members and their FCP receive information about CBPC that reflects their individualized risk as identified by the Medicare Advantage program's validated 12-month mortality risk algorithm. The clinical trial portion of the study refers to the pilot test (Aim 3 as described below).

Conditions

Alzheimer's Disease and Related Dementias

Keywords

Palliative care; Community based palliative care; Family care partner; Algorithm

Outcome Measures

Primary Outcomes (1)

• Palliative Care Refusal Rate

  The investigators will assess refusal rate using the MA plan's electronic health records. Refusal rate will be calculated as # of eligible individuals refusing palliative care / total # of individuals eligible for palliative care

  Baseline through 10 months. Pre (control group) test for 5 months prior to intervention. Post (intervention group) for 5 months during intervention.

Secondary Outcomes (1)

• CBPC Team Members Satisfaction

  Baseline, 2.5 and 5 months into intervention delivery.

Study Arms (2)

Intervention Group

EXPERIMENTAL

Intervention group will consist of all MA plan members eligible for community-based palliative care and of those who refused it (to calculate refusal rate) during the six month period following the introduction of tailored informational materials developed on CBPC

Other: Tailored Palliative Care Information

Control Group

NO INTERVENTION

Control group will be a retrospective review of individuals who were eligible for community-based palliative care and of those who refused it, for the 6-month period prior to introducing the tailored informational materials. All of these individuals will have received usual care/information regarding community-based palliative care.

Interventions

Tailored Palliative Care Information OTHER

This study test feasibility and acceptability of implementing tailored informational materials into clinician's discussions about CBPC with MA plan members who are eligible for the service.

Intervention Group

Eligibility Criteria

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

You may qualify if:

• VNS Health Total Medicare Advantage Plan member
• identified as eligible for community-based palliative care by the VNS Health Total palliative care team during the study period (6-month period prior to introduction of the intervention and the 6-month period following the intervention)
• years of age or older

You may not qualify if:

• non-VNS Health Total Medicare Advantage Plan member
• VNS Health Total plan members not identified as eligible for community-based palliative care by the palliative care team during the study period (6-month period prior to introduction of the intervention and the 6-month period following the intervention)
• under 18 years of age

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

VNS Health

New York, New York, 10017, United States

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Elizabeth Luth, Principal Investigator
• Organization: Rutgers University

eluth@rwjms.rutgers.edu

6465120670

Study Officials

• Elizabeth Luth, PhD

  Rutgers University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: June 22, 2023
• First Posted: July 12, 2023
• Study Start: February 15, 2024
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: November 18, 2025
• Results First Posted: November 18, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)