Translating Data Science to Palliative Care

Translating Data Science to Palliative Care Practice for Persons Living With Dementia

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).

Study Overview

• Status: Completed
• Conditions: Alzheimer's Disease and Related Dementias
• Intervention / Treatment: Other: Tailored Palliative Care Information

Detailed Description

Aim 1. Engage Family Care Partners (FCPs) and Community Based Palliative Care (CBPC) team members to identify barriers to CBPC. Aim 1 will incorporate the perspectives of CBPC team members and Medicare Advantage (MA) plan members and FCPs of person living with dementia (PLwD) and those with other diagnoses who refused CBPC services. Aim 2. Develop and obtain feedback on a) informational materials for CBPC team members to use when speaking with MA members and FCPs about CBPC and b) processes for tailoring information delivery based on a members's algorithm-identified risk profile. Most participants will be recruited from Aim 1 participants. Additional participants will be recruited as necessary. Aim 3. Conduct a pre-post trial to determine the feasibility and acceptability of the materials and using them in existing clinical workflows for their a) impact on CBPC enrollment for CBPC-eligible individuals, including PLwD, and b) end-user satisfaction.

• Study Type: Interventional
• Enrollment (Actual): 301
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10017
      • VNS Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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)
• 18 years of age or older

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group; 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; 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.
No Intervention: Control Group; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
CBPC Team Members Satisfaction	Investigators will assess intervention feasibility and acceptability using the end-user satisfaction survey. End-User Satisfaction ratings for each concept are scored as 1 (almost never); 2 (some of the time); 3 (about half the time); 4 (most of the time); 5 (almost always). Minimum score is 12; maximum 60, with higher scores indicating greater satisfaction.	Baseline, 2.5 and 5 months into intervention delivery.

Collaborators and Investigators

• Sponsor: Rutgers, The State University of New Jersey
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Elizabeth Luth, PhD, Rutgers University

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2024
• Primary Completion (Actual): September 30, 2024
• Study Completion (Actual): September 30, 2024

Study Registration Dates

• First Submitted: June 22, 2023
• First Submitted That Met QC Criteria: July 3, 2023
• First Posted (Actual): July 12, 2023

Study Record Updates

• Last Update Posted (Actual): November 18, 2025
• Last Update Submitted That Met QC Criteria: November 3, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Palliative care; Algorithm; Community based palliative care; Family care partner
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neurocognitive Disorders; Dementia; Tauopathies; Neurodegenerative Diseases; Alzheimer Disease
• Other Study ID Numbers: Pro2023000794; P30AG064105 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No