Clinical trial NCT05942040: Translating Data Science to Palliative Care
Official title: Translating Data Science to Palliative Care Practice for Persons Living With Dementia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alzheimer's Disease and Related Dementias
Keywords: Palliative care
Community based palliative care
Family care partner
Algorithm
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2023-07-12
Enrollment: 293
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Palliative care refusal rate (# of eligible individuals refusing palliative care / total # of individuals eligible for palliative care)
timeFrame: Baseline through 12 months. Pre (control group) test for 6 months prior to intervention. Post (intervention group) for 6 months during intervention.
Secondary outcomes:
measure: CBPC team members Satisfaction
timeFrame: Baseline, 1 month, 3 months, and 6 months into intervention delivery.
Other outcomes:
Locations:
city: New York
country: United States
facility: VNS Health
state: New York
Study officials:
affiliation: Rutgers University
name: Elizabeth Luth, PhD
role: PRINCIPAL_INVESTIGATOR
References: