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| ID | Type | Description | Link |
|---|---|---|---|
| P30AG064105 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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. |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elizabeth Luth, PhD | Rutgers University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VNS Health | New York | New York | 10017 | United States |
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301 individuals enrolled in the study. 294 participants enrolled via a waiver of consent to retrospectively analyze electronic records (primary outcome only). Of these, 111 were in intervention; 182 in control. 7 participants were palliative care team members who provided satisfaction data (secondary outcome only). Of these 7, 1 individual dropped out of the study after consent and prior to providing any data. Reported results are based on 300 participants for whom data were provided.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. Note: Post-intervention planned to be 6 months, in implementation was 5-months due to delayed initiation of intervention. |
| FG001 | 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. Note: Pre-intervention planned to be 6 months, in implementation was 5-months due to delayed initiation of intervention. |
| FG002 | Community Based Palliative Care Team Members | 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. Note: Post-intervention planned to be 6 months, in implementation was 5-months due to delayed initiation of intervention. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. Note: Post-intervention planned to be 6 months, in implementation was 5-months due to delayed initiation of intervention. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | All participants who were eligible for the VNS Health Total Medicare Advantage plan's community-based palliative care program in the 5 months pre-intervention or 5-months post-intervention. | Posted | Count of Participants | Participants | Baseline through 10 months. Pre (control group) test for 5 months prior to intervention. Post (intervention group) for 5 months during intervention. |
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Primary outcome: Electronic record data were retrospectively analyzed via waiver of consent for 294 individuals from 12/1/23-9/30/24. Although we initially planned for two 6-month periods, in implementation we conducted the intervention over two 5-month periods (5 months pre-intervention and 5 months post-intervention). Secondary outcome: We collected feasibility data from 7 palliative care team members from 2/14/24-9/30/24 who consented. Study start now reflects date of team member consent.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. Note: Post-intervention planned to be 6 months, in implementation was 5-months due to delayed initiation of intervention. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Elizabeth Luth, Principal Investigator | Rutgers University | 6465120670 | eluth@rwjms.rutgers.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 1, 2023 | Oct 2, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 19, 2023 | Oct 6, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| BG001 | 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. Note: Pre-intervention planned to be 6 months, in implementation was 5-months due to delayed initiation of intervention. |
| BG002 | Community Based Palliative Care Team Members | 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. Note: Post-intervention planned to be 6 months, in implementation was 5-months due to delayed initiation of intervention. |
| BG003 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Palliative care refusal rate | This measure was assessed for intervention and control group participants only. community palliative care team members did not complete it. | Count of Participants | Participants |
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| End-User Satisfaction Survey | End-User Satisfaction was assessed using The Measurement of End-User Computing Satisfaction 12-item survey (Doll & Torkzadeh (1988). This survey assesses satisfaction with an information system related to accuracy, format, ease of use, and timeliness. Each item is rated 1-5, with higher scores representing more positive ratings. Total minimum score=12 (lowest satisfaction), maximum score=60 (highest satisfaction). | This feasibility and acceptability measure was only assessed for community based palliative care team members. It was not assessed for intervention and control group participants. | Mean | Standard Deviation | units on a scale |
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| OG001 | 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. Note: Pre-intervention planned to be 6 months, in implementation was 5-months due to delayed initiation of intervention. |
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| Secondary | 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. | All CBPC Team Member participants who provided survey responses to the End-User Satisfaction survey at 2.5 and 5 months | Posted | Mean | Standard Deviation | score on a scale | Baseline, 2.5 and 5 months into intervention delivery. |
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| 0 |
| 111 |
| 0 |
| 111 |
| 0 |
| 111 |
| EG001 | 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. Note: Pre-intervention planned to be 6 months, in implementation was 5-months due to delayed initiation of intervention. | 0 | 182 | 0 | 182 | 0 | 182 |
| EG002 | Community Based Pallaitve Care Team Members | 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. Note: Post-intervention planned to be 6 months, in implementation was 5-months due to delayed initiation of intervention. | 0 | 7 | 0 | 7 | 0 | 7 |
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| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Did not contribute data |
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| Title | Measurements |
|---|---|
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