Alzheimer's Disease and Related Dementias
Conditions
Keywords
Palliative care, Community based palliative care, Family care partner, Algorithm
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.
Interventions
OTHERTailored 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.
Sponsors
National Institute on Aging (NIA)
Rutgers, The State University of New Jersey
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Palliative Care Refusal Rate | Baseline through 10 months. Pre (control group) test for 5 months prior to intervention. Post (intervention group) for 5 months during intervention. | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| CBPC Team Members Satisfaction | Baseline, 2.5 and 5 months into intervention delivery. | 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. |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 111 |
| 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. | 182 |
| 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. | 7 |
| Total | 300 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | No longer employed at study site. | 0 | 0 | 3 |
Baseline characteristics
| Characteristic | Intervention Group | Control Group | Community Based Palliative Care Team Members | Total |
|---|---|---|---|---|
| Age, Continuous | 84.7 years STANDARD_DEVIATION 10.7 | 86.5 years STANDARD_DEVIATION 11.1 | 50.1 years STANDARD_DEVIATION 12.6 | 84.0 years STANDARD_DEVIATION 11 |
| End-User Satisfaction Survey | — | — | 35.4 units on a scale STANDARD_DEVIATION 5.7 | 35.4 units on a scale STANDARD_DEVIATION 5.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 38 Participants | 79 Participants | 1 Participants | 118 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 0 Participants | 6 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 73 Participants | 103 Participants | 0 Participants | 176 Participants |
| Palliative care refusal rate Declined Palliative Care | 61 Participants | 113 Participants | — | 174 Participants |
| Palliative care refusal rate Did not contribute data | 0 Participants | 0 Participants | — | 0 Participants |
| Palliative care refusal rate Enrolled in Palliative Care | 50 Participants | 69 Participants | — | 119 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 4 Participants | 0 Participants | 5 Participants |
| Race (NIH/OMB) Asian | 14 Participants | 13 Participants | 0 Participants | 27 Participants |
| Race (NIH/OMB) Black or African American | 33 Participants | 58 Participants | 4 Participants | 95 Participants |
| Race (NIH/OMB) More than one race | 6 Participants | 8 Participants | 0 Participants | 14 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 21 Participants | 19 Participants | 1 Participants | 41 Participants |
| Race (NIH/OMB) White | 36 Participants | 80 Participants | 2 Participants | 118 Participants |
| Region of Enrollment United States | 111 Participants | 182 Participants | 7 Participants | 300 Participants |
| Sex: Female, Male Female | 89 Participants | 130 Participants | 7 Participants | 226 Participants |
| Sex: Female, Male Male | 22 Participants | 52 Participants | 0 Participants | 74 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 111 | 0 / 182 | 0 / 7 |
| other Total, other adverse events | 0 / 111 | 0 / 182 | 0 / 7 |
| serious Total, serious adverse events | 0 / 111 | 0 / 182 | 0 / 7 |
Outcome results
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
Time frame: Baseline through 10 months. Pre (control group) test for 5 months prior to intervention. Post (intervention group) for 5 months during intervention.
Population: 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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention Group | Palliative Care Refusal Rate | Enrolled in Palliative Care | 50 Participants |
| Intervention Group | Palliative Care Refusal Rate | Declined Palliative Care | 61 Participants |
| Control Group | Palliative Care Refusal Rate | Enrolled in Palliative Care | 69 Participants |
| Control Group | Palliative Care Refusal Rate | Declined Palliative Care | 113 Participants |
p-value: 0.1795% CI: [0.43, 1.16]Regression, Logistic
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.
Time frame: Baseline, 2.5 and 5 months into intervention delivery.
Population: All CBPC Team Member participants who provided survey responses to the End-User Satisfaction survey at 2.5 and 5 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Group | CBPC Team Members Satisfaction | Baseline | 35 score on a scale | Standard Deviation 5.7 |
| Intervention Group | CBPC Team Members Satisfaction | 2.5 months | 47.5 score on a scale | Standard Deviation 9.7 |
| Intervention Group | CBPC Team Members Satisfaction | 5 months | 52 score on a scale | Standard Deviation 11.8 |