Trial Outcomes & Findings for Implementation of the Care Ecosystem Training Model for Individuals With Dementia in a High-risk, Integrated Care Management (NCT NCT04556097)
NCT ID: NCT04556097
Last Updated: 2025-08-05
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
524 participants
Primary outcome timeframe
6 months
Results posted on
2025-08-05
Participant Flow
This is a pragmatic trial where nurse managers at various primary care practices were randomized to the control group which had delayed training or the intervention group which was the early intervention training. The enrollment number in the protocol section conflicts with the number of participants started in the flow module as some patients without a designated caregiver, who were deceased or who had moved to a skilled nursing facility were excluded.
Participant milestones
| Measure |
Intervention- PWD
Patients of nurse care managers who received adapted Care Ecosystem training in December 2020 and January 2021.
|
Control- PWD
Patients of nurse care managers who did not receive adapted Care Ecosystem training in December 2020 and January 2021.
|
Intervention - NCM
Nurse care managers who received adapted Care Ecosystem training in December 2020 and January 2021. Their patients are persons with dementia and their primary caregiver under the care of these nurse care managers were defines as Medicare beneficiaries aligned to the Mass General Brigham Medicare ACO with an ICD-10 diagnosis code consistent with dementia in Medicare claims between August 1, 2019, and July 31, 2020.
|
Control- NCM
Nurse care managers who did not receive adapted Care Ecosystem training in December 2020 and January 2021. Their patients are persons with dementia and their primary caregiver under the care of these nurse care managers were defines as Medicare beneficiaries aligned to the Mass General Brigham Medicare ACO with an ICD-10 diagnosis code consistent with dementia in Medicare claims between August 1, 2019, and July 31, 2020.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
206
|
187
|
15
|
15
|
|
Overall Study
Mailed Caregiver Survey
|
143
|
113
|
0
|
0
|
|
Overall Study
Completed Baseline Survey
|
57
|
43
|
0
|
0
|
|
Overall Study
Completed 6-month Follow-up Survey
|
35
|
26
|
0
|
0
|
|
Overall Study
COMPLETED
|
126
|
105
|
14
|
15
|
|
Overall Study
NOT COMPLETED
|
80
|
82
|
1
|
0
|
Reasons for withdrawal
| Measure |
Intervention- PWD
Patients of nurse care managers who received adapted Care Ecosystem training in December 2020 and January 2021.
|
Control- PWD
Patients of nurse care managers who did not receive adapted Care Ecosystem training in December 2020 and January 2021.
|
Intervention - NCM
Nurse care managers who received adapted Care Ecosystem training in December 2020 and January 2021. Their patients are persons with dementia and their primary caregiver under the care of these nurse care managers were defines as Medicare beneficiaries aligned to the Mass General Brigham Medicare ACO with an ICD-10 diagnosis code consistent with dementia in Medicare claims between August 1, 2019, and July 31, 2020.
|
Control- NCM
Nurse care managers who did not receive adapted Care Ecosystem training in December 2020 and January 2021. Their patients are persons with dementia and their primary caregiver under the care of these nurse care managers were defines as Medicare beneficiaries aligned to the Mass General Brigham Medicare ACO with an ICD-10 diagnosis code consistent with dementia in Medicare claims between August 1, 2019, and July 31, 2020.
|
|---|---|---|---|---|
|
Overall Study
Death
|
0
|
5
|
0
|
0
|
|
Overall Study
No caregiver
|
43
|
53
|
0
|
0
|
|
Overall Study
Ineligible, SNF
|
2
|
2
|
0
|
0
|
|
Overall Study
Ineligible, health
|
3
|
4
|
0
|
0
|
|
Overall Study
Ineligible, language
|
0
|
1
|
0
|
0
|
|
Overall Study
Ineligible, no longer in care management
|
0
|
2
|
1
|
0
|
|
Overall Study
No dementia
|
13
|
3
|
0
|
0
|
|
Overall Study
Missing identifier
|
2
|
4
|
0
|
0
|
|
Overall Study
Did not have at least 1 member month in pre and post period
|
17
|
8
|
0
|
0
|
Baseline Characteristics
Age was not measured for nurse care managers in the intervention or control groups.
Baseline characteristics by cohort
| Measure |
Intervention- PWD
n=126 Participants
Persons with Dementia Intervention: Patients of nurse care managers who received adapted Care Ecosystem training in December 2020 and January 2021.
|
Control- PWD
n=105 Participants
Persons with Dementia Control: Patients of nurse care managers who did not receive adapted Care Ecosystem training in December 2020 and January 2021.
|
Intervention- NCM
n=14 Participants
Nurse Care Managers Intervention: Nurse care managers who received adapted Care Ecosystem training in December 2020 and January 2021. Their patients are persons with dementia and their primary caregiver under the care of these nurse care managers were defines as Medicare beneficiaries aligned to the Mass General Brigham Medicare ACO with an ICD-10 diagnosis code consistent with dementia in Medicare claims between August 1, 2019, and July 31, 2020.
|
Control- NCM
n=15 Participants
Nurse Care Managers Control: Nurse care managers who did not receive adapted Care Ecosystem training in December 2020 and January 2021. Their patients are persons with dementia and their primary caregiver under the care of these nurse care managers were defines as Medicare beneficiaries aligned to the Mass General Brigham Medicare ACO with an ICD-10 diagnosis code consistent with dementia in Medicare claims between August 1, 2019, and July 31, 2020.
|
Total
n=260 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=126 Participants
|
0 Participants
n=105 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=260 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=126 Participants
|
5 Participants
n=105 Participants
|
14 Participants
n=14 Participants
|
15 Participants
n=15 Participants
|
34 Participants
n=260 Participants
|
|
Age, Categorical
>=65 years
|
126 Participants
n=126 Participants
|
100 Participants
n=105 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=15 Participants
|
226 Participants
n=260 Participants
|
|
Age, Continuous
|
84.83 years
STANDARD_DEVIATION 8.17 • n=126 Participants • Age was not measured for nurse care managers in the intervention or control groups.
|
82.88 years
STANDARD_DEVIATION 9.37 • n=105 Participants • Age was not measured for nurse care managers in the intervention or control groups.
|
—
|
—
|
83.94 years
STANDARD_DEVIATION 8.77 • n=231 Participants • Age was not measured for nurse care managers in the intervention or control groups.
|
|
Sex: Female, Male
Female
|
82 Participants
n=126 Participants
|
68 Participants
n=105 Participants
|
12 Participants
n=14 Participants
|
13 Participants
n=15 Participants
|
175 Participants
n=260 Participants
|
|
Sex: Female, Male
Male
|
44 Participants
n=126 Participants
|
37 Participants
n=105 Participants
|
2 Participants
n=14 Participants
|
2 Participants
n=15 Participants
|
85 Participants
n=260 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
19 Participants
n=126 Participants
|
6 Participants
n=105 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=15 Participants
|
25 Participants
n=260 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
103 Participants
n=126 Participants
|
97 Participants
n=105 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=15 Participants
|
200 Participants
n=260 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=126 Participants
|
2 Participants
n=105 Participants
|
14 Participants
n=14 Participants
|
15 Participants
n=15 Participants
|
35 Participants
n=260 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=126 Participants
|
0 Participants
n=105 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=260 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=126 Participants
|
0 Participants
n=105 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=260 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=126 Participants
|
0 Participants
n=105 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=260 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=126 Participants
|
3 Participants
n=105 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=15 Participants
|
12 Participants
n=260 Participants
|
|
Race (NIH/OMB)
White
|
93 Participants
n=126 Participants
|
94 Participants
n=105 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=15 Participants
|
187 Participants
n=260 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=126 Participants
|
0 Participants
n=105 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=260 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
24 Participants
n=126 Participants
|
8 Participants
n=105 Participants
|
14 Participants
n=14 Participants
|
15 Participants
n=15 Participants
|
61 Participants
n=260 Participants
|
|
Region of Enrollment
United States
|
126 participants
n=126 Participants
|
105 participants
n=105 Participants
|
14 participants
n=14 Participants
|
15 participants
n=15 Participants
|
231 participants
n=260 Participants
|
|
ED Visits Per Member Per Month
|
0.060 Visits per member per month
STANDARD_DEVIATION 0.158 • n=126 Participants • Measure was not collected for nurse care managers as it only applies to PWD.
|
0.052 Visits per member per month
STANDARD_DEVIATION 0.080 • n=105 Participants • Measure was not collected for nurse care managers as it only applies to PWD.
|
—
|
—
|
0.057 Visits per member per month
STANDARD_DEVIATION 0.128 • n=231 Participants • Measure was not collected for nurse care managers as it only applies to PWD.
|
|
NPI-Q Distress Score
|
11.17 Score on a scale
STANDARD_DEVIATION 9.27 • n=35 Participants • The analysis population for the outcome of NPI-Q Distress among caregivers for persons with dementia was restricted only to those who completed the baseline and 6-month follow-up surveys (Intervention, N=35; Control, N=28). Measure was not collected for NCMs as it only applies to PWD.
|
9.29 Score on a scale
STANDARD_DEVIATION 6.41 • n=28 Participants • The analysis population for the outcome of NPI-Q Distress among caregivers for persons with dementia was restricted only to those who completed the baseline and 6-month follow-up surveys (Intervention, N=35; Control, N=28). Measure was not collected for NCMs as it only applies to PWD.
|
—
|
—
|
10.33 Score on a scale
STANDARD_DEVIATION 8.12 • n=63 Participants • The analysis population for the outcome of NPI-Q Distress among caregivers for persons with dementia was restricted only to those who completed the baseline and 6-month follow-up surveys (Intervention, N=35; Control, N=28). Measure was not collected for NCMs as it only applies to PWD.
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: The analysis population for the primary outcome of Emergency Department visits includes all patients eligible for the baseline survey who had at least 1 member month during pre-intervention and post-intervention.
Outcome measures
| Measure |
Intervention
n=126 Participants
Persons with dementia and their primary caregiver who were under the care of nurse care managers who received adapted Care Ecosystem training in December 2020 and January 2021. Persons with dementia were defined as Medicare beneficiaries aligned to the Mass General Brigham Medicare ACO with an ICD-10 diagnosis code consistent with dementia in Medicare claims between August 1, 2019 and July 31, 2020.
|
Control
n=105 Participants
Persons with dementia and their primary caregiver who were under the care of nurse care managers who did not receive adapted Care Ecosystem training in December 2020 and January 2021. Persons with dementia were defined as Medicare beneficiaries aligned to the Mass General Brigham Medicare ACO with an ICD-10 diagnosis code consistent with dementia in Medicare claims between August 1, 2019 and July 31, 2020.
|
|---|---|---|
|
ED Visits Per Member Per Month 6 Months Post Intervention
|
0.056 Visits per member per month
Standard Deviation 0.129
|
0.075 Visits per member per month
Standard Deviation 0.144
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: The analysis population for the outcome of NPI-Q Distress among caregivers for persons with dementia was restricted only to those who completed the baseline and 6-month follow-up surveys (Intervention, N=35; Control, N=28).
Mean Neuropsychiatric Inventory Questionnaire (NPI-Q) distress score at 6-month follow-up survey. The NPI-Q distress scale assesses caregiver distress. Scores can range from 0 to 60 and higher scores indicate greater distress.
Outcome measures
| Measure |
Intervention
n=35 Participants
Persons with dementia and their primary caregiver who were under the care of nurse care managers who received adapted Care Ecosystem training in December 2020 and January 2021. Persons with dementia were defined as Medicare beneficiaries aligned to the Mass General Brigham Medicare ACO with an ICD-10 diagnosis code consistent with dementia in Medicare claims between August 1, 2019 and July 31, 2020.
|
Control
n=28 Participants
Persons with dementia and their primary caregiver who were under the care of nurse care managers who did not receive adapted Care Ecosystem training in December 2020 and January 2021. Persons with dementia were defined as Medicare beneficiaries aligned to the Mass General Brigham Medicare ACO with an ICD-10 diagnosis code consistent with dementia in Medicare claims between August 1, 2019 and July 31, 2020.
|
|---|---|---|
|
Caregiver Distress (NPI-Q) 6 Months Post
|
10.86 Score on a scale
Standard Deviation 8.79
|
11.68 Score on a scale
Standard Deviation 8.60
|
Adverse Events
Intervention- PWD
Serious events: 0 serious events
Other events: 0 other events
Deaths: 21 deaths
Control-PWD
Serious events: 0 serious events
Other events: 0 other events
Deaths: 14 deaths
Intervention- NCM
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control- NCM
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place