Trial Outcomes & Findings for Care Ecosystem: Navigating Patients and Families Through Stages of Care (NCT NCT02213458)

Last Updated: 2024-02-20

Results Overview

An established 13-item measure, with a 1-4 ordinal scale for each item, to obtain a rating of the patient's quality of life from the caregiver. Item scores are summed for a total score ranging from 13-52, with higher scores representing better quality of life

Recruitment status

COMPLETED

Study phase

Target enrollment

1560 participants

Primary outcome timeframe

Baseline to one year

Results posted on

2024-02-20

Participant Flow

Participant milestones

Participant milestones
Measure	Navigated Care Comprehensive longitudinal continuing care program Navigated Care: Navigated Care emphasizes continuous and personalized care and is based on 3 modules: the Caregiver Module that includes educational interventions and connects families with community resources, the Decision-Making Module that facilitates proactive medical, financial, and safety decisions, and the Medication Module that identifies inappropriate medication usage via pharmacist review. Innovative technology in the form of a "dashboard" functions as a patient care management system used by Care Team Navigators (CTNs).	Survey of Care Control group that will undergo the same regular assessments as patients enrolled in Navigated Care
Overall Study STARTED	1024	536
Overall Study COMPLETED	970	526
Overall Study NOT COMPLETED	54	10

Reasons for withdrawal

Reasons for withdrawal
Measure	Navigated Care Comprehensive longitudinal continuing care program Navigated Care: Navigated Care emphasizes continuous and personalized care and is based on 3 modules: the Caregiver Module that includes educational interventions and connects families with community resources, the Decision-Making Module that facilitates proactive medical, financial, and safety decisions, and the Medication Module that identifies inappropriate medication usage via pharmacist review. Innovative technology in the form of a "dashboard" functions as a patient care management system used by Care Team Navigators (CTNs).	Survey of Care Control group that will undergo the same regular assessments as patients enrolled in Navigated Care
Overall Study No longer meets criteria: caregiver deceased	4	0
Overall Study No longer meets criteria: caregiver no longer caregiving	4	0
Overall Study No longer meets criteria: caregiver too sick to participate	2	0
Overall Study No longer meets criteria: patient moved out of state	10	0
Overall Study Refused re-consent	6	0
Overall Study Lost to Follow-up	2	2
Overall Study Withdrawal by Subject	26	8

Baseline Characteristics

Care Ecosystem: Navigating Patients and Families Through Stages of Care

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Navigated Care n=1024 Participants Comprehensive longitudinal continuing care program Navigated Care: Navigated Care emphasizes continuous and personalized care and is based on 3 modules: the Caregiver Module that includes educational interventions and connects families with community resources, the Decision-Making Module that facilitates proactive medical, financial, and safety decisions, and the Medication Module that identifies inappropriate medication usage via pharmacist review. Innovative technology in the form of a "dashboard" functions as a patient care management system used by Care Team Navigators (CTNs).	Survey of Care n=536 Participants Control group that will undergo the same regular assessments as patients enrolled in Navigated Care	Total n=1560 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	241 Participants n=5 Participants	157 Participants n=7 Participants	398 Participants n=5 Participants
Age, Categorical >=65 years	783 Participants n=5 Participants	379 Participants n=7 Participants	1162 Participants n=5 Participants
Age, Continuous	78.1 years STANDARD_DEVIATION 8.66 • n=5 Participants	78.1 years STANDARD_DEVIATION 12.0 • n=7 Participants	78.1 years STANDARD_DEVIATION 9.9 • n=5 Participants
Sex/Gender, Customized Female	656 Participants n=5 Participants	336 Participants n=7 Participants	992 Participants n=5 Participants
Sex/Gender, Customized Male	226 Participants n=5 Participants	200 Participants n=7 Participants	426 Participants n=5 Participants
Sex/Gender, Customized Other	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	107 Participants n=5 Participants	58 Participants n=7 Participants	165 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	911 Participants n=5 Participants	477 Participants n=7 Participants	1388 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	6 Participants n=5 Participants	1 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	73 Participants n=5 Participants	29 Participants n=7 Participants	102 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	5 Participants n=5 Participants	1 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) Black or African American	45 Participants n=5 Participants	19 Participants n=7 Participants	64 Participants n=5 Participants
Race (NIH/OMB) White	825 Participants n=5 Participants	447 Participants n=7 Participants	1272 Participants n=5 Participants
Race (NIH/OMB) More than one race	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	72 Participants n=5 Participants	37 Participants n=7 Participants	109 Participants n=5 Participants
Region of Enrollment United States	1024 participants n=5 Participants	536 participants n=7 Participants	1560 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to one year

Population: The subset of caregivers with completed QDRS and Quality of Life questionnaires at baseline and 12 months

Outcome measures

Outcome measures
Measure	Navigated Care n=504 Participants Comprehensive longitudinal continuing care program Navigated Care: Navigated Care emphasizes continuous and personalized care and is based on 3 modules: the Caregiver Module that includes educational interventions and connects families with community resources, the Decision-Making Module that facilitates proactive medical, financial, and safety decisions, and the Medication Module that identifies inappropriate medication usage via pharmacist review. Innovative technology in the form of a "dashboard" functions as a patient care management system used by Care Team Navigators (CTNs).	Survey of Care n=261 Participants Control group that will undergo the same regular assessments as patients enrolled in Navigated Care
Quality of Life-Alzheimer's Disease, Change From Baseline to 1 Year	-1.43 units on a scale Standard Deviation 5.64	-1.12 units on a scale Standard Deviation 5.87

SECONDARY outcome

Timeframe: Baseline to one year

Population: Subset of patients with complete data on QDRS and emergency department visits at baseline

Health care utilization based upon caregiver survey to assess emergency department, hospitalization, and ambulance use rates. To be confirmed using Medicare claims data.

Outcome measures

Outcome measures
Measure	Navigated Care n=503 Participants Comprehensive longitudinal continuing care program Navigated Care: Navigated Care emphasizes continuous and personalized care and is based on 3 modules: the Caregiver Module that includes educational interventions and connects families with community resources, the Decision-Making Module that facilitates proactive medical, financial, and safety decisions, and the Medication Module that identifies inappropriate medication usage via pharmacist review. Innovative technology in the form of a "dashboard" functions as a patient care management system used by Care Team Navigators (CTNs).	Survey of Care n=261 Participants Control group that will undergo the same regular assessments as patients enrolled in Navigated Care
Change in Caregiver Reported Rate of Emergency Department Utilization: Baseline to One Year	.0483 number of encounters Standard Deviation .703	.175 number of encounters Standard Deviation .840

SECONDARY outcome

Timeframe: Baseline to one year

Population: Subset of patients with complete data on QDRS and Zarit burden at baseline

Zarit Burden Interview (short version). An established 12-item measure, with a 0-4 ordinal scale for each item, to measure caregiver burden. Item scores are summed for a total score ranging from 0-48, with higher scores representing higher levels of burden.

Outcome measures

Outcome measures
Measure	Navigated Care n=503 Participants Comprehensive longitudinal continuing care program Navigated Care: Navigated Care emphasizes continuous and personalized care and is based on 3 modules: the Caregiver Module that includes educational interventions and connects families with community resources, the Decision-Making Module that facilitates proactive medical, financial, and safety decisions, and the Medication Module that identifies inappropriate medication usage via pharmacist review. Innovative technology in the form of a "dashboard" functions as a patient care management system used by Care Team Navigators (CTNs).	Survey of Care n=262 Participants Control group that will undergo the same regular assessments as patients enrolled in Navigated Care
Change in Caregiver Burden, Baseline to One Year	-1.682 score on a scale Standard Deviation 8.144	-1.482 score on a scale Standard Deviation 8.641

SECONDARY outcome

Timeframe: One year

Population: Navigated Care caregivers with completed caregiver satisfaction questionnaire at 12 months

A novel 1-item measure, with a 1-5 ordinal scale, to measure caregiver satisfaction with dementia care provided by the patient's clinical team. Also, one question asking caregivers whether they would recommend the Care Ecosystem to another caregiver. Collected in the treatment group only.

Outcome measures

Outcome measures
Measure	Navigated Care n=325 Participants Comprehensive longitudinal continuing care program Navigated Care: Navigated Care emphasizes continuous and personalized care and is based on 3 modules: the Caregiver Module that includes educational interventions and connects families with community resources, the Decision-Making Module that facilitates proactive medical, financial, and safety decisions, and the Medication Module that identifies inappropriate medication usage via pharmacist review. Innovative technology in the form of a "dashboard" functions as a patient care management system used by Care Team Navigators (CTNs).	Survey of Care Control group that will undergo the same regular assessments as patients enrolled in Navigated Care
Satisfaction With Dementia Care Satisfied with Care Ecosystem services	107 Participants	—
Satisfaction With Dementia Care Very satisfied with Care Ecosystem services	148 Participants	—
Satisfaction With Dementia Care Neutral toward Care Ecosystem services	57 Participants	—
Satisfaction With Dementia Care Unsatisfied with Care Ecosystem services	9 Participants	—
Satisfaction With Dementia Care Very unsatisfied with Care Ecosystem services	4 Participants	—

SECONDARY outcome

Timeframe: Baseline to one year

Patient Health Questionnaire 9 (PHQ-9). Higher scores represent more severe depression. Scores range from 0-27.

Outcome measures

Outcome measures
Measure	Navigated Care n=503 Participants Comprehensive longitudinal continuing care program Navigated Care: Navigated Care emphasizes continuous and personalized care and is based on 3 modules: the Caregiver Module that includes educational interventions and connects families with community resources, the Decision-Making Module that facilitates proactive medical, financial, and safety decisions, and the Medication Module that identifies inappropriate medication usage via pharmacist review. Innovative technology in the form of a "dashboard" functions as a patient care management system used by Care Team Navigators (CTNs).	Survey of Care n=262 Participants Control group that will undergo the same regular assessments as patients enrolled in Navigated Care
Change in Caregiver Depression, Baseline to One Year	-0.831 score on a scale Standard Deviation 4.312	-0.238 score on a scale Standard Deviation 4.053

SECONDARY outcome

Timeframe: Baseline to one year

Population: Dyads with baseline data on dementia severity (QDRS) and self-efficacy

A novel 4-item measure on a 1-5 ordinal scale to measure self-efficacy around dementia caregiving. Higher scores represent greater self-efficacy. Scores range from 5-15.

Outcome measures

Outcome measures
Measure	Navigated Care n=503 Participants Comprehensive longitudinal continuing care program Navigated Care: Navigated Care emphasizes continuous and personalized care and is based on 3 modules: the Caregiver Module that includes educational interventions and connects families with community resources, the Decision-Making Module that facilitates proactive medical, financial, and safety decisions, and the Medication Module that identifies inappropriate medication usage via pharmacist review. Innovative technology in the form of a "dashboard" functions as a patient care management system used by Care Team Navigators (CTNs).	Survey of Care n=262 Participants Control group that will undergo the same regular assessments as patients enrolled in Navigated Care
Change in Caregiver Self-efficacy, Baseline to One Year	1.356 units on a scale Standard Deviation 3.038	1.043 units on a scale Standard Deviation 2.647

Adverse Events

Navigated Care

Serious events: 269 serious events

Other events: 0 other events

Deaths: 74 deaths

Survey of Care

Serious events: 143 serious events

Other events: 0 other events

Deaths: 39 deaths

Serious adverse events

Serious adverse events
Measure	Navigated Care n=1024 participants at risk Comprehensive longitudinal continuing care program Navigated Care: Navigated Care emphasizes continuous and personalized care and is based on 3 modules: the Caregiver Module that includes educational interventions and connects families with community resources, the Decision-Making Module that facilitates proactive medical, financial, and safety decisions, and the Medication Module that identifies inappropriate medication usage via pharmacist review. Innovative technology in the form of a "dashboard" functions as a patient care management system used by Care Team Navigators (CTNs).	Survey of Care n=536 participants at risk Control group that will undergo the same regular assessments as patients enrolled in Navigated Care
General disorders Overnight hospitalization	21.3% 218/1024 • Number of events 433 • 1 year	21.6% 116/536 • Number of events 194 • 1 year
General disorders Severe fall	5.0% 51/1024 • Number of events 57 • 1 year	6.0% 32/536 • Number of events 34 • 1 year

Other adverse events

Adverse event data not reported

Additional Information

Dr. Katherine Possin

University of California, San Francisco

Phone: (415) 476-1889

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place