Trial Outcomes & Findings for Improving How People Living With Dementia Are Selected for Care Coordination (NCT NCT05651308)

NCT ID: NCT05651308

Last Updated: 2025-03-13

Results Overview

Occurrence of an emergency department visit or hospital admission, as measured in Medicare claims

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 385 participants
• Primary outcome timeframe: Over 12 months (beginning 1 month after the start of care coordination)
• Results posted on: 2025-03-13

Participant Flow

Participant milestones

Measure	Intervention The intervention group will assign care coordinators to PLWD based on perceived need for assistance with care coordination. Perceived need will be measured through a proxy's responses to a previously validated telephone survey on perceptions of care coordination. Care coordination delivered based on perceived need: If proxies for patients in intervention group report on the survey that they experience difficulty coordinating care among the patients' providers, the patient will be selected for care management services. Those services will attempt to address the problems with care coordination that the proxy reported.	Control Usual care assigns patients to care coordinators in response to a discharge from a hospital or a direct referral from a physician. Care coordination delivered based on usual care (e.g. discharge from hospital): If a patient is discharged from a hospital, the patient will be selected for care management services.
Overall Study STARTED	193	192
Overall Study COMPLETED	193	192
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Improving How People Living With Dementia Are Selected for Care Coordination

Baseline characteristics by cohort

Measure	Intervention n=193 Participants The intervention group will assign care coordinators to PLWD based on perceived need for assistance with care coordination. Perceived need will be measured through a proxy's responses to a previously validated telephone survey on perceptions of care coordination. Care coordination delivered based on perceived need: If proxies for patients in intervention group report on the survey that they experience difficulty coordinating care among the patients' providers, the patient will be selected for care management services. Those services will attempt to address the problems with care coordination that the proxy reported.	Control n=192 Participants Usual care assigns patients to care coordinators in response to a discharge from a hospital or a direct referral from a physician. Care coordination delivered based on usual care (e.g. discharge from hospital): If a patient is discharged from a hospital, the patient will be selected for care management services.	Total n=385 Participants Total of all reporting groups
Age, Continuous	82.8 years STANDARD_DEVIATION 6.9 • n=5 Participants	82.3 years STANDARD_DEVIATION 7.0 • n=7 Participants	82.6 years STANDARD_DEVIATION 6.9 • n=5 Participants
Sex: Female, Male Female	109 Participants n=5 Participants	108 Participants n=7 Participants	217 Participants n=5 Participants
Sex: Female, Male Male	84 Participants n=5 Participants	84 Participants n=7 Participants	168 Participants n=5 Participants
Race/Ethnicity, Customized White	154 Participants n=5 Participants	153 Participants n=7 Participants	307 Participants n=5 Participants
Race/Ethnicity, Customized Non-White	39 Participants n=5 Participants	39 Participants n=7 Participants	78 Participants n=5 Participants
Medicare enrollment type Aged duals	48 Participants n=5 Participants	33 Participants n=7 Participants	81 Participants n=5 Participants
Medicare enrollment type Aged non-duals	141 Participants n=5 Participants	158 Participants n=7 Participants	299 Participants n=5 Participants
Medicare enrollment type End-stage renal disease	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants
Medicare enrollment type Disabled	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Co-morbidities Acute myocardial infarction	10 Participants n=5 Participants	7 Participants n=7 Participants	17 Participants n=5 Participants
Co-morbidities Atrial fibrillation	32 Participants n=5 Participants	18 Participants n=7 Participants	50 Participants n=5 Participants
Co-morbidities Chronic kidney disease (any stage other than ESRD)	50 Participants n=5 Participants	51 Participants n=7 Participants	101 Participants n=5 Participants
Co-morbidities Chronic obstructive pulmonary disease or bronchiectasis	28 Participants n=5 Participants	28 Participants n=7 Participants	56 Participants n=5 Participants
Co-morbidities Colorectal cancer	15 Participants n=5 Participants	6 Participants n=7 Participants	21 Participants n=5 Participants
Co-morbidities Depression	65 Participants n=5 Participants	57 Participants n=7 Participants	122 Participants n=5 Participants
Co-morbidities Diabetes	39 Participants n=5 Participants	38 Participants n=7 Participants	77 Participants n=5 Participants
Co-morbidities Endometrial cancer	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Co-morbidities End-stage renal disease (ESRD)	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Co-morbidities Female or male breast cancer	18 Participants n=5 Participants	15 Participants n=7 Participants	33 Participants n=5 Participants
Co-morbidities Heart failure	63 Participants n=5 Participants	51 Participants n=7 Participants	114 Participants n=5 Participants
Co-morbidities Hyperlipidemia	123 Participants n=5 Participants	123 Participants n=7 Participants	246 Participants n=5 Participants
Co-morbidities Hypertension	130 Participants n=5 Participants	122 Participants n=7 Participants	252 Participants n=5 Participants
Co-morbidities Ischemic heart disease	86 Participants n=5 Participants	81 Participants n=7 Participants	167 Participants n=5 Participants
Co-morbidities Lung cancer	6 Participants n=5 Participants	2 Participants n=7 Participants	8 Participants n=5 Participants
Co-morbidities Prostate cancer	13 Participants n=5 Participants	17 Participants n=7 Participants	30 Participants n=5 Participants
Co-morbidities Stroke / transient ischemic attack	10 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants

PRIMARY outcome

Timeframe: Over 12 months (beginning 1 month after the start of care coordination)

Population: Intention-to-treat analysis

Occurrence of an emergency department visit or hospital admission, as measured in Medicare claims

Outcome measures

Measure	Intervention n=193 Participants The intervention group will assign care coordinators to PLWD based on perceived need for assistance with care coordination. Perceived need will be measured through a proxy's responses to a previously validated telephone survey on perceptions of care coordination. Care coordination delivered based on perceived need: If proxies for patients in intervention group report on the survey that they experience difficulty coordinating care among the patients' providers, the patient will be selected for care management services. Those services will attempt to address the problems with care coordination that the proxy reported.	Control n=192 Participants Usual care assigns patients to care coordinators in response to a discharge from a hospital or a direct referral from a physician. Care coordination delivered based on usual care (e.g. discharge from hospital): If a patient is discharged from a hospital, the patient will be selected for care management services.
Number of Emergency Department Visits or Hospital Admissions	0.33 events per 100 person-days alive Interval 0.28 to 0.39	0.35 events per 100 person-days alive Interval 0.3 to 0.41

SECONDARY outcome

Timeframe: Up to 1 year

The number of people who accepted care management in each group

Outcome measures

Measure	Intervention n=193 Participants The intervention group will assign care coordinators to PLWD based on perceived need for assistance with care coordination. Perceived need will be measured through a proxy's responses to a previously validated telephone survey on perceptions of care coordination. Care coordination delivered based on perceived need: If proxies for patients in intervention group report on the survey that they experience difficulty coordinating care among the patients' providers, the patient will be selected for care management services. Those services will attempt to address the problems with care coordination that the proxy reported.	Control n=192 Participants Usual care assigns patients to care coordinators in response to a discharge from a hospital or a direct referral from a physician. Care coordination delivered based on usual care (e.g. discharge from hospital): If a patient is discharged from a hospital, the patient will be selected for care management services.
Acceptability	19 Participants	14 Participants

SECONDARY outcome

Timeframe: Up to 1 year

Population: The only participants who were analyzed in this measure were those who received care management services (as shown in Secondary Outcome #1).

The number of people with problems in scope for care coordinators, out of all people who received care management

Outcome measures

Measure	Intervention n=19 Participants The intervention group will assign care coordinators to PLWD based on perceived need for assistance with care coordination. Perceived need will be measured through a proxy's responses to a previously validated telephone survey on perceptions of care coordination. Care coordination delivered based on perceived need: If proxies for patients in intervention group report on the survey that they experience difficulty coordinating care among the patients' providers, the patient will be selected for care management services. Those services will attempt to address the problems with care coordination that the proxy reported.	Control n=14 Participants Usual care assigns patients to care coordinators in response to a discharge from a hospital or a direct referral from a physician. Care coordination delivered based on usual care (e.g. discharge from hospital): If a patient is discharged from a hospital, the patient will be selected for care management services.
Appropriateness	19 Participants	14 Participants

SECONDARY outcome

Timeframe: Up to 1 year

Population: The only people analyzed for this measure were people who agreed to receive care management (as shown in Secondary Outcome #1).

The number of people who actually received care coordination services, out of all of those who agreed to receive it

Outcome measures

Measure	Intervention n=19 Participants The intervention group will assign care coordinators to PLWD based on perceived need for assistance with care coordination. Perceived need will be measured through a proxy's responses to a previously validated telephone survey on perceptions of care coordination. Care coordination delivered based on perceived need: If proxies for patients in intervention group report on the survey that they experience difficulty coordinating care among the patients' providers, the patient will be selected for care management services. Those services will attempt to address the problems with care coordination that the proxy reported.	Control n=14 Participants Usual care assigns patients to care coordinators in response to a discharge from a hospital or a direct referral from a physician. Care coordination delivered based on usual care (e.g. discharge from hospital): If a patient is discharged from a hospital, the patient will be selected for care management services.
Fidelity	19 Participants	14 Participants

SECONDARY outcome

Timeframe: Up to 1 year

The number of care coordinator encounters in each group. This measure allows more than one encounter per person.

Outcome measures

Measure	Intervention n=193 Participants The intervention group will assign care coordinators to PLWD based on perceived need for assistance with care coordination. Perceived need will be measured through a proxy's responses to a previously validated telephone survey on perceptions of care coordination. Care coordination delivered based on perceived need: If proxies for patients in intervention group report on the survey that they experience difficulty coordinating care among the patients' providers, the patient will be selected for care management services. Those services will attempt to address the problems with care coordination that the proxy reported.	Control n=192 Participants Usual care assigns patients to care coordinators in response to a discharge from a hospital or a direct referral from a physician. Care coordination delivered based on usual care (e.g. discharge from hospital): If a patient is discharged from a hospital, the patient will be selected for care management services.
Efficiency	77 Encounters	54 Encounters

Adverse Events

Intervention

Serious events: 52 serious events

Other events: 47 other events

Deaths: 32 deaths

Control

Serious events: 45 serious events

Other events: 57 other events

Deaths: 37 deaths

Serious adverse events

Measure	Intervention n=193 participants at risk The intervention group will assign care coordinators to PLWD based on perceived need for assistance with care coordination. Perceived need will be measured through a proxy's responses to a previously validated telephone survey on perceptions of care coordination. Care coordination delivered based on perceived need: If proxies for patients in intervention group report on the survey that they experience difficulty coordinating care among the patients' providers, the patient will be selected for care management services. Those services will attempt to address the problems with care coordination that the proxy reported.	Control n=192 participants at risk Usual care assigns patients to care coordinators in response to a discharge from a hospital or a direct referral from a physician. Care coordination delivered based on usual care (e.g. discharge from hospital): If a patient is discharged from a hospital, the patient will be selected for care management services.
General disorders All-cause hospitalization	26.9% 52/193 • Number of events 90 • Up to 1 year	23.4% 45/192 • Number of events 74 • Up to 1 year

Other adverse events

Measure	Intervention n=193 participants at risk The intervention group will assign care coordinators to PLWD based on perceived need for assistance with care coordination. Perceived need will be measured through a proxy's responses to a previously validated telephone survey on perceptions of care coordination. Care coordination delivered based on perceived need: If proxies for patients in intervention group report on the survey that they experience difficulty coordinating care among the patients' providers, the patient will be selected for care management services. Those services will attempt to address the problems with care coordination that the proxy reported.	Control n=192 participants at risk Usual care assigns patients to care coordinators in response to a discharge from a hospital or a direct referral from a physician. Care coordination delivered based on usual care (e.g. discharge from hospital): If a patient is discharged from a hospital, the patient will be selected for care management services.
General disorders Emergency department visit	24.4% 47/193 • Number of events 63 • Up to 1 year	29.7% 57/192 • Number of events 84 • Up to 1 year

Additional Information

Lisa M. Kern, MD, MPH

Weill Cornell Medicine

Phone: 646-962-5889

Email: lmk2003@med.cornell.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place