Trial Outcomes & Findings for Improving How Older Adults at Risk for Cardiovascular Outcomes Are Selected for Care Coordination (NCT NCT05820295)

NCT ID: NCT05820295

Last Updated: 2025-09-04

Results Overview

Occurrence of an emergency department visit or hospital admission, as measured in Medicare claims. This outcome measure allows more than one event per participant.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 400 participants
• Primary outcome timeframe: Over 12 months (beginning 1 month after the start of care coordination)
• Results posted on: 2025-09-04

Participant Flow

Participant milestones

Measure	Intervention The intervention group will assign care coordinators to individuals 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 patients in intervention group report on the survey that they experience difficulty coordinating care among their 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	202	198
Overall Study COMPLETED	202	198
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Improving How Older Adults at Risk for Cardiovascular Outcomes Are Selected for Care Coordination

Baseline characteristics by cohort

Measure	Intervention n=202 Participants The intervention group will assign care coordinators to individuals 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 patients in intervention group report on the survey that they experience difficulty coordinating care among their 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=198 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=400 Participants Total of all reporting groups
Age, Continuous	76.1 years STANDARD_DEVIATION 7.1 • n=5 Participants	75.8 years STANDARD_DEVIATION 7.0 • n=7 Participants	75.8 years STANDARD_DEVIATION 7.0 • n=5 Participants
Sex: Female, Male Female	141 Participants n=5 Participants	146 Participants n=7 Participants	287 Participants n=5 Participants
Sex: Female, Male Male	61 Participants n=5 Participants	52 Participants n=7 Participants	113 Participants n=5 Participants
Race/Ethnicity, Customized White	143 Participants n=5 Participants	141 Participants n=7 Participants	284 Participants n=5 Participants
Race/Ethnicity, Customized Non-white	59 Participants n=5 Participants	57 Participants n=7 Participants	116 Participants n=5 Participants
Enrollment type 65 years and older, and dually eligible for Medicaid	69 Participants n=5 Participants	67 Participants n=7 Participants	136 Participants n=5 Participants
Enrollment type 65 years and older, not dually eligible for Medicaid	132 Participants n=5 Participants	131 Participants n=7 Participants	263 Participants n=5 Participants
Enrollment type End-stage renal disease	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Enrollment type Disability	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Co-morbidities Acute myocardial infarction	0 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants
Co-morbidities Atrial fibrillation	19 Participants n=5 Participants	28 Participants n=7 Participants	47 Participants n=5 Participants
Co-morbidities Chronic kidney disease (not end-stage)	35 Participants n=5 Participants	34 Participants n=7 Participants	69 Participants n=5 Participants
Co-morbidities Chronic obstructive pulmonary disease and bronchiectasis	19 Participants n=5 Participants	37 Participants n=7 Participants	56 Participants n=5 Participants
Co-morbidities Colorectal cancer	9 Participants n=5 Participants	4 Participants n=7 Participants	13 Participants n=5 Participants
Co-morbidities Depression	43 Participants n=5 Participants	44 Participants n=7 Participants	87 Participants n=5 Participants
Co-morbidities Diabetes	64 Participants n=5 Participants	60 Participants n=7 Participants	124 Participants n=5 Participants
Co-morbidities Endometrial cancer	2 Participants n=5 Participants	6 Participants n=7 Participants	8 Participants n=5 Participants
Co-morbidities End-stage renal disease	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Co-morbidities Female or male breast cancer	25 Participants n=5 Participants	25 Participants n=7 Participants	50 Participants n=5 Participants
Co-morbidities Heart failure	29 Participants n=5 Participants	30 Participants n=7 Participants	59 Participants n=5 Participants
Co-morbidities Hyperlipidemia	162 Participants n=5 Participants	159 Participants n=7 Participants	321 Participants n=5 Participants
Co-morbidities Hypertension	154 Participants n=5 Participants	143 Participants n=7 Participants	297 Participants n=5 Participants
Co-morbidities Ischemic heart disease	71 Participants n=5 Participants	82 Participants n=7 Participants	153 Participants n=5 Participants
Co-morbidities Lung cancer	7 Participants n=5 Participants	4 Participants n=7 Participants	11 Participants n=5 Participants
Co-morbidities Prostate cancer	13 Participants n=5 Participants	13 Participants n=7 Participants	26 Participants n=5 Participants
Co-morbidities Stroke / transient ischemic attack	7 Participants n=5 Participants	9 Participants n=7 Participants	16 Participants n=5 Participants

PRIMARY outcome

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

Occurrence of an emergency department visit or hospital admission, as measured in Medicare claims. This outcome measure allows more than one event per participant.

Outcome measures

Measure	Intervention n=202 Participants The intervention group will assign care coordinators to individuals 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 patients in intervention group report on the survey that they experience difficulty coordinating care among their 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=198 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	0.25 events per 100 person-days alive Interval 0.21 to 0.31	0.21 events per 100 person-days alive Interval 0.17 to 0.27

SECONDARY outcome

Timeframe: Up to 1 year of follow-up

Number of people in each group who accept care management

Outcome measures

Measure	Intervention n=202 Participants The intervention group will assign care coordinators to individuals 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 patients in intervention group report on the survey that they experience difficulty coordinating care among their 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=198 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	13 Participants	17 Participants

SECONDARY outcome

Timeframe: Up to 1 year of follow-up

Population: This outcome is restricted to those who accepted care management.

Number of participants who requested care management services that were in scope for the care managers' credentials

Outcome measures

Measure	Intervention n=13 Participants The intervention group will assign care coordinators to individuals 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 patients in intervention group report on the survey that they experience difficulty coordinating care among their 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=17 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	13 Participants	17 Participants

SECONDARY outcome

Timeframe: Up to 1 year of follow-up

Population: This measure is restricted to those who requested care management services.

Number of participants who received care management services, among those who requested care management services.

Outcome measures

Measure	Intervention n=13 Participants The intervention group will assign care coordinators to individuals 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 patients in intervention group report on the survey that they experience difficulty coordinating care among their 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=17 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	13 Participants	17 Participants

SECONDARY outcome

Timeframe: Up to 1 year of follow-up

The total number of care management encounters per group. This measure allows more than one encounter per participant.

Outcome measures

Measure	Intervention n=202 Participants The intervention group will assign care coordinators to individuals 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 patients in intervention group report on the survey that they experience difficulty coordinating care among their 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=198 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	52 Encounters	45 Encounters

Adverse Events

Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 4 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Lisa 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