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Video-Enhanced Care Management for Medically Complex Veterans

Video-Enhanced Care Management for Medically Complex Veterans

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02962687
Enrollment
80
Registered
2016-11-11
Start date
2017-05-31
Completion date
2018-02-28
Last updated
2019-09-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cognitive Impairments, Multimorbidity

Keywords

Veterans, Cognitive impairments, Nursing care management, Videoconferencing

Brief summary

The purpose of this study is to examine the feasibility and acceptability of a 12-week care management program for medically complex Veterans with cognitive impairment, delivered via telephone or videoconferencing.

Detailed description

BACKGROUND Older adults with complex care needs constitute a large and rapidly expanding group of Veterans receiving care within Veterans Health Administration (VHA). Medically complex older Veterans, who often have multiple chronic conditions (MCC) as well as interacting functional and psychosocial challenges, account for a disproportionate amount of health care resources. Importantly, these Veterans also experience a disproportionate amount of suffering; they have worse functional status, higher symptom burden, and spend more of their time in acute care settings such as the hospital and emergency department. The investigators' experience and recent studies suggest that a substantial proportion of older medically complex Veterans have unrecognized cognitive impairment (CI), and this contributes to their disproportionate need for care and adverse outcomes. The Cumulative Complexity model posits that complexity results from accumulating and interacting clinical and social factors that each contribute to a patient's workload (e.g. making appointments and managing complicated medicine regimens) as well as impact a patient's capacity to perform everyday tasks including those related to health care. Imbalance between the two- i.e. workload that exceeds capacity-is a primary driver of disruptions in care and negative outcomes. Older patients with MCC, high health care utilization, and CI often find themselves in the perfect storm of complexity, simultaneously experiencing escalated workload demands in the setting of reduced capacity. OBJECTIVES The primary objectives of this pilot study are to: Examine the feasibility and acceptability of a 12-week care management program for medically complex Veterans with CI, delivered via telephone or through video visits. * Feasibility will be examined by calculating overall rates of eligibility and enrollment, as well as rates of attrition, adherence to nurse calls or video visits, and interview completion. * Acceptability will be assessed using in-depth interviews with study participants (Veterans and Care Partners), primary care providers, and study staff. Assess the usability and perceived value of video-enhanced care management, compared to telephone-based, among older Veterans with medical complexity and CI. * Usability of the video-enhanced program will be examined using the System Usability Scale (SUS). * Perceived value associated with each delivery method will be explored through questionnaires and in-depth interviews with study participants and study staff. METHODS Veterans aged 65 or older with high medical complexity based on Care Assessment Need (CAN) score will be screened for CI using a reliable and valid instrument developed for use over the telephone. Veterans with CI, and a self-identified Care Partner, will participate in a nurse-led care management program designed to provide structured cognitively-appropriate information and support in two key areas: (1) care coordination (reduce workload) and (2) protecting cognitive health (build capacity). Evidence-based strategies to improve care coordination and promote cognitive health are enhanced by video visits that allow for improved communication between the nurse and Veteran/Care Partner, and facilitate expanded assessments of the Veteran and his/her home environment. Study measures will include the SUS, participant feedback, and measures of intervention effectiveness including health and physical function (PROMIS 29), physical activity levels (PASE), depression (PHQ-9), anxiety (GAD-7), and acute care days (hospital and ER). ANTICIPATED IMPACT Results from this preliminary study will be used to inform the development of a randomized clinical trial to evaluate the impact of a 12-month video-enhanced care management program for medically complex older adults with CI. Given the large number of medically complex Veterans affected by unrecognized CI, it is essential that interventions targeting this population be scalable, and technology-enhanced interventions offer a way to expand the reach of new care models. Proactive recognition and management of medically complex patients is a high priority for VHA, and medically complex Veterans with CI constitute one such high risk group. The results of this study will be of high relevance to VHA, and outside VA, given the urgent need to develop innovative means of improving care for medically complex older adults.

Interventions

BEHAVIORALCare management via videoconference

12-week nurse care management for medically complex Veterans with CI delivered via videoconference

BEHAVIORALCare management via telephone calls

12-week nurse care management for medically complex Veterans with CI delivered via telephone calls

Sponsors

VA Office of Research and Development
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Receive primary care from a Durham Veterans Affairs Medical Center (VAMC) affiliated primary care clinic (1 visit within the previous 12 months) * Age \> or = 65 * CAN score \> or = 90 * Valid telephone number in the medical record * Identifies a friend or family member that we may contact for study participation as the Care Partner * Telephone Instrument for Cognitive Status - modified (TICS-m) score 20-31

Exclusion criteria

* Cognitive impairment or dementia (identified via ICD diagnosis codes or Primary Care Provider note in previous 2 years) * Enrolled in or have an active consult for a special population Patient Aligned Care Teams (PACT), e.g.: * GeriPACT * Home Based Primary Care * Mental Health * Post-Deployment, etc. * Serious mental illness defined as diagnosis of psychosis of any type: * schizophrenia * bipolar disorder * psychiatric hospitalization in the previous year * or current high-risk suicide flag in their Computerized Patient Record System (CPRS) medical record * Active substance abuse, documented in the medical record within the previous year * Eligible for hospice, palliative care, or prognosis of less than 6 months to live * Lacks decision-making capacity, documented in the medical record * Referred to institutional care or residing in nursing home * Unable to communicate on the telephone, or no telephone access for duration of study * Currently hospitalized or incapacitated * Enrolled in a study that prohibits participation in another study

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants Reporting That They Would Be Likely to See a Healthcare Provider Using Videochat14 weeksAcceptability will be assessed using the measure of likelihood of seeing a healthcare provider using videochat.
Number of Scheduled Intervention Phone or Video Calls Completed by Participants14 weeksFeasibility will be assessed by examining rates of adherence to intervention phone/video calls.
Usability of Video-Enhanced Care Management for Medically Complex Veterans With CI14 weeksUsability of the video-enhanced care management program will be examined using the System Usability Scale (SUS; range 0 - 100; higher scores are better).

Other

MeasureTime frameDescription
Depression14 weeksDescriptive analysis of depression as measured by Patient Health Questionnaire-Depression (PHQ-9; range 0 - 27; lower scores are better)
Number of Participants With Hospitalizations or Emergency Department Visits14 weeksDescriptive analysis of emergency department visits and hospitalizations in the two study arms
Anxiety14 weeksDescriptive analysis of anxiety as measured by the Generalized Anxiety Disorder Scale (GAD-7; range 0 - 21; lower scores are better)
Social Support14 weeksDescriptive analysis of social support as measured by modified Medical Outcomes Study Social Support Survey (mMOS-SS; range 0 - 100; higher scores are better)
Physical Activity14 weeksDescriptive analysis of physical activity as measured by the Physical Activity Scale for the Elderly (PASE; range 0 - 360; higher scores are better)
Quality of Life Outcome14 weeksDescriptive analysis of health-related quality of life as measured by 3 subscales of the Patient Reported Outcomes Measurement Information System (PROMIS-29; range 4 - 20 for each; lower scores are better)

Countries

United States

Participant flow

Participants by arm

ArmCount
Videoconference Care Management
12-week nurse care management for medically complex Veterans with CI delivered via videoconferencing Care management via videoconference: 12-week nurse care management for medically complex Veterans with CI delivered via videoconference
40
Telephone Care Management
12-week nurse care management for medically complex Veterans with CI delivered via telephone calls Care management via telephone calls: 12-week nurse care management for medically complex Veterans with CI delivered via telephone calls
40
Total80

Baseline characteristics

CharacteristicVideoconference Care ManagementTotalTelephone Care Management
Age, Continuous
Caregivers
60.6 years
STANDARD_DEVIATION 12
64.7 years
STANDARD_DEVIATION 10.8
68.9 years
STANDARD_DEVIATION 7.7
Age, Continuous
Veterans
70.2 years
STANDARD_DEVIATION 3.8
72.4 years
STANDARD_DEVIATION 6.1
74.6 years
STANDARD_DEVIATION 7.1
Comfortable with Using the Internet
Caregivers
16 Participants27 Participants11 Participants
Comfortable with Using the Internet
Veterans
7 Participants15 Participants8 Participants
Ethnicity (NIH/OMB)
Caregivers
Hispanic or Latino
0 Participants0 Participants0 Participants
Ethnicity (NIH/OMB)
Caregivers
Not Hispanic or Latino
20 Participants40 Participants20 Participants
Ethnicity (NIH/OMB)
Caregivers
Unknown or Not Reported
0 Participants0 Participants0 Participants
Ethnicity (NIH/OMB)
Veterans
Hispanic or Latino
0 Participants0 Participants0 Participants
Ethnicity (NIH/OMB)
Veterans
Not Hispanic or Latino
20 Participants40 Participants20 Participants
Ethnicity (NIH/OMB)
Veterans
Unknown or Not Reported
0 Participants0 Participants0 Participants
Has Accessed Internet with Tablet Computer
Caregivers
12 Participants16 Participants4 Participants
Has Accessed Internet with Tablet Computer
Veterans
4 Participants6 Participants2 Participants
Internet Use in Last Year
Caregivers
19 Participants32 Participants13 Participants
Internet Use in Last Year
Veterans
15 Participants28 Participants13 Participants
Likely to see healthcare provider using videochat
Caregivers
12 Participants26 Participants14 Participants
Likely to see healthcare provider using videochat
Veterans
11 Participants19 Participants8 Participants
Previously Used Videochat
Caregivers
13 Participants23 Participants10 Participants
Previously Used Videochat
Veterans
5 Participants11 Participants6 Participants
Race (NIH/OMB)
Caregivers
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Caregivers
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Caregivers
Black or African American
8 Participants11 Participants3 Participants
Race (NIH/OMB)
Caregivers
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Caregivers
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Caregivers
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Caregivers
White
12 Participants29 Participants17 Participants
Race (NIH/OMB)
Veterans
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Veterans
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Veterans
Black or African American
8 Participants15 Participants7 Participants
Race (NIH/OMB)
Veterans
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Veterans
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Veterans
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Veterans
White
12 Participants25 Participants13 Participants
Region of Enrollment
United States
40 Participants80 Participants40 Participants
Sex: Female, Male
Caregivers
Female
19 Participants38 Participants19 Participants
Sex: Female, Male
Caregivers
Male
1 Participants2 Participants1 Participants
Sex: Female, Male
Veterans
Female
0 Participants0 Participants0 Participants
Sex: Female, Male
Veterans
Male
20 Participants40 Participants20 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
deaths
Total, all-cause mortality
1 / 200 / 200 / 200 / 20
other
Total, other adverse events
4 / 203 / 200 / 200 / 20
serious
Total, serious adverse events
1 / 201 / 200 / 200 / 20

Outcome results

Primary

Number of Participants Reporting That They Would Be Likely to See a Healthcare Provider Using Videochat

Acceptability will be assessed using the measure of likelihood of seeing a healthcare provider using videochat.

Time frame: 14 weeks

Population: These numbers represent the Veterans in the sample (Care Partners not analyzed)

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Videoconference Care ManagementNumber of Participants Reporting That They Would Be Likely to See a Healthcare Provider Using Videochat6 Participants
Telephone Care ManagementNumber of Participants Reporting That They Would Be Likely to See a Healthcare Provider Using Videochat5 Participants
Primary

Number of Scheduled Intervention Phone or Video Calls Completed by Participants

Feasibility will be assessed by examining rates of adherence to intervention phone/video calls.

Time frame: 14 weeks

Population: These number represent the Veterans in the sample (Care Partners not analyzed)

ArmMeasureValue (COUNT_OF_UNITS)
Videoconference Care ManagementNumber of Scheduled Intervention Phone or Video Calls Completed by Participants46 calls
Telephone Care ManagementNumber of Scheduled Intervention Phone or Video Calls Completed by Participants53 calls
Primary

Usability of Video-Enhanced Care Management for Medically Complex Veterans With CI

Usability of the video-enhanced care management program will be examined using the System Usability Scale (SUS; range 0 - 100; higher scores are better).

Time frame: 14 weeks

Population: The System Usability Scale was administered only to the videoconference care management Veteran participants.

ArmMeasureValue (MEAN)Dispersion
Videoconference Care ManagementUsability of Video-Enhanced Care Management for Medically Complex Veterans With CI59.3 score on a scaleStandard Deviation 18.6
Other Pre-specified

Anxiety

Descriptive analysis of anxiety as measured by the Generalized Anxiety Disorder Scale (GAD-7; range 0 - 21; lower scores are better)

Time frame: 14 weeks

Population: The GAD-7 was administered to the Veteran participants only.

ArmMeasureValue (MEAN)Dispersion
Videoconference Care ManagementAnxiety4.2 score on a scaleStandard Deviation 3.5
Telephone Care ManagementAnxiety4.3 score on a scaleStandard Deviation 3.8
Other Pre-specified

Depression

Descriptive analysis of depression as measured by Patient Health Questionnaire-Depression (PHQ-9; range 0 - 27; lower scores are better)

Time frame: 14 weeks

Population: The PHQ-9 was administered to the Veteran participants only.

ArmMeasureValue (MEAN)Dispersion
Videoconference Care ManagementDepression6.4 score on a scaleStandard Deviation 5.8
Telephone Care ManagementDepression4.6 score on a scaleStandard Deviation 3.7
Other Pre-specified

Number of Participants With Hospitalizations or Emergency Department Visits

Descriptive analysis of emergency department visits and hospitalizations in the two study arms

Time frame: 14 weeks

Population: Utilization data was collected for Veteran participants only.

ArmMeasureGroupValue (NUMBER)
Videoconference Care ManagementNumber of Participants With Hospitalizations or Emergency Department VisitsHospitalizations2 participants
Videoconference Care ManagementNumber of Participants With Hospitalizations or Emergency Department VisitsED Visits4 participants
Telephone Care ManagementNumber of Participants With Hospitalizations or Emergency Department VisitsHospitalizations1 participants
Telephone Care ManagementNumber of Participants With Hospitalizations or Emergency Department VisitsED Visits1 participants
Other Pre-specified

Physical Activity

Descriptive analysis of physical activity as measured by the Physical Activity Scale for the Elderly (PASE; range 0 - 360; higher scores are better)

Time frame: 14 weeks

Population: The PASE was administered to the Veteran participants only.

ArmMeasureValue (MEAN)Dispersion
Videoconference Care ManagementPhysical Activity75.1 weighted sumStandard Deviation 65.1
Telephone Care ManagementPhysical Activity108.9 weighted sumStandard Deviation 73.8
Other Pre-specified

Quality of Life Outcome

Descriptive analysis of health-related quality of life as measured by 3 subscales of the Patient Reported Outcomes Measurement Information System (PROMIS-29; range 4 - 20 for each; lower scores are better)

Time frame: 14 weeks

Population: The PROMIS subscales were administered to the Veteran participants only.

ArmMeasureGroupValue (MEAN)Dispersion
Videoconference Care ManagementQuality of Life OutcomePROMIS-29 (Pain Interference)11.5 score on a scaleStandard Deviation 5.7
Videoconference Care ManagementQuality of Life OutcomePROMIS-29 (Physical Function)12.3 score on a scaleStandard Deviation 4.2
Videoconference Care ManagementQuality of Life OutcomePROMIS-29 (Social Roles)10.8 score on a scaleStandard Deviation 3.8
Telephone Care ManagementQuality of Life OutcomePROMIS-29 (Pain Interference)10.9 score on a scaleStandard Deviation 4.8
Telephone Care ManagementQuality of Life OutcomePROMIS-29 (Physical Function)11.4 score on a scaleStandard Deviation 5.5
Telephone Care ManagementQuality of Life OutcomePROMIS-29 (Social Roles)11.5 score on a scaleStandard Deviation 4.9
Other Pre-specified

Social Support

Descriptive analysis of social support as measured by modified Medical Outcomes Study Social Support Survey (mMOS-SS; range 0 - 100; higher scores are better)

Time frame: 14 weeks

Population: The mMOS-SS was administered to the Veteran participants only.

ArmMeasureValue (MEAN)Dispersion
Videoconference Care ManagementSocial Support70.2 score on a scaleStandard Deviation 26
Telephone Care ManagementSocial Support72.7 score on a scaleStandard Deviation 26

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026