Trial Outcomes & Findings for Video-Enhanced Care Management for Medically Complex Veterans (NCT NCT02962687)

NCT ID: NCT02962687

Last Updated: 2019-09-13

Results Overview

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

Recruitment status

COMPLETED

Study phase

Target enrollment

80 participants

Primary outcome timeframe

14 weeks

Results posted on

2019-09-13

Participant Flow

Participant milestones

Participant milestones
Measure	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 cognitive impairment delivered via videoconference	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 cognitive impairment delivered via telephone calls
Overall Study STARTED	40	40
Overall Study COMPLETED	30	32
Overall Study NOT COMPLETED	10	8

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The overall number of baseline participants differs from the number of analyzed participants because this study involved dyads (couples/pairs). Number analyzed in video intervention group=20 dyads (20 Veterans + 20 caregivers = 40 participants). Phone intervention group=20 dyads(20 Veterans + 20 caregivers = 40 participants).

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: 14 weeks

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

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

Outcome measures

Outcome measures
Measure	Videoconference Care Management n=15 Participants 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	Telephone Care Management n=16 Participants 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
Number of Participants Reporting That They Would Be Likely to See a Healthcare Provider Using Videochat	6 Participants	5 Participants

PRIMARY outcome

Timeframe: 14 weeks

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

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

Outcome measures

Outcome measures
Measure	Videoconference Care Management n=60 calls 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	Telephone Care Management n=60 calls 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
Number of Scheduled Intervention Phone or Video Calls Completed by Participants	46 calls	53 calls

PRIMARY outcome

Timeframe: 14 weeks

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

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

Outcome measures

Outcome measures
Measure	Videoconference Care Management n=15 Participants 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	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
Usability of Video-Enhanced Care Management for Medically Complex Veterans With CI	59.3 score on a scale Standard Deviation 18.6	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 14 weeks

Population: Utilization data was collected for Veteran participants only.

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

Outcome measures

Outcome measures
Measure	Videoconference Care Management n=20 Participants 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	Telephone Care Management n=20 Participants 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
Number of Participants With Hospitalizations or Emergency Department Visits Hospitalizations	2 participants	1 participants
Number of Participants With Hospitalizations or Emergency Department Visits ED Visits	4 participants	1 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 14 weeks

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

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

Outcome measures

Outcome measures
Measure	Videoconference Care Management n=15 Participants 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	Telephone Care Management n=15 Participants 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
Physical Activity	75.1 weighted sum Standard Deviation 65.1	108.9 weighted sum Standard Deviation 73.8

OTHER_PRE_SPECIFIED outcome

Timeframe: 14 weeks

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

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)

Outcome measures

Outcome measures
Measure	Videoconference Care Management n=15 Participants 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	Telephone Care Management n=15 Participants 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
Quality of Life Outcome PROMIS-29 (Pain Interference)	11.5 score on a scale Standard Deviation 5.7	10.9 score on a scale Standard Deviation 4.8
Quality of Life Outcome PROMIS-29 (Physical Function)	12.3 score on a scale Standard Deviation 4.2	11.4 score on a scale Standard Deviation 5.5
Quality of Life Outcome PROMIS-29 (Social Roles)	10.8 score on a scale Standard Deviation 3.8	11.5 score on a scale Standard Deviation 4.9

OTHER_PRE_SPECIFIED outcome

Timeframe: 14 weeks

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

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

Outcome measures

Outcome measures
Measure	Videoconference Care Management n=15 Participants 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	Telephone Care Management n=16 Participants 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
Depression	6.4 score on a scale Standard Deviation 5.8	4.6 score on a scale Standard Deviation 3.7

OTHER_PRE_SPECIFIED outcome

Timeframe: 14 weeks

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

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

Outcome measures

Outcome measures
Measure	Videoconference Care Management n=15 Participants 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	Telephone Care Management n=15 Participants 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
Social Support	70.2 score on a scale Standard Deviation 26.0	72.7 score on a scale Standard Deviation 26.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 14 weeks

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

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

Outcome measures

Outcome measures
Measure	Videoconference Care Management n=15 Participants 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	Telephone Care Management n=16 Participants 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
Anxiety	4.2 score on a scale Standard Deviation 3.5	4.3 score on a scale Standard Deviation 3.8

Adverse Events

Videoconference Care Management - Veterans

Serious events: 1 serious events

Other events: 4 other events

Deaths: 1 deaths

Telephone Care Management - Veterans

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Videoconference Care Management - Care Partners

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Telephone Care Management - Care Partners

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Videoconference Care Management - Veterans n=20 participants at risk 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	Telephone Care Management - Veterans n=20 participants at risk 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	Videoconference Care Management - Care Partners n=20 participants at risk 12-week nurse care management for medically complex Veterans with CI and their care partners delivered via videoconferencing Care management via videoconference: 12-week nurse care management for medically complex Veterans with CI and their care partners delivered via videoconference	Telephone Care Management - Care Partners n=20 participants at risk 12-week nurse care management for medically complex Veterans with CI and their care partners delivered via telephone calls Care management via telephone calls: 12-week nurse care management for medically complex Veterans with CI and their care partners delivered via telephone calls
Vascular disorders Hospitalization	0.00% 0/20 • 14 weeks	5.0% 1/20 • Number of events 1 • 14 weeks	0.00% 0/20 • 14 weeks	0.00% 0/20 • 14 weeks
Cardiac disorders Hospitalization	5.0% 1/20 • Number of events 1 • 14 weeks	0.00% 0/20 • 14 weeks	0.00% 0/20 • 14 weeks	0.00% 0/20 • 14 weeks

Other adverse events

Other adverse events
Measure	Videoconference Care Management - Veterans n=20 participants at risk 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	Telephone Care Management - Veterans n=20 participants at risk 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	Videoconference Care Management - Care Partners n=20 participants at risk 12-week nurse care management for medically complex Veterans with CI and their care partners delivered via videoconferencing Care management via videoconference: 12-week nurse care management for medically complex Veterans with CI and their care partners delivered via videoconference	Telephone Care Management - Care Partners n=20 participants at risk 12-week nurse care management for medically complex Veterans with CI and their care partners delivered via telephone calls Care management via telephone calls: 12-week nurse care management for medically complex Veterans with CI and their care partners delivered via telephone calls
Infections and infestations ED Visit	10.0% 2/20 • Number of events 2 • 14 weeks	5.0% 1/20 • Number of events 1 • 14 weeks	0.00% 0/20 • 14 weeks	0.00% 0/20 • 14 weeks
Respiratory, thoracic and mediastinal disorders ED Visit	5.0% 1/20 • Number of events 1 • 14 weeks	0.00% 0/20 • 14 weeks	0.00% 0/20 • 14 weeks	0.00% 0/20 • 14 weeks
Cardiac disorders ED Visit	5.0% 1/20 • Number of events 1 • 14 weeks	0.00% 0/20 • 14 weeks	0.00% 0/20 • 14 weeks	0.00% 0/20 • 14 weeks
Psychiatric disorders ED Visit	0.00% 0/20 • 14 weeks	5.0% 1/20 • Number of events 1 • 14 weeks	0.00% 0/20 • 14 weeks	0.00% 0/20 • 14 weeks
General disorders ED Visit	0.00% 0/20 • 14 weeks	5.0% 1/20 • Number of events 1 • 14 weeks	0.00% 0/20 • 14 weeks	0.00% 0/20 • 14 weeks

Additional Information

Susan N Hastings

Durham VA HSR&D

Phone: 919-286-6986

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place