Trial Outcomes & Findings for A Technology Assisted Care Transition Intervention for Veterans With CHF or COPD (NCT NCT02632552)

Last Updated: 2023-07-27

Results Overview

Comparing Total Number of Combined Emergency and Urgent Care Utilization for Veterans with CHF and/or COPD between Intervention and Control across time. This measure is defined as the total number of VA emergency department visits and VA urgent care visits for each participant during the study period.

Recruitment status

COMPLETED

Study phase

Target enrollment

140 participants

Primary outcome timeframe

18 months prior to enrollment and 12 months post-discharge

Results posted on

2023-07-27

Participant Flow

Participant milestones

Participant milestones
Measure	Intervention In-patient virtual nurse on-screen touchscreen and outpatient virtual nurse follow-up by texting	Active Attention Control In-patient brief animated power-point style didactic onscreen tutorial covering the core pillars of care transitions and brief outpatient texting
Overall Study STARTED	80	60
Overall Study COMPLETED	57	50
Overall Study NOT COMPLETED	23	10

Reasons for withdrawal

Reasons for withdrawal
Measure	Intervention In-patient virtual nurse on-screen touchscreen and outpatient virtual nurse follow-up by texting	Active Attention Control In-patient brief animated power-point style didactic onscreen tutorial covering the core pillars of care transitions and brief outpatient texting
Overall Study Lost to Follow-up	14	8
Overall Study Withdrawal by Subject	2	0
Overall Study Did not receive allocated protocol (did not enroll in texting program)	7	2

Baseline Characteristics

A Technology Assisted Care Transition Intervention for Veterans With CHF or COPD

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Technology-assisted Care Transition Arm n=80 Participants In-patient virtual nurse on-screen touchscreen and outpatient virtual nurse follow-up by texting Technology-assisted care transition intervention: In-patient virtual nurse on-screen touchscreen and outpatient virtual nurse follow-up by texting	Active Attention Control n=60 Participants In-patient brief animated power-point style didactic onscreen tutorial covering the core pillars of care transitions and brief outpatient texting Active attention control: In-patient brief animated power-point style didactic onscreen tutorial covering the core pillars of care transitions and brief outpatient texting	Total n=140 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	25 Participants n=5 Participants	18 Participants n=7 Participants	43 Participants n=5 Participants
Age, Categorical >=65 years	55 Participants n=5 Participants	42 Participants n=7 Participants	97 Participants n=5 Participants
Age, Continuous	69.01 years STANDARD_DEVIATION 8.40 • n=5 Participants	68.40 years STANDARD_DEVIATION 7.70 • n=7 Participants	68.705 years STANDARD_DEVIATION 8.05 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Sex: Female, Male Male	78 Participants n=5 Participants	59 Participants n=7 Participants	137 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	77 Participants n=5 Participants	58 Participants n=7 Participants	135 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	8 Participants n=5 Participants	10 Participants n=7 Participants	18 Participants n=5 Participants
Race (NIH/OMB) White	66 Participants n=5 Participants	42 Participants n=7 Participants	108 Participants n=5 Participants
Race (NIH/OMB) More than one race	5 Participants n=5 Participants	7 Participants n=7 Participants	12 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	80 participants n=5 Participants	60 participants n=7 Participants	140 participants n=5 Participants
Problems learning about medical conditions Always	2 Participants n=5 Participants	6 Participants n=7 Participants	8 Participants n=5 Participants
Problems learning about medical conditions Often	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Problems learning about medical conditions Sometimes	2 Participants n=5 Participants	9 Participants n=7 Participants	11 Participants n=5 Participants
Problems learning about medical conditions Occasionally	14 Participants n=5 Participants	5 Participants n=7 Participants	19 Participants n=5 Participants
Problems learning about medical conditions Never	57 Participants n=5 Participants	39 Participants n=7 Participants	96 Participants n=5 Participants
Problems learning about medical conditions No response	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: 18 months prior to enrollment and 12 months post-discharge

Population: Enrolled Veterans who had complete data for this measure

Outcome measures

Outcome measures
Measure	Intervention n=79 Participants Technology-assisted care transition intervention: In-patient virtual nurse on-screen touchscreen and outpatient virtual nurse follow-up by texting	Active Attention Control n=59 Participants In-patient brief animated power-point style didactic onscreen tutorial covering the core pillars of care transitions and brief outpatient texting
Pre-post Change in Combined Emergency and Urgent Care Service Utilization Pre-Trial Utilization	1.06 care utilization events Standard Deviation 3.05	1.03 care utilization events Standard Deviation 2.67
Pre-post Change in Combined Emergency and Urgent Care Service Utilization Post-Trial Utilization	0.92 care utilization events Standard Deviation 2.86	0.71 care utilization events Standard Deviation 1.78

SECONDARY outcome

Timeframe: Responses to the CTM were collected from the intervention and control groups 7 days post-discharge.

Population: Enrolled Veterans who had complete data for this measure.

The Care Transition Measure (CTM) is a validated, 15-item instrument used to measure the quality of a patient's care transition. The CTM has been shown to discriminate between patients discharged from the hospital who did and did not have a subsequent emergency department visit or rehospitalization for their index condition. Each of the CTM items has a 4-point Likert response scale ranging from 1 (strongly disagree) to 4 (strongly agree). When scoring the CTM, the lowest possible score is 0 and the highest possible score is 100, where higher scores indicate a better quality care transition.

Outcome measures

Outcome measures
Measure	Intervention n=80 Participants Technology-assisted care transition intervention: In-patient virtual nurse on-screen touchscreen and outpatient virtual nurse follow-up by texting	Active Attention Control n=59 Participants In-patient brief animated power-point style didactic onscreen tutorial covering the core pillars of care transitions and brief outpatient texting
Care Transition Measure (CTM) Score Comparison	75.96 score on a scale Standard Deviation 13.90	77.00 score on a scale Standard Deviation 14.41

SECONDARY outcome

Timeframe: ARMS questionnaires were given to all participants at baseline and again at 30-day post-discharge follow-up

Population: Enrolled Veterans with CHF and/or COPD who completed baseline and 30-day follow-up and had complete data for this measure.

The Adherence to Refills and Medication Scale (ARMS) is a validated, 12-question instrument that assesses patient medication adherence across all literacy levels. Additionally, ARMS can be used to identify potential adherence barriers. The ARMS uses a 4-point Likert scale ranging from 1 (none of the time) to 4 (all of the time). The score range is 12-48 with lower scores indicating better adherence.

Outcome measures

Outcome measures
Measure	Intervention n=63 Participants Technology-assisted care transition intervention: In-patient virtual nurse on-screen touchscreen and outpatient virtual nurse follow-up by texting	Active Attention Control n=48 Participants In-patient brief animated power-point style didactic onscreen tutorial covering the core pillars of care transitions and brief outpatient texting
Adherence to Refills and Medications Scale (ARMS) Score Comparison Baseline Score	15.24 score on a scale Standard Deviation 2.61	16.91 score on a scale Standard Deviation 5.03
Adherence to Refills and Medications Scale (ARMS) Score Comparison 30-Day Follow-Up Score	15.0 score on a scale Standard Deviation 1.71	15.0 score on a scale Standard Deviation 2.26

SECONDARY outcome

Timeframe: The Health Distress measure was assessed at baseline, 7 days post-discharge, and 30 days post-discharge.

Population: Enrolled Veterans with CHF and/or COPD who completed baseline, 7-day, and 30-day follow-up and had complete data for this measure.

We used the Lorig Health Distress Scale to assess overall health-related distress. This 4-item instrument uses a 6-point Likert scale ranging from 0 (none of the time) to 5 (all of the time). The score range is 0-5 with a higher score indicating more distress about health.

Outcome measures

Outcome measures
Measure	Intervention n=63 Participants Technology-assisted care transition intervention: In-patient virtual nurse on-screen touchscreen and outpatient virtual nurse follow-up by texting	Active Attention Control n=49 Participants In-patient brief animated power-point style didactic onscreen tutorial covering the core pillars of care transitions and brief outpatient texting
Health Distress Score Comparison Baseline Score	3.48 score on a scale Standard Deviation 1.33	3.27 score on a scale Standard Deviation 1.58
Health Distress Score Comparison 30-Day Follow-Up Score	2.90 score on a scale Standard Deviation 1.34	2.79 score on a scale Standard Deviation 1.36

SECONDARY outcome

Timeframe: Baseline and 30-day follow-up.

Population: Enrolled Veterans with CHF and/or COPD who completed baseline and 30-day follow-up and had complete data for this measure.

The Self-Efficacy for Managing Chronic Disease Scale is a validated instrument that assesses symptom control, role, and emotional functioning. This 6-question instrument uses a 1-10-point scale ranging from 1 (not at all confident) to 10 (totally confident). The score range is 1-10 with higher scores indicating higher self-efficacy.

Outcome measures

Outcome measures
Measure	Intervention n=63 Participants Technology-assisted care transition intervention: In-patient virtual nurse on-screen touchscreen and outpatient virtual nurse follow-up by texting	Active Attention Control n=49 Participants In-patient brief animated power-point style didactic onscreen tutorial covering the core pillars of care transitions and brief outpatient texting
Self Efficacy for Managing Chronic Disease Scale Comparison Baseline Score	6.23 score on a scale Standard Deviation 2.32	6.29 score on a scale Standard Deviation 2.52
Self Efficacy for Managing Chronic Disease Scale Comparison 30-Day Follow-Up Score	6.34 score on a scale Standard Deviation 2.13	6.21 score on a scale Standard Deviation 2.59

SECONDARY outcome

Timeframe: Baseline and 30-day follow-up

Population: Enrolled Veterans with CHF who completed baseline and 30-day follow-up and had complete data for this measure.

The Self-Care of Heart Failure Index, version 6.2, is a validated instrument that assesses patient management and maintenance of their heart failure and uses a 4-point Likert scale ranging from 1 (never or rarely) to 4 (always or daily). We used the maintenance subscale of this instrument which includes 10 items that measure daily activities known to assist in the health of heart failure patients. The score range is 10 to 100 with higher scores indicating better patient self-management.

Outcome measures

Outcome measures
Measure	Intervention n=45 Participants Technology-assisted care transition intervention: In-patient virtual nurse on-screen touchscreen and outpatient virtual nurse follow-up by texting	Active Attention Control n=38 Participants In-patient brief animated power-point style didactic onscreen tutorial covering the core pillars of care transitions and brief outpatient texting
Outcome Measure Title: Self-Care of Heart Failure Index Score Comparison Baseline Score	28.51 score on a scale Standard Deviation 5.62	27.20 score on a scale Standard Deviation 6.22
Outcome Measure Title: Self-Care of Heart Failure Index Score Comparison -Day Follow-Up Score	31.11 score on a scale Standard Deviation 5.92	30.71 score on a scale Standard Deviation 5.63

SECONDARY outcome

Timeframe: Baseline and 30-day follow-up

Population: Enrolled Veterans with COPD who completed baseline and 30-day follow-up and had complete data for this measure.

The COPD Self-Management Scale by Zhang is a validated instrument to assess patient self-management of COPD and uses a 5-point Likert scale ranging from 1 (never) to 5 (always). We used 10 question items from this instrument that measure common activities associated with the management of COPD. The scoring range is 10-50, with higher scores indicating better COPD self-management.

Outcome measures

Outcome measures
Measure	Intervention n=24 Participants Technology-assisted care transition intervention: In-patient virtual nurse on-screen touchscreen and outpatient virtual nurse follow-up by texting	Active Attention Control n=14 Participants In-patient brief animated power-point style didactic onscreen tutorial covering the core pillars of care transitions and brief outpatient texting
COPD Self-Management Scale Score Comparison Baseline Score	37.91 score on a scale Standard Deviation 6.58	36.95 score on a scale Standard Deviation 6.29
COPD Self-Management Scale Score Comparison 30-Day Follow-Up Score	39.58 score on a scale Standard Deviation 5.65	35.71 score on a scale Standard Deviation 4.86

SECONDARY outcome

Timeframe: Enrolled Veterans with CHF and/or COPD who completed baseline and 30-day follow-up

Population: Enrolled Veterans with CHF and/or COPD who completed baseline and 30-day follow-up and had complete data for this measure.

The Self-Efficacy for Managing Symptoms scale is a 4-question, validated measure and is a part of the larger Patient-Reported Outcomes Measurement Information System (PROMIS) used to assess physical, mental, and social health in patients with chronic conditions. We used the 4-question items from this scale with response options on a 6-point Likert scale ranging from 1 (not at all confident) to 6 (very confident). The scoring range is 4-24, with higher scores indicating higher self-efficacy for symptom management.

Outcome measures

Outcome measures
Measure	Intervention n=63 Participants Technology-assisted care transition intervention: In-patient virtual nurse on-screen touchscreen and outpatient virtual nurse follow-up by texting	Active Attention Control n=49 Participants In-patient brief animated power-point style didactic onscreen tutorial covering the core pillars of care transitions and brief outpatient texting
Self-Efficacy for Managing Symptoms (PROMIS) Baseline Score	17.87 score on a scale Standard Deviation 5.28	18.20 score on a scale Standard Deviation 5.17
Self-Efficacy for Managing Symptoms (PROMIS) 30-Day Follow-Up Score	18.87 score on a scale Standard Deviation 4.64	17.53 score on a scale Standard Deviation 5.62

SECONDARY outcome

Timeframe: Enrolled Veterans with CHF and/or COPD who completed baseline and 30-day follow-up.

Population: Enrolled Veterans with CHF and/or COPD who completed baseline and 30-day follow-up and completed data for this measure.

The Self-Efficacy for Managing Medications and Treatments scale is a 4-question, validated measure and is a part of the larger Patient-Reported Outcomes Measurement Information System (PROMIS) used to assess physical, mental, and social health in patients with chronic conditions. We used the 4-question items from this scale with response options on a 6-point Likert scale ranging from 1 (not at all confident) to 6 (very confident). The scoring range is 4-24, with higher scores indicating higher self-efficacy for managing medications and treatments.

Outcome measures

Outcome measures
Measure	Intervention n=63 Participants Technology-assisted care transition intervention: In-patient virtual nurse on-screen touchscreen and outpatient virtual nurse follow-up by texting	Active Attention Control n=49 Participants In-patient brief animated power-point style didactic onscreen tutorial covering the core pillars of care transitions and brief outpatient texting
Self-Efficacy for Managing Medications and Treatments (PROMIS) Baseline Score	18.89 score on a scale Standard Deviation 5.42	18.63 score on a scale Standard Deviation 4.88
Self-Efficacy for Managing Medications and Treatments (PROMIS) 30-Day Follow-Up Score	19.08 score on a scale Standard Deviation 4.54	18.12 score on a scale Standard Deviation 5.36

Adverse Events

Technology-assisted Care Transition Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 24 deaths

Active Attention Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 21 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Timothy P. Hogan, PhD,

U.S. Department of Veterans Affairs, Center for Healthcare Organization and Implementation Research (CHOIR)

Phone: 508-244-2303

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place