CHF, COPD
Conditions
Keywords
care transition, technology, chronic heart failure, chronic obstructive pulmonary disease, virtual nurse, texting, informatics, Veterans
Brief summary
Transition from hospital to home places patients in jeopardy of adverse events and increases their risk for rehospitalization. CHF is the most prevalent chronic condition among U.S. adults and COPD is the third leading cause of death in the U.S. Both CHF and COPD represent significant burdens for the VHA healthcare system. Care transitions can be supported through multi-component interventions, but are costly to implement. Virtual nurses provide an effective medium for explaining health concepts to patients, and previous work indicates patients find virtual nurses acceptable. The investigators will implement and evaluate a virtual nurse intervention to provide automated, tailored, and timely support to Veterans transitioning from hospital to home. As effective care transition interventions incorporate both inpatient and outpatient components, the virtual nurse will first engage with patient onscreen during their inpatient stay and then via text message post-discharge. This project has the potential to improve the care transition experience for patients, caregivers and healthcare providers.
Detailed description
The last decade has seen a steady increase in the resources that VHA uses to treat chronic heart failure (CHF) and Chronic Obstructive Pulmonary Disease (COPD), both of which are among the most common reasons for admission and re-admission in VHA facilities. Multi-component care transition interventions can be effective, but are costly. One approach to reduce complexity and costs is to offload some work to technology. Informed by the sociotechnical model, this study proposes a technology-assisted care transition intervention founded on the concept of a virtual nurse that interacts with Veterans through different technology channels. The virtual nurse is an anthropomorphized computer program designed to simulate a discharge nurse. During the inpatient stay, the virtual nurse will appear on a computer touch screen and will educate Veterans with CHF or COPD about the important components of a care transition (drawing on the Coleman Care Transition Model) as well as how to send and receive text messages on their mobile phone. Following discharge to home, the virtual nurse will continue to coach Veterans and their family members and improve post-discharge access to care through two-way computer-tailored text messaging made possible by VHA's new HealtheDialog system. Specific aims are to: 1. Refine methods and collect formative measures to guide implementation 2. Conduct a randomized trial of the technology-assisted care transition intervention 3. Evaluate the intervention, including its effectiveness, implementation, and budget impact The investigators propose a mixed methods formative assessment and simulation experiment to refine existing technologies to the VA care transition setting (Aim 1). This will be followed by a multi-site randomized type1 hybrid implementation trial (Aims 2 and 3). The trial will evaluate the effectiveness of the virtual nurse intervention in twelve clinical teams and also gather information about its implementation to inform broader rollout.
Interventions
BEHAVIORALTechnology-assisted care transition intervention
In-patient virtual nurse on-screen touchscreen and outpatient virtual nurse follow-up by texting
BEHAVIORALActive attention control
In-patient brief animated power-point style didactic onscreen tutorial covering the core pillars of care transitions and brief outpatient texting
Sponsors
Northeastern University
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Veterans * Diagnosis of chronic heart failure or chronic obstructive pulmonary disease * Admission to a general medical service * Able and willing to engage with touchscreen technology * Have a text-enabled cellular phone to receive the post-discharge text messages
Exclusion criteria
* Not Veterans * Not diagnosed of chronic heart failure or chronic obstructive pulmonary disease * Not admitted to a general medical service * Not capable of using touchscreen technology * Do not have a text-enabled cellular phone
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pre-post Change in Combined Emergency and Urgent Care Service Utilization | 18 months prior to enrollment and 12 months post-discharge | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adherence to Refills and Medications Scale (ARMS) Score Comparison | ARMS questionnaires were given to all participants at baseline and again at 30-day post-discharge follow-up | 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. |
| Health Distress Score Comparison | The Health Distress measure was assessed at baseline, 7 days post-discharge, and 30 days post-discharge. | 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. |
| Self Efficacy for Managing Chronic Disease Scale Comparison | Baseline and 30-day follow-up. | 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. |
| Care Transition Measure (CTM) Score Comparison | Responses to the CTM were collected from the intervention and control groups 7 days post-discharge. | 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. |
| COPD Self-Management Scale Score Comparison | Baseline and 30-day follow-up | 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. |
| Self-Efficacy for Managing Symptoms (PROMIS) | Enrolled Veterans with CHF and/or COPD who completed baseline and 30-day follow-up | 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. |
| Self-Efficacy for Managing Medications and Treatments (PROMIS) | Enrolled Veterans with CHF and/or COPD who completed baseline and 30-day follow-up. | 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 Measure Title: Self-Care of Heart Failure Index Score Comparison | Baseline and 30-day follow-up | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Technology-assisted Care Transition Arm 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 | 80 |
| Active Attention Control 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 | 60 |
| Total | 140 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Did not receive allocated protocol (did not enroll in texting program) | 7 | 2 |
| Overall Study | Lost to Follow-up | 14 | 8 |
| Overall Study | Withdrawal by Subject | 2 | 0 |
Baseline characteristics
| Characteristic | Technology-assisted Care Transition Arm | Total | Active Attention Control |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 55 Participants | 97 Participants | 42 Participants |
| Age, Categorical Between 18 and 65 years | 25 Participants | 43 Participants | 18 Participants |
| Age, Continuous | 69.01 years STANDARD_DEVIATION 8.4 | 68.705 years STANDARD_DEVIATION 8.05 | 68.40 years STANDARD_DEVIATION 7.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 5 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 77 Participants | 135 Participants | 58 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Problems learning about medical conditions Always | 2 Participants | 8 Participants | 6 Participants |
| Problems learning about medical conditions Never | 57 Participants | 96 Participants | 39 Participants |
| Problems learning about medical conditions No response | 2 Participants | 2 Participants | 0 Participants |
| Problems learning about medical conditions Occasionally | 14 Participants | 19 Participants | 5 Participants |
| Problems learning about medical conditions Often | 3 Participants | 4 Participants | 1 Participants |
| Problems learning about medical conditions Sometimes | 2 Participants | 11 Participants | 9 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 8 Participants | 18 Participants | 10 Participants |
| Race (NIH/OMB) More than one race | 5 Participants | 12 Participants | 7 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 66 Participants | 108 Participants | 42 Participants |
| Region of Enrollment United States | 80 participants | 140 participants | 60 participants |
| Sex: Female, Male Female | 2 Participants | 3 Participants | 1 Participants |
| Sex: Female, Male Male | 78 Participants | 137 Participants | 59 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 24 / 80 | 21 / 60 |
| other Total, other adverse events | 0 / 80 | 0 / 60 |
| serious Total, serious adverse events | 0 / 80 | 0 / 60 |
Outcome results
Primary
Pre-post Change in Combined Emergency and Urgent Care Service Utilization
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.
Time frame: 18 months prior to enrollment and 12 months post-discharge
Population: Enrolled Veterans who had complete data for this measure
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Pre-post Change in Combined Emergency and Urgent Care Service Utilization | Pre-Trial Utilization | 1.06 care utilization events | Standard Deviation 3.05 |
| Intervention | Pre-post Change in Combined Emergency and Urgent Care Service Utilization | Post-Trial Utilization | 0.92 care utilization events | Standard Deviation 2.86 |
| Active Attention Control | Pre-post Change in Combined Emergency and Urgent Care Service Utilization | Pre-Trial Utilization | 1.03 care utilization events | Standard Deviation 2.67 |
| Active Attention Control | Pre-post Change in Combined Emergency and Urgent Care Service Utilization | Post-Trial Utilization | 0.71 care utilization events | Standard Deviation 1.78 |
p-value: 0.4595% CI: [0.85, 1.45]Mixed Effects Negative Binomial Model
Secondary
Adherence to Refills and Medications Scale (ARMS) Score Comparison
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Adherence to Refills and Medications Scale (ARMS) Score Comparison | Baseline Score | 15.24 score on a scale | Standard Deviation 2.61 |
| Intervention | Adherence to Refills and Medications Scale (ARMS) Score Comparison | 30-Day Follow-Up Score | 15.0 score on a scale | Standard Deviation 1.71 |
| Active Attention Control | Adherence to Refills and Medications Scale (ARMS) Score Comparison | Baseline Score | 16.91 score on a scale | Standard Deviation 5.03 |
| Active Attention Control | Adherence to Refills and Medications Scale (ARMS) Score Comparison | 30-Day Follow-Up Score | 15.0 score on a scale | Standard Deviation 2.26 |
p-value: 0.0395% CI: [0.08, 1.57]Mixed Models Analysis
Secondary
Care Transition Measure (CTM) Score Comparison
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Care Transition Measure (CTM) Score Comparison | 75.96 score on a scale | Standard Deviation 13.9 |
| Active Attention Control | Care Transition Measure (CTM) Score Comparison | 77.00 score on a scale | Standard Deviation 14.41 |
p-value: 0.0595% CI: [-7.21, 3.61]Mixed Models Analysis
Secondary
COPD Self-Management Scale Score Comparison
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | COPD Self-Management Scale Score Comparison | Baseline Score | 37.91 score on a scale | Standard Deviation 6.58 |
| Intervention | COPD Self-Management Scale Score Comparison | 30-Day Follow-Up Score | 39.58 score on a scale | Standard Deviation 5.65 |
| Active Attention Control | COPD Self-Management Scale Score Comparison | Baseline Score | 36.95 score on a scale | Standard Deviation 6.29 |
| Active Attention Control | COPD Self-Management Scale Score Comparison | 30-Day Follow-Up Score | 35.71 score on a scale | Standard Deviation 4.86 |
p-value: 0.2395% CI: [-0.97, 4.05]Mixed Models Analysis
Secondary
Health Distress Score Comparison
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Health Distress Score Comparison | Baseline Score | 3.48 score on a scale | Standard Deviation 1.33 |
| Intervention | Health Distress Score Comparison | 30-Day Follow-Up Score | 2.90 score on a scale | Standard Deviation 1.34 |
| Active Attention Control | Health Distress Score Comparison | Baseline Score | 3.27 score on a scale | Standard Deviation 1.58 |
| Active Attention Control | Health Distress Score Comparison | 30-Day Follow-Up Score | 2.79 score on a scale | Standard Deviation 1.36 |
p-value: 0.7595% CI: [-0.41, 0.29]Mixed Models Analysis
Secondary
Outcome Measure Title: Self-Care of Heart Failure Index Score Comparison
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Outcome Measure Title: Self-Care of Heart Failure Index Score Comparison | Baseline Score | 28.51 score on a scale | Standard Deviation 5.62 |
| Intervention | 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 |
| Active Attention Control | Outcome Measure Title: Self-Care of Heart Failure Index Score Comparison | Baseline Score | 27.20 score on a scale | Standard Deviation 6.22 |
| Active Attention Control | Outcome Measure Title: Self-Care of Heart Failure Index Score Comparison | -Day Follow-Up Score | 30.71 score on a scale | Standard Deviation 5.63 |
p-value: 0.6395% CI: [-2.21, 1.29]Mixed Models Analysis
Secondary
Self Efficacy for Managing Chronic Disease Scale Comparison
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Self Efficacy for Managing Chronic Disease Scale Comparison | Baseline Score | 6.23 score on a scale | Standard Deviation 2.32 |
| Intervention | Self Efficacy for Managing Chronic Disease Scale Comparison | 30-Day Follow-Up Score | 6.34 score on a scale | Standard Deviation 2.13 |
| Active Attention Control | Self Efficacy for Managing Chronic Disease Scale Comparison | Baseline Score | 6.29 score on a scale | Standard Deviation 2.52 |
| Active Attention Control | Self Efficacy for Managing Chronic Disease Scale Comparison | 30-Day Follow-Up Score | 6.21 score on a scale | Standard Deviation 2.59 |
p-value: 0.7495% CI: [-0.5, 0.7]Mixed Models Analysis
Secondary
Self-Efficacy for Managing Medications and Treatments (PROMIS)
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Self-Efficacy for Managing Medications and Treatments (PROMIS) | Baseline Score | 18.89 score on a scale | Standard Deviation 5.42 |
| Intervention | Self-Efficacy for Managing Medications and Treatments (PROMIS) | 30-Day Follow-Up Score | 19.08 score on a scale | Standard Deviation 4.54 |
| Active Attention Control | Self-Efficacy for Managing Medications and Treatments (PROMIS) | Baseline Score | 18.63 score on a scale | Standard Deviation 4.88 |
| Active Attention Control | Self-Efficacy for Managing Medications and Treatments (PROMIS) | 30-Day Follow-Up Score | 18.12 score on a scale | Standard Deviation 5.36 |
p-value: 0.3895% CI: [-9.1, 3.52]Mixed Models Analysis
Secondary
Self-Efficacy for Managing Symptoms (PROMIS)
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Self-Efficacy for Managing Symptoms (PROMIS) | Baseline Score | 17.87 score on a scale | Standard Deviation 5.28 |
| Intervention | Self-Efficacy for Managing Symptoms (PROMIS) | 30-Day Follow-Up Score | 18.87 score on a scale | Standard Deviation 4.64 |
| Active Attention Control | Self-Efficacy for Managing Symptoms (PROMIS) | Baseline Score | 18.20 score on a scale | Standard Deviation 5.17 |
| Active Attention Control | Self-Efficacy for Managing Symptoms (PROMIS) | 30-Day Follow-Up Score | 17.53 score on a scale | Standard Deviation 5.62 |
p-value: 0.3895% CI: [-7.95, 3.1]Mixed Models Analysis