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| Name | Class |
|---|---|
| Northeastern University | OTHER |
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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Technology-assisted care transition arm | Experimental | In-patient virtual nurse on-screen touchscreen and outpatient virtual nurse follow-up by texting |
|
| Active attention control | Active Comparator | In-patient brief animated power-point style didactic onscreen tutorial covering the core pillars of care transitions and brief outpatient texting |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Technology-assisted care transition intervention | Behavioral | In-patient virtual nurse on-screen touchscreen and outpatient virtual nurse follow-up by texting |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 18 months prior to enrollment and 12 months post-discharge |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Timothy Patrick Hogan, PhD MS BS | VA Bedford HealthCare System, Bedford, MA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Palo Alto Health Care System, Palo Alto, CA | Palo Alto | California | 94304-1207 | United States | ||
| Edward Hines Jr. VA Hospital, Hines, IL |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention | In-patient virtual nurse on-screen touchscreen and outpatient virtual nurse follow-up by texting |
| FG001 | Active Attention Control | In-patient brief animated power-point style didactic onscreen tutorial covering the core pillars of care transitions and brief outpatient texting |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Enrolled Veterans who had complete data for this measure | Posted | Mean | Standard Deviation | care utilization events | 18 months prior to enrollment and 12 months post-discharge |
|
Study participants were monitored for adverse events during the active enrollment period of thirty (30) days from their hospital discharge date.
In monitoring, collecting, and reporting data, the study did not consider rehospitalization to be a serious adverse event as the primary outcome of focus was healthcare utilization, including rehospitalization. The target population for this study, hospitalized Veterans with congestive heart failure and/or chronic obstructive pulmonary disease, tends to be older, sicker, and faced with more complex medical needs. For these reasons, rehospitalization can be common among this population.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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It is important to interpret the results in light of this study's sample size limitations. Enrollment was slow and compounded by a recruitment halt during COVID-19. While we believe that we have a sufficient sample to examine utilization outcomes, enrollment was still less than anticipated. Lastly, it can be difficult to determine meaningful differences for the secondary outcomes used in this study, especially in light of the complex patient population and the novelty of the intervention tested.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Timothy P. Hogan, PhD, | U.S. Department of Veterans Affairs, Center for Healthcare Organization and Implementation Research (CHOIR) | 508-244-2303 | Timothy.Hogan@VA.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 24, 2021 | Jun 30, 2021 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 10, 2013 | Feb 17, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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|
| Active attention control | Behavioral | In-patient brief animated power-point style didactic onscreen tutorial covering the core pillars of care transitions and brief outpatient texting |
|
| Responses to the CTM were collected from the intervention and control groups 7 days post-discharge. |
| 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. | ARMS questionnaires were given to all participants at baseline and again at 30-day post-discharge follow-up |
| 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. | The Health Distress measure was assessed at baseline, 7 days post-discharge, and 30 days post-discharge. |
| 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. | Baseline and 30-day follow-up. |
| 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. | Baseline and 30-day follow-up |
| 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. | Baseline and 30-day follow-up |
| 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. | Enrolled Veterans with CHF and/or COPD who completed baseline and 30-day follow-up |
| 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. | Enrolled Veterans with CHF and/or COPD who completed baseline and 30-day follow-up. |
| Hines |
| Illinois |
| 60141-5000 |
| United States |
| Iowa City VA Health Care System, Iowa City, IA | Iowa City | Iowa | 52246-2292 | United States |
| VA Bedford HealthCare System, Bedford, MA | Bedford | Massachusetts | 01730-1114 | United States |
| VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA | Boston | Massachusetts | 02130-4817 | United States |
| Did not receive allocated protocol (did not enroll in texting program) |
|
| 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 |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Problems learning about medical conditions | We administered a health literacy screening question, "How often do you have problems learning about your medical condition because of difficulty understanding written information?" We scored the responses on a five-point Likert scale (always; often; sometimes; occasionally; never) from 1 to 5, with a score range of 1-5, with a higher score indicating fewer problems learning about their medical conditions. | Count of Participants | Participants |
|
In-patient brief animated power-point style didactic onscreen tutorial covering the core pillars of care transitions and brief outpatient texting |
|
|
|
| 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. | Enrolled Veterans who had complete data for this measure. | Posted | Mean | Standard Deviation | score on a scale | Responses to the CTM were collected from the intervention and control groups 7 days post-discharge. |
|
|
|
|
| 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. | Enrolled Veterans with CHF and/or COPD who completed baseline and 30-day follow-up and had complete data for this measure. | Posted | Mean | Standard Deviation | score on a scale | ARMS questionnaires were given to all participants at baseline and again at 30-day post-discharge follow-up |
|
|
|
|
| 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. | Enrolled Veterans with CHF and/or COPD who completed baseline, 7-day, and 30-day follow-up and had complete data for this measure. | Posted | Mean | Standard Deviation | score on a scale | The Health Distress measure was assessed at baseline, 7 days post-discharge, and 30 days post-discharge. |
|
|
|
|
| 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. | Enrolled Veterans with CHF and/or COPD who completed baseline and 30-day follow-up and had complete data for this measure. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 30-day follow-up. |
|
|
|
|
| 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. | Enrolled Veterans with CHF who completed baseline and 30-day follow-up and had complete data for this measure. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 30-day follow-up |
|
|
|
|
| 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. | Enrolled Veterans with COPD who completed baseline and 30-day follow-up and had complete data for this measure. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 30-day follow-up |
|
|
|
|
| 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. | Enrolled Veterans with CHF and/or COPD who completed baseline and 30-day follow-up and had complete data for this measure. | Posted | Mean | Standard Deviation | score on a scale | Enrolled Veterans with CHF and/or COPD who completed baseline and 30-day follow-up |
|
|
|
|
| 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. | Enrolled Veterans with CHF and/or COPD who completed baseline and 30-day follow-up and completed data for this measure. | Posted | Mean | Standard Deviation | score on a scale | Enrolled Veterans with CHF and/or COPD who completed baseline and 30-day follow-up. |
|
|
|
|
| 24 |
| 80 |
| 0 |
| 80 |
| 0 |
| 80 |
| EG001 | 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 | 21 | 60 | 0 | 60 | 0 | 60 |
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| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |