CHFTACTNCT02632552
A Technology Assisted Care Transition Intervention for Veterans With CHF or COPD
A study testing Technology-assisted care transition intervention in people with CHF and COPD, run by VA Office of Research and Development at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Technology-assisted care transition intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 5 sitesUnited States
- Study dates
- 1 May 2018to 31 Aug 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
VA Bedford HealthCare System, Bedford, MA
Bedford, Massachusetts, 01730-1114
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Boston, Massachusetts, 02130-4817
Edward Hines Jr. VA Hospital, Hines, IL
Hines, Illinois, 60141-5000
Iowa City VA Health Care System, Iowa City, IA
Iowa City, Iowa, 52246-2292
VA Palo Alto Health Care System, Palo Alto, CA
Palo Alto, California, 94304-1207
About this study
Official title: A Technology-Assisted Care Transition Intervention for Veterans With Chronic Heart Failure or Chronic Obstructive Pulmonary Disease
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.
Read the 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:
- Refine methods and collect formative measures to guide implementation
- Conduct a randomized trial of the technology-assisted care transition intervention
- 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.
- Being tested
- Technology-assisted care transition intervention, Active attention control
- Keywords
- care transition, technology, chronic heart failure, chronic obstructive pulmonary disease, virtual nurse, texting, informatics, Veterans
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Technology-assisted care transition interventionBehavioural
Also called Virtual Nurse Annie Fox Intervention
In-patient virtual nurse on-screen touchscreen and outpatient virtual nurse follow-up by texting
Active attention controlBehavioural
In-patient brief animated power-point style didactic onscreen tutorial covering the core pillars of care transitions and brief outpatient texting
| Study group | Role | What they receive |
|---|---|---|
| Technology-assisted care transition arm | Experimental | In-patient virtual nurse on-screen touchscreen and outpatient virtual nurse follow-up by texting Receives: Behavioral: Technology-assisted care transition intervention |
| 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 Receives: Behavioral: Active attention control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 18 months prior to enrollment and 12 months post-discharge
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Enrolled Veterans with CHF and/or COPD who completed baseline and 30-day follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2015 (estimated)
- Study start1 May 2018
- Primary completion30 Jun 2020
- Study completion31 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for CHFStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- Northeastern University
- Responsible party
- Sponsor
- Investigators
- Timothy Patrick Hogan, PhD MS BS, Principal investigator, VA Bedford HealthCare System, Bedford, MA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02632552
- Sponsor's protocol ID
- IIR 15-101
- Acronym
- TACT
- Status last verified
- Jul 2023
- First submitted
- 11 Dec 2015
- Last updated
- 27 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Technology-Assisted Care Transition Intervention for Veterans With Chronic Heart Failure or Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT02632552
- Acronym / sponsor ID
- TACT / IIR 15-101
- Keywords
- care transition, technology, chronic heart failure, chronic obstructive pulmonary disease, virtual nurse, texting, informatics, Veterans
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- Northeastern University
- Study start
- 1 May 2018 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 31 Aug 2021 (actual)
- First posted
- 16 Dec 2015 (estimated)
- Results
- Posted 4 Nov 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Refine methods and collect formative measures to guide implementation
- Conduct a randomized trial of the technology-assisted care transition intervention
- 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Technology-assisted care transition arm | Experimental | Behavioral: Technology-assisted care transition interventionIn-patient virtual nurse on-screen touchscreen and outpatient virtual nurse follow-up by texting |
| Active attention control | Active comparator | Behavioral: Active attention controlIn-patient brief animated power-point style didactic onscreen tutorial covering the core pillars of care transitions and brief outpatient texting |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Technology-assisted care transition interventionAlso: Virtual Nurse Annie Fox InterventionIn-patient virtual nurse on-screen touchscreen and outpatient virtual nurse follow-up by texting | Behavioural | Technology-assisted care transition arm |
| Active attention controlIn-patient brief animated power-point style didactic onscreen tutorial covering the core pillars of care transitions and brief outpatient texting | Behavioural | Active attention control |
Primary outcome
Pre-post Change in Combined Emergency and Urgent Care Service Utilization
Time frame: 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.
8 secondary outcomes
Care Transition Measure (CTM) Score Comparison
Time frame: 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
Time frame: ARMS questionnaires were given to all participants at baseline and again at 30-day post-discharge follow-up
Health Distress Score Comparison
Time frame: 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
Time frame: Baseline and 30-day follow-up.
Outcome Measure Title: Self-Care of Heart Failure Index Score Comparison
Time frame: Baseline and 30-day follow-up
COPD Self-Management Scale Score Comparison
Time frame: Baseline and 30-day follow-up
Self-Efficacy for Managing Symptoms (PROMIS)
Time frame: Enrolled Veterans with CHF and/or COPD who completed baseline and 30-day follow-up
Self-Efficacy for Managing Medications and Treatments (PROMIS)
Time frame: Enrolled Veterans with CHF and/or COPD who completed baseline and 30-day follow-up.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Timothy Patrick Hogan, PhD MS BS principal investigator
VA Bedford HealthCare System, Bedford, MA
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Technology-assisted care transition intervention in people with CHF and COPD, run by VA Office of Research and Development at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Nov 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pre-post Change in Combined Emergency and Urgent Care Service Utilization (time frame: 18 months prior to enrollment and 12 months post-discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2023.