Clinical trial NCT02632552: A Technology Assisted Care Transition Intervention for Veterans With CHF or COPD
Official title: A Technology-Assisted Care Transition Intervention for Veterans With Chronic Heart Failure or Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: CHF
COPD
Keywords: care transition
technology
chronic heart failure
chronic obstructive pulmonary disease
virtual nurse
texting
informatics
Veterans
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: Northeastern University
First posted: 2015-12-16
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pre-post Change in Combined Emergency and Urgent Care Service Utilization
timeFrame: 18 months prior to enrollment and 12 months post-discharge
Secondary outcomes:
measure: Care Transition Measure (CTM) Score Comparison
timeFrame: Responses to the CTM were collected from the intervention and control groups 7 days post-discharge.
measure: Adherence to Refills and Medications Scale (ARMS) Score Comparison
timeFrame: ARMS questionnaires were given to all participants at baseline and again at 30-day post-discharge follow-up
measure: Health Distress Score Comparison
timeFrame: The Health Distress measure was assessed at baseline, 7 days post-discharge, and 30 days post-discharge.
measure: Self Efficacy for Managing Chronic Disease Scale Comparison
timeFrame: Baseline and 30-day follow-up.
measure: Outcome Measure Title: Self-Care of Heart Failure Index Score Comparison
timeFrame: Baseline and 30-day follow-up
measure: COPD Self-Management Scale Score Comparison
timeFrame: Baseline and 30-day follow-up
measure: Self-Efficacy for Managing Symptoms (PROMIS)
timeFrame: Enrolled Veterans with CHF and/or COPD who completed baseline and 30-day follow-up
measure: Self-Efficacy for Managing Medications and Treatments (PROMIS)
timeFrame: Enrolled Veterans with CHF and/or COPD who completed baseline and 30-day follow-up.
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: VA Palo Alto Health Care System, Palo Alto, CA
state: California
city: Hines
country: United States
facility: Edward Hines Jr. VA Hospital, Hines, IL
state: Illinois
city: Iowa City
country: United States
facility: Iowa City VA Health Care System, Iowa City, IA
state: Iowa
city: Bedford
country: United States
facility: VA Bedford HealthCare System, Bedford, MA
state: Massachusetts
city: Boston
country: United States
facility: VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
state: Massachusetts
Study officials:
affiliation: VA Bedford HealthCare System, Bedford, MA
name: Timothy Patrick Hogan, PhD MS BS
role: PRINCIPAL_INVESTIGATOR
References: