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

NCT ID: NCT02632552

Last Updated: 2023-07-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-01
• Study Completion Date: 2021-08-31

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.

Conditions

CHF; COPD

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

Technology-assisted care transition arm

In-patient virtual nurse on-screen touchscreen and outpatient virtual nurse follow-up by texting

Group Type: EXPERIMENTAL

Technology-assisted care transition intervention

Intervention Type: BEHAVIORAL

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

Group Type: ACTIVE_COMPARATOR

Active attention control

Intervention Type: BEHAVIORAL

In-patient brief animated power-point style didactic onscreen tutorial covering the core pillars of care transitions and brief outpatient texting

Interventions

Technology-assisted care transition intervention

In-patient virtual nurse on-screen touchscreen and outpatient virtual nurse follow-up by texting

Intervention Type: BEHAVIORAL

Active attention control

In-patient brief animated power-point style didactic onscreen tutorial covering the core pillars of care transitions and brief outpatient texting

Intervention Type: BEHAVIORAL

Other Intervention Names

Virtual Nurse Annie Fox Intervention

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Northeastern University

OTHER

Sponsor Role: collaborator

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Timothy Patrick Hogan, PhD MS BS

Role: PRINCIPAL_INVESTIGATOR

VA Bedford HealthCare System, Bedford, MA

Locations

VA Palo Alto Health Care System, Palo Alto, CA

Palo Alto, California, United States

Edward Hines Jr. VA Hospital, Hines, IL

Hines, Illinois, United States

Iowa City VA Health Care System, Iowa City, IA

Iowa City, Iowa, United States

VA Bedford HealthCare System, Bedford, MA

Bedford, Massachusetts, United States

VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Boston, Massachusetts, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

IIR 15-101

Identifier Type: -

Identifier Source: org_study_id