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

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ClinicalTrials.gov Identifier: NCT02632552
Recruitment Status : Recruiting
First Posted : December 16, 2015
Last Update Posted : August 26, 2019
Sponsor:
Collaborator:
Northeastern University
Information provided by (Responsible Party):
VA Office of Research and Development

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.

Condition or disease Intervention/treatment Phase
CHF COPD Behavioral: Technology-assisted care transition intervention Behavioral: Active attention control Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Health Services Research
Official Title: A Technology-Assisted Care Transition Intervention for Veterans With Chronic Heart Failure or Chronic Obstructive Pulmonary Disease
Actual Study Start Date : May 1, 2018
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : September 30, 2020

Arm Intervention/treatment
Experimental: Technology-assisted care transition arm
In-patient virtual nurse on-screen touchscreen and outpatient virtual nurse follow-up by texting
Behavioral: Technology-assisted care transition intervention
In-patient virtual nurse on-screen touchscreen and outpatient virtual nurse follow-up by texting
Other Name: Virtual Nurse Annie Fox Intervention

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




Primary Outcome Measures :
  1. Pre-post change in urgent care service utilization [ Time Frame: Within six months ]
    Change in urgent care service utilization between intervention and control groups


Secondary Outcome Measures :
  1. 30-day sustained community tenure [ Time Frame: Within 30 days ]
    Sustained community tenure compared between the intervention and control groups post-intervention

  2. 30-day urgent care utilization [ Time Frame: Within 30 days ]
    30-day urgent care utilization compared between the intervention and control groups post-intervention



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02632552


Contacts
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Contact: Timothy P Hogan, PhD MS BS (781) 687-3181 timothy.hogan@va.gov
Contact: Lorilei M Richardson, MS MS PhD (781) 687-4032 lorilei.richardson@va.gov

Locations
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United States, California
VA Palo Alto Health Care System, Palo Alto, CA Recruiting
Palo Alto, California, United States, 94304-1290
Contact: Paul A Heidenreich, MD MS    650-493-5000    paul.heidenreich@va.gov   
Sub-Investigator: Paul A. Heidenreich, MD MS         
United States, Illinois
Edward Hines Jr. VA Hospital, Hines, IL Not yet recruiting
Hines, Illinois, United States, 60141-5000
Contact: Bridget M Smith    708-202-8387 ext 24870    bridget.smith@va.gov   
United States, Iowa
Iowa City VA Health Care System, Iowa City, IA Recruiting
Iowa City, Iowa, United States, 52246-2208
Contact: Bonnie J Wakefield, PhD RN    319-338-0581 ext 3869    Bonnie.Wakefield@va.gov   
Sub-Investigator: Peter J. Kaboli, MD MS         
United States, Massachusetts
Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA Active, not recruiting
Bedford, Massachusetts, United States, 01730
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA Recruiting
Boston, Massachusetts, United States, 02130
Contact: Steven R Simon, MD MPH BS    857-364-5704    steven.simon2@va.gov   
Sub-Investigator: Steven R Simon, MD MPH BS         
Sponsors and Collaborators
VA Office of Research and Development
Northeastern University
Investigators
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Principal Investigator: Timothy Patrick Hogan, PhD MS BS Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA

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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT02632552     History of Changes
Other Study ID Numbers: IIR 15-101
First Posted: December 16, 2015    Key Record Dates
Last Update Posted: August 26, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by VA Office of Research and Development:
care transition
technology
chronic heart failure
chronic obstructive pulmonary disease
virtual nurse
texting
informatics
Veterans