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Clinical Trials/NCT02632552
NCT02632552
Completed
Not Applicable

A Technology-Assisted Care Transition Intervention for Veterans With Chronic Heart Failure or Chronic Obstructive Pulmonary Disease

VA Office of Research and Development5 sites in 1 country140 target enrollmentMay 1, 2018
ConditionsCHFCOPD

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
CHF
Sponsor
VA Office of Research and Development
Enrollment
140
Locations
5
Primary Endpoint
Pre-post Change in Combined Emergency and Urgent Care Service Utilization
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 1, 2018
End Date
August 31, 2021
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Outcome Measure Title: Self-Care of Heart Failure Index Score Comparison(Baseline and 30-day follow-up)
  • Health Distress Score Comparison(The Health Distress measure was assessed at baseline, 7 days post-discharge, and 30 days post-discharge.)
  • COPD Self-Management Scale Score Comparison(Baseline and 30-day follow-up)
  • Self-Efficacy for Managing Symptoms (PROMIS)(Enrolled Veterans with CHF and/or COPD who completed baseline and 30-day follow-up)
  • Self Efficacy for Managing Chronic Disease Scale Comparison(Baseline and 30-day follow-up.)
  • Self-Efficacy for Managing Medications and Treatments (PROMIS)(Enrolled Veterans with CHF and/or COPD who completed baseline and 30-day follow-up.)
  • Care Transition Measure (CTM) Score Comparison(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(ARMS questionnaires were given to all participants at baseline and again at 30-day post-discharge follow-up)

Study Sites (5)

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