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

COPD Clinical Trial

— TACT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02632552
• Other study ID #: IIR 15-101
• Status: Completed
• Phase: N/A
• Start date: May 1, 2018
• Est. completion date: August 31, 2021

Study information

• Verified date: July 2023
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: August 31, 2021
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• CHF
• COPD

Intervention

Behavioral:
• Technology-assisted care transition intervention
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

Locations

Country	Name	City	State
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	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 Palo Alto Health Care System, Palo Alto, CA	Palo Alto	California

Sponsors (2)

Lead Sponsor	Collaborator
VA Office of Research and Development	Northeastern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	18 months prior to enrollment and 12 months post-discharge
Secondary	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.	Responses to the CTM were collected from the intervention and control groups 7 days post-discharge.
Secondary	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.	ARMS questionnaires were given to all participants at baseline and again at 30-day post-discharge follow-up
Secondary	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.	The Health Distress measure was assessed at baseline, 7 days post-discharge, and 30 days post-discharge.
Secondary	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.	Baseline and 30-day follow-up.
Secondary	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.	Baseline and 30-day follow-up
Secondary	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.	Baseline and 30-day follow-up
Secondary	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.	Enrolled Veterans with CHF and/or COPD who completed baseline and 30-day follow-up
Secondary	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.	Enrolled Veterans with CHF and/or COPD who completed baseline and 30-day follow-up.