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

NCT02632552 | Completed Results DMC

• 1 other identifier: IIR 15-101
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 5

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.

Conditions

CHF; COPD

Keywords

care transition; technology; chronic heart failure; chronic obstructive pulmonary disease; virtual nurse; texting; informatics; Veterans

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• 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

• Health Distress Score Comparison

  The Health Distress measure was assessed at baseline, 7 days post-discharge, and 30 days post-discharge.

• Self Efficacy for Managing Chronic Disease Scale Comparison

  Baseline and 30-day follow-up.

• Outcome Measure Title: Self-Care of Heart Failure Index Score Comparison

  Baseline and 30-day follow-up

Study Arms (2)

Technology-assisted care transition arm

EXPERIMENTAL

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

Behavioral: Technology-assisted care transition intervention

Active attention control

ACTIVE COMPARATOR

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

Interventions

Technology-assisted care transition intervention BEHAVIORAL

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

Also known as: Virtual Nurse Annie Fox Intervention

Technology-assisted care transition arm

Active attention control BEHAVIORAL

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

Active attention control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead
• Northeastern University: collaborator

Study Sites (5)

VA Palo Alto Health Care System, Palo Alto, CA

Palo Alto, California, 94304-1207, United States

Location

Edward Hines Jr. VA Hospital, Hines, IL

Hines, Illinois, 60141-5000, United States

Location

Iowa City VA Health Care System, Iowa City, IA

Iowa City, Iowa, 52246-2292, United States

Location

VA Bedford HealthCare System, Bedford, MA

Bedford, Massachusetts, 01730-1114, United States

Location

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

Boston, Massachusetts, 02130-4817, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

It is important to interpret the results in light of this study's sample size limitations. Enrollment was slow and compounded by a recruitment halt during COVID-19. While we believe that we have a sufficient sample to examine utilization outcomes, enrollment was still less than anticipated. Lastly, it can be difficult to determine meaningful differences for the secondary outcomes used in this study, especially in light of the complex patient population and the novelty of the intervention tested.

Results Point of Contact

• Title: Timothy P. Hogan, PhD,
• Organization: U.S. Department of Veterans Affairs, Center for Healthcare Organization and Implementation Research (CHOIR)

Timothy.Hogan@VA.gov

508-244-2303

Study Officials

• Timothy Patrick Hogan, PhD MS BS

  VA Bedford HealthCare System, Bedford, MA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2015
• First Posted: December 16, 2015
• Study Start: May 1, 2018
• Primary Completion: June 30, 2020
• Study Completion: August 31, 2021
• Last Updated: July 27, 2023
• Results First Posted: November 4, 2021

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)