Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03089801 |
| Other study ID # |
1 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
May 2016 |
| Est. completion date |
September 2018 |
Study information
| Verified date |
November 2018 |
| Source |
VA Palo Alto Health Care System |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
In order to enhance access to clinical and mental health services for Veterans who have
geographic, clinical, or social barriers to in-person care, VA Offices of Connected Care and
Rural Health began distributing 5,000 tablets to Veterans with access barriers in 2016. The
objective of this Quality Improvement evaluation is to:
1. Understand characteristics of Veterans who received tablets, the frequency and ways in
which they used the tablets, and the effects of tablet use on access to VA services.
2. Through a survey of Veterans, evaluate patient experiences using the tablets, and
determine how tablets influenced patients' experiences with VA care, including their
satisfaction, communication with providers, and access to needed services.
3. Identify implementation barriers and facilitators to tablet distribution and use through
interviews with clinicians and staff in a purposive sample of VA facilities
4. Evaluate the effects of tablet use on chronic medical condition outcomes (e.g.,
hypertension, diabetes) and mental health treatment initiation and engagement (e.g., for
depression, PTSD, and substance use).
Description:
Background:
Telehealth is a cornerstone of enhanced access for Veterans and across a range of conditions
is associated with improved disease control, quality of life, and patient satisfaction.
Increasingly Veterans are able to monitor their chronic conditions and communicate with
clinicians and care teams via tablets and other devices. However, this service is currently
only available to Veterans with in-home Internet and video capability, or Veterans who are
able to travel to a VA community based outpatient clinics to connect with providers at other
facilities. In 2016, in order to address this access gap and disparity, VA launched an
initiative to distribute tablets to Veterans who have clinical needs for remote care, and
barriers to traditional in-person access.
Veterans who meet specific need-based (access, technology, and clinical) criteria may be
issued one of two devices: Commercially available Off the Shelf (COTS) for basic connectivity
or Healthcare Access Tablet (HAT) with a general exam camera and optional peripheral devices
(i.e., stethoscope, BP monitor, pulse oximeter, thermometer, or weight scale). VA providers
refer eligible patients for the devices using a consult template in VA's electronic health
record. Care delivered via the tablet is indicated in the referral and may include one or
more of the following: Home Based Primary Care, Palliative Care, Mental Health Intensive Case
Management, Spinal Cord Injury, Mental Health Care, care for patients with marked mobility
problems, care for patients with cognitive problems (these patients must have a caregiver who
can assist with technology), home evaluations, and rehabilitation/prosthetics. Once the
patient is issued the device, he or she will receive tablet services from trained
teleproviders.
The VA began distributing tablets in the spring of 2016, with the plan of distributing 5,000
tablets over the following 1-2 years. Veteran eligibility criteria for tablets include the
following: 1) Enrolled in VA Healthcare, 2) Does not own a device or does not have working
broadband or cellular internet connection, 3) Physically and cognitively able to operate the
technology (or has caregiver who can assist), 4) Barriers to access, such as a) distance or
geography, b) transportation issues, c) homebound or difficulty leaving home, d) other
(described by provider), and 5) Provider and patient give informed consent agreeing to
utilize telehealth for care.
The tablet initiative and evaluation have been designated as Quality Improvement by VA's
Office of Rural Health. The evaluation will include the following:
1. Tablet Recipient Characteristics, Use of Tablets, and Effects on Access. The
investigators will first characterize Veterans who are issued and use the devices (e.g.,
age, sex, medical and mental health conditions, rural location/distance from VA).
Investigators will describe the frequency of tablet use and the types of services that
the Veteran receives (e.g., chronic disease management, mental health therapy,
palliative care, home-based primary care). Investigators will analyze rates of in-person
(outpatient, emergency care), telephone, and telehealth-based care before and after
tablet distribution, and compare patterns to those observed in a cohort of comparable
patients to assess whether tablets influence access and patterns of use.
2. Effects on Patient Experience. For patients receiving tablets beginning in March, 2017,
the investigators will administer a survey at time of tablet receipt, and 3-6 months
after that time, to examine changes in patients' satisfaction with VA care and their
perceived access and communication, and to evaluate their experiences using the tablets.
The survey will also assess patients' needs and risk factors (e.g., social support,
health literacy), and how these factors impact patients' experiences with the tablets
and VA care. If resources permit, the survey may be administered to a cohort of
comparable patients who have not received tablets (to be determined as of March, 2017).
3. Implementation Evaluation. The implementation evaluation will be guided by the
Consolidated Framework for Implementation Research (CFIR). The investigators will first
administer an online survey to Facility Telehealth Coordinators (FTCs) at facilities
that are distributing tablets. The survey will query FTCs about the tablet initiative,
resources that facilitated implementation, and barriers that impeded implementation. The
investigators will use survey responses to identify FTCs who represent a range of VA
facilities (in terms of high vs. low tablet distribution rates). Follow-up interviews
will be conducted by telephone. The investigators will transcribe and code the
interviews using standard content analysis methods with the goal of understanding
barriers and facilitators to tablet distribution within each of the CFIR domains.
4. Effects on Chronic Disease and Mental Health Outcomes. If resources are available in
FY18, the investigators will evaluate how device distribution influences clinical
outcomes for Veterans with common and high-risk conditions, such as hypertension,
diabetes, and PTSD (conditions to be determined based on prevalence rates in the tablet
recipient population). The investigators will compare measures of disease control (e.g.,
blood pressure readings, hemoglobin A1C levels) at 3 and 6 months after device shipment,
and compare these levels to comparable patients from other facilities, using propensity
scores to match patients on the basis of sociodemographic and clinical characteristics.
The investigators will use similar methods to examine treatment initiation and
engagement rates among patients with common mental health conditions, such as
depression, PTSD, and substance use disorder.
The proposed project will be conducted with support from the eHealth Partnered Evaluation
Initiative, a partnership between QUERI and Office of Connected Health that aims to evaluate
the implementation of patient-provider technologies across VA, and understand their impacts
on Veteran experience, perceived burdens and benefits to clinical teams, access to care,
other care processes, and Veteran health outcomes.
