Chronic Disease, Mental IllnessNCT03089801
Tablet-Enabled Video Telehealth to Enhance Veterans' Access and Care
An observational study of Chronic Disease, Mental Illness, run by VA Palo Alto Health Care System at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Disease, Mental Illness
- What is being tested?
- Tablet-Enabled Video Telehealth
- Type of treatment
- Pill or oral medicine
- How many people
- 32,186 participants
- Where
- 1 siteUnited States
- Study dates
- May 2016to Sep 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All participants are Veterans who have received care at a VA facility in the past year.
Who may be able to join
- Must be a Veteran enrolled in a Veterans Affairs Health Care System, currently receiving care
- Must have a geographic, clinical, or social barrier that impedes access to in-person clinical and mental health services
- Veterans are referred for VA-issued tablets by their provider
- Exclusion Criteria: All Veterans who receive VA-issued tablets will be included in the evaluation. Veterans may opt out of the survey.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Palo Alto Health Care System
Palo Alto, California, 94304
About this study
Official title: Making Connections: Tablet-Enabled Video Telehealth to Enhance Veterans' Access and Care
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:
- 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.
- 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.
- Identify implementation barriers and facilitators to tablet distribution and use through interviews with clinicians and staff in a purposive sample of VA facilities
- 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).
Read the detailed 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:
- 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.
- 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).
- 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.
- 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.
- Conditions
- Chronic Disease, Mental Illness
- Being tested
- Tablet-Enabled Video Telehealth
- Keywords
- health care access, eHealth, telehealth
- Medical subject headings
- Chronic Disease, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tablet-Enabled Video TelehealthOther
Also called eHealth
Veterans referred for tablet-enabled video telehealth will receive a VA-issued tablet that can be used to communicate via video with health care providers (e.g., for chronic disease management, mental health treatment, palliative care).
| Study group | Role | What they receive |
|---|---|---|
| Tablet Recipients | Veteran patients who have received a VA-issued tablet for tablet-enabled video telehealth. Receives: Other: Tablet-Enabled Video Telehealth | |
| Usual Care | Veteran patients who match tablet recipients based on sociodemographic/clinical characteristics but have not received a VA-issued tablet. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Utilization of VA Services
Changes in patient use of VA services before/after receiving tablet
Measured: Up to 1 year after receipt of tablet
Secondary outcomes (4)
Satisfaction with VA Care
Survey-based measure of patient satisfaction with VA care
Measured: Baseline and 6 months follow-up after receipt of tablet
Access to VA Care
Survey-based measure of patient perceived access to needed services
Measured: Baseline and 6 months follow-up after receipt of tablet
Communication with Providers
Survey-based measure of patient perceived communication with providers
Measured: Baseline and 6 months follow-up after receipt of tablet
Evaluate feedback from the facilities that implement the tablet program
Assessment: Interview and survey questions on CFIR implementation constructs
Measured: Beginning 1 year after initial implementation of the program during 2017-2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2017
- Study startMay 2016
- Primary completionSep 2018
- Study completionSep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Disease, Mental IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 32,186 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Palo Alto Health Care System
- Sponsor type
- US federal agency
- Collaborators
- US Department of Veterans Affairs
- Responsible party
- Principal investigator, Donna Zulman, VA Palo Alto Health Care System
- Investigators
- Donna M Zulman, MD, MS, Principal investigator, VA Palo Alto Health Care System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03089801
- Sponsor's protocol ID
- 1
- Status last verified
- Nov 2018
- First submitted
- 9 Mar 2017
- Last updated
- 6 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Making Connections: Tablet-Enabled Video Telehealth to Enhance Veterans' Access and Care
- ClinicalTrials.gov ID
- NCT03089801
- Acronym / sponsor ID
- 1
- Conditions
- Chronic Disease, Mental Illness
- Keywords
- health care access, eHealth, telehealth
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32,186 participants (actual)
- Lead sponsor
- VA Palo Alto Health Care SystemUS federal agency
- Collaborators
- US Department of Veterans Affairs
- Study start
- May 2016 (actual)
- Primary completion
- Sep 2018 (actual)
- Study completion
- Sep 2018 (actual)
- First posted
- 24 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
- Identify implementation barriers and facilitators to tablet distribution and use through interviews with clinicians and staff in a purposive sample of VA facilities
- 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).
Detailed 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:
- 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.
- 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).
- 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.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tablet Recipients | – | Other: Tablet-Enabled Video TelehealthVeteran patients who have received a VA-issued tablet for tablet-enabled video telehealth. |
| Usual Care | – | –Veteran patients who match tablet recipients based on sociodemographic/clinical characteristics but have not received a VA-issued tablet. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All participants are Veterans who have received care at a VA facility in the past year.
Key inclusion criteria (4 listed)
- Must be a Veteran enrolled in a Veterans Affairs Health Care System, currently receiving care
- Must have a geographic, clinical, or social barrier that impedes access to in-person clinical and mental health services
- Veterans are referred for VA-issued tablets by their provider
- Exclusion Criteria: All Veterans who receive VA-issued tablets will be included in the evaluation. Veterans may opt out of the survey.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tablet-Enabled Video TelehealthAlso: eHealthVeterans referred for tablet-enabled video telehealth will receive a VA-issued tablet that can be used to communicate via video with health care providers (e.g., for chronic disease management, mental health treatment, palliative care). | Other | Tablet Recipients |
Primary outcome
Utilization of VA Services
Time frame: Up to 1 year after receipt of tablet
Changes in patient use of VA services before/after receiving tablet
4 secondary outcomes
Satisfaction with VA Care
Time frame: Baseline and 6 months follow-up after receipt of tablet
Access to VA Care
Time frame: Baseline and 6 months follow-up after receipt of tablet
Communication with Providers
Time frame: Baseline and 6 months follow-up after receipt of tablet
Evaluate feedback from the facilities that implement the tablet program
Time frame: Beginning 1 year after initial implementation of the program during 2017-2018
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Donna M Zulman, MD, MS principal investigator
VA Palo Alto Health Care System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Disease, Mental Illness, run by VA Palo Alto Health Care System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Utilization of VA Services (time frame: Up to 1 year after receipt of tablet). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2025.