TelemedicineNCT01382186

Veterans Experiences Using Secure Messaging

An observational study of Telemedicine, run by US Department of Veterans Affairs at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Telemedicine
How many people: 852 participants
Where: 2 sitesUnited States
Study dates: Apr 2012to Sep 2013
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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
Healthy volunteers accepted
Adult, Older adult

Study population: Veterans in Tampa and Boston who have been Personally Authenticated for the SM feature on MHV.

Who may be able to join

Individuals who have been Personally Authenticated for the SM feature on MHV and
who use SM independent of other caregivers, and
cognitive impairment that prevents use of a personal computer.

Who cannot join

Unable or unwilling to provide informed consent.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Boston, Massachusetts, 02130
James A. Haley Veterans' Hospital, Tampa, FL
Tampa, Florida, 33612

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About this study

Official title: Veterans' Experiences Using Secure Messaging on MyHealtheVet

Deployment of Secure Messaging (SM) in primary care and women's clinics throughout the Veteran Health System by 2011 was an implementation priority for the Secretary and Under Secretary for Health for FY11 under the VHA T21 initiative. Secure Messaging is in early phases of implementation, this eHealth tool requires thoughtful evaluation to promote the successful implementation and dissemination of this tool. The primary aim of this project is to describe Veterans' experiences when using the SM feature on MyHealtheVet (MHV). This project has local, VISN, and national impact on the implementation and sustainability of the SM feature on MHV through its qualitative and quantitative examination of users' experiences. Findings from this research explores why Veterans choose to, or not to, use the SM feature on MHV, identify facilitators and barriers, and examine if experiences differ by health literacy or computer literacy. In addition to the interview data, findings from the usability testing and the quantitative survey findings build knowledge about Veterans' experiences using the SM feature on MyHealtheVet. These data will inform systems improvements, educational approaches, and marketing strategies to increase adoption and long-term utilization among Veterans.

Read the detailed description

Project Background:

Secure Messaging is a VHA implementation priority to improve Veteran access to care. Successful deployment of Secure Messaging will support improved access to care, and improved healthcare outcomes in the Veteran population. To support these initiatives, and the successful implementation of this health informatics tools in the VHA, this project is exploring Veterans' perspectives' about adopting Secure Messaging and their experiences using Secure Messaging to inform systems improvements, educational approaches, and marketing strategies.

Objectives:

The primary aim of this project is to describe Veterans' experiences when using the Secure Messaging feature on My HealtheVet (MHV). This research is designed to explore why Veterans choose to, or not to, use the Secure Messaging feature on MHV, identify facilitators and barriers, and examine if experiences differ by health literacy or computer literacy. In addition to the interview data, findings from the usability testing provide user data about Veterans' skills and patterns when using Secure Messaging. This study was extended to conduct a mail-in quantitative survey evaluation of Veterans experiences, preferences, purposes and perceived facilitators and barriers for using, or not using Secure Messaging.

Methods:

This is a prospective mixed-methods descriptive study.

In Phase One: A purposive sampling was used to identify the sample of Veterans who have been Personally Authenticated for the Secure Messaging feature on My HealtheVet. Participants were recruited from two sites (Tampa n=18, Boston n=15). Phase 1 data collection procedures included: (1) surveys; (2) In-person interviews; (3) usability testing; (4) Secure Messaging secondary data collection; and (5) telephone interviews to complete study objectives.

In Phase Two: Random sampling was used to collect mail-in survey data from up to 1,000 Veteran participants who have been personally authenticated to use secure messaging. Quantitative data will be summarized using descriptive statistics to describe sample characteristics, frequency counts and proportions.

Study Status: The project team has completed data collection and analysis for Phase 1 and 2. Team is currently working on publications for dissemination.

Conditions: Telemedicine
Keywords: Qualitative, User, Computer Interface, quantitative, survey, telemedicine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01382186
Study group	Role	What they receive
Purposive Sampling		Purposive sampling was used to identify a sample of 33 Veterans who have been Personally Authenticated for the SM feature on MHV. Participants were recruited from each site (Tampa, Boston). Women were purposively recruited to ensure females were represented in data findings.
Random Sampling		Random sampling was used to conduct a quantitative survey with 819 veterans to explore their experiences using secure messaging.

What is being measured

The primary outcome is the main question the study is designed to answer.

Usability of Secure Messaging
To determine ease of use and usefulness of secure messaging. Purposive sample of 33 participants were assessed for their ability to complete the following tasks: navigate to Secure Messaging, log-in to My HealtheVet and Secure Messaging, Set user preferences, check Secure Message inbox, open and send Secure Message, Open and read Secure Message attachment. Measured as: (1) able to complete task; (2) able to complete task with some difficulty; (3) not able to complete task.
Measured: baseline
Secure Messaging Use and Content Patterns
Extraction of secure messages over a three-month time frame to examine message content type, including: general, tests, medication, and appointments.
Measured: 3 months
Frequency of Electronic Resource Use
Mail surveys examine Veterans frequency of electronic resource use.
Measured: baseline
Reasons for Using Secure Messaging Tool on My HealtheVet
Participants reported reasons for Using Secure Messaging tool on My HealtheVet
Measured: baseline
Benefits of Using Secure Messaging
Veterans report benefits of using Secure Messaging
Measured: baseline
Intention to Use Secure Messaging in the Future
Veteran respondent intention to use Secure Messaging in the future
Measured: baseline
Veterans That Believed Improvements to the Secure Messaging System Would Make the Tool More Useful in the Future Are Presented in the Table.
Veterans were asked to report if improvements to the secure messaging system would make the tool more useful for use in the future.
Measured: baseline
Veteran Need for Education Support for My HealtheVet and Secure Messaging Use.
Veterans were asked to report if they would like to have education and support using My HealtheVet and the Secure Messaging tool.
Measured: baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2012Sep 2013

First posted27 Jun 2011 (estimated)
Study startApr 2012
Primary completionSep 2013
Study completionSep 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for TelemedicineStudies 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: Prospective
Enrolment: 852 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01382186
Sponsor's protocol ID: RRP 11-397
Status last verified: Oct 2014
First submitted: 15 Jun 2011
Last updated: 28 Apr 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Haun JN, Lind JD, Shimada SL, Martin TL, Gosline RM, Antinori N, Stewart M, Simon SR. Evaluating user experiences of the secure messaging tool on the Veterans Affairs' patient portal system. J Med Internet Res. 2014 Mar 6;16(3):e75. doi: 10.2196/jmir.2976.
PubMed 24610454
Haun J, Lind JD, Shimada SL, Simon SR. Secure Messaging as a tool to facilitate Veteran-provider communication. Annals of anthropological practice. 2013 Jan 1; 37(2):57-74.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 28 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Veterans' Experiences Using Secure Messaging on MyHealtheVet
ClinicalTrials.gov ID: NCT01382186
Acronym / sponsor ID: RRP 11-397
Conditions: Telemedicine
Keywords: Qualitative, User, Computer Interface, quantitative, survey, telemedicine
Study type: Observational
Recruitment status: Completed
Enrolment: 852 participants (actual)
Lead sponsor: US Department of Veterans AffairsUS federal agency
Study start: Apr 2012
Primary completion: Sep 2013 (actual)
Study completion: Sep 2013 (actual)
First posted: 27 Jun 2011 (estimated)
Results: Posted 23 Feb 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Project Background:

Objectives:

Methods:

This is a prospective mixed-methods descriptive study.

Study Status: The project team has completed data collection and analysis for Phase 1 and 2. Team is currently working on publications for dissemination.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
Purposive Sampling	–	–Purposive sampling was used to identify a sample of 33 Veterans who have been Personally Authenticated for the SM feature on MHV. Participants were recruited from each site (Tampa, Boston). Women were purposively recruited to ensure females were represented in data findings.
Random Sampling	–	–Random sampling was used to conduct a quantitative survey with 819 veterans to explore their experiences using secure messaging.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult
Study population: Veterans in Tampa and Boston who have been Personally Authenticated for the SM feature on MHV.

Key inclusion criteria (3 listed)

Individuals who have been Personally Authenticated for the SM feature on MHV and
who use SM independent of other caregivers, and
cognitive impairment that prevents use of a personal computer.

Key exclusion criteria (1 listed)

Unable or unwilling to provide informed consent.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Usability of Secure Messaging
Time frame: baseline
To determine ease of use and usefulness of secure messaging. Purposive sample of 33 participants were assessed for their ability to complete the following tasks: navigate to Secure Messaging, log-in to My HealtheVet and Secure Messaging, Set user preferences, check Secure Message inbox, open and send Secure Message, Open and read Secure Message attachment. Measured as: (1) able to complete task; (2) able to complete task with some difficulty; (3) not able to complete task.
Secure Messaging Use and Content Patterns
Time frame: 3 months
Extraction of secure messages over a three-month time frame to examine message content type, including: general, tests, medication, and appointments.
Frequency of Electronic Resource Use
Time frame: baseline
Mail surveys examine Veterans frequency of electronic resource use.
Reasons for Using Secure Messaging Tool on My HealtheVet
Time frame: baseline
Participants reported reasons for Using Secure Messaging tool on My HealtheVet
Benefits of Using Secure Messaging
Time frame: baseline
Veterans report benefits of using Secure Messaging
Intention to Use Secure Messaging in the Future
Time frame: baseline
Veteran respondent intention to use Secure Messaging in the future
Veterans That Believed Improvements to the Secure Messaging System Would Make the Tool More Useful in the Future Are Presented in the Table.
Time frame: baseline
Veterans were asked to report if improvements to the secure messaging system would make the tool more useful for use in the future.
Veteran Need for Education Support for My HealtheVet and Secure Messaging Use.
Time frame: baseline
Veterans were asked to report if they would like to have education and support using My HealtheVet and the Secure Messaging tool.

Results and safety

Results posted to the registry on 23 Feb 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Purposive Sampling	33	32
Random Sampling	819	819

Primary outcome: Usability of Secure Messaging

Time frame: baseline. Number. Unit: participants

Measure	Purposive Sampling: Able to Complete Task n = 33	Purposive Sampling: Able to Complete Task With Difficulty n = 33	Purposive Sampling: Not Able to Complete Task n = 33
Navigate to My HealtheVet Site	21	10	2
Log in to site	30	2	1
Set "User Preferences"	23	8	2
Check inbox	33	0	0
Use links within Secure Messaging	33	0	0
Open Secure Message	33	0	0
Open attachment	33	0	0
Send secure message	30	3	0

Population analysed: This user-testing method was conducted with the first purposive sample of 33 participants in phase 1 of the study. The random sample of 819 participants in phase 2 were not a part of the user-testing study method.

Primary outcome: Secure Messaging Use and Content Patterns

Time frame: 3 months. Number. Unit: secure messages

Measure	Purposive Sampling n = 33
General	36
Test	1
Appointment	15
Medication	10
Other: System Related not Content Related	4

Population analysed: This method of secondary data collection was conducted with the purposive sample of 33 Veterans in phase 1 of the study. The random sample of 819 Veteran survey respondents in phase 2 were not included in this method of data collection.

Primary outcome: Frequency of Electronic Resource Use

Time frame: baseline. Number. Unit: participants

Measure	Random Sampling n = 819
Everyday use of computer	662
Everyday use of internet	653
Use My HealtheVet "a few times a month or less"	629
Using secure messaging 6 months or longer	499
Use secure messaging at least once a year	486
Use secure messaging at least once a month	131

Population analysed: This is a primary outcome for phase 2 of the study which was measured in random sample of 819 Veterans. The purposive sample of 33 Veterans from phase 1 was not included in this method of the study.

Primary outcome: Reasons for Using Secure Messaging Tool on My HealtheVet

Time frame: baseline. Number. Unit: participant

Measure	Random Sampling n = 819
Completing medication refills	546
Medication questions	313
Managing appointments	343
Test results	350
Health related questions	340
Sensitive health topics	67

Population analysed: This is a primary outcome for phase 2 of the study which was measured in random sample of 819 Veterans registered for My HealtheVet and opted in to use Secure Messaging. The sample of 33 Veterans from phase 1 was not included in this method of the study.

Adverse events

Time frame: 2 years. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Purposive Sampling	0 of 0	0 of 0	Not reported
Random Sampling	0 of 0	0 of 0	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 24610454Haun JN, Lind JD, Shimada SL, Martin TL, Gosline RM, Antinori N, Stewart M, Simon SR. Evaluating user experiences of the secure messaging tool on the Veterans Affairs' patient portal system. J Med Internet Res. 2014 Mar 6;16(3):e75. doi: 10.2196/jmir.2976.
Results publicationHaun J, Lind JD, Shimada SL, Simon SR. Secure Messaging as a tool to facilitate Veteran-provider communication. Annals of anthropological practice. 2013 Jan 1; 37(2):57-74.

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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.

Jolie N. Haun, PhD MS BS principal investigator

James A. Haley Veterans' Hospital, Tampa, FL

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Telemedicine, run by US Department of Veterans Affairs at 2 sites 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 3 inclusion and 1 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 28 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

Yes. Results are posted in the registry (first posted 23 Feb 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Usability of Secure Messaging (time frame: baseline). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01382186, which also lists 2 linked publications.

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 28 Apr 2015.