Chronic IllnessNCT01955005
Use of the My HealtheVet for Health Information Sharing
A study testing My HealtheVet Training and Internet Skills Training in people with Chronic Illness, run by VA Office of Research and Development at 1 site in United States.
Trial summary
This study aims to conduct a pilot of an intervention to improve care coordination between VA and non-VA providers using the Department of Veteran's Affairs' (VA) personal health record, My HealtheVet (MHV). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Illness
- What is being tested?
- My HealtheVet Training and Internet Skills Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2013to Sep 2014
- Phase
- Interventional
- 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
Who may be able to join
- Upcoming Non-VA provider appointment
- Take 5 or more prescribed medications
- Have or obtain a My HealtheVet premium account
- Access to computer, printer, \& Internet to complete study protocol
Who cannot join
- No non-VA provider or upcoming appointment
- Less than 5 medications
- No premium MHV account
Trial locations and contacts
1 site in 1 country.
United States1 site
Iowa City VA Health Care System, Iowa City, IA
Iowa City, Iowa, 52246-2208
About this study
Official title: Pilot of My HealtheVet Training to Improve Co-Managed Care for Veterans
This study aims to conduct a pilot of an intervention to improve care coordination between VA and non-VA providers using the Department of Veteran's Affairs' (VA) personal health record, My HealtheVet (MHV). Participants will be randomized to receive either training on 1) how to use My HealtheVet to share VA health information or 2) training on how to how to search the Internet for health information and decide which Internet sites have good quality information. The investigators predict that Veterans who receive the My HealtheVet training will have fewer medication errors and duplication of services between the VA and outside providers.
Read the detailed description
This study aims to conduct a pilot of an intervention to improve care coordination between VA and non-VA providers using the Department of Veteran's Affairs' (VA) personal health record, My HealtheVet (MHV). Background: The Blue Button feature of My HealtheVet allows Veterans to print out a comprehensive summary of their health that can be shared with non-VA providers. Dual use is common and has been associated with negative health outcomes including higher mortality. Preliminary data collected by the principal investigator in collaboration with the My HealtheVet Performance Evaluation workgroup shows that few Veterans enrolled in My HealtheVet use it to inform either VA or non-VA providers of their care. To remedy this, the principal investigator has developed an online video and companion paper-based training. This training will teach Veterans how to use the Blue Button feature and why it is important to share the print out with their non-VA provider. Methods: To participate, Veterans must have an upcoming non-VA provider appointment, be prescribed 5 or more medications, and be registered on My HealtheVet with a premium account. Participants will be randomized to receive either training on how to use the Blue Button or training on how to search for health information on the Internet and if that information is good quality. Veterans in both arms will receive training materials and phone support. After the non-VA provider visit, both the Veteran and the provider will be asked to indicate what occurred during the visit, including whether or not the Veteran gave the provider the Blue Button print out. Both Veterans and providers will also be asked to complete a 15-minute qualitative interview about their experience during the visit. Medical records of the non-VA provider visit will be obtained. Outcomes: The main outcome for the study is whether the patient provided the non-VA provider a copy of his or her health information printed from My HealtheVet. In addition, comparison between the VA and non-VA provider records will be conducted to test whether Veterans who completed the training had 1) better medication reconciliation between the VA and the non-VA provider and 2) fewer instances of therapeutic or laboratory duplication. The results of this pilot will be used to inform a larger randomized controlled trial of the training intervention.
- Conditions
- Chronic Illness
- Being tested
- My HealtheVet Training, Internet Skills Training
- Keywords
- Health Records, Personal, Delivery of healthcare, Consumer Participation, Internet
- Medical subject headings
- Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
My HealtheVet TrainingBehavioural
Participants will be asked to watch an on-line training video, review written materials, and print a document containing health information from their My HealtheVet account.
Internet Skills TrainingOther
Participants will review written training materials to learn how to search the Internet for health information and how to decide which Internet sites have good quality information.
| Study group | Role | What they receive |
|---|---|---|
| My HealtheVet Training | Experimental | Participants will be asked to watch an on-line training video, review written materials, and print a document containing health information from their My HealtheVet account. Receives: Behavioral: My HealtheVet Training |
| Internet Skills Training | Active comparator | Participants will review written training materials to learn how to search the Internet for health information and how to decide which Internet sites have good quality information. Receives: Other: Internet Skills Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Who Brought Their VA Information From My HealtheVet to Their Visit With Their Non-VA Provider
The primary outcome is whether or not the veteran brings their VA information from My HealtheVet to their visit with their non-VA provider. Providers will be asked to complete a form during the appointment where assessment of sharing this information is embedded in a checklist of possible visit activities. Participants will also if they provided this information to the provider in the event the provider opts to not return the form.
Measured: Within 1-2 week of non-VA provider visit
Secondary outcomes (2)
Proportion of Total Number of Unique Medications Discrepant Between VA and Non-VA Medication Lists
A medication discrepancy metric was be calculated by comparing the current VA medication list with the non-VA provider medication list to determine the total number of distinct medications. The number of discrepant medications between these lists is the numerator and is divided by the total number of distinct medications on both lists combined. This will yield a range of scores between score between 0 and 1, with 1 indicating perfect agreement between the two lists.
Measured: Typically within 1 month of non-VA provider visit
Proportion of Participants Who Received One or More Duplicate Laboratory Tests in the Non-VA Provider Visit.
Therapeutic duplication will be defined as concurrent use of more than one medication from the same therapeutic class. For laboratory duplication, we will review non-VA and VA medical records 6 months prior to the non-VA provider visit. Each patient will be assigned a dichotomous indicator for whether they received therapeutic duplication and/or laboratory duplication during their non-VA provider visit
Measured: Typically within 1 month of non-VA provider visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2013 (estimated)
- Study startOct 2013
- Primary completionSep 2014
- Study completionSep 2014
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.
- Other trials for Chronic IllnessStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Carolyn L Turvey, PhD MS, Principal investigator, Iowa City VA Health Care System, Iowa City, IA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01955005
- Sponsor's protocol ID
- PPO 13-178
- Status last verified
- Jan 2016
- First submitted
- 20 Aug 2013
- Last updated
- 5 Feb 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot of My HealtheVet Training to Improve Co-Managed Care for Veterans
- ClinicalTrials.gov ID
- NCT01955005
- Acronym / sponsor ID
- PPO 13-178
- Conditions
- Chronic Illness
- Keywords
- Health Records, Personal, Delivery of healthcare, Consumer Participation, Internet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- Oct 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 7 Oct 2013 (estimated)
- Results
- Posted 7 Jan 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to conduct a pilot of an intervention to improve care coordination between VA and non-VA providers using the Department of Veteran's Affairs' (VA) personal health record, My HealtheVet (MHV). Participants will be randomized to receive either training on 1) how to use My HealtheVet to share VA health information or 2) training on how to how to search the Internet for health information and decide which Internet sites have good quality information. The investigators predict that Veterans who receive the My HealtheVet training will have fewer medication errors and duplication of services between the VA and outside providers.
Detailed description
This study aims to conduct a pilot of an intervention to improve care coordination between VA and non-VA providers using the Department of Veteran's Affairs' (VA) personal health record, My HealtheVet (MHV). Background: The Blue Button feature of My HealtheVet allows Veterans to print out a comprehensive summary of their health that can be shared with non-VA providers. Dual use is common and has been associated with negative health outcomes including higher mortality. Preliminary data collected by the principal investigator in collaboration with the My HealtheVet Performance Evaluation workgroup shows that few Veterans enrolled in My HealtheVet use it to inform either VA or non-VA providers of their care. To remedy this, the principal investigator has developed an online video and companion paper-based training. This training will teach Veterans how to use the Blue Button feature and why it is important to share the print out with their non-VA provider. Methods: To participate, Veterans must have an upcoming non-VA provider appointment, be prescribed 5 or more medications, and be registered on My HealtheVet with a premium account. Participants will be randomized to receive either training on how to use the Blue Button or training on how to search for health information on the Internet and if that information is good quality. Veterans in both arms will receive training materials and phone support. After the non-VA provider visit, both the Veteran and the provider will be asked to indicate what occurred during the visit, including whether or not the Veteran gave the provider the Blue Button print out. Both Veterans and providers will also be asked to complete a 15-minute qualitative interview about their experience during the visit. Medical records of the non-VA provider visit will be obtained. Outcomes: The main outcome for the study is whether the patient provided the non-VA provider a copy of his or her health information printed from My HealtheVet. In addition, comparison between the VA and non-VA provider records will be conducted to test whether Veterans who completed the training had 1) better medication reconciliation between the VA and the non-VA provider and 2) fewer instances of therapeutic or laboratory duplication. The results of this pilot will be used to inform a larger randomized controlled trial of the training intervention.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| My HealtheVet Training | Experimental | Behavioral: My HealtheVet TrainingParticipants will be asked to watch an on-line training video, review written materials, and print a document containing health information from their My HealtheVet account. |
| Internet Skills Training | Active comparator | Other: Internet Skills TrainingParticipants will review written training materials to learn how to search the Internet for health information and how to decide which Internet sites have good quality information. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Upcoming Non-VA provider appointment
- Take 5 or more prescribed medications
- Have or obtain a My HealtheVet premium account
- Access to computer, printer, \& Internet to complete study protocol
Key exclusion criteria (3 listed)
- No non-VA provider or upcoming appointment
- Less than 5 medications
- No premium MHV account
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 |
|---|---|---|
| My HealtheVet TrainingParticipants will be asked to watch an on-line training video, review written materials, and print a document containing health information from their My HealtheVet account. | Behavioural | My HealtheVet Training |
| Internet Skills TrainingParticipants will review written training materials to learn how to search the Internet for health information and how to decide which Internet sites have good quality information. | Other | Internet Skills Training |
Primary outcome
Percentage of Participants Who Brought Their VA Information From My HealtheVet to Their Visit With Their Non-VA Provider
Time frame: Within 1-2 week of non-VA provider visit
The primary outcome is whether or not the veteran brings their VA information from My HealtheVet to their visit with their non-VA provider. Providers will be asked to complete a form during the appointment where assessment of sharing this information is embedded in a checklist of possible visit activities. Participants will also if they provided this information to the provider in the event the provider opts to not return the form.
2 secondary outcomes
Proportion of Total Number of Unique Medications Discrepant Between VA and Non-VA Medication Lists
Time frame: Typically within 1 month of non-VA provider visit
Proportion of Participants Who Received One or More Duplicate Laboratory Tests in the Non-VA Provider Visit.
Time frame: Typically within 1 month of non-VA provider visit
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Carolyn L Turvey, PhD MS principal investigator
Iowa City VA Health Care System, Iowa City, IA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing My HealtheVet Training and Internet Skills Training in people with Chronic Illness, run by VA Office of Research and Development 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 3 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 5 Feb 2016. 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?
Yes. Results are posted in the registry (first posted 7 Jan 2016). 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?
Percentage of Participants Who Brought Their VA Information From My HealtheVet to Their Visit With Their Non-VA Provider (time frame: Within 1-2 week of non-VA provider visit). 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 5 Feb 2016.