- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01955005
Use of the My HealtheVet for Health Information Sharing
January 8, 2016 updated by: VA Office of Research and Development
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Iowa
-
Iowa City, Iowa, United States, 52246-2208
- Iowa City VA Health Care System, Iowa City, IA
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- No non-VA provider or upcoming appointment
- Less than 5 medications
- No premium MHV account
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: My HealtheVet Training
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.
|
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.
|
|
Active Comparator: Internet Skills Training
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Within 1-2 week of non-VA provider visit
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
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.
|
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
|
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
|
Typically within 1 month of non-VA provider visit
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Carolyn L Turvey, PhD MS, Iowa City VA Health Care System, Iowa City, IA
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2013
Primary Completion (Actual)
September 1, 2014
Study Completion (Actual)
September 1, 2014
Study Registration Dates
First Submitted
August 20, 2013
First Submitted That Met QC Criteria
September 26, 2013
First Posted (Estimate)
October 7, 2013
Study Record Updates
Last Update Posted (Estimate)
February 5, 2016
Last Update Submitted That Met QC Criteria
January 8, 2016
Last Verified
January 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PPO 13-178
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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