- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02953262
Improving Diabetes Care Through Effective Personalized Patient Portal Interactions
Study Overview
Status
Conditions
Detailed Description
The goal of this small scale study is to test the feasibility of engaging Veterans in a supported adoption intervention to promote effective patient portal use in a sample of Veterans with uncontrolled Type II diabetes.
Participants were eligible for recruitment if they were Veterans age 18-85 who were actively receiving care at one of the study sites (as determined by having an upcoming scheduled appointment), had uncontrolled glucose (HbA1c >= 8.5%), and had either never used the VA patient portal or were inactive registrants who have not used the patient portal in the past 12 months. Participants who met these conditions and did not opt out of the study were randomized to one of four arms: 1) Encouragement I (brochure + mailed training guide), 2) Encouragement II (brochure + mailed training guide + invitation to group training), 3) Encouragement III (brochure + mailed training guide + invitation to group and one-on-one training), and 4) Comparison (standard patient portal enrollment brochure only). All arms received the standard My HealtheVet patient portal enrollment brochure along with an invitation to participate in the study. Those randomized to any of the Encouragement Arms received a mailed training guide. The My HealtheVet Training Guide for Veterans Living with Diabetes was designed in conjunction with Veteran co-investigators based on feedback from patients living with diabetes who were My HealtheVet users. It provided step by step guidance on how to use the features Veterans living with diabetes find most helpful with specific examples of use for diabetes self-management. Those in Encouragement Arm II were also invited to attend one of several group training sessions. Those in Encouragement III were invited to schedule a one-on one session to learn how to use the patient portal. Those in the comparison condition were asked during their interview if they would like a Training Guide mailed to them at the end of the trial, and those interested were mailed a Training Guide.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Massachusetts
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Bedford, Massachusetts, United States, 01730-1114
- VA Bedford HealthCare System, Bedford, MA
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Boston, Massachusetts, United States, 02130-4817
- VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Veterans
- Hemoglobin A1c result >=8.5% at most recent lab test prior to recruitment
- Non use of the VA patient portal, defined by not being registered or registered with no activity in 12 months
- Currently being seen at one of the sites participating in the study (upcoming appointment scheduled)
Exclusion Criteria:
- Non-Veterans
- Controlled hemoglobin A1c levels (A1c<8.5%) at most recent lab test prior to recruitment
- Recent use of the patient portal
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Encouragement Arm 1
Participants in this encouragement condition will receive a mailed brochure with basic My HealtheVet content and a training guide with (a) insights from other Veterans on how to use My HealtheVet for diabetes self-management, (b) step-by-step guidance for how to sign up for My HealtheVet and, (c) detailed guidance on how to learn to use key features.
|
Participants will receive a mailed brochure with basic My HealtheVet content.
Participants will be mailed a bound My HealtheVet training guide with step by step instructions on how to register, upgrade to Premium account, refill prescriptions, use secure messaging, download their Blue Button reports, and other features
Participants will be invited to participate in a scheduled group training to learn how to use My HealtheVet to help manage their diabetes
Participants will be invited to participate in a one-on-one training to learn how to use My HealtheVet to help manage their diabetes at a time of their convenience.
|
Experimental: Encouragement Arm 2
Participants in this encouragement condition will receive the same brochure and training guide as Arm 1 but will also be offered optional attendance at one of several group training sessions.
|
Participants will receive a mailed brochure with basic My HealtheVet content.
Participants will be mailed a bound My HealtheVet training guide with step by step instructions on how to register, upgrade to Premium account, refill prescriptions, use secure messaging, download their Blue Button reports, and other features
Participants will be invited to participate in a scheduled group training to learn how to use My HealtheVet to help manage their diabetes
|
Experimental: Encouragement Arm 3
Participants in this encouragement condition will receive the same as in Arm 2 (brochure, training guide, and group training offer) but will also be offered a one-on-one My HealtheVet training session.
|
Participants will be mailed a bound My HealtheVet training guide with step by step instructions on how to register, upgrade to Premium account, refill prescriptions, use secure messaging, download their Blue Button reports, and other features
Participants will be invited to participate in a scheduled group training to learn how to use My HealtheVet to help manage their diabetes
|
Other: Brochure Only Comparison Arm
The Comparison condition will only receive a mailed brochure with basic My HealtheVet content during the trial.
(The training guide will be mailed to them after completion of the interview at the end.)
|
Participants will be invited to participate in a scheduled group training to learn how to use My HealtheVet to help manage their diabetes
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Any My HealtheVet Patient Portal Use
Time Frame: Portal use within 180 days of initial brochure mailing
|
This measure captures any use of MHV within 180 days of the brochure mailing, including use of prescription refills, secure messaging, Blue Button, or any other portal features.
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Portal use within 180 days of initial brochure mailing
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient Upgraded to a Premium My HealtheVet Portal Account
Time Frame: 180 days from brochure mailing
|
After registering for the portal, patients must confirm their identity and accept the terms and conditions of the portal in order to upgrade to Premium status which allows access to secure messaging, their VA appointments, and electronic health record extracts such as lab results, medical imaging and reports, clinical notes, and their VA health summary.
Patients can access a limited subset of portal features, including online prescription refills, without upgrading to Premium.
This measure captures whether a participant upgraded to a Premium account during the trial.
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180 days from brochure mailing
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Use of Online Prescription Refills
Time Frame: 180 days from brochure mailing
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This measure captures whether the participant used the portal's online prescription refill feature at least once within 180 days of mailing the brochure.
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180 days from brochure mailing
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Use of Secure Messaging
Time Frame: 180 days from brochure mailing
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Patient used the secure messaging feature during the trial
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180 days from brochure mailing
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Collaborators and Investigators
Investigators
- Principal Investigator: Stephanie L Shimada, PhD, VA Bedford HealthCare System, Bedford, MA
Publications and helpful links
General Publications
- Robinson SA, Zocchi MS, Netherton D, Ash A, Purington CM, Connolly SL, Vimalananda VG, Hogan TP, Shimada SL. Secure Messaging, Diabetes Self-management, and the Importance of Patient Autonomy: a Mixed Methods Study. J Gen Intern Med. 2020 Oct;35(10):2955-2962. doi: 10.1007/s11606-020-05834-x. Epub 2020 May 21.
- Stewart MT, Hogan TP, Nicklas J, Robinson SA, Purington CM, Miller CJ, Vimalananda VG, Connolly SL, Wolfe HL, Nazi KM, Netherton D, Shimada SL. The Promise of Patient Portals for Individuals Living With Chronic Illness: Qualitative Study Identifying Pathways of Patient Engagement. J Med Internet Res. 2020 Jul 17;22(7):e17744. doi: 10.2196/17744.
- Zocchi MS, Robinson SA, Ash AS, Vimalananda VG, Wolfe HL, Hogan TP, Connolly SL, Stewart MT, Am L, Netherton D, Shimada SL. Patient portal engagement and diabetes management among new portal users in the Veterans Health Administration. J Am Med Inform Assoc. 2021 Sep 18;28(10):2176-2183. doi: 10.1093/jamia/ocab115.
- Robinson SA, Netherton D, Zocchi M, Purington C, Ash AS, Shimada SL. Differences in Secure Messaging, Self-management, and Glycemic Control Between Rural and Urban Patients: Secondary Data Analysis. JMIR Diabetes. 2021 Nov 19;6(4):e32320. doi: 10.2196/32320.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IIR 15-307
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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