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Improving Diabetes Care Through Effective Personalized Patient Portal Interactions

Improving Diabetes Care Through Effective Personalized Patient Portal Interactions

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02953262
Enrollment
275
Registered
2016-11-02
Start date
2019-07-22
Completion date
2020-09-30
Last updated
2023-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus

Keywords

Diabetes Mellitus, Personal Health Records, Patient Outcome Assessment, Mental Health

Brief summary

Patient-facing eHealth technologies, such as online patient portals, connect patients with the healthcare system, help them access their health information, and support self-management of health conditions. This study tested an intervention to improve adoption and use of the My HealtheVet patient portal for diabetes management.

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.

Interventions

BEHAVIORALMy HealtheVet Training Guide for Veterans Living with Diabetes

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

BEHAVIORALMy HealtheVet Brochure

Participants will receive a mailed brochure with basic My HealtheVet content.

BEHAVIORALMy HealtheVet Group Training

Participants will be invited to participate in a scheduled group training to learn how to use My HealtheVet to help manage their diabetes

BEHAVIORALMy HealtheVet Individual Training

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.

Sponsors

VA Office of Research and Development
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Subject)

Masking description

Participants were not explicitly told which group they were randomized to

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Any My HealtheVet Patient Portal UsePortal use within 180 days of initial brochure mailingThis 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.

Secondary

MeasureTime frameDescription
Patient Upgraded to a Premium My HealtheVet Portal Account180 days from brochure mailingAfter 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.
Use of Online Prescription Refills180 days from brochure mailingThis measure captures whether the participant used the portal's online prescription refill feature at least once within 180 days of mailing the brochure.
Use of Secure Messaging180 days from brochure mailingPatient used the secure messaging feature during the trial

Countries

United States

Participant flow

Recruitment details

Patients meeting eligibility criteria were identified from clinical records and mailed an invitation to participate in the study along with a My HealtheVet brochure and an information sheet describing the study. Initial invitations were sent out in June 2019 at Site 1 and in December 2019 at Site 2. Patients who did not opt out were enrolled and randomized into study arms in July 2019 and January 2020, respectively.

Pre-assignment details

One patient was mistakenly randomized to an arm even though he was deceased shortly prior to enrollment because he met the eligibility criteria according to our databases, including having a future appointment scheduled. Fifteen patients from one site were incorrectly identified as not having used the portal in the 12 months prior to the trial and were excluded from the analyses.

Participants by arm

ArmCount
Brochure Only Comparison Arm
The comparison condition only received a mailed brochure with basic My HealtheVet content during the trial. After the completion of their telephone interview, they were offered a copy of the training guide.
65
Encouragement Arm 1
Participants in this encouragement condition received a brochure about the My HealtheVet portal and were also mailed 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.
63
Encouragement Arm 2
Participants in this encouragement condition received the My HealtheVet brochure and training guide, but were also offered optional attendance at one of several group training sessions.
65
Encouragement Arm 3
Participants in this encouragement condition received the same encouragement as in Arm 2 (brochure, training guide and group training offer) but were also offered a one-on-one My HealtheVet training session.
67
Total260

Withdrawals & dropouts

PeriodReasonFG000FG001FG002FG003
Overall StudyUsed portal during 6 months prior to randomization3633

Baseline characteristics

CharacteristicEncouragement Arm 1TotalEncouragement Arm 3Brochure Only Comparison ArmEncouragement Arm 2
Age, Continuous68.3 years
STANDARD_DEVIATION 8.8
68.7 years
STANDARD_DEVIATION 9.2
70.0 years
STANDARD_DEVIATION 9.1
67.7 years
STANDARD_DEVIATION 10.3
68.5 years
STANDARD_DEVIATION 8.8
Average HbA1c at baseline (2019)9.3 % (DCCT units)
STANDARD_DEVIATION 1
9.4 % (DCCT units)
STANDARD_DEVIATION 1.2
9.3 % (DCCT units)
STANDARD_DEVIATION 1.1
9.6 % (DCCT units)
STANDARD_DEVIATION 1.3
9.5 % (DCCT units)
STANDARD_DEVIATION 1.3
Marital Status
Divorced/Separated
14 Participants75 Participants18 Participants19 Participants24 Participants
Marital Status
Married
30 Participants125 Participants34 Participants30 Participants31 Participants
Marital Status
Single
15 Participants44 Participants12 Participants12 Participants5 Participants
Marital Status
Widowed
4 Participants16 Participants3 Participants4 Participants5 Participants
Race/Ethnicity, Customized
Black/African-American
6 Participants20 Participants5 Participants5 Participants4 Participants
Race/Ethnicity, Customized
Latino
5 Participants13 Participants0 Participants4 Participants4 Participants
Race/Ethnicity, Customized
Other
1 Participants3 Participants2 Participants0 Participants0 Participants
Race/Ethnicity, Customized
Unknown/Missing
4 Participants11 Participants5 Participants2 Participants0 Participants
Race/Ethnicity, Customized
White
47 Participants213 Participants55 Participants54 Participants57 Participants
Region of Enrollment
United States
63 Participants260 Participants67 Participants65 Participants65 Participants
Rural Residence2 Participants7 Participants2 Participants0 Participants3 Participants
Sex: Female, Male
Female
1 Participants5 Participants0 Participants2 Participants2 Participants
Sex: Female, Male
Male
62 Participants255 Participants67 Participants63 Participants63 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
deaths
Total, all-cause mortality
1 / 680 / 694 / 680 / 70
other
Total, other adverse events
0 / 680 / 690 / 680 / 70
serious
Total, serious adverse events
0 / 680 / 690 / 680 / 70

Outcome results

Primary

Any My HealtheVet Patient Portal Use

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.

Time frame: Portal use within 180 days of initial brochure mailing

Population: Patients randomized to each arm who had not used My HealtheVet in the 12 months prior to randomization. At the second site, 15 people who should have been excluded were inadvertently included in the sample because the criteria of no secure messaging use in previous 12 months was mistakenly used instead of no patient portal use in the previous 12 months. We did not discover this until after the trial was complete because there were delays in receiving actual portal use data.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Brochure Only Comparison ArmAny My HealtheVet Patient Portal Use6 Participants
Encouragement Arm 1Any My HealtheVet Patient Portal Use1 Participants
Encouragement Arm 2Any My HealtheVet Patient Portal Use5 Participants
Encouragement Arm 3Any My HealtheVet Patient Portal Use8 Participants
p-value: 0.057Chi-squared
p-value: 0.753Chi-squared
p-value: 0.613Chi-squared
Secondary

Patient Upgraded to a Premium My HealtheVet Portal Account

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.

Time frame: 180 days from brochure mailing

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Brochure Only Comparison ArmPatient Upgraded to a Premium My HealtheVet Portal Account0 Participants
Encouragement Arm 1Patient Upgraded to a Premium My HealtheVet Portal Account1 Participants
Encouragement Arm 2Patient Upgraded to a Premium My HealtheVet Portal Account2 Participants
Encouragement Arm 3Patient Upgraded to a Premium My HealtheVet Portal Account5 Participants
p-value: 0.308Chi-squared
p-value: 0.154Chi-squared
p-value: 0.025Chi-squared
Secondary

Use of Online Prescription Refills

This measure captures whether the participant used the portal's online prescription refill feature at least once within 180 days of mailing the brochure.

Time frame: 180 days from brochure mailing

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Brochure Only Comparison ArmUse of Online Prescription Refills5 Participants
Encouragement Arm 1Use of Online Prescription Refills1 Participants
Encouragement Arm 2Use of Online Prescription Refills0 Participants
Encouragement Arm 3Use of Online Prescription Refills3 Participants
p-value: 0.102Chi-squared
p-value: 0.023Chi-squared
p-value: 0.439Chi-squared
Secondary

Use of Secure Messaging

Patient used the secure messaging feature during the trial

Time frame: 180 days from brochure mailing

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Brochure Only Comparison ArmUse of Secure Messaging1 Participants
Encouragement Arm 1Use of Secure Messaging1 Participants
Encouragement Arm 2Use of Secure Messaging2 Participants
Encouragement Arm 3Use of Secure Messaging7 Participants
p-value: 0.982Chi-squared
p-value: 0.559Chi-squared
p-value: 0.032Chi-squared

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026