Diabetes Mellitus
Conditions
Keywords
Diabetes Mellitus, Medical Informatics, Preventative Care
Brief summary
The purpose of this study is to evaluate the usability of a novel patient portal intervention designed to: (a) notify patients when selected, clinically meaningful, evidence-based diabetes monitoring & preventative care (e.g., annual diabetes eye exam) become due and (b) allow patients to initiate orders for the care. In addition, the investigators will assess pre-post change on secondary psychosocial outcomes (e.g., self-efficacy).
Detailed description
Up to 60 adult patients with type 1 or 2 diabetes mellitus will be enrolled and given access to a new feature within the patient portal at Vanderbilt University Medical Center. The new feature will be available via the patient portal native app (i.e., My Health at Vanderbilt (MHAV) app) for mobile devices (smartphone or tablet). The new feature will allow patients to: (1) receive notifications when the patient is due for certain types of diabetes monitoring and preventative care and (2) initiate an order for the care. Study participants will complete questionnaires electronically via email at three time points: baseline (T0), immediately after first use of the intervention (T1), and three-month follow-up (T2) to as assess study outcomes including usability and pre-post change in secondary psychosocial outcomes.
Interventions
The Diabetes Care Gaps Patient Portal Intervention involves a new feature embedded with the My Health At Vanderbilt (MHAV) native app (on Epic's MyChart platform) for mobile devices that allows patients to: (a) receive notifications when the patient is due for certain types of diabetes monitoring and preventative care and (b) initiate an order for the care. Automated notifications will be sent to patients if, according to the evidence-based guidelines, the patients are due for a hemoglobin A1C blood test, microalbumin urine test, diabetes eye exam, or pneumonia vaccination. Once notified patients can initiate orders for the care within the MHAV app. The patient will receive confirmation when the order has been processed and will be provided instructions to receive the relevant care.
Sponsors
National Institutes of Health (NIH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Vanderbilt University Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Established patient at participating primary care clinic * Type 1 or 2 diabetes mellitus * Able to speak and read in English * Age 18 to 75 years old * Mobile device (smartphone or tablet) with internet access * Active MHAV account and willing and able to use the MHAV native app on a mobile device * Due (based on evidence-based guidelines) for any of the following: hemoglobin A1C, urine microalbumin, diabetes eye exam, and/or pneumococcal vaccination.
Exclusion criteria
* Known cognitive deficits or functional impairment preventing the use of a mobile device * Pregnant or planning to become pregnant during the study period * Severe difficulty seeing * Severe difficulty hearing * Medical condition that make it hard for people to understand what they are saying
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Usability | Immediately after first use T(1), at approximately 1 month | The System Usability Scale (SUS) is a validated measure of usability. The ten items are scored on a five-point Likert scale. The item scores are summed and then converted to a score ranging from 0 (worst) to 100 (best). A score of above 68 indicative of above average usability. |
| User Experience | 3-month follow up (T2) | User experience will be assessed by study-specific survey items administered to all participants at the end of the study period (T2). The survey items will inquire about participants' perspectives on the acceptability of the intervention and on particular components of the intervention such as notifications. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Understanding of Diabetes Monitoring and Preventative Care | Enrollment (T0) and 3-month follow up (T2) | Unique study specific items to assess participants' understanding of measures of diabetes monitoring and preventative care (e.g., Diabetes Eye Exams) will be administered to all study participants. |
| Change in Attitudes Toward Managing Diabetes in General | Enrollment (T0) and 3-month follow up (T2) | The 5-item Manage Disease in General Scale of the Chronic Disease Self-Efficacy Scales is a validated measure of self-efficacy (i.e., the confidence a person has in managing their own health and health care) and is closely related to patient activation. The items were adapted to be specific to diabetes rather than a generic condition or illness. Each item uses a 10-point Likert-type scale of response options ranging from 1 (not at all confident) to 10 (totally confident). The score for the scale is the mean of the items. Higher scores indicate greater self-efficacy. |
| Order Completion | 3-month follow up (T2) | The investigators will collect data on the number of completed (i.e., care received) evidence-based diabetes monitoring and preventative services after a corresponding patient initiated order. |
| Patient Initiated Orders | 3-month follow up (T2) | The investigators will collect data on the number of patient-initiated orders for evidence-based diabetes monitoring and preventative services (e.g., hemoglobin A1c). Participants with more than one diabetes care gap can initiated an order for more than one evidence-based diabetes monitoring and preventative service (e.g. hemoglobin A1c and diabetes eye exam). |
| Change in Diabetes Distress | Enrollment (T0) and 3-month follow up (T2) | The Problem Areas in Diabetes Scale (PAID-5) is a valid measure of diabetes distress. Total scores on the PAID-5 can range from 0 to 20, with higher scores suggesting greater diabetes-related emotional distress. |
Countries
United States
Participant flow
Pre-assignment details
Of the 60 enrolled participants, 50 completed the baseline questionnaire and still had at least one diabetes care gap (due for any of the following: hemoglobin A1C, urine microalbumin, diabetes eye exam, and/or pneumococcal vaccination) and were then assigned to the intervention.
Participants by arm
| Arm | Count |
|---|---|
| Intervention Participants will have access to a new feature within an established patient portal native app on mobile devices. The new feature aims to address diabetes care gaps.
Diabetes Care Gaps Patient Portal Intervention: The Diabetes Care Gaps Patient Portal Intervention involves a new feature embedded with the My Health At Vanderbilt (MHAV) native app (on Epic's MyChart platform) for mobile devices that allows patients to: (a) receive notifications when the patient is due for certain types of diabetes monitoring and preventative care and (b) initiate an order for the care. Automated notifications will be sent to patients if, according to the evidence-based guidelines, the patients are due for a hemoglobin A1C blood test, microalbumin urine test, diabetes eye exam, or pneumonia vaccination. Once notified patients can initiate orders for the care within the MHAV app. The patient will receive confirmation when the order has been processed and will be provided instructions to receive the relevant care. | 50 |
| Total | 50 |
Baseline characteristics
| Characteristic | Intervention |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 18 Participants |
| Age, Categorical Between 18 and 65 years | 32 Participants |
| Age, Continuous | 55.5 years STANDARD_DEVIATION 13.8 |
| Health Literacy Adequate Health Literacy | 36 Participants |
| Health Literacy Limited Health Literacy | 14 Participants |
| Race/Ethnicity, Customized Black or African American | 15 Participants |
| Race/Ethnicity, Customized Other | 5 Participants |
| Race/Ethnicity, Customized White or Caucasian | 30 Participants |
| Region of Enrollment United States | 50 participants |
| Sex: Female, Male Female | 26 Participants |
| Sex: Female, Male Male | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 50 |
| other Total, other adverse events | 0 / 50 |
| serious Total, serious adverse events | 3 / 50 |
Outcome results
Primary
Usability
The System Usability Scale (SUS) is a validated measure of usability. The ten items are scored on a five-point Likert scale. The item scores are summed and then converted to a score ranging from 0 (worst) to 100 (best). A score of above 68 indicative of above average usability.
Time frame: Immediately after first use T(1), at approximately 1 month
Population: 36 participants used to the study intervention during the study period and completed the SUS scale after first use.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Usability | 79.3 score on a scale | Standard Deviation 14.9 |
Comparison: One-sample t-test comparing the sample mean to the threshold value of 71 indicative of good usability. The null hypothesis: true mean is 71 or less.p-value: 0.001t-test, 1 sided
Primary
User Experience
User experience will be assessed by study-specific survey items administered to all participants at the end of the study period (T2). The survey items will inquire about participants' perspectives on the acceptability of the intervention and on particular components of the intervention such as notifications.
Time frame: 3-month follow up (T2)
Population: Not all patients completed this item on the final questionnaire (T2), results limited to the 47 who responded to the items.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Intervention | User Experience | Would recommend the intervention to other patients | Strongly agree/agree | 37 Participants |
| Intervention | User Experience | Would recommend the intervention to other patients | Neutral/disagree/strongly disagree | 10 Participants |
| Intervention | User Experience | Would continue to use the intervention in future if it remained available | Strongly agree/agree | 38 Participants |
| Intervention | User Experience | Would continue to use the intervention in future if it remained available | Neutral/disagree/strongly disagree | 9 Participants |
Secondary
Change in Attitudes Toward Managing Diabetes in General
The 5-item Manage Disease in General Scale of the Chronic Disease Self-Efficacy Scales is a validated measure of self-efficacy (i.e., the confidence a person has in managing their own health and health care) and is closely related to patient activation. The items were adapted to be specific to diabetes rather than a generic condition or illness. Each item uses a 10-point Likert-type scale of response options ranging from 1 (not at all confident) to 10 (totally confident). The score for the scale is the mean of the items. Higher scores indicate greater self-efficacy.
Time frame: Enrollment (T0) and 3-month follow up (T2)
Population: 4 participants did not complete the Manage Disease in General Scale on the three-month follow-up post-questionnaire and were excluded from this analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Change in Attitudes Toward Managing Diabetes in General | baseline questionnaire (T0) | 8.1 score on a scale | Standard Deviation 1.5 |
| Intervention | Change in Attitudes Toward Managing Diabetes in General | three-month follow-up questionnaire (T2) | 8.6 score on a scale | Standard Deviation 1.2 |
p-value: 0.005t-test, 2 sided
Secondary
Change in Diabetes Distress
The Problem Areas in Diabetes Scale (PAID-5) is a valid measure of diabetes distress. Total scores on the PAID-5 can range from 0 to 20, with higher scores suggesting greater diabetes-related emotional distress.
Time frame: Enrollment (T0) and 3-month follow up (T2)
Population: 4 participants did not complete the Problem Areas in Diabetes Scale (PAID-5) on the three-month follow-up post-questionnaire and were excluded from this analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Change in Diabetes Distress | baseline questionnaire (T0) | 6.6 score on a scale | Standard Deviation 5 |
| Intervention | Change in Diabetes Distress | three-month follow-up questionnaire (T2) | 5.8 score on a scale | Standard Deviation 4.9 |
p-value: 0.19t-test, 2 sided
Secondary
Change in Understanding of Diabetes Monitoring and Preventative Care
Unique study specific items to assess participants' understanding of measures of diabetes monitoring and preventative care (e.g., Diabetes Eye Exams) will be administered to all study participants.
Time frame: Enrollment (T0) and 3-month follow up (T2)
Population: Not all patients answers all Understanding of Diabetes Monitoring and Preventative Care items on both the baseline (T0) and three-months (T2). Participants with missing this data at either time point were excluded from the analysis with up to 5 participants missing data for one of items.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention | Change in Understanding of Diabetes Monitoring and Preventative Care | Correctly identify the recommended frequency of A1c monitoring at baseline (T0) | 38 Participants |
| Intervention | Change in Understanding of Diabetes Monitoring and Preventative Care | Correctly identify the recommended frequency of A1c monitoring at three-months (T2) | 38 Participants |
| Intervention | Change in Understanding of Diabetes Monitoring and Preventative Care | Correctly identify the recommended frequency of urine microalbumin screening at baseline (T0) | 24 Participants |
| Intervention | Change in Understanding of Diabetes Monitoring and Preventative Care | Correctly identify the recommended frequency of urine microalbumin screening at three-months (T2) | 23 Participants |
| Intervention | Change in Understanding of Diabetes Monitoring and Preventative Care | Correctly identify the recommended frequency of pneumonia vaccination at baseline (T0) | 13 Participants |
| Intervention | Change in Understanding of Diabetes Monitoring and Preventative Care | Correctly identify the recommended frequency of pneumonia vaccination at three-months (T2) | 13 Participants |
| Intervention | Change in Understanding of Diabetes Monitoring and Preventative Care | Correctly identify the recommended frequency of diabetes eye exams at baseline (T0) | 45 Participants |
| Intervention | Change in Understanding of Diabetes Monitoring and Preventative Care | Correctly identify the recommended frequency of diabetes eye exams at three-months (T2) | 45 Participants |
Comparison: Analysis for pre-post change in knowledge of recommended A1c monitoring frequencyp-value: 1McNemar
Comparison: Analysis for pre-post change in knowledge of recommended urine microalbumin screening frequencyp-value: 1McNemar
Comparison: Analysis for pre-post change in knowledge of recommended pneumonia vaccination frequencyp-value: 1McNemar
Comparison: Analysis for pre-post change in knowledge of recommended diabetes eye exam frequencyp-value: 1McNemar
Secondary
Order Completion
The investigators will collect data on the number of completed (i.e., care received) evidence-based diabetes monitoring and preventative services after a corresponding patient initiated order.
Time frame: 3-month follow up (T2)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention | Order Completion | Completed a hemoglobin A1c lab test after patient initiated order | 13 Participants |
| Intervention | Order Completion | Completed a urine microalbumin lab test after patient initiated order | 15 Participants |
| Intervention | Order Completion | Completed a pneumococcal vaccination after patient initiated order | 6 Participants |
| Intervention | Order Completion | Completed a diabetes eye exam after patient initiated order | 5 Participants |
Secondary
Patient Initiated Orders
The investigators will collect data on the number of patient-initiated orders for evidence-based diabetes monitoring and preventative services (e.g., hemoglobin A1c). Participants with more than one diabetes care gap can initiated an order for more than one evidence-based diabetes monitoring and preventative service (e.g. hemoglobin A1c and diabetes eye exam).
Time frame: 3-month follow up (T2)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention | Patient Initiated Orders | Initiated order for hemoglobin A1c | 14 Participants |
| Intervention | Patient Initiated Orders | Initiated order for urine microalbumin | 17 Participants |
| Intervention | Patient Initiated Orders | Initiated order for pneumococcal vaccination | 6 Participants |
| Intervention | Patient Initiated Orders | Initiated order for diabetes eye exam | 10 Participants |