Trial Outcomes & Findings for Evaluation of a Patient Portal Intervention to Address Diabetes Care Gaps (NCT NCT04728620)
NCT ID: NCT04728620
Last Updated: 2023-08-01
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
60 participants
Primary outcome timeframe
Immediately after first use T(1), at approximately 1 month
Results posted on
2023-08-01
Participant Flow
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.
Participant milestones
| Measure |
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.
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|---|---|
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Overall Study
STARTED
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50
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Overall Study
COMPLETED
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50
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of a Patient Portal Intervention to Address Diabetes Care Gaps
Baseline characteristics by cohort
| Measure |
Intervention
n=50 Participants
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.
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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=99 Participants
|
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Age, Categorical
Between 18 and 65 years
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32 Participants
n=99 Participants
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Age, Categorical
>=65 years
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18 Participants
n=99 Participants
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Age, Continuous
|
55.5 years
STANDARD_DEVIATION 13.8 • n=99 Participants
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Sex: Female, Male
Female
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26 Participants
n=99 Participants
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Sex: Female, Male
Male
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24 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
White or Caucasian
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30 Participants
n=99 Participants
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Race/Ethnicity, Customized
Black or African American
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15 Participants
n=99 Participants
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Race/Ethnicity, Customized
Other
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5 Participants
n=99 Participants
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Region of Enrollment
United States
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50 participants
n=99 Participants
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Health Literacy
Adequate Health Literacy
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36 Participants
n=99 Participants
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Health Literacy
Limited Health Literacy
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14 Participants
n=99 Participants
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PRIMARY outcome
Timeframe: Immediately after first use T(1), at approximately 1 monthPopulation: 36 participants used to the study intervention during the study period and completed the SUS scale after first use.
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.
Outcome measures
| Measure |
Intervention
n=36 Participants
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.
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|---|---|
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Usability
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79.3 score on a scale
Standard Deviation 14.9
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PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Intervention
n=47 Participants
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.
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User Experience
Would recommend the intervention to other patients · Strongly agree/agree
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37 Participants
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User Experience
Would recommend the intervention to other patients · Neutral/disagree/strongly disagree
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10 Participants
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User Experience
Would continue to use the intervention in future if it remained available · Strongly agree/agree
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38 Participants
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User Experience
Would continue to use the intervention in future if it remained available · Neutral/disagree/strongly disagree
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9 Participants
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SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Intervention
n=46 Participants
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.
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Change in Attitudes Toward Managing Diabetes in General
baseline questionnaire (T0)
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8.1 score on a scale
Standard Deviation 1.5
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Change in Attitudes Toward Managing Diabetes in General
three-month follow-up questionnaire (T2)
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8.6 score on a scale
Standard Deviation 1.2
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SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Intervention
n=46 Participants
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.
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|---|---|
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Change in Diabetes Distress
baseline questionnaire (T0)
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6.6 score on a scale
Standard Deviation 5.0
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Change in Diabetes Distress
three-month follow-up questionnaire (T2)
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5.8 score on a scale
Standard Deviation 4.9
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SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Intervention
n=46 Participants
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.
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Change in Understanding of Diabetes Monitoring and Preventative Care
Correctly identify the recommended frequency of A1c monitoring at baseline (T0)
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38 Participants
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Change in Understanding of Diabetes Monitoring and Preventative Care
Correctly identify the recommended frequency of A1c monitoring at three-months (T2)
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38 Participants
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Change in Understanding of Diabetes Monitoring and Preventative Care
Correctly identify the recommended frequency of urine microalbumin screening at baseline (T0)
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24 Participants
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Change in Understanding of Diabetes Monitoring and Preventative Care
Correctly identify the recommended frequency of urine microalbumin screening at three-months (T2)
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23 Participants
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Change in Understanding of Diabetes Monitoring and Preventative Care
Correctly identify the recommended frequency of pneumonia vaccination at baseline (T0)
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13 Participants
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Change in Understanding of Diabetes Monitoring and Preventative Care
Correctly identify the recommended frequency of pneumonia vaccination at three-months (T2)
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13 Participants
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Change in Understanding of Diabetes Monitoring and Preventative Care
Correctly identify the recommended frequency of diabetes eye exams at baseline (T0)
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45 Participants
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Change in Understanding of Diabetes Monitoring and Preventative Care
Correctly identify the recommended frequency of diabetes eye exams at three-months (T2)
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45 Participants
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SECONDARY outcome
Timeframe: 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).
Outcome measures
| Measure |
Intervention
n=50 Participants
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.
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|---|---|
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Patient Initiated Orders
Initiated order for hemoglobin A1c
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14 Participants
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Patient Initiated Orders
Initiated order for urine microalbumin
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17 Participants
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Patient Initiated Orders
Initiated order for pneumococcal vaccination
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6 Participants
|
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Patient Initiated Orders
Initiated order for diabetes eye exam
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10 Participants
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SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Intervention
n=50 Participants
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.
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Order Completion
Completed a hemoglobin A1c lab test after patient initiated order
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13 Participants
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Order Completion
Completed a urine microalbumin lab test after patient initiated order
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15 Participants
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Order Completion
Completed a pneumococcal vaccination after patient initiated order
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6 Participants
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Order Completion
Completed a diabetes eye exam after patient initiated order
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5 Participants
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Adverse Events
Intervention
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Intervention
n=50 participants at risk
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.
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|---|---|
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General disorders
Hospitalization
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6.0%
3/50 • Number of events 5 • 3 months
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Other adverse events
Adverse event data not reported
Additional Information
William Martinez, MD
Vanderbilt University Medical Center
Phone: (615) 936-1010
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place