Trial Outcomes & Findings for Effects of a Patient Portal Intervention to Address Diabetes Care Gaps (NCT NCT04894903)
NCT ID: NCT04894903
Last Updated: 2025-04-09
Results Overview
Number of diabetes care gaps per patient out of four possible: 1. no diabetes eye exam in the last 12 months, 2. no hemoglobin A1C blood test in the last 6 months, 3. no urine microalbumin in the last 12 months, and 4. no pneumococcal vaccination of any kind ( i.e., never received PPSV-23, PCV-13, PCV-15, or PCV-20) The presence of a diabetes care gap will be assessed by electronic health record (EHR) abstraction.
COMPLETED
NA
440 participants
Baseline, 3-month follow-up, 6-month follow-up, and 12-month follow-up
2025-04-09
Participant Flow
440 patients were enrolled and sent the baseline survey. 433 patients completed the baseline survey. Completion of the baseline survey was required prior randomization and assignment to a study arm.
Participant milestones
| Measure |
Usual Care
Patients will have access to an existing patient web portal (My Health at Vanderbilt) NOT embedded with the intervention (i.e., usual care).
|
Intervention
Patients have access to an existing patient web portal (My Health at Vanderbilt) embedded with the Diabetes Care Gaps Patient Portal Intervention.
Diabetes Care Gaps Patient Portal Intervention: The Diabetes Care Gaps Patient Portal Intervention is embedded within an existing patient web portal (My Health at Vanderbilt). The intervention (a) notifies patients when selected, clinically meaningful, evidence-based diabetes preventative care (e.g., annual urine microalbumin) are due and (b) allows patients to initiate orders for the care.
|
|---|---|---|
|
Overall Study
STARTED
|
217
|
216
|
|
Overall Study
COMPLETED
|
213
|
212
|
|
Overall Study
NOT COMPLETED
|
4
|
4
|
Reasons for withdrawal
| Measure |
Usual Care
Patients will have access to an existing patient web portal (My Health at Vanderbilt) NOT embedded with the intervention (i.e., usual care).
|
Intervention
Patients have access to an existing patient web portal (My Health at Vanderbilt) embedded with the Diabetes Care Gaps Patient Portal Intervention.
Diabetes Care Gaps Patient Portal Intervention: The Diabetes Care Gaps Patient Portal Intervention is embedded within an existing patient web portal (My Health at Vanderbilt). The intervention (a) notifies patients when selected, clinically meaningful, evidence-based diabetes preventative care (e.g., annual urine microalbumin) are due and (b) allows patients to initiate orders for the care.
|
|---|---|---|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Pregnancy
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
|
Overall Study
moved or exited health system
|
1
|
3
|
Baseline Characteristics
Effects of a Patient Portal Intervention to Address Diabetes Care Gaps
Baseline characteristics by cohort
| Measure |
Usual Care
n=215 Participants
Patients will have access to an existing patient web portal (My Health at Vanderbilt) NOT embedded with the intervention (i.e., usual care).
|
Intervention
n=216 Participants
Patients have access to an existing patient web portal (My Health at Vanderbilt) embedded with the Diabetes Care Gaps Patient Portal Intervention.
Diabetes Care Gaps Patient Portal Intervention: The Diabetes Care Gaps Patient Portal Intervention is embedded within an existing patient web portal (My Health at Vanderbilt). The intervention (a) notifies patients when selected, clinically meaningful, evidence-based diabetes preventative care (e.g., annual urine microalbumin) are due and (b) allows patients to initiate orders for the care.
|
Total
n=431 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
146 Participants
n=99 Participants
|
139 Participants
n=107 Participants
|
285 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
69 Participants
n=99 Participants
|
77 Participants
n=107 Participants
|
146 Participants
n=206 Participants
|
|
Age, Continuous
|
56.9 years
STANDARD_DEVIATION 12.3 • n=99 Participants
|
58.3 years
STANDARD_DEVIATION 12.5 • n=107 Participants
|
57.6 years
STANDARD_DEVIATION 12.5 • n=206 Participants
|
|
Sex/Gender, Customized
Sex/Gender · Female
|
122 Participants
n=99 Participants
|
107 Participants
n=107 Participants
|
229 Participants
n=206 Participants
|
|
Sex/Gender, Customized
Sex/Gender · Male
|
91 Participants
n=99 Participants
|
109 Participants
n=107 Participants
|
200 Participants
n=206 Participants
|
|
Sex/Gender, Customized
Sex/Gender · Other
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Sex/Gender, Customized
Sex/Gender · Unknown or Not Reported
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
206 Participants
n=99 Participants
|
202 Participants
n=107 Participants
|
408 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
56 Participants
n=99 Participants
|
50 Participants
n=107 Participants
|
106 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race · White or Caucasian
|
143 Participants
n=99 Participants
|
154 Participants
n=107 Participants
|
297 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race · American Indian or Alaska Native
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
8 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
7 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
215 participants
n=99 Participants
|
216 participants
n=107 Participants
|
431 participants
n=206 Participants
|
|
eHealth Literacy
|
33.3 units on a scale
STANDARD_DEVIATION 5.4 • n=99 Participants
|
33.0 units on a scale
STANDARD_DEVIATION 6.0 • n=107 Participants
|
33.1 units on a scale
STANDARD_DEVIATION 5.7 • n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline, 3-month follow-up, 6-month follow-up, and 12-month follow-upPopulation: Two participants in the control group were excluded from analysis because they dropped out from the study prior to 3-month data collection. The mixed effects regression analysis requires at least one measurement in the follow-up period. Two individuals dropped out prior the any follow-up data collection and therefore are not included in the mixed effects regression analysis.
Number of diabetes care gaps per patient out of four possible: 1. no diabetes eye exam in the last 12 months, 2. no hemoglobin A1C blood test in the last 6 months, 3. no urine microalbumin in the last 12 months, and 4. no pneumococcal vaccination of any kind ( i.e., never received PPSV-23, PCV-13, PCV-15, or PCV-20) The presence of a diabetes care gap will be assessed by electronic health record (EHR) abstraction.
Outcome measures
| Measure |
Usual Care
n=215 Participants
Patients will have access to an existing patient web portal (My Health at Vanderbilt) NOT embedded with the intervention (i.e., usual care).
|
Intervention
n=216 Participants
Patients have access to an existing patient web portal (My Health at Vanderbilt) embedded with the Diabetes Care Gaps Patient Portal Intervention.
Diabetes Care Gaps Patient Portal Intervention: The Diabetes Care Gaps Patient Portal Intervention is embedded within an existing patient web portal (My Health at Vanderbilt). The intervention (a) notifies patients when selected, clinically meaningful, evidence-based diabetes preventative care (e.g., annual urine microalbumin) are due and (b) allows patients to initiate orders for the care.
|
|---|---|---|
|
Number of Participants With Diabetes Care Gaps at Baseline, 3 Months, 6 Months, and 12 Months
Baseline · No Care Gaps
|
75 Participants
|
57 Participants
|
|
Number of Participants With Diabetes Care Gaps at Baseline, 3 Months, 6 Months, and 12 Months
Baseline · One Care Gap
|
77 Participants
|
79 Participants
|
|
Number of Participants With Diabetes Care Gaps at Baseline, 3 Months, 6 Months, and 12 Months
Baseline · Two Care Gaps
|
37 Participants
|
56 Participants
|
|
Number of Participants With Diabetes Care Gaps at Baseline, 3 Months, 6 Months, and 12 Months
Baseline · Three Care Gaps
|
25 Participants
|
18 Participants
|
|
Number of Participants With Diabetes Care Gaps at Baseline, 3 Months, 6 Months, and 12 Months
Baseline · Four Care Gaps
|
1 Participants
|
6 Participants
|
|
Number of Participants With Diabetes Care Gaps at Baseline, 3 Months, 6 Months, and 12 Months
3-months follow-up · No Care Gaps
|
83 Participants
|
91 Participants
|
|
Number of Participants With Diabetes Care Gaps at Baseline, 3 Months, 6 Months, and 12 Months
3-months follow-up · One Care Gap
|
75 Participants
|
87 Participants
|
|
Number of Participants With Diabetes Care Gaps at Baseline, 3 Months, 6 Months, and 12 Months
3-months follow-up · Two Care Gaps
|
33 Participants
|
26 Participants
|
|
Number of Participants With Diabetes Care Gaps at Baseline, 3 Months, 6 Months, and 12 Months
3-months follow-up · Three Care Gaps
|
18 Participants
|
10 Participants
|
|
Number of Participants With Diabetes Care Gaps at Baseline, 3 Months, 6 Months, and 12 Months
3-months follow-up · Four Care Gaps
|
6 Participants
|
2 Participants
|
|
Number of Participants With Diabetes Care Gaps at Baseline, 3 Months, 6 Months, and 12 Months
6-months follow-up · No Care Gaps
|
95 Participants
|
102 Participants
|
|
Number of Participants With Diabetes Care Gaps at Baseline, 3 Months, 6 Months, and 12 Months
6-months follow-up · One Care Gap
|
71 Participants
|
78 Participants
|
|
Number of Participants With Diabetes Care Gaps at Baseline, 3 Months, 6 Months, and 12 Months
6-months follow-up · Two Care Gaps
|
26 Participants
|
22 Participants
|
|
Number of Participants With Diabetes Care Gaps at Baseline, 3 Months, 6 Months, and 12 Months
6-months follow-up · Three Care Gaps
|
16 Participants
|
12 Participants
|
|
Number of Participants With Diabetes Care Gaps at Baseline, 3 Months, 6 Months, and 12 Months
6-months follow-up · Four Care Gaps
|
7 Participants
|
2 Participants
|
|
Number of Participants With Diabetes Care Gaps at Baseline, 3 Months, 6 Months, and 12 Months
12-months follow-up · No Care Gaps
|
89 Participants
|
102 Participants
|
|
Number of Participants With Diabetes Care Gaps at Baseline, 3 Months, 6 Months, and 12 Months
12-months follow-up · One Care Gap
|
68 Participants
|
69 Participants
|
|
Number of Participants With Diabetes Care Gaps at Baseline, 3 Months, 6 Months, and 12 Months
12-months follow-up · Two Care Gaps
|
36 Participants
|
29 Participants
|
|
Number of Participants With Diabetes Care Gaps at Baseline, 3 Months, 6 Months, and 12 Months
12-months follow-up · Three Care Gaps
|
17 Participants
|
11 Participants
|
|
Number of Participants With Diabetes Care Gaps at Baseline, 3 Months, 6 Months, and 12 Months
12-months follow-up · Four Care Gaps
|
5 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: 12-month follow-upPopulation: This analysis is limited to the intervention arm only because only patients in the intervention arm were able to initiate orders via the study intervention.
The number of patient-initiated orders via the study intervention for evidence-based diabetes monitoring and preventative services (e.g., A1c).
Outcome measures
| Measure |
Usual Care
n=216 Participants
Patients will have access to an existing patient web portal (My Health at Vanderbilt) NOT embedded with the intervention (i.e., usual care).
|
Intervention
Patients have access to an existing patient web portal (My Health at Vanderbilt) embedded with the Diabetes Care Gaps Patient Portal Intervention.
Diabetes Care Gaps Patient Portal Intervention: The Diabetes Care Gaps Patient Portal Intervention is embedded within an existing patient web portal (My Health at Vanderbilt). The intervention (a) notifies patients when selected, clinically meaningful, evidence-based diabetes preventative care (e.g., annual urine microalbumin) are due and (b) allows patients to initiate orders for the care.
|
|---|---|---|
|
Patient Initiated Orders
Hemoglobin a1c
|
97 orders initiated
|
—
|
|
Patient Initiated Orders
Urine microalbumin
|
107 orders initiated
|
—
|
|
Patient Initiated Orders
Pneumococcal vaccine
|
19 orders initiated
|
—
|
|
Patient Initiated Orders
Diabetes eye exam
|
46 orders initiated
|
—
|
SECONDARY outcome
Timeframe: Baseline to 3-month follow-up, baseline to 6-month follow-up, and baseline to 12-month follow-upPopulation: Number analyzed varies because not all participants answered all items at each timepoint.
Unique study specific items (four items) to assess participant's understanding of measures of diabetes monitoring and preventative care (e.g., Diabetes Eye Exams) will be administered to all study participants. Each multiple-choice item has only one correct answer and the overall measure is scored as the percent of the items answered correctly.
Outcome measures
| Measure |
Usual Care
n=215 Participants
Patients will have access to an existing patient web portal (My Health at Vanderbilt) NOT embedded with the intervention (i.e., usual care).
|
Intervention
n=216 Participants
Patients have access to an existing patient web portal (My Health at Vanderbilt) embedded with the Diabetes Care Gaps Patient Portal Intervention.
Diabetes Care Gaps Patient Portal Intervention: The Diabetes Care Gaps Patient Portal Intervention is embedded within an existing patient web portal (My Health at Vanderbilt). The intervention (a) notifies patients when selected, clinically meaningful, evidence-based diabetes preventative care (e.g., annual urine microalbumin) are due and (b) allows patients to initiate orders for the care.
|
|---|---|---|
|
Change in Understanding of Diabetes Monitoring and Preventative Care
Baseline to 6-months: Recommended frequency of urine microalbumin testing · Wrong to Correct
|
30 Participants
|
39 Participants
|
|
Change in Understanding of Diabetes Monitoring and Preventative Care
Baseline to 3-months: Recommended frequency of diabetes eye exam · Wrong to Correct
|
6 Participants
|
3 Participants
|
|
Change in Understanding of Diabetes Monitoring and Preventative Care
Baseline to 6-months: Recommended frequency of diabetes eye exam · Correct to Wrong
|
4 Participants
|
2 Participants
|
|
Change in Understanding of Diabetes Monitoring and Preventative Care
Baseline to 6-months: Recommended frequency of diabetes eye exam · No Change
|
199 Participants
|
200 Participants
|
|
Change in Understanding of Diabetes Monitoring and Preventative Care
Baseline to 6-months: Recommended frequency of diabetes eye exam · Wrong to Correct
|
5 Participants
|
3 Participants
|
|
Change in Understanding of Diabetes Monitoring and Preventative Care
Baseline to 12-months: Recommended frequency of diabetes eye exam · Correct to Wrong
|
3 Participants
|
5 Participants
|
|
Change in Understanding of Diabetes Monitoring and Preventative Care
Baseline to 12-months: Recommended frequency of diabetes eye exam · No Change
|
194 Participants
|
190 Participants
|
|
Change in Understanding of Diabetes Monitoring and Preventative Care
Baseline to 12-months: Recommended frequency of diabetes eye exam · Wrong to Correct
|
6 Participants
|
5 Participants
|
|
Change in Understanding of Diabetes Monitoring and Preventative Care
Baseline to 3-months: Recommended frequency of hemoglobin A1C testing · Correct to Wrong
|
13 Participants
|
21 Participants
|
|
Change in Understanding of Diabetes Monitoring and Preventative Care
Baseline to 3-months: Recommended frequency of hemoglobin A1C testing · No Change
|
170 Participants
|
173 Participants
|
|
Change in Understanding of Diabetes Monitoring and Preventative Care
Baseline to 3-months: Recommended frequency of hemoglobin A1C testing · Wrong to Correct
|
22 Participants
|
15 Participants
|
|
Change in Understanding of Diabetes Monitoring and Preventative Care
Baseline to 6-months: Recommended frequency of hemoglobin A1C testing · Correct to Wrong
|
11 Participants
|
16 Participants
|
|
Change in Understanding of Diabetes Monitoring and Preventative Care
Baseline to 6-months: Recommended frequency of hemoglobin A1C testing · No Change
|
173 Participants
|
171 Participants
|
|
Change in Understanding of Diabetes Monitoring and Preventative Care
Baseline to 6-months: Recommended frequency of hemoglobin A1C testing · Wrong to Correct
|
25 Participants
|
18 Participants
|
|
Change in Understanding of Diabetes Monitoring and Preventative Care
Baseline to 12-months: Recommended frequency of hemoglobin A1C testing · Correct to Wrong
|
8 Participants
|
16 Participants
|
|
Change in Understanding of Diabetes Monitoring and Preventative Care
Baseline to 12-months: Recommended frequency of hemoglobin A1C testing · No Change
|
173 Participants
|
168 Participants
|
|
Change in Understanding of Diabetes Monitoring and Preventative Care
Baseline to 12-months: Recommended frequency of hemoglobin A1C testing · Wrong to Correct
|
22 Participants
|
16 Participants
|
|
Change in Understanding of Diabetes Monitoring and Preventative Care
Baseline to 3-months: Recommended frequency of urine microalbumin testing · Correct to Wrong
|
36 Participants
|
37 Participants
|
|
Change in Understanding of Diabetes Monitoring and Preventative Care
Baseline to 3-months: Recommended frequency of urine microalbumin testing · No Change
|
141 Participants
|
140 Participants
|
|
Change in Understanding of Diabetes Monitoring and Preventative Care
Baseline to 3-months: Recommended frequency of urine microalbumin testing · Wrong to Correct
|
28 Participants
|
32 Participants
|
|
Change in Understanding of Diabetes Monitoring and Preventative Care
Baseline to 6-months: Recommended frequency of urine microalbumin testing · Correct to Wrong
|
34 Participants
|
28 Participants
|
|
Change in Understanding of Diabetes Monitoring and Preventative Care
Baseline to 6-months: Recommended frequency of urine microalbumin testing · No Change
|
144 Participants
|
135 Participants
|
|
Change in Understanding of Diabetes Monitoring and Preventative Care
Baseline to 12-months: Recommended frequency of urine microalbumin testing · Correct to Wrong
|
26 Participants
|
32 Participants
|
|
Change in Understanding of Diabetes Monitoring and Preventative Care
Baseline to 12-months: Recommended frequency of urine microalbumin testing · No Change
|
142 Participants
|
125 Participants
|
|
Change in Understanding of Diabetes Monitoring and Preventative Care
Baseline to 12-months: Recommended frequency of urine microalbumin testing · Wrong to Correct
|
34 Participants
|
42 Participants
|
|
Change in Understanding of Diabetes Monitoring and Preventative Care
Baseline to 3-months: Recommended frequency of pneumococcal vaccination · Correct to Wrong
|
19 Participants
|
28 Participants
|
|
Change in Understanding of Diabetes Monitoring and Preventative Care
Baseline to 3-months: Recommended frequency of pneumococcal vaccination · No Change
|
149 Participants
|
158 Participants
|
|
Change in Understanding of Diabetes Monitoring and Preventative Care
Baseline to 3-months: Recommended frequency of pneumococcal vaccination · Wrong to Correct
|
36 Participants
|
21 Participants
|
|
Change in Understanding of Diabetes Monitoring and Preventative Care
Baseline to 6-months: Recommended frequency of pneumococcal vaccination · Correct to Wrong
|
20 Participants
|
27 Participants
|
|
Change in Understanding of Diabetes Monitoring and Preventative Care
Baseline to 6-months: Recommended frequency of pneumococcal vaccination · No Change
|
166 Participants
|
152 Participants
|
|
Change in Understanding of Diabetes Monitoring and Preventative Care
Baseline to 6-months: Recommended frequency of pneumococcal vaccination · Wrong to Correct
|
19 Participants
|
25 Participants
|
|
Change in Understanding of Diabetes Monitoring and Preventative Care
Baseline to 12-months: Recommended frequency of pneumococcal vaccination · Correct to Wrong
|
19 Participants
|
27 Participants
|
|
Change in Understanding of Diabetes Monitoring and Preventative Care
Baseline to 12-months: Recommended frequency of pneumococcal vaccination · No Change
|
157 Participants
|
151 Participants
|
|
Change in Understanding of Diabetes Monitoring and Preventative Care
Baseline to 12-months: Recommended frequency of pneumococcal vaccination · Wrong to Correct
|
27 Participants
|
20 Participants
|
|
Change in Understanding of Diabetes Monitoring and Preventative Care
Baseline to 3-months: Recommended frequency of diabetes eye exam · Correct to Wrong
|
6 Participants
|
2 Participants
|
|
Change in Understanding of Diabetes Monitoring and Preventative Care
Baseline to 3-months: Recommended frequency of diabetes eye exam · No Change
|
193 Participants
|
203 Participants
|
SECONDARY outcome
Timeframe: Baseline to 3-month follow-up, baseline to 6-month follow-up, and baseline to 12-month follow-upPopulation: Number analyzed varies because not all participants answered all items at each timepoint.
The 5-item Manage Disease in General Scale of the Chronic Disease Self-Efficacy Scales is a validated measure of 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). Responses result in total raw scores ranging from 1 to 10. The score for the scale is the mean of the items. Higher scores indicate greater confidence in managing diabetes in general.
Outcome measures
| Measure |
Usual Care
n=215 Participants
Patients will have access to an existing patient web portal (My Health at Vanderbilt) NOT embedded with the intervention (i.e., usual care).
|
Intervention
n=216 Participants
Patients have access to an existing patient web portal (My Health at Vanderbilt) embedded with the Diabetes Care Gaps Patient Portal Intervention.
Diabetes Care Gaps Patient Portal Intervention: The Diabetes Care Gaps Patient Portal Intervention is embedded within an existing patient web portal (My Health at Vanderbilt). The intervention (a) notifies patients when selected, clinically meaningful, evidence-based diabetes preventative care (e.g., annual urine microalbumin) are due and (b) allows patients to initiate orders for the care.
|
|---|---|---|
|
Change in Confidence Toward Managing Diabetes in General
Baseline
|
8.0 score on a scale
Standard Deviation 1.6
|
8.1 score on a scale
Standard Deviation 1.5
|
|
Change in Confidence Toward Managing Diabetes in General
3-month follow-up
|
7.9 score on a scale
Standard Deviation 1.7
|
7.9 score on a scale
Standard Deviation 1.6
|
|
Change in Confidence Toward Managing Diabetes in General
6-month follow-up
|
7.9 score on a scale
Standard Deviation 1.7
|
7.9 score on a scale
Standard Deviation 1.5
|
|
Change in Confidence Toward Managing Diabetes in General
12-month follow-up
|
7.9 score on a scale
Standard Deviation 1.8
|
8.1 score on a scale
Standard Deviation 1.7
|
|
Change in Confidence Toward Managing Diabetes in General
Change baseline to 3-month follow-up
|
-0.1 score on a scale
Standard Deviation 1.5
|
-0.2 score on a scale
Standard Deviation 1.4
|
|
Change in Confidence Toward Managing Diabetes in General
Change baseline to 6-month follow-up
|
-0.1 score on a scale
Standard Deviation 1.4
|
-0.2 score on a scale
Standard Deviation 1.3
|
|
Change in Confidence Toward Managing Diabetes in General
Change baseline to 12-month follow-up
|
-0.1 score on a scale
Standard Deviation 1.7
|
-0.1 score on a scale
Standard Deviation 1.3
|
SECONDARY outcome
Timeframe: Baseline to 3-month follow-up, baseline to 6-month follow-up, and baseline to 12-month follow-upPopulation: Number analyzed varies because not all participants answered all items at each timepoint.
The Problem Areas in Diabetes Scale (PAID-5) is a valid measure of diabetes distress. The PAID-5 contains 5 items which have a five-point response option (0-4 representing 'Not a problem' through to 'Serious problem'). Total scores on the PAID-5 can range from 0 to 20, with higher scores suggesting greater diabetes-related emotional distress care (e.g., Diabetes Eye Exams) will be administered to all study participants.
Outcome measures
| Measure |
Usual Care
n=215 Participants
Patients will have access to an existing patient web portal (My Health at Vanderbilt) NOT embedded with the intervention (i.e., usual care).
|
Intervention
n=216 Participants
Patients have access to an existing patient web portal (My Health at Vanderbilt) embedded with the Diabetes Care Gaps Patient Portal Intervention.
Diabetes Care Gaps Patient Portal Intervention: The Diabetes Care Gaps Patient Portal Intervention is embedded within an existing patient web portal (My Health at Vanderbilt). The intervention (a) notifies patients when selected, clinically meaningful, evidence-based diabetes preventative care (e.g., annual urine microalbumin) are due and (b) allows patients to initiate orders for the care.
|
|---|---|---|
|
Change in Diabetes Distress
Change baseline to 3-month follow-up
|
0.4 score on a scale
Standard Deviation 3.7
|
0.1 score on a scale
Standard Deviation 3.7
|
|
Change in Diabetes Distress
Baseline
|
5.5 score on a scale
Standard Deviation 4.8
|
5.5 score on a scale
Standard Deviation 4.6
|
|
Change in Diabetes Distress
3-month follow-up
|
6.0 score on a scale
Standard Deviation 5.1
|
5.8 score on a scale
Standard Deviation 5.0
|
|
Change in Diabetes Distress
6-month follow-up
|
5.7 score on a scale
Standard Deviation 5.0
|
5.8 score on a scale
Standard Deviation 4.8
|
|
Change in Diabetes Distress
12-month follow-up
|
5.1 score on a scale
Standard Deviation 4.5
|
5.3 score on a scale
Standard Deviation 4.7
|
|
Change in Diabetes Distress
Change baseline to 6-month follow-up
|
0.2 score on a scale
Standard Deviation 3.7
|
0.2 score on a scale
Standard Deviation 3.9
|
|
Change in Diabetes Distress
Change baseline to 12-month follow-up
|
-0.2 score on a scale
Standard Deviation 3.8
|
-0.2 score on a scale
Standard Deviation 4.1
|
SECONDARY outcome
Timeframe: Baseline, 3-month follow-up, 6-month follow-up, and 12-month follow-upPopulation: Number analyzed varies because not all participants answered all items at each timepoint.
The System Usability Scale (SUS) is a valid measure of usability and assesses user's perceptions of ease of use, likability of the interface, and overall satisfaction. Each question on the 10-item questionnaire is scored on a 5-point Likert scale \[0 (Strongly disagree) to 4 (strongly agree)\] and the sum is totaled (0-40). The total sum is then multiplied by 2.5 to convert the original scores to a range of 0 (worst) to 100 (best). Based on prior research, a score above 68 would be above average and a score of 85 or above suggests excellent usability. The SUS has been used in several studies of patient facing health information technology (the article describing its psychometric properties has been cited over 500 times) and has excellent internal consistency reliability (Cronbach's alpha of 0.91).
Outcome measures
| Measure |
Usual Care
n=215 Participants
Patients will have access to an existing patient web portal (My Health at Vanderbilt) NOT embedded with the intervention (i.e., usual care).
|
Intervention
n=216 Participants
Patients have access to an existing patient web portal (My Health at Vanderbilt) embedded with the Diabetes Care Gaps Patient Portal Intervention.
Diabetes Care Gaps Patient Portal Intervention: The Diabetes Care Gaps Patient Portal Intervention is embedded within an existing patient web portal (My Health at Vanderbilt). The intervention (a) notifies patients when selected, clinically meaningful, evidence-based diabetes preventative care (e.g., annual urine microalbumin) are due and (b) allows patients to initiate orders for the care.
|
|---|---|---|
|
Satisfaction/Usability of My Health at Vanderbilt
Baseline
|
81.3 score on a scale
Standard Deviation 13.4
|
80.2 score on a scale
Standard Deviation 12.8
|
|
Satisfaction/Usability of My Health at Vanderbilt
6-month follow-up
|
82.0 score on a scale
Standard Deviation 13.1
|
79.0 score on a scale
Standard Deviation 14.8
|
|
Satisfaction/Usability of My Health at Vanderbilt
3-month follow-up
|
81.1 score on a scale
Standard Deviation 14.3
|
79.4 score on a scale
Standard Deviation 14.8
|
|
Satisfaction/Usability of My Health at Vanderbilt
12-month follow-up
|
81.6 score on a scale
Standard Deviation 14.7
|
80.5 score on a scale
Standard Deviation 16.1
|
|
Satisfaction/Usability of My Health at Vanderbilt
Change baseline to 3-month follow-up
|
-0.1 score on a scale
Standard Deviation 14.4
|
-0.7 score on a scale
Standard Deviation 12.4
|
|
Satisfaction/Usability of My Health at Vanderbilt
Change baseline to 6-month follow-up
|
0.6 score on a scale
Standard Deviation 12.8
|
-1.2 score on a scale
Standard Deviation 11.6
|
|
Satisfaction/Usability of My Health at Vanderbilt
Change baseline to 12-month follow-up
|
0.3 score on a scale
Standard Deviation 13.2
|
0.2 score on a scale
Standard Deviation 15.9
|
SECONDARY outcome
Timeframe: Baseline to 12-month follow-upPopulation: Number analyzed differs because not all patients had a qualifying A1c value in the EHR for the timepoint.
Participants' most recent hemoglobin A1C will be abstracted from participants' electronic medical record.
Outcome measures
| Measure |
Usual Care
n=215 Participants
Patients will have access to an existing patient web portal (My Health at Vanderbilt) NOT embedded with the intervention (i.e., usual care).
|
Intervention
n=216 Participants
Patients have access to an existing patient web portal (My Health at Vanderbilt) embedded with the Diabetes Care Gaps Patient Portal Intervention.
Diabetes Care Gaps Patient Portal Intervention: The Diabetes Care Gaps Patient Portal Intervention is embedded within an existing patient web portal (My Health at Vanderbilt). The intervention (a) notifies patients when selected, clinically meaningful, evidence-based diabetes preventative care (e.g., annual urine microalbumin) are due and (b) allows patients to initiate orders for the care.
|
|---|---|---|
|
Change in Blood Glucose Control
Baseline
|
7.0 percentage of glycated hemoglobin
Standard Deviation 1.3
|
7.2 percentage of glycated hemoglobin
Standard Deviation 1.5
|
|
Change in Blood Glucose Control
12-month follow-up
|
6.8 percentage of glycated hemoglobin
Standard Deviation 1.4
|
6.9 percentage of glycated hemoglobin
Standard Deviation 1.3
|
|
Change in Blood Glucose Control
Change in Hemoglobin A1C: Baseline to 12-month follow-up
|
-0.17 percentage of glycated hemoglobin
Standard Deviation 1.21
|
-0.35 percentage of glycated hemoglobin
Standard Deviation 1.30
|
SECONDARY outcome
Timeframe: Baseline to 3-month follow-up, baseline to 6-month follow-up, and baseline to 12-month follow-upThe addition of: (a) antihyperglycemic medications and (b) antihypertensive medications will be assessed by EHR abstraction.
Outcome measures
| Measure |
Usual Care
n=215 Participants
Patients will have access to an existing patient web portal (My Health at Vanderbilt) NOT embedded with the intervention (i.e., usual care).
|
Intervention
n=216 Participants
Patients have access to an existing patient web portal (My Health at Vanderbilt) embedded with the Diabetes Care Gaps Patient Portal Intervention.
Diabetes Care Gaps Patient Portal Intervention: The Diabetes Care Gaps Patient Portal Intervention is embedded within an existing patient web portal (My Health at Vanderbilt). The intervention (a) notifies patients when selected, clinically meaningful, evidence-based diabetes preventative care (e.g., annual urine microalbumin) are due and (b) allows patients to initiate orders for the care.
|
|---|---|---|
|
Treatment Intensification
Antihypertensive medications: baseline to 3-month follow-up · Decrease in the number of medications
|
11 Participants
|
14 Participants
|
|
Treatment Intensification
Antihyperglycemic medications: baseline to 3-month follow-up · No change in the number of medications
|
145 Participants
|
163 Participants
|
|
Treatment Intensification
Antihyperglycemic medications: baseline to 3-month follow-up · Decrease in the number of medications
|
34 Participants
|
29 Participants
|
|
Treatment Intensification
Antihyperglycemic medications: baseline to 3-month follow-up · Increase in the number of medications
|
35 Participants
|
24 Participants
|
|
Treatment Intensification
Antihyperglycemic medications: baseline to 3-month follow-up · Unknown
|
1 Participants
|
0 Participants
|
|
Treatment Intensification
Antihyperglycemic medications: baseline to 6-month follow-up · No change in the number of medications
|
122 Participants
|
143 Participants
|
|
Treatment Intensification
Antihyperglycemic medications: baseline to 6-month follow-up · Decrease in the number of medications
|
47 Participants
|
36 Participants
|
|
Treatment Intensification
Antihyperglycemic medications: baseline to 6-month follow-up · Increase in the number of medications
|
45 Participants
|
37 Participants
|
|
Treatment Intensification
Antihyperglycemic medications: baseline to 6-month follow-up · Unknown
|
1 Participants
|
0 Participants
|
|
Treatment Intensification
Antihyperglycemic medications: baseline to 12-month follow-up · No change in the number of medications
|
103 Participants
|
118 Participants
|
|
Treatment Intensification
Antihyperglycemic medications: baseline to 12-month follow-up · Decrease in the number of medications
|
59 Participants
|
51 Participants
|
|
Treatment Intensification
Antihyperglycemic medications: baseline to 12-month follow-up · Increase in the number of medications
|
52 Participants
|
47 Participants
|
|
Treatment Intensification
Antihyperglycemic medications: baseline to 12-month follow-up · Unknown
|
1 Participants
|
0 Participants
|
|
Treatment Intensification
Antihypertensive medications: baseline to 3-month follow-up · No change in the number of medications
|
190 Participants
|
196 Participants
|
|
Treatment Intensification
Antihypertensive medications: baseline to 3-month follow-up · Increase in the number of medications
|
13 Participants
|
6 Participants
|
|
Treatment Intensification
Antihypertensive medications: baseline to 3-month follow-up · Unknown
|
1 Participants
|
0 Participants
|
|
Treatment Intensification
Antihypertensive medications: baseline to 6-month follow-up · No change in the number of medications
|
184 Participants
|
189 Participants
|
|
Treatment Intensification
Antihypertensive medications: baseline to 6-month follow-up · Decrease in the number of medications
|
15 Participants
|
18 Participants
|
|
Treatment Intensification
Antihypertensive medications: baseline to 6-month follow-up · Increase in the number of medications
|
15 Participants
|
9 Participants
|
|
Treatment Intensification
Antihypertensive medications: baseline to 6-month follow-up · Unknown
|
1 Participants
|
0 Participants
|
|
Treatment Intensification
Antihypertensive medications: baseline to 12-month follow-up · No change in the number of medications
|
162 Participants
|
171 Participants
|
|
Treatment Intensification
Antihypertensive medications: baseline to 12-month follow-up · Decrease in the number of medications
|
26 Participants
|
26 Participants
|
|
Treatment Intensification
Antihypertensive medications: baseline to 12-month follow-up · Increase in the number of medications
|
26 Participants
|
19 Participants
|
|
Treatment Intensification
Antihypertensive medications: baseline to 12-month follow-up · Unknown
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline to 3-month follow-up, baseline to 6-month follow-up, and baseline to 12-month follow-upPopulation: Number analyzed varies because not all participants answered all items at each timepoint.
The Perceived Diabetes Self-Management Scale (PDSMS) is a valid measure of diabetes self-efficacy (i.e., how confident they feel about their ability to carry out multiple self management tasks). The uni-dimensional, 8-item scale is scored on a five-point Likert scale. The total PDSMS score can range from 8 to 40, with higher scores indicating more confidence in self-managing one's diabetes.
Outcome measures
| Measure |
Usual Care
n=215 Participants
Patients will have access to an existing patient web portal (My Health at Vanderbilt) NOT embedded with the intervention (i.e., usual care).
|
Intervention
n=216 Participants
Patients have access to an existing patient web portal (My Health at Vanderbilt) embedded with the Diabetes Care Gaps Patient Portal Intervention.
Diabetes Care Gaps Patient Portal Intervention: The Diabetes Care Gaps Patient Portal Intervention is embedded within an existing patient web portal (My Health at Vanderbilt). The intervention (a) notifies patients when selected, clinically meaningful, evidence-based diabetes preventative care (e.g., annual urine microalbumin) are due and (b) allows patients to initiate orders for the care.
|
|---|---|---|
|
Change in Diabetes Self-efficacy
3-month follow-up
|
29.6 score on a scale
Standard Deviation 6.1
|
30.2 score on a scale
Standard Deviation 6.2
|
|
Change in Diabetes Self-efficacy
Baseline
|
29.7 score on a scale
Standard Deviation 5.6
|
29.8 score on a scale
Standard Deviation 5.4
|
|
Change in Diabetes Self-efficacy
6-month follow-up
|
30.0 score on a scale
Standard Deviation 6.2
|
30.7 score on a scale
Standard Deviation 5.6
|
|
Change in Diabetes Self-efficacy
12-month follow-up
|
30.5 score on a scale
Standard Deviation 6.2
|
30.8 score on a scale
Standard Deviation 6.0
|
|
Change in Diabetes Self-efficacy
Change baseline to 3-month follow-up
|
-0.1 score on a scale
Standard Deviation 4.9
|
0.4 score on a scale
Standard Deviation 5.3
|
|
Change in Diabetes Self-efficacy
Change baseline to 6-month follow-up
|
0.3 score on a scale
Standard Deviation 5.3
|
1.0 score on a scale
Standard Deviation 5.0
|
|
Change in Diabetes Self-efficacy
Change baseline to 12-month follow-up
|
0.9 score on a scale
Standard Deviation 5.8
|
1.0 score on a scale
Standard Deviation 5.3
|
SECONDARY outcome
Timeframe: 12-month follow-upPopulation: This analysis is limited to the intervention arm only because only patients in the intervention arm were able to report diabetes eye exams received outside the Vanderbilt University Medical Center health system using the study intervention.
The number of patient reports of diabetes eye exams received outside the Vanderbilt University Medical Center health system submitted via the study intervention.
Outcome measures
| Measure |
Usual Care
n=216 Participants
Patients will have access to an existing patient web portal (My Health at Vanderbilt) NOT embedded with the intervention (i.e., usual care).
|
Intervention
Patients have access to an existing patient web portal (My Health at Vanderbilt) embedded with the Diabetes Care Gaps Patient Portal Intervention.
Diabetes Care Gaps Patient Portal Intervention: The Diabetes Care Gaps Patient Portal Intervention is embedded within an existing patient web portal (My Health at Vanderbilt). The intervention (a) notifies patients when selected, clinically meaningful, evidence-based diabetes preventative care (e.g., annual urine microalbumin) are due and (b) allows patients to initiate orders for the care.
|
|---|---|---|
|
Reported Services Completed Outside Vanderbilt System
|
101 reports
|
—
|
Adverse Events
Usual Care
Intervention
Serious adverse events
| Measure |
Usual Care
n=217 participants at risk
Patients will have access to an existing patient web portal (My Health at Vanderbilt) NOT embedded with the intervention (i.e., usual care).
|
Intervention
n=216 participants at risk
Patients have access to an existing patient web portal (My Health at Vanderbilt) embedded with the Diabetes Care Gaps Patient Portal Intervention.
Diabetes Care Gaps Patient Portal Intervention: The Diabetes Care Gaps Patient Portal Intervention is embedded within an existing patient web portal (My Health at Vanderbilt). The intervention (a) notifies patients when selected, clinically meaningful, evidence-based diabetes preventative care (e.g., annual urine microalbumin) are due and (b) allows patients to initiate orders for the care.
|
|---|---|---|
|
Vascular disorders
Hospitalization
|
0.46%
1/217 • Number of events 1 • 12 months
|
0.00%
0/216 • 12 months
|
|
Gastrointestinal disorders
Hospitalization
|
0.92%
2/217 • Number of events 2 • 12 months
|
0.46%
1/216 • Number of events 2 • 12 months
|
|
Infections and infestations
Hospitalization
|
0.46%
1/217 • Number of events 1 • 12 months
|
0.93%
2/216 • Number of events 2 • 12 months
|
|
Nervous system disorders
Hospitalization
|
0.46%
1/217 • Number of events 1 • 12 months
|
0.93%
2/216 • Number of events 5 • 12 months
|
|
Cardiac disorders
Hospitalization
|
0.92%
2/217 • Number of events 6 • 12 months
|
0.93%
2/216 • Number of events 2 • 12 months
|
|
Injury, poisoning and procedural complications
Death
|
0.46%
1/217 • Number of events 1 • 12 months
|
0.00%
0/216 • 12 months
|
|
General disorders
Hospitalization
|
0.00%
0/217 • 12 months
|
0.46%
1/216 • Number of events 1 • 12 months
|
|
Blood and lymphatic system disorders
Hospitalization
|
0.00%
0/217 • 12 months
|
0.46%
1/216 • Number of events 1 • 12 months
|
Other adverse events
Adverse event data not reported
Additional Information
William Martinez, MD, MS
Vanderbilt University Medical Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place