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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

440 participants

Primary outcome timeframe

Baseline, 3-month follow-up, 6-month follow-up, and 12-month follow-up

Results posted on

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

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

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

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-up

Population: 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

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-up

Population: 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

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-up

Population: 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

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-up

Population: 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

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-up

Population: 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

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-up

Population: 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

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-up

Population: 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

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-up

The addition of: (a) antihyperglycemic medications and (b) antihypertensive medications will be assessed by EHR abstraction.

Outcome measures

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-up

Population: 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

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-up

Population: 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

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

Serious events: 7 serious events
Other events: 0 other events
Deaths: 1 deaths

Intervention

Serious events: 7 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

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

Phone: 615-936-1010

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place