Diabetes Mellitus
Conditions
Keywords
Diabetes Mellitus, Self-efficacy, Patient Web Portals, Health Information Technology
Brief summary
The purpose of this study is to evaluate the effect of a novel patient portal intervention on the number of patients with diabetes care gaps (e.g., no diabetes eye exam i the last 12 months). The intervention is designed to: (a) notify patients when selected, clinically meaningful, evidence-based diabetes monitoring & preventative care (e.g., annual urine microalbumin) are due and (b) allow patients to initiate orders for the care.
Detailed description
Participants will be recruited from 14 VUMC-affiliate adult primary care clinics located throughout Middle Tennessee. Patients will be randomized 1:1 to the intervention or usual care. 500 adult patients with type 1 or 2 diabetes mellitus will be assigned to one of two arms. 250 will be assigned to receive access to the intervention embedded within an existing patient web portal (My Health at Vanderbilt) at Vanderbilt University Medical Center. 250 will be assigned to a usual care comparison arm with access to the currently available version of My Health at Vanderbilt without the study intervention. At enrollment, participants will complete a baseline questionnaire and diabetes health data will be abstracted from the patients' electronic health record (EHR) before being assigned to the intervention or control arm. Participants will receive additional follow-up questionnaires and diabetes health data will be abstracted from the EHR at 3-month, 6-month, and 12-month follow-ups to assess outcomes. In addition, system usage data (user analytics) will be collected throughout the study period.
Interventions
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 monitoring & preventative care (e.g., annual urine microalbumin) are due and (b) allows patients to initiate orders for the care.
Sponsors
National Institutes of Health (NIH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Vanderbilt University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Established patient with a participating primary care physician from a participating clinic * Type 1 or 2 diabetes mellitus * Able to read in English * Age 18 to 75 years old * Mobile device (smartphone or tablet) with internet access * Active My Health at Vanderbilt (MHAV) account
Exclusion criteria
* A medical condition that prevents use of a mobile device * Pregnant or planning to become pregnant during the study period * Severe difficulty seeing * On dialysis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Diabetes Care Gaps at Baseline, 3 Months, 6 Months, and 12 Months | Baseline, 3-month follow-up, 6-month follow-up, and 12-month follow-up | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Understanding of Diabetes Monitoring and Preventative Care | Baseline to 3-month follow-up, baseline to 6-month follow-up, and baseline to 12-month follow-up | 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. |
| Change in Confidence Toward Managing Diabetes in General | Baseline to 3-month follow-up, baseline to 6-month follow-up, and baseline to 12-month follow-up | 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. |
| Change in Diabetes Distress | Baseline to 3-month follow-up, baseline to 6-month follow-up, and baseline to 12-month follow-up | 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. |
| Satisfaction/Usability of My Health at Vanderbilt | Baseline, 3-month follow-up, 6-month follow-up, and 12-month follow-up | 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). |
| Patient Initiated Orders | 12-month follow-up | The number of patient-initiated orders via the study intervention for evidence-based diabetes monitoring and preventative services (e.g., A1c). |
| Treatment Intensification | 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. |
| Change in Diabetes Self-efficacy | Baseline to 3-month follow-up, baseline to 6-month follow-up, and baseline to 12-month follow-up | 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. |
| Reported Services Completed Outside Vanderbilt System | 12-month follow-up | The number of patient reports of diabetes eye exams received outside the Vanderbilt University Medical Center health system submitted via the study intervention. |
| Change in Blood Glucose Control | Baseline to 12-month follow-up | Participants' most recent hemoglobin A1C will be abstracted from participants' electronic medical record. |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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). | 215 |
| 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. | 216 |
| Total | 431 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 1 | 0 |
| Overall Study | moved or exited health system | 1 | 3 |
| Overall Study | Pregnancy | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | Usual Care | Intervention | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 69 Participants | 77 Participants | 146 Participants |
| Age, Categorical Between 18 and 65 years | 146 Participants | 139 Participants | 285 Participants |
| Age, Continuous | 56.9 years STANDARD_DEVIATION 12.3 | 58.3 years STANDARD_DEVIATION 12.5 | 57.6 years STANDARD_DEVIATION 12.5 |
| eHealth Literacy | 33.3 units on a scale STANDARD_DEVIATION 5.4 | 33.0 units on a scale STANDARD_DEVIATION 6 | 33.1 units on a scale STANDARD_DEVIATION 5.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 8 Participants | 8 Participants | 16 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 206 Participants | 202 Participants | 408 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 6 Participants | 7 Participants |
| Race/Ethnicity, Customized Race American Indian or Alaska Native | 1 Participants | 3 Participants | 4 Participants |
| Race/Ethnicity, Customized Race Asian | 8 Participants | 2 Participants | 10 Participants |
| Race/Ethnicity, Customized Race Black or African American | 56 Participants | 50 Participants | 106 Participants |
| Race/Ethnicity, Customized Race Other | 7 Participants | 7 Participants | 14 Participants |
| Race/Ethnicity, Customized Race White or Caucasian | 143 Participants | 154 Participants | 297 Participants |
| Region of Enrollment United States | 215 participants | 216 participants | 431 participants |
| Sex/Gender, Customized Sex/Gender Female | 122 Participants | 107 Participants | 229 Participants |
| Sex/Gender, Customized Sex/Gender Male | 91 Participants | 109 Participants | 200 Participants |
| Sex/Gender, Customized Sex/Gender Other | 1 Participants | 0 Participants | 1 Participants |
| Sex/Gender, Customized Sex/Gender Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 217 | 0 / 216 |
| other Total, other adverse events | 0 / 217 | 0 / 216 |
| serious Total, serious adverse events | 7 / 217 | 7 / 216 |
Outcome results
Primary
Number of Participants With Diabetes Care Gaps at Baseline, 3 Months, 6 Months, and 12 Months
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.
Time frame: 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.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Usual Care | Number of Participants With Diabetes Care Gaps at Baseline, 3 Months, 6 Months, and 12 Months | Baseline | No Care Gaps | 75 Participants |
| Usual Care | Number of Participants With Diabetes Care Gaps at Baseline, 3 Months, 6 Months, and 12 Months | Baseline | One Care Gap | 77 Participants |
| Usual Care | Number of Participants With Diabetes Care Gaps at Baseline, 3 Months, 6 Months, and 12 Months | Baseline | Two Care Gaps | 37 Participants |
| Usual Care | Number of Participants With Diabetes Care Gaps at Baseline, 3 Months, 6 Months, and 12 Months | Baseline | Three Care Gaps | 25 Participants |
| Usual Care | Number of Participants With Diabetes Care Gaps at Baseline, 3 Months, 6 Months, and 12 Months | Baseline | Four Care Gaps | 1 Participants |
| Usual Care | 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 |
| Usual Care | 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 |
| Usual Care | 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 |
| Usual Care | 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 |
| Usual Care | 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 |
| Usual Care | 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 |
| Usual Care | 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 |
| Usual Care | 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 |
| Usual Care | 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 |
| Usual Care | 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 |
| Usual Care | 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 |
| Usual Care | 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 |
| Usual Care | 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 |
| Usual Care | 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 |
| Usual Care | 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 |
| Intervention | Number of Participants With Diabetes Care Gaps at Baseline, 3 Months, 6 Months, and 12 Months | 12-months follow-up | Two Care Gaps | 29 Participants |
| Intervention | Number of Participants With Diabetes Care Gaps at Baseline, 3 Months, 6 Months, and 12 Months | Baseline | No Care Gaps | 57 Participants |
| Intervention | Number of Participants With Diabetes Care Gaps at Baseline, 3 Months, 6 Months, and 12 Months | 6-months follow-up | No Care Gaps | 102 Participants |
| Intervention | Number of Participants With Diabetes Care Gaps at Baseline, 3 Months, 6 Months, and 12 Months | Baseline | One Care Gap | 79 Participants |
| Intervention | Number of Participants With Diabetes Care Gaps at Baseline, 3 Months, 6 Months, and 12 Months | 12-months follow-up | No Care Gaps | 102 Participants |
| Intervention | Number of Participants With Diabetes Care Gaps at Baseline, 3 Months, 6 Months, and 12 Months | Baseline | Two Care Gaps | 56 Participants |
| Intervention | Number of Participants With Diabetes Care Gaps at Baseline, 3 Months, 6 Months, and 12 Months | 6-months follow-up | One Care Gap | 78 Participants |
| Intervention | Number of Participants With Diabetes Care Gaps at Baseline, 3 Months, 6 Months, and 12 Months | Baseline | Three Care Gaps | 18 Participants |
| Intervention | 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 |
| Intervention | Number of Participants With Diabetes Care Gaps at Baseline, 3 Months, 6 Months, and 12 Months | Baseline | Four Care Gaps | 6 Participants |
| Intervention | Number of Participants With Diabetes Care Gaps at Baseline, 3 Months, 6 Months, and 12 Months | 6-months follow-up | Two Care Gaps | 22 Participants |
| Intervention | Number of Participants With Diabetes Care Gaps at Baseline, 3 Months, 6 Months, and 12 Months | 3-months follow-up | No Care Gaps | 91 Participants |
| Intervention | Number of Participants With Diabetes Care Gaps at Baseline, 3 Months, 6 Months, and 12 Months | 12-months follow-up | One Care Gap | 69 Participants |
| Intervention | Number of Participants With Diabetes Care Gaps at Baseline, 3 Months, 6 Months, and 12 Months | 3-months follow-up | One Care Gap | 87 Participants |
| Intervention | Number of Participants With Diabetes Care Gaps at Baseline, 3 Months, 6 Months, and 12 Months | 6-months follow-up | Three Care Gaps | 12 Participants |
| Intervention | Number of Participants With Diabetes Care Gaps at Baseline, 3 Months, 6 Months, and 12 Months | 3-months follow-up | Two Care Gaps | 26 Participants |
| Intervention | Number of Participants With Diabetes Care Gaps at Baseline, 3 Months, 6 Months, and 12 Months | 12-months follow-up | Three Care Gaps | 11 Participants |
| Intervention | Number of Participants With Diabetes Care Gaps at Baseline, 3 Months, 6 Months, and 12 Months | 3-months follow-up | Three Care Gaps | 10 Participants |
| Intervention | Number of Participants With Diabetes Care Gaps at Baseline, 3 Months, 6 Months, and 12 Months | 6-months follow-up | Four Care Gaps | 2 Participants |
| Intervention | Number of Participants With Diabetes Care Gaps at Baseline, 3 Months, 6 Months, and 12 Months | 3-months follow-up | Four Care Gaps | 2 Participants |
p-value: <0.00195% CI: [0.3, 0.68]Mixed Models Analysis
Secondary
Change in Blood Glucose Control
Participants' most recent hemoglobin A1C will be abstracted from participants' electronic medical record.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Usual Care | Change in Blood Glucose Control | 12-month follow-up | 6.8 percentage of glycated hemoglobin | Standard Deviation 1.4 |
| Usual Care | 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 |
| Usual Care | Change in Blood Glucose Control | Baseline | 7.0 percentage of glycated hemoglobin | Standard Deviation 1.3 |
| Intervention | Change in Blood Glucose Control | 12-month follow-up | 6.9 percentage of glycated hemoglobin | Standard Deviation 1.3 |
| Intervention | Change in Blood Glucose Control | Change in Hemoglobin A1C: Baseline to 12-month follow-up | -0.35 percentage of glycated hemoglobin | Standard Deviation 1.3 |
| Intervention | Change in Blood Glucose Control | Baseline | 7.2 percentage of glycated hemoglobin | Standard Deviation 1.5 |
Secondary
Change in Confidence Toward Managing Diabetes in General
The 5-item Manage Disease in General Scale of the Chronic Disease Self-Efficacy Scales is a validated measure of 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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Usual Care | Change in Confidence Toward Managing Diabetes in General | 6-month follow-up | 7.9 score on a scale | Standard Deviation 1.7 |
| Usual Care | 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 |
| Usual Care | Change in Confidence Toward Managing Diabetes in General | 3-month follow-up | 7.9 score on a scale | Standard Deviation 1.7 |
| Usual Care | 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 |
| Usual Care | Change in Confidence Toward Managing Diabetes in General | 12-month follow-up | 7.9 score on a scale | Standard Deviation 1.8 |
| Usual Care | 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 |
| Usual Care | Change in Confidence Toward Managing Diabetes in General | Baseline | 8.0 score on a scale | Standard Deviation 1.6 |
| Intervention | Change in Confidence Toward Managing Diabetes in General | Change baseline to 12-month follow-up | -0.1 score on a scale | Standard Deviation 1.3 |
| Intervention | Change in Confidence Toward Managing Diabetes in General | Baseline | 8.1 score on a scale | Standard Deviation 1.5 |
| Intervention | Change in Confidence Toward Managing Diabetes in General | 3-month follow-up | 7.9 score on a scale | Standard Deviation 1.6 |
| Intervention | Change in Confidence Toward Managing Diabetes in General | 6-month follow-up | 7.9 score on a scale | Standard Deviation 1.5 |
| Intervention | Change in Confidence Toward Managing Diabetes in General | 12-month follow-up | 8.1 score on a scale | Standard Deviation 1.7 |
| Intervention | Change in Confidence Toward Managing Diabetes in General | Change baseline to 3-month follow-up | -0.2 score on a scale | Standard Deviation 1.4 |
| Intervention | Change in Confidence Toward Managing Diabetes in General | Change baseline to 6-month follow-up | -0.2 score on a scale | Standard Deviation 1.3 |
p-value: 0.7495% CI: [-0.24, 0.17]Mixed Models Analysis
Secondary
Change in Diabetes Distress
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Usual Care | Change in Diabetes Distress | 6-month follow-up | 5.7 score on a scale | Standard Deviation 5 |
| Usual Care | Change in Diabetes Distress | Change baseline to 3-month follow-up | 0.4 score on a scale | Standard Deviation 3.7 |
| Usual Care | Change in Diabetes Distress | 3-month follow-up | 6.0 score on a scale | Standard Deviation 5.1 |
| Usual Care | Change in Diabetes Distress | Change baseline to 6-month follow-up | 0.2 score on a scale | Standard Deviation 3.7 |
| Usual Care | Change in Diabetes Distress | Change baseline to 12-month follow-up | -0.2 score on a scale | Standard Deviation 3.8 |
| Usual Care | Change in Diabetes Distress | 12-month follow-up | 5.1 score on a scale | Standard Deviation 4.5 |
| Usual Care | Change in Diabetes Distress | Baseline | 5.5 score on a scale | Standard Deviation 4.8 |
| Intervention | Change in Diabetes Distress | Change baseline to 6-month follow-up | 0.2 score on a scale | Standard Deviation 3.9 |
| Intervention | Change in Diabetes Distress | Baseline | 5.5 score on a scale | Standard Deviation 4.6 |
| Intervention | Change in Diabetes Distress | 3-month follow-up | 5.8 score on a scale | Standard Deviation 5 |
| Intervention | Change in Diabetes Distress | 6-month follow-up | 5.8 score on a scale | Standard Deviation 4.8 |
| Intervention | Change in Diabetes Distress | 12-month follow-up | 5.3 score on a scale | Standard Deviation 4.7 |
| Intervention | Change in Diabetes Distress | Change baseline to 3-month follow-up | 0.1 score on a scale | Standard Deviation 3.7 |
| Intervention | Change in Diabetes Distress | Change baseline to 12-month follow-up | -0.2 score on a scale | Standard Deviation 4.1 |
p-value: 0.8895% CI: [-0.6, 0.51]Mixed Models Analysis
Secondary
Change in Diabetes Self-efficacy
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Usual Care | Change in Diabetes Self-efficacy | 12-month follow-up | 30.5 score on a scale | Standard Deviation 6.2 |
| Usual Care | Change in Diabetes Self-efficacy | 3-month follow-up | 29.6 score on a scale | Standard Deviation 6.1 |
| Usual Care | Change in Diabetes Self-efficacy | 6-month follow-up | 30.0 score on a scale | Standard Deviation 6.2 |
| Usual Care | Change in Diabetes Self-efficacy | Change baseline to 3-month follow-up | -0.1 score on a scale | Standard Deviation 4.9 |
| Usual Care | Change in Diabetes Self-efficacy | Change baseline to 6-month follow-up | 0.3 score on a scale | Standard Deviation 5.3 |
| Usual Care | Change in Diabetes Self-efficacy | Change baseline to 12-month follow-up | 0.9 score on a scale | Standard Deviation 5.8 |
| Usual Care | Change in Diabetes Self-efficacy | Baseline | 29.7 score on a scale | Standard Deviation 5.6 |
| Intervention | Change in Diabetes Self-efficacy | Change baseline to 6-month follow-up | 1.0 score on a scale | Standard Deviation 5 |
| Intervention | Change in Diabetes Self-efficacy | Baseline | 29.8 score on a scale | Standard Deviation 5.4 |
| Intervention | Change in Diabetes Self-efficacy | Change baseline to 3-month follow-up | 0.4 score on a scale | Standard Deviation 5.3 |
| Intervention | Change in Diabetes Self-efficacy | 3-month follow-up | 30.2 score on a scale | Standard Deviation 6.2 |
| Intervention | Change in Diabetes Self-efficacy | Change baseline to 12-month follow-up | 1.0 score on a scale | Standard Deviation 5.3 |
| Intervention | Change in Diabetes Self-efficacy | 6-month follow-up | 30.7 score on a scale | Standard Deviation 5.6 |
| Intervention | Change in Diabetes Self-efficacy | 12-month follow-up | 30.8 score on a scale | Standard Deviation 6 |
p-value: 0.2195% CI: [-0.27, 1.22]Mixed Models Analysis
Secondary
Change in Understanding of Diabetes Monitoring and Preventative Care
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.
Time frame: 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.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Usual Care | Change in Understanding of Diabetes Monitoring and Preventative Care | Baseline to 3-months: Recommended frequency of hemoglobin A1C testing | Correct to Wrong | 13 Participants |
| Usual Care | Change in Understanding of Diabetes Monitoring and Preventative Care | Baseline to 3-months: Recommended frequency of hemoglobin A1C testing | No Change | 170 Participants |
| Usual Care | Change in Understanding of Diabetes Monitoring and Preventative Care | Baseline to 3-months: Recommended frequency of hemoglobin A1C testing | Wrong to Correct | 22 Participants |
| Usual Care | Change in Understanding of Diabetes Monitoring and Preventative Care | Baseline to 6-months: Recommended frequency of hemoglobin A1C testing | Correct to Wrong | 11 Participants |
| Usual Care | Change in Understanding of Diabetes Monitoring and Preventative Care | Baseline to 6-months: Recommended frequency of hemoglobin A1C testing | No Change | 173 Participants |
| Usual Care | Change in Understanding of Diabetes Monitoring and Preventative Care | Baseline to 6-months: Recommended frequency of hemoglobin A1C testing | Wrong to Correct | 25 Participants |
| Usual Care | Change in Understanding of Diabetes Monitoring and Preventative Care | Baseline to 12-months: Recommended frequency of hemoglobin A1C testing | Correct to Wrong | 8 Participants |
| Usual Care | Change in Understanding of Diabetes Monitoring and Preventative Care | Baseline to 12-months: Recommended frequency of hemoglobin A1C testing | No Change | 173 Participants |
| Usual Care | Change in Understanding of Diabetes Monitoring and Preventative Care | Baseline to 12-months: Recommended frequency of hemoglobin A1C testing | Wrong to Correct | 22 Participants |
| Usual Care | Change in Understanding of Diabetes Monitoring and Preventative Care | Baseline to 3-months: Recommended frequency of urine microalbumin testing | Correct to Wrong | 36 Participants |
| Usual Care | Change in Understanding of Diabetes Monitoring and Preventative Care | Baseline to 3-months: Recommended frequency of urine microalbumin testing | No Change | 141 Participants |
| Usual Care | Change in Understanding of Diabetes Monitoring and Preventative Care | Baseline to 3-months: Recommended frequency of urine microalbumin testing | Wrong to Correct | 28 Participants |
| Usual Care | Change in Understanding of Diabetes Monitoring and Preventative Care | Baseline to 6-months: Recommended frequency of urine microalbumin testing | Correct to Wrong | 34 Participants |
| Usual Care | Change in Understanding of Diabetes Monitoring and Preventative Care | Baseline to 6-months: Recommended frequency of urine microalbumin testing | No Change | 144 Participants |
| Usual 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 |
| Usual Care | Change in Understanding of Diabetes Monitoring and Preventative Care | Baseline to 12-months: Recommended frequency of urine microalbumin testing | Correct to Wrong | 26 Participants |
| Usual Care | Change in Understanding of Diabetes Monitoring and Preventative Care | Baseline to 12-months: Recommended frequency of urine microalbumin testing | No Change | 142 Participants |
| Usual Care | Change in Understanding of Diabetes Monitoring and Preventative Care | Baseline to 12-months: Recommended frequency of urine microalbumin testing | Wrong to Correct | 34 Participants |
| Usual Care | Change in Understanding of Diabetes Monitoring and Preventative Care | Baseline to 3-months: Recommended frequency of pneumococcal vaccination | Correct to Wrong | 19 Participants |
| Usual Care | Change in Understanding of Diabetes Monitoring and Preventative Care | Baseline to 3-months: Recommended frequency of pneumococcal vaccination | No Change | 149 Participants |
| Usual Care | Change in Understanding of Diabetes Monitoring and Preventative Care | Baseline to 6-months: Recommended frequency of pneumococcal vaccination | Correct to Wrong | 20 Participants |
| Usual Care | Change in Understanding of Diabetes Monitoring and Preventative Care | Baseline to 6-months: Recommended frequency of pneumococcal vaccination | No Change | 166 Participants |
| Usual Care | Change in Understanding of Diabetes Monitoring and Preventative Care | Baseline to 6-months: Recommended frequency of pneumococcal vaccination | Wrong to Correct | 19 Participants |
| Usual Care | Change in Understanding of Diabetes Monitoring and Preventative Care | Baseline to 12-months: Recommended frequency of pneumococcal vaccination | Correct to Wrong | 19 Participants |
| Usual Care | Change in Understanding of Diabetes Monitoring and Preventative Care | Baseline to 12-months: Recommended frequency of pneumococcal vaccination | No Change | 157 Participants |
| Usual Care | Change in Understanding of Diabetes Monitoring and Preventative Care | Baseline to 12-months: Recommended frequency of pneumococcal vaccination | Wrong to Correct | 27 Participants |
| Usual Care | Change in Understanding of Diabetes Monitoring and Preventative Care | Baseline to 3-months: Recommended frequency of diabetes eye exam | Correct to Wrong | 6 Participants |
| Usual Care | Change in Understanding of Diabetes Monitoring and Preventative Care | Baseline to 3-months: Recommended frequency of diabetes eye exam | No Change | 193 Participants |
| Usual Care | Change in Understanding of Diabetes Monitoring and Preventative Care | Baseline to 3-months: Recommended frequency of diabetes eye exam | Wrong to Correct | 6 Participants |
| Usual Care | Change in Understanding of Diabetes Monitoring and Preventative Care | Baseline to 6-months: Recommended frequency of diabetes eye exam | Correct to Wrong | 4 Participants |
| Usual Care | Change in Understanding of Diabetes Monitoring and Preventative Care | Baseline to 6-months: Recommended frequency of diabetes eye exam | No Change | 199 Participants |
| Usual Care | Change in Understanding of Diabetes Monitoring and Preventative Care | Baseline to 6-months: Recommended frequency of diabetes eye exam | Wrong to Correct | 5 Participants |
| Usual Care | Change in Understanding of Diabetes Monitoring and Preventative Care | Baseline to 12-months: Recommended frequency of diabetes eye exam | Correct to Wrong | 3 Participants |
| Usual Care | Change in Understanding of Diabetes Monitoring and Preventative Care | Baseline to 12-months: Recommended frequency of diabetes eye exam | No Change | 194 Participants |
| Usual Care | Change in Understanding of Diabetes Monitoring and Preventative Care | Baseline to 12-months: Recommended frequency of diabetes eye exam | Wrong to Correct | 6 Participants |
| Usual Care | Change in Understanding of Diabetes Monitoring and Preventative Care | Baseline to 3-months: Recommended frequency of pneumococcal vaccination | Wrong to Correct | 36 Participants |
| Intervention | Change in Understanding of Diabetes Monitoring and Preventative Care | Baseline to 3-months: Recommended frequency of diabetes eye exam | Correct to Wrong | 2 Participants |
| Intervention | Change in Understanding of Diabetes Monitoring and Preventative Care | Baseline to 3-months: Recommended frequency of hemoglobin A1C testing | Correct to Wrong | 21 Participants |
| Intervention | Change in Understanding of Diabetes Monitoring and Preventative Care | Baseline to 3-months: Recommended frequency of pneumococcal vaccination | Correct to Wrong | 28 Participants |
| Intervention | Change in Understanding of Diabetes Monitoring and Preventative Care | Baseline to 3-months: Recommended frequency of hemoglobin A1C testing | No Change | 173 Participants |
| Intervention | Change in Understanding of Diabetes Monitoring and Preventative Care | Baseline to 12-months: Recommended frequency of diabetes eye exam | Wrong to Correct | 5 Participants |
| Intervention | Change in Understanding of Diabetes Monitoring and Preventative Care | Baseline to 3-months: Recommended frequency of hemoglobin A1C testing | Wrong to Correct | 15 Participants |
| Intervention | Change in Understanding of Diabetes Monitoring and Preventative Care | Baseline to 3-months: Recommended frequency of pneumococcal vaccination | No Change | 158 Participants |
| Intervention | Change in Understanding of Diabetes Monitoring and Preventative Care | Baseline to 6-months: Recommended frequency of hemoglobin A1C testing | Correct to Wrong | 16 Participants |
| Intervention | Change in Understanding of Diabetes Monitoring and Preventative Care | Baseline to 3-months: Recommended frequency of pneumococcal vaccination | Wrong to Correct | 21 Participants |
| Intervention | Change in Understanding of Diabetes Monitoring and Preventative Care | Baseline to 6-months: Recommended frequency of hemoglobin A1C testing | No Change | 171 Participants |
| Intervention | Change in Understanding of Diabetes Monitoring and Preventative Care | Baseline to 3-months: Recommended frequency of diabetes eye exam | No Change | 203 Participants |
| Intervention | Change in Understanding of Diabetes Monitoring and Preventative Care | Baseline to 6-months: Recommended frequency of hemoglobin A1C testing | Wrong to Correct | 18 Participants |
| Intervention | Change in Understanding of Diabetes Monitoring and Preventative Care | Baseline to 6-months: Recommended frequency of pneumococcal vaccination | Correct to Wrong | 27 Participants |
| Intervention | Change in Understanding of Diabetes Monitoring and Preventative Care | Baseline to 12-months: Recommended frequency of hemoglobin A1C testing | Correct to Wrong | 16 Participants |
| Intervention | Change in Understanding of Diabetes Monitoring and Preventative Care | Baseline to 6-months: Recommended frequency of diabetes eye exam | Wrong to Correct | 3 Participants |
| Intervention | Change in Understanding of Diabetes Monitoring and Preventative Care | Baseline to 12-months: Recommended frequency of hemoglobin A1C testing | No Change | 168 Participants |
| Intervention | Change in Understanding of Diabetes Monitoring and Preventative Care | Baseline to 6-months: Recommended frequency of pneumococcal vaccination | No Change | 152 Participants |
| Intervention | Change in Understanding of Diabetes Monitoring and Preventative Care | Baseline to 12-months: Recommended frequency of hemoglobin A1C testing | Wrong to Correct | 16 Participants |
| Intervention | Change in Understanding of Diabetes Monitoring and Preventative Care | Baseline to 3-months: Recommended frequency of diabetes eye exam | Wrong to Correct | 3 Participants |
| Intervention | Change in Understanding of Diabetes Monitoring and Preventative Care | Baseline to 3-months: Recommended frequency of urine microalbumin testing | Correct to Wrong | 37 Participants |
| Intervention | Change in Understanding of Diabetes Monitoring and Preventative Care | Baseline to 6-months: Recommended frequency of pneumococcal vaccination | Wrong to Correct | 25 Participants |
| Intervention | Change in Understanding of Diabetes Monitoring and Preventative Care | Baseline to 3-months: Recommended frequency of urine microalbumin testing | No Change | 140 Participants |
| Intervention | Change in Understanding of Diabetes Monitoring and Preventative Care | Baseline to 12-months: Recommended frequency of diabetes eye exam | No Change | 190 Participants |
| Intervention | Change in Understanding of Diabetes Monitoring and Preventative Care | Baseline to 3-months: Recommended frequency of urine microalbumin testing | Wrong to Correct | 32 Participants |
| Intervention | Change in Understanding of Diabetes Monitoring and Preventative Care | Baseline to 12-months: Recommended frequency of pneumococcal vaccination | Correct to Wrong | 27 Participants |
| Intervention | Change in Understanding of Diabetes Monitoring and Preventative Care | Baseline to 6-months: Recommended frequency of urine microalbumin testing | Correct to Wrong | 28 Participants |
| Intervention | Change in Understanding of Diabetes Monitoring and Preventative Care | Baseline to 6-months: Recommended frequency of diabetes eye exam | Correct to Wrong | 2 Participants |
| Intervention | Change in Understanding of Diabetes Monitoring and Preventative Care | Baseline to 6-months: Recommended frequency of urine microalbumin testing | No Change | 135 Participants |
| Intervention | Change in Understanding of Diabetes Monitoring and Preventative Care | Baseline to 12-months: Recommended frequency of pneumococcal vaccination | No Change | 151 Participants |
| Intervention | Change in Understanding of Diabetes Monitoring and Preventative Care | Baseline to 6-months: Recommended frequency of urine microalbumin testing | Wrong to Correct | 39 Participants |
| Intervention | Change in Understanding of Diabetes Monitoring and Preventative Care | Baseline to 12-months: Recommended frequency of diabetes eye exam | Correct to Wrong | 5 Participants |
| Intervention | Change in Understanding of Diabetes Monitoring and Preventative Care | Baseline to 12-months: Recommended frequency of urine microalbumin testing | Correct to Wrong | 32 Participants |
| Intervention | Change in Understanding of Diabetes Monitoring and Preventative Care | Baseline to 12-months: Recommended frequency of pneumococcal vaccination | Wrong to Correct | 20 Participants |
| Intervention | Change in Understanding of Diabetes Monitoring and Preventative Care | Baseline to 12-months: Recommended frequency of urine microalbumin testing | No Change | 125 Participants |
| Intervention | Change in Understanding of Diabetes Monitoring and Preventative Care | Baseline to 6-months: Recommended frequency of diabetes eye exam | No Change | 200 Participants |
| Intervention | Change in Understanding of Diabetes Monitoring and Preventative Care | Baseline to 12-months: Recommended frequency of urine microalbumin testing | Wrong to Correct | 42 Participants |
p-value: 0.2995% CI: [0.2, 1.62]Mixed Models Analysis
Secondary
Patient Initiated Orders
The number of patient-initiated orders via the study intervention for evidence-based diabetes monitoring and preventative services (e.g., A1c).
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Usual Care | Patient Initiated Orders | Urine microalbumin | 107 orders initiated |
| Usual Care | Patient Initiated Orders | Pneumococcal vaccine | 19 orders initiated |
| Usual Care | Patient Initiated Orders | Diabetes eye exam | 46 orders initiated |
| Usual Care | Patient Initiated Orders | Hemoglobin a1c | 97 orders initiated |
Secondary
Reported Services Completed Outside Vanderbilt System
The number of patient reports of diabetes eye exams received outside the Vanderbilt University Medical Center health system submitted via the study intervention.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Usual Care | Reported Services Completed Outside Vanderbilt System | 101 reports |
Secondary
Satisfaction/Usability of My Health at Vanderbilt
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).
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Usual Care | Satisfaction/Usability of My Health at Vanderbilt | 6-month follow-up | 82.0 score on a scale | Standard Deviation 13.1 |
| Usual Care | Satisfaction/Usability of My Health at Vanderbilt | Change baseline to 3-month follow-up | -0.1 score on a scale | Standard Deviation 14.4 |
| Usual Care | Satisfaction/Usability of My Health at Vanderbilt | 3-month follow-up | 81.1 score on a scale | Standard Deviation 14.3 |
| Usual Care | Satisfaction/Usability of My Health at Vanderbilt | Change baseline to 6-month follow-up | 0.6 score on a scale | Standard Deviation 12.8 |
| Usual Care | Satisfaction/Usability of My Health at Vanderbilt | 12-month follow-up | 81.6 score on a scale | Standard Deviation 14.7 |
| Usual Care | Satisfaction/Usability of My Health at Vanderbilt | Change baseline to 12-month follow-up | 0.3 score on a scale | Standard Deviation 13.2 |
| Usual Care | Satisfaction/Usability of My Health at Vanderbilt | Baseline | 81.3 score on a scale | Standard Deviation 13.4 |
| Intervention | Satisfaction/Usability of My Health at Vanderbilt | Change baseline to 12-month follow-up | 0.2 score on a scale | Standard Deviation 15.9 |
| Intervention | Satisfaction/Usability of My Health at Vanderbilt | Baseline | 80.2 score on a scale | Standard Deviation 12.8 |
| Intervention | Satisfaction/Usability of My Health at Vanderbilt | 3-month follow-up | 79.4 score on a scale | Standard Deviation 14.8 |
| Intervention | Satisfaction/Usability of My Health at Vanderbilt | 6-month follow-up | 79.0 score on a scale | Standard Deviation 14.8 |
| Intervention | Satisfaction/Usability of My Health at Vanderbilt | 12-month follow-up | 80.5 score on a scale | Standard Deviation 16.1 |
| Intervention | Satisfaction/Usability of My Health at Vanderbilt | Change baseline to 3-month follow-up | -0.7 score on a scale | Standard Deviation 12.4 |
| Intervention | Satisfaction/Usability of My Health at Vanderbilt | Change baseline to 6-month follow-up | -1.2 score on a scale | Standard Deviation 11.6 |
p-value: 0.2195% CI: [-3.19, 0.71]Mixed Models Analysis
Secondary
Treatment Intensification
The addition of: (a) antihyperglycemic medications and (b) antihypertensive medications will be assessed by EHR abstraction.
Time frame: Baseline to 3-month follow-up, baseline to 6-month follow-up, and baseline to 12-month follow-up
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Usual Care | Treatment Intensification | Antihyperglycemic medications: baseline to 6-month follow-up | Increase in the number of medications | 45 Participants |
| Usual Care | Treatment Intensification | Antihyperglycemic medications: baseline to 3-month follow-up | Decrease in the number of medications | 34 Participants |
| Usual Care | Treatment Intensification | Antihyperglycemic medications: baseline to 3-month follow-up | Increase in the number of medications | 35 Participants |
| Usual Care | Treatment Intensification | Antihyperglycemic medications: baseline to 3-month follow-up | Unknown | 1 Participants |
| Usual Care | Treatment Intensification | Antihyperglycemic medications: baseline to 6-month follow-up | No change in the number of medications | 122 Participants |
| Usual Care | Treatment Intensification | Antihyperglycemic medications: baseline to 6-month follow-up | Decrease in the number of medications | 47 Participants |
| Usual Care | Treatment Intensification | Antihyperglycemic medications: baseline to 3-month follow-up | No change in the number of medications | 145 Participants |
| Usual Care | Treatment Intensification | Antihyperglycemic medications: baseline to 6-month follow-up | Unknown | 1 Participants |
| Usual Care | Treatment Intensification | Antihyperglycemic medications: baseline to 12-month follow-up | No change in the number of medications | 103 Participants |
| Usual Care | Treatment Intensification | Antihyperglycemic medications: baseline to 12-month follow-up | Decrease in the number of medications | 59 Participants |
| Usual Care | Treatment Intensification | Antihyperglycemic medications: baseline to 12-month follow-up | Increase in the number of medications | 52 Participants |
| Usual Care | Treatment Intensification | Antihyperglycemic medications: baseline to 12-month follow-up | Unknown | 1 Participants |
| Usual Care | Treatment Intensification | Antihypertensive medications: baseline to 3-month follow-up | No change in the number of medications | 190 Participants |
| Usual Care | Treatment Intensification | Antihypertensive medications: baseline to 3-month follow-up | Decrease in the number of medications | 11 Participants |
| Usual Care | Treatment Intensification | Antihypertensive medications: baseline to 3-month follow-up | Increase in the number of medications | 13 Participants |
| Usual Care | Treatment Intensification | Antihypertensive medications: baseline to 3-month follow-up | Unknown | 1 Participants |
| Usual Care | Treatment Intensification | Antihypertensive medications: baseline to 6-month follow-up | No change in the number of medications | 184 Participants |
| Usual Care | Treatment Intensification | Antihypertensive medications: baseline to 6-month follow-up | Decrease in the number of medications | 15 Participants |
| Usual Care | Treatment Intensification | Antihypertensive medications: baseline to 6-month follow-up | Increase in the number of medications | 15 Participants |
| Usual Care | Treatment Intensification | Antihypertensive medications: baseline to 6-month follow-up | Unknown | 1 Participants |
| Usual Care | Treatment Intensification | Antihypertensive medications: baseline to 12-month follow-up | Decrease in the number of medications | 26 Participants |
| Usual Care | Treatment Intensification | Antihypertensive medications: baseline to 12-month follow-up | Increase in the number of medications | 26 Participants |
| Usual Care | Treatment Intensification | Antihypertensive medications: baseline to 12-month follow-up | Unknown | 1 Participants |
| Usual Care | Treatment Intensification | Antihypertensive medications: baseline to 12-month follow-up | No change in the number of medications | 162 Participants |
| Intervention | Treatment Intensification | Antihypertensive medications: baseline to 12-month follow-up | Unknown | 0 Participants |
| Intervention | Treatment Intensification | Antihyperglycemic medications: baseline to 3-month follow-up | No change in the number of medications | 163 Participants |
| Intervention | Treatment Intensification | Antihypertensive medications: baseline to 3-month follow-up | No change in the number of medications | 196 Participants |
| Intervention | Treatment Intensification | Antihyperglycemic medications: baseline to 3-month follow-up | Decrease in the number of medications | 29 Participants |
| Intervention | Treatment Intensification | Antihypertensive medications: baseline to 6-month follow-up | Increase in the number of medications | 9 Participants |
| Intervention | Treatment Intensification | Antihyperglycemic medications: baseline to 3-month follow-up | Increase in the number of medications | 24 Participants |
| Intervention | Treatment Intensification | Antihypertensive medications: baseline to 3-month follow-up | Decrease in the number of medications | 14 Participants |
| Intervention | Treatment Intensification | Antihyperglycemic medications: baseline to 3-month follow-up | Unknown | 0 Participants |
| Intervention | Treatment Intensification | Antihypertensive medications: baseline to 12-month follow-up | Increase in the number of medications | 19 Participants |
| Intervention | Treatment Intensification | Antihyperglycemic medications: baseline to 6-month follow-up | No change in the number of medications | 143 Participants |
| Intervention | Treatment Intensification | Antihypertensive medications: baseline to 3-month follow-up | Increase in the number of medications | 6 Participants |
| Intervention | Treatment Intensification | Antihyperglycemic medications: baseline to 6-month follow-up | Decrease in the number of medications | 36 Participants |
| Intervention | Treatment Intensification | Antihypertensive medications: baseline to 6-month follow-up | Unknown | 0 Participants |
| Intervention | Treatment Intensification | Antihyperglycemic medications: baseline to 6-month follow-up | Increase in the number of medications | 37 Participants |
| Intervention | Treatment Intensification | Antihypertensive medications: baseline to 3-month follow-up | Unknown | 0 Participants |
| Intervention | Treatment Intensification | Antihyperglycemic medications: baseline to 6-month follow-up | Unknown | 0 Participants |
| Intervention | Treatment Intensification | Antihypertensive medications: baseline to 12-month follow-up | No change in the number of medications | 171 Participants |
| Intervention | Treatment Intensification | Antihyperglycemic medications: baseline to 12-month follow-up | No change in the number of medications | 118 Participants |
| Intervention | Treatment Intensification | Antihypertensive medications: baseline to 6-month follow-up | No change in the number of medications | 189 Participants |
| Intervention | Treatment Intensification | Antihyperglycemic medications: baseline to 12-month follow-up | Decrease in the number of medications | 51 Participants |
| Intervention | Treatment Intensification | Antihypertensive medications: baseline to 12-month follow-up | Decrease in the number of medications | 26 Participants |
| Intervention | Treatment Intensification | Antihyperglycemic medications: baseline to 12-month follow-up | Increase in the number of medications | 47 Participants |
| Intervention | Treatment Intensification | Antihypertensive medications: baseline to 6-month follow-up | Decrease in the number of medications | 18 Participants |
| Intervention | Treatment Intensification | Antihyperglycemic medications: baseline to 12-month follow-up | Unknown | 0 Participants |