Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R18DK123373-01 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate the usability of a novel patient portal intervention designed to: (a) notify patients when selected, clinically meaningful, evidence-based diabetes monitoring & preventative care (e.g., annual diabetes eye exam) become due and (b) allow patients to initiate orders for the care. In addition, the investigators will assess pre-post change on secondary psychosocial outcomes (e.g., self-efficacy).
Up to 60 adult patients with type 1 or 2 diabetes mellitus will be enrolled and given access to a new feature within the patient portal at Vanderbilt University Medical Center. The new feature will be available via the patient portal native app (i.e., My Health at Vanderbilt (MHAV) app) for mobile devices (smartphone or tablet). The new feature will allow patients to: (1) receive notifications when the patient is due for certain types of diabetes monitoring and preventative care and (2) initiate an order for the care.
Study participants will complete questionnaires electronically via email at three time points: baseline (T0), immediately after first use of the intervention (T1), and three-month follow-up (T2) to as assess study outcomes including usability and pre-post change in secondary psychosocial outcomes.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Participants will have access to a new feature within an established patient portal native app on mobile devices. The new feature aims to address diabetes care gaps. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diabetes Care Gaps Patient Portal Intervention | Other | The Diabetes Care Gaps Patient Portal Intervention involves a new feature embedded with the My Health At Vanderbilt (MHAV) native app (on Epic's MyChart platform) for mobile devices that allows patients to: (a) receive notifications when the patient is due for certain types of diabetes monitoring and preventative care and (b) initiate an order for the care. Automated notifications will be sent to patients if, according to the evidence-based guidelines, the patients are due for a hemoglobin A1C blood test, microalbumin urine test, diabetes eye exam, or pneumonia vaccination. Once notified patients can initiate orders for the care within the MHAV app. The patient will receive confirmation when the order has been processed and will be provided instructions to receive the relevant care. |
| Measure | Description | Time Frame |
|---|---|---|
| Usability | The System Usability Scale (SUS) is a validated measure of usability. The ten items are scored on a five-point Likert scale. The item scores are summed and then converted to a score ranging from 0 (worst) to 100 (best). A score of above 68 indicative of "above average" usability. | Immediately after first use T(1), at approximately 1 month |
| User Experience | User experience will be assessed by study-specific survey items administered to all participants at the end of the study period (T2). The survey items will inquire about participants' perspectives on the acceptability of the intervention and on particular components of the intervention such as notifications. | 3-month follow up (T2) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Attitudes Toward Managing Diabetes in General | The 5-item Manage Disease in General Scale of the Chronic Disease Self-Efficacy Scales is a validated measure of self-efficacy (i.e., the confidence a person has in managing their own health and health care) and is closely related to patient activation. The items were adapted to be specific to diabetes rather than a generic condition or illness. Each item uses a 10-point Likert-type scale of response options ranging from 1 (not at all confident) to 10 (totally confident). The score for the scale is the mean of the items. Higher scores indicate greater self-efficacy. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| William Martinez, MD, MS | Vanderbilt University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University Medical Center | Nashville | Tennessee | 37212 | United States |
After study results are posted on clinical trials and published in a peer-reviewed journal, de-identified individual participant data that underlie the results reported will be available upon requests made to the principal investigator and ending after 36 months after publication.
Deidentified individual participant data that underlie the results reported will be available after publication in a peer reviewed journal and posted on clinical trials and ending after 36 months after publication.
Researchers should provide a methodologically sound proposal to achieve their proposed aims. Proposals may be submitted to the principal investigator up to 36 months following publication. To gain access, data requestors will need to sign a data access agreement.
Not provided
Of the 60 enrolled participants, 50 completed the baseline questionnaire and still had at least one diabetes care gap (due for any of the following: hemoglobin A1C, urine microalbumin, diabetes eye exam, and/or pneumococcal vaccination) and were then assigned to the intervention.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Intervention | Participants will have access to a new feature within an established patient portal native app on mobile devices. The new feature aims to address diabetes care gaps. Diabetes Care Gaps Patient Portal Intervention: The Diabetes Care Gaps Patient Portal Intervention involves a new feature embedded with the My Health At Vanderbilt (MHAV) native app (on Epic's MyChart platform) for mobile devices that allows patients to: (a) receive notifications when the patient is due for certain types of diabetes monitoring and preventative care and (b) initiate an order for the care. Automated notifications will be sent to patients if, according to the evidence-based guidelines, the patients are due for a hemoglobin A1C blood test, microalbumin urine test, diabetes eye exam, or pneumonia vaccination. Once notified patients can initiate orders for the care within the MHAV app. The patient will receive confirmation when the order has been processed and will be provided instructions to receive the relevant care. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Intervention | Participants will have access to a new feature within an established patient portal native app on mobile devices. The new feature aims to address diabetes care gaps. Diabetes Care Gaps Patient Portal Intervention: The Diabetes Care Gaps Patient Portal Intervention involves a new feature embedded with the My Health At Vanderbilt (MHAV) native app (on Epic's MyChart platform) for mobile devices that allows patients to: (a) receive notifications when the patient is due for certain types of diabetes monitoring and preventative care and (b) initiate an order for the care. Automated notifications will be sent to patients if, according to the evidence-based guidelines, the patients are due for a hemoglobin A1C blood test, microalbumin urine test, diabetes eye exam, or pneumonia vaccination. Once notified patients can initiate orders for the care within the MHAV app. The patient will receive confirmation when the order has been processed and will be provided instructions to receive the relevant care. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Usability | The System Usability Scale (SUS) is a validated measure of usability. The ten items are scored on a five-point Likert scale. The item scores are summed and then converted to a score ranging from 0 (worst) to 100 (best). A score of above 68 indicative of "above average" usability. | 36 participants used to the study intervention during the study period and completed the SUS scale after first use. | Posted | Mean | Standard Deviation | score on a scale | Immediately after first use T(1), at approximately 1 month |
|
3 months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention | Participants will have access to a new feature within an established patient portal native app on mobile devices. The new feature aims to address diabetes care gaps. Diabetes Care Gaps Patient Portal Intervention: The Diabetes Care Gaps Patient Portal Intervention involves a new feature embedded with the My Health At Vanderbilt (MHAV) native app (on Epic's MyChart platform) for mobile devices that allows patients to: (a) receive notifications when the patient is due for certain types of diabetes monitoring and preventative care and (b) initiate an order for the care. Automated notifications will be sent to patients if, according to the evidence-based guidelines, the patients are due for a hemoglobin A1C blood test, microalbumin urine test, diabetes eye exam, or pneumonia vaccination. Once notified patients can initiate orders for the care within the MHAV app. The patient will receive confirmation when the order has been processed and will be provided instructions to receive the relevant care. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization | General disorders | Non-systematic Assessment | Not related to study participation |
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| William Martinez, MD | Vanderbilt University Medical Center | (615) 936-1010 | william.martinez@vumc.org |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 8, 2022 | May 23, 2023 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 18, 2021 | Jul 24, 2022 | ICF_000.pdf |
Not provided
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Enrollment (T0) and 3-month follow up (T2) |
| Change in Diabetes Distress | The Problem Areas in Diabetes Scale (PAID-5) is a valid measure of diabetes distress. Total scores on the PAID-5 can range from 0 to 20, with higher scores suggesting greater diabetes-related emotional distress. | Enrollment (T0) and 3-month follow up (T2) |
| Change in Understanding of Diabetes Monitoring and Preventative Care | Unique study specific items to assess participants' understanding of measures of diabetes monitoring and preventative care (e.g., Diabetes Eye Exams) will be administered to all study participants. | Enrollment (T0) and 3-month follow up (T2) |
| Patient Initiated Orders | The investigators will collect data on the number of patient-initiated orders for evidence-based diabetes monitoring and preventative services (e.g., hemoglobin A1c). Participants with more than one diabetes care gap can initiated an order for more than one evidence-based diabetes monitoring and preventative service (e.g. hemoglobin A1c and diabetes eye exam). | 3-month follow up (T2) |
| Order Completion | The investigators will collect data on the number of completed (i.e., care received) evidence-based diabetes monitoring and preventative services after a corresponding patient initiated order. | 3-month follow up (T2) |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Health Literacy | Count of Participants | Participants |
|
|
|
|
| Primary | User Experience | User experience will be assessed by study-specific survey items administered to all participants at the end of the study period (T2). The survey items will inquire about participants' perspectives on the acceptability of the intervention and on particular components of the intervention such as notifications. | Not all patients completed this item on the final questionnaire (T2), results limited to the 47 who responded to the items. | Posted | Count of Participants | Participants | 3-month follow up (T2) |
|
|
|
| Secondary | Change in Attitudes Toward Managing Diabetes in General | The 5-item Manage Disease in General Scale of the Chronic Disease Self-Efficacy Scales is a validated measure of self-efficacy (i.e., the confidence a person has in managing their own health and health care) and is closely related to patient activation. The items were adapted to be specific to diabetes rather than a generic condition or illness. Each item uses a 10-point Likert-type scale of response options ranging from 1 (not at all confident) to 10 (totally confident). The score for the scale is the mean of the items. Higher scores indicate greater self-efficacy. | 4 participants did not complete the Manage Disease in General Scale on the three-month follow-up post-questionnaire and were excluded from this analysis. | Posted | Mean | Standard Deviation | score on a scale | Enrollment (T0) and 3-month follow up (T2) |
|
|
|
|
| Secondary | Change in Diabetes Distress | The Problem Areas in Diabetes Scale (PAID-5) is a valid measure of diabetes distress. Total scores on the PAID-5 can range from 0 to 20, with higher scores suggesting greater diabetes-related emotional distress. | 4 participants did not complete the Problem Areas in Diabetes Scale (PAID-5) on the three-month follow-up post-questionnaire and were excluded from this analysis. | Posted | Mean | Standard Deviation | score on a scale | Enrollment (T0) and 3-month follow up (T2) |
|
|
|
|
| Secondary | Change in Understanding of Diabetes Monitoring and Preventative Care | Unique study specific items to assess participants' understanding of measures of diabetes monitoring and preventative care (e.g., Diabetes Eye Exams) will be administered to all study participants. | Not all patients answers all Understanding of Diabetes Monitoring and Preventative Care items on both the baseline (T0) and three-months (T2). Participants with missing this data at either time point were excluded from the analysis with up to 5 participants missing data for one of items. | Posted | Count of Participants | Participants | Enrollment (T0) and 3-month follow up (T2) |
|
|
|
|
| Secondary | Patient Initiated Orders | The investigators will collect data on the number of patient-initiated orders for evidence-based diabetes monitoring and preventative services (e.g., hemoglobin A1c). Participants with more than one diabetes care gap can initiated an order for more than one evidence-based diabetes monitoring and preventative service (e.g. hemoglobin A1c and diabetes eye exam). | Posted | Count of Participants | Participants | 3-month follow up (T2) |
|
|
|
| Secondary | Order Completion | The investigators will collect data on the number of completed (i.e., care received) evidence-based diabetes monitoring and preventative services after a corresponding patient initiated order. | Posted | Count of Participants | Participants | 3-month follow up (T2) |
|
|
|
| 0 |
| 50 |
| 3 |
| 50 |
| 0 |
| 50 |
|
Not provided
Not provided
Not provided
|
| Neutral/disagree/strongly disagree |
|
|
| Correctly identify the recommended frequency of urine microalbumin screening at baseline (T0) |
|
|
| Correctly identify the recommended frequency of urine microalbumin screening at three-months (T2) |
|
|
| Correctly identify the recommended frequency of pneumonia vaccination at baseline (T0) |
|
|
| Correctly identify the recommended frequency of pneumonia vaccination at three-months (T2) |
|
|
| Correctly identify the recommended frequency of diabetes eye exams at baseline (T0) |
|
|
| Correctly identify the recommended frequency of diabetes eye exams at three-months (T2) |
|
|
| 1 |
| Other |
| Analysis for pre-post change in knowledge of recommended pneumonia vaccination frequency | McNemar | 1 | Other |
| Analysis for pre-post change in knowledge of recommended diabetes eye exam frequency | McNemar | 1 | Other |
| Title | Measurements |
|---|---|
|
| Initiated order for diabetes eye exam |
|
|
| Completed a diabetes eye exam after patient initiated order |
|