Evaluation a of Patient Portal Intervention to Address Diabetes Care Gaps
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|ClinicalTrials.gov Identifier: NCT04728620|
Recruitment Status : Not yet recruiting
First Posted : January 28, 2021
Last Update Posted : January 28, 2021
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus||Other: Diabetes Care Gaps Patient Portal Intervention||Not Applicable|
Up to 65 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 two-month follow-up (T2) to as assess study outcomes including usability and pre-post change in secondary psychosocial outcomes.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||65 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||A Patient Portal Intervention to Address Diabetes Care Gaps: A Usability Study|
|Estimated Study Start Date :||March 2021|
|Estimated Primary Completion Date :||July 2021|
|Estimated Study Completion Date :||July 2021|
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.
Other: 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, pneumonia vaccination, or influenza 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.
- Usability [ Time Frame: Immediately After First Use T(1) ]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.
- User Experience [ Time Frame: 2-month follow up (T2) ]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.
- Changes in Patient Activation [ Time Frame: Enrollment (T0), Immediately After First Use (T1) and 2-month follow up (T2) ]The Patient Activation Measure® (PAM-13) is a validated measure of patient activation (i.e., the knowledge, skills and confidence a person has in managing their own health and health care) and consists of 13 items. Each item uses a 4-point Likert-type scale of response options ranging from strongly disagree to strongly agree to elicit endorsement of a particular statement. PAM® survey item responses result in total raw scores ranging from 13 to 52, which is converted to the linear interval scale of patient activation scores, ranging from 0 (lowest activation) to 100 (highest activation).
- Change in Diabetes Distress [ Time Frame: Enrollment (T0) and 2-month follow up (T2) ]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.
- Change in Diabetes Self-Efficacy [ Time Frame: Enrollment (T0), Immediately After First Use (T1) and 2-month follow up (T2) ]The Perceived Diabetes Self-Management Scale (PDSMS) is a valid measure of diabetes self-efficacy. Eight items are 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.
- Change in Understanding of Diabetes Health Measures [ Time Frame: Enrollment (T0), Immediately After First Use (T1) and 2-month follow up (T2) ]Unique study specific items to assess participants' understanding of measures of diabetes health status (e.g., Hemoglobin A1C) will be administered to all study participants.
- Patient Initiated Orders [ Time Frame: 2-month follow up (T2) ]The investigators will collect data on the number of patient-initiated orders for evidence-based diabetes monitoring and preventative services (e.g., A1c).
- Order Completion [ Time Frame: 2-month follow up (T2) ]The investigators will collect data on the number of completed (i.e., care received) patient-initiated orders for evidence-based diabetes monitoring and preventative services.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04728620
|Contact: William Martinez, MD, MSfirstname.lastname@example.org|
|Principal Investigator:||William Martinez, MD, MS||Vanderbilt University Medical Center|