Evaluation of a Patient Portal Intervention to Address Diabetes Care Gaps

Not Applicable

Completed

Conditions: Diabetes Mellitus

Interventions: Other: Diabetes Care Gaps Patient Portal Intervention

Registration Number: NCT04728620

Lead Sponsor: Vanderbilt University Medical Center

Brief Summary: 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).

Detailed Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 60

Inclusion Criteria

Established patient at participating primary care clinic
Type 1 or 2 diabetes mellitus
Able to speak and read in English
Age 18 to 75 years old
Mobile device (smartphone or tablet) with internet access
Active MHAV account and willing and able to use the MHAV native app on a mobile device
Due (based on evidence-based guidelines) for any of the following: hemoglobin A1C, urine microalbumin, diabetes eye exam, and/or pneumococcal vaccination.

Exclusion Criteria

Known cognitive deficits or functional impairment preventing the use of a mobile device
Pregnant or planning to become pregnant during the study period
Severe difficulty seeing
Severe difficulty hearing
Medical condition that make it hard for people to understand what they are saying

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention	Diabetes Care Gaps Patient Portal 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.

Primary Outcome Measures

Name	Time	Method
Usability	Immediately after first use T(1), at approximately 1 month	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	3-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.

Secondary Outcome Measures

Name	Time	Method
Change in Understanding of Diabetes Monitoring and Preventative Care	Enrollment (T0) and 3-month follow up (T2)	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.
Order Completion	3-month follow up (T2)	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.
Change in Attitudes Toward Managing Diabetes in General	Enrollment (T0) and 3-month follow up (T2)	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.
Patient Initiated Orders	3-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., 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).
Change in Diabetes Distress	Enrollment (T0) and 3-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.