Effects 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: NCT04894903

Lead Sponsor: Vanderbilt University Medical Center

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 440

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Diabetes Care Gaps Patient Portal Intervention	Patients have access to an existing patient web portal (My Health at Vanderbilt) embedded with the Diabetes Care Gaps Patient Portal Intervention. .

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).
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 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 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).
Change in Blood Glucose Control	Baseline to 12-month follow-up	Participants' most recent hemoglobin A1C will be abstracted from participants' electronic medical record.
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.