Effects of a Patient Portal Intervention to Address Diabetes Care Gaps

Diabetes Mellitus Clinical Trial

Official title:

Effects of a Patient Portal Intervention to Address Diabetes Care Gaps: A Pragmatic Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04894903
• Other study ID #: 212257
• Secondary ID: R18DK123373
• Status: Completed
• Phase: N/A
• Start date: April 30, 2022
• Est. completion date: March 2, 2024

Study information

• Verified date: May 2024
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 440
• Est. completion date: March 2, 2024
• Est. primary completion date: February 3, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Other:
• 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 monitoring & preventative care (e.g., annual urine microalbumin) are due and (b) allows patients to initiate orders for the care.

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (3)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Diabetes Care Gaps at 12 months	Number of diabetes care gaps per patient out of four possible: no diabetes eye exam in the last 12 months,; no hemoglobin A1C blood test in the last 6 months,; no urine microalbumin in the last 12 months, and; 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.	Baseline and 12-month follow-up
Secondary	Number of Diabetes Care Gaps at 6 months	Number of diabetes care gaps per patient out of four possible: no diabetes eye exam in the last 12 months,; no hemoglobin A1C blood test in the last 6 months,; no urine microalbumin in the last 12 months, and; 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	Baseline and 6-month follow-up
Secondary	Patient Initiated Orders	The number of patient-initiated orders for evidence-based diabetes monitoring and preventative services (e.g., A1c).	Baseline, 3-month follow-up, 6-month follow-up, and 12-month follow-up
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.	Baseline to 3-month follow-up, baseline to 6-month follow-up, and baseline to 12-month follow-up
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.	Baseline to 3-month follow-up, baseline to 6-month follow-up, and baseline to 12-month follow-up
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.	Baseline to 3-month follow-up, baseline to 6-month follow-up, and baseline to 12-month follow-up
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).	Baseline, 3-month follow-up, 6-month follow-up, and 12-month follow-up
Secondary	Change in Blood Glucose Control	Participants' most recent hemoglobin A1C will be abstracted from participants' electronic medical record.	Baseline to 3-month follow-up, baseline to 6-month follow-up, and baseline to 12-month follow-up
Secondary	Treatment Intensification	The addition or increase in dose of: (a) antihyperglycemic medications and (b) antihypertensive medications will be assessed by EHR abstraction.	Baseline to 3-month follow-up, baseline to 6-month follow-up, and baseline to 12-month follow-up
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.	Baseline to 3-month follow-up, baseline to 6-month follow-up, and baseline to 12-month follow-up
Secondary	Reported Services Completed Outside Vanderbilt System	The number of reports of diabetes eye exams outside the Vanderbilt University Medical Center health system received through the study intervention.	Baseline, 3-month follow-up, 6-month follow-up, and 12-month follow-up