Blood Glucose Monitoring in Electronic Health Records

Diabetes Mellitus Clinical Trial

Official title:

Integration of Blood Glucose Monitoring Into Electronic Health Records

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03542487
• Other study ID #: 17-2642
• Secondary ID: Project Code: 17
• Status: Completed
• Phase: N/A
• Start date: May 1, 2018
• Est. completion date: October 31, 2018

Study information

• Verified date: May 2018
• Source: Inova Health Care Services
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This multi-site randomized tral aims to test methods of increasing adoption and integration of blood glucose monitoring into electronic medical records, and to measure the impact of widescale adoption on health status of patients with diabetes. To investigate determinants of adoption, the research will combine and test doctor and patient focused approaches to encouraging patient use of blood glucose flow sheets through the online patient portal, MyChart. Adoption will be measured on both the extensive and intensive margin: the number of patients who enter data into the flowsheets at all during the study period, and the mean number of entries per patient during the study period. Conditional on statistically significant increases in adoption, the study will examine corresponding intent-to-treat effects on patient A1c, and consider other indicators of possible mechanisms through which A1c improves or does not improve.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7052
• Est. completion date: October 31, 2018
• Est. primary completion date: October 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients of Inova physicians at primary care sites other than Ashburn II Primary Care, Lake Ridge Primary Care and Springfield Primary Care

• Current diabetes mellitus diagnosis

• Active MyChart account at time of treatment administration

Exclusion Criteria:

• Patients who participating physicians identify as pregnant

• Patients who participating physicians identify as having contraindications for tracking of blood glucose

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Behavioral:
• Practice Orientation
Practices will be encouraged to batch order blood glucose flowsheets for all patients with diabetes with active MyChart accounts. This will allow diabetic patients at these practices to enter any self-monitored glucose measurements. The research team will contact physicians and practice managers with an explanation of the initiative and instructions for completing batch orders and viewing entries through the system. Additionally, providers will be given a template for a secure smart-text message to send to all patients receiving the flowsheets, instructing them to enter data for the study period. The secure message will also provide them with information on how to enter data, and on the benefits of tracking blood glucose.
• Standard Reminder
Patients receive generic biweekly reminders, addressed from Inova Medical Group, to enter glucose measurements in the electronic flowsheets
• Gift Card Reminder
Patients receive generic biweekly reminders, addressed from Inova Medical Group, to enter glucose measurements in the electronic flowsheets. In these reminders, they will also be notified that that they will be entered to win a $50 gift card for each day entering data.
• Physician Reminders
Patients receive biweekly reminders, addressed from their physician, encouraging them to enter glucose measurements in the electronic flowsheets (Note that though messages will be addressed from physician, they will be sent by Inova IT)

Locations

Country	Name	City	State
United States	Inova Heath System	Falls Church	Virginia

Sponsors (5)

Lead Sponsor	Collaborator
Inova Health Care Services	Abdul Latif Jameel Poverty Action Lab, Department of Health and Human Services, General Services Administration (GSA), University of California, Berkeley

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Flowsheet use, extensive	Whether patient enters data to an electronic glucose flowsheet during the measurement period (binary)	(0-14) weeks after initial practice orientation
Primary	Patient A1c	Most recent HbA1c test value in electronic medical records	26 weeks after initial practice orientation
Secondary	Flowsheet use, extensive	Whether patient enters data to an electronic glucose flowsheet during the measurement period (binary)	(14-26) weeks after initial practice orientation
Secondary	Flowsheet use, total	Patient total days of entry to an electronic glucose flowsheet during the measurement period	(0-14); (14-26) weeks after initial practice orientation
Secondary	Flowsheet Orders	Whether patient has open physician order for electronic flowsheet (binary)	(0-14); (14-26) weeks after initial practice orientation
Secondary	Patient HbA1c	Most recent HbA1c test value in electronic medical records, quantile regression analysis	14; 26 weeks after initial practice orientation
Secondary	Patient HbA1c	Most recent HbA1c test value in electronic medical records	14 weeks after initial practice orientation
Secondary	Improvement in Patient HbA1c	Reduction in most recent HbA1c test value in electronic medical record from test value from baseline (binary)	14; 26 weeks after initial practice orientation
Secondary	Patient HbA1c below benchmark	Most recent HbA1c test value in electronic medical records below 7 (binary)	14; 26 weeks after initial practice orientation
Secondary	Total secure messages sent by patient	Total number of MyChart messages sent by patient during the measurement period	(0-14); (14-26) weeks after initial practice orientation
Secondary	Total secure messages sent by patient to PCP	Total number of MyChart messages sent by patient to the PCP during the measurement period	(0-14); (14-26) weeks after initial practice orientation
Secondary	Total secure messages sent by PCP to patient	Total number of MyChart messages sent by PCP to the patient during the measurement period	(0-14); (14-26) weeks after initial practice orientation
Secondary	Total number of patient phone appointments	Total number of patient phone appointments during the measurement period	(0-14); (14-26) weeks after initial practice orientation
Secondary	Total number of patient in-person appointments	Total number of patient in-person appointments during the measurement period	(0-14); (14-26) weeks after initial practice orientation
Secondary	Change to patient active medications	Change (Any; Addition;Removal) to patient list of active medications during measurement period	(0-14); (14-26) weeks after initial practice orientation
Secondary	Prescription Orders	Number of prescription orders for patient during measurement period (Total all; Total new/non-refill; Total diabetes related)	(0-14); (14-26) weeks after initial practice orientation
Secondary	Flowsheet Entry Values (descriptive)	Value of blood glucose entered into flowsheet (descriptive analysis)	2; 4; 6; 8; 10; 12; 14; 18; 22; 26 weeks after initial orientation meeting