Blood Glucose Monitoring in Electronic Health Records

Integration of Blood Glucose Monitoring Into Electronic Health Records

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus
• Intervention / Treatment: Behavioral: Practice Orientation; Behavioral: Standard Reminder; Behavioral: Gift Card Reminder; Behavioral: Physician Reminders

• Study Type: Interventional
• Enrollment (Actual): 7052
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Falls Church, Virginia, United States, 22042
      • Inova Heath System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: 1: Control; A randomly selected half of primary care practices in the study sample at Inova Health Care Services will not receive any intervention and patients/physicians located at these practices will continue with business as usual.
Experimental: 2a: Practice Orientation- No Reminder; In the other randomly selected half of primary care practices in the study sample at Inova Health Care Services, practices will be encouraged to batch order blood glucose flowsheets for all patients with diabetes with active MyChart accounts. 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. Of this group of practices, patients will be divided at the individual level into 4 reminder groups. Arm 2a will receive no additional reminder messaging to enter glucose measurements in the electronic flowsheets.	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.
Experimental: 2b: Practice Orientation- Standard Reminder; Practices will be encouraged to batch order blood glucose flowsheets for all patients with diabetes with active MyChart accounts. 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. Of this group of practices, patients will be divided at the individual level into 4 reminder groups. Arm 2b will receive generic biweekly reminders, addressed from Inova Medical Group, to enter glucose measurements in the electronic flowsheets.	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.; Behavioral: Standard Reminder; Patients receive generic biweekly reminders, addressed from Inova Medical Group, to enter glucose measurements in the electronic flowsheets
Experimental: 2c: Practice Orientation- Gift Card Reminder; Practices will be encouraged to batch order blood glucose flowsheets for all patients with diabetes with active MyChart accounts. 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. Of this group of practices, patients will be divided at the individual level into 4 reminder groups. Arm 2c will receive generic biweekly reminders to enter data, addressed from Inova Medical Group, that will also notify that the patient will be entered to win a $50 gift card for each day entering data.	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.; Behavioral: 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.
Experimental: 2d: Practice Orientation- Physician Reminder; Practices will be encouraged to batch order blood glucose flowsheets for all patients with diabetes with active MyChart accounts. 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. Of this group of practices, patients will be divided at the individual level into 4 reminder groups. Arm 2d will 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).	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.; Behavioral: 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Flowsheet use, extensive	Whether patient enters data to an electronic glucose flowsheet during the measurement period (binary)	(0-14) weeks after initial practice orientation
Patient A1c	Most recent HbA1c test value in electronic medical records	26 weeks after initial practice orientation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Flowsheet use, extensive	Whether patient enters data to an electronic glucose flowsheet during the measurement period (binary)	(14-26) weeks after initial practice orientation
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
Flowsheet Orders	Whether patient has open physician order for electronic flowsheet (binary)	(0-14); (14-26) weeks after initial practice orientation
Patient HbA1c	Most recent HbA1c test value in electronic medical records, quantile regression analysis	14; 26 weeks after initial practice orientation
Patient HbA1c	Most recent HbA1c test value in electronic medical records	14 weeks after initial practice orientation
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
Patient HbA1c below benchmark	Most recent HbA1c test value in electronic medical records below 7 (binary)	14; 26 weeks after initial practice orientation
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Inova Health Care Services
• Collaborators: University of California, Berkeley; Department of Health and Human Services; Abdul Latif Jameel Poverty Action Lab; General Services Administration (GSA)
• Investigators: Principal Investigator: Allyson B Root, MS, General Services Administration, UC Berkeley; Principal Investigator: Season Majors, MSN,RN, Inova Health Care Services; Principal Investigator: Mary Ann Friesen, PhD, Inova Health Care Services; Principal Investigator: Christopher P Connolly, MD, Inova Health Care Services

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2018
• Primary Completion (Actual): October 31, 2018
• Study Completion (Actual): October 31, 2018

Study Registration Dates

• First Submitted: May 15, 2018
• First Submitted That Met QC Criteria: May 30, 2018
• First Posted (Actual): May 31, 2018

Study Record Updates

• Last Update Posted (Actual): December 20, 2018
• Last Update Submitted That Met QC Criteria: December 19, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: Electronic Medical Records; Behavioral Economics; Nudge; Self Monitoring of Blood Glucose; Secure Messaging
• Other Study ID Numbers: 17-2642; Project Code: 1729 (Other Identifier: General Services Administration (OES))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No