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 wide-scale 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

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
Count of Participants Entering Flowsheet Data During Measurement Period, Extensive Margin	Count of participants that entered data to an electronic glucose flowsheet during the measurement period (Count of participants determined with a binary aggregation method; 1= Participant used Flow Sheet at least once during measurement period; 0= Participant did not use Flow Sheet during Measurement Period)	(1-14) weeks after initial practice orientation
Participant A1c Test Results (as Percent A1c) at 26 Weeks	Percent A1c represents average blood sugar levels as determined by Hemoglobin A1c (HbA1c) test. The HbA1c test measures what percentage of hemoglobin proteins in blood are glycated. The most recent and available HbA1c test value (percent A1c) in electronic medical records at appropriate time period was used.	26 weeks after initial practice orientation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Count of Participants Entering Flowsheet Data During Measurement Period, Extensive Margin	Count of participants that entered data to an electronic glucose flowsheet during the measurement period (Count of participants determined with a binary aggregation method; 1= Participant used Flow Sheet at least once during measurement period; 0= Participant did not use Flow Sheet during Measurement Period)	Beginning of week 15 to 26 weeks after initial practice orientation
Number of Days Participant Used Flowsheet, Intensive	The total number of days of participant use of the electronic glucose flowsheet during the measurement period. A day of Participant use of electronic glucose flowsheet is defined here as as day (24 hours) in which the participant performed an entry into an electronic glucose flowsheet.	(1-14); (15-26) weeks after initial practice orientation
Count of Participants With an Open Physician Order for Electronic Glucose Flowsheet	Count of participants that have an open physician order for electronic glucose flowsheet end of the measurement period (Count of participants determined with a binary aggregation method; 1= Participant had an open physician order for electronic Glucose Flow Sheet at end of measurement period; 0= Participant did not have an open physician order for electronic Glucose Flow Sheet at end of measurement period)	at 14 and 26 weeks after initial practice orientation
Number of Days Since Last HbA1c Test	The total number of days that elapsed since participant last had and HbA1c test. The number of days was measured by the number of days that passed from the date of the most recent HbA1c test in the Electronic Medical Record and the date of the data extraction at the specified time point.	14; 26 weeks after initial practice orientation
Participant A1c Test Results (as Percent A1c) at 14 Weeks	Percent A1c represents average blood sugar levels as determined by Hemoglobin A1c (HbA1c) test. The HbA1c test measures what percentage of hemoglobin proteins in blood are glycated. The most recent and available HbA1c test value (percent A1c) in electronic medical records at appropriate time period was used	14 weeks after initial practice orientation
Count of Participants With Improvement of HbA1c Test Results	Count of participants with improved HbA1c test result values in most recent Electronic Medical Record (EMR) during measurement period as compared to HbA1c test value at baseline. (Count of participants determined with a binary aggregation method; 1= Participant Improved, most recent A1c test value less than baseline A1c test value; 0= Participant did not Improve; most recent A1c test value greater than or equal to baseline A1c test value) Improvement of HbA1c test results is defined as a reduction of the most recent and available HbA1c test value (a lower percent A1c) in the EMR at appropriate time period relative to the baseline. Percent A1c represents average blood sugar levels as determined by Hemoglobin A1c (HbA1c) test The HbA1c test measures what percentage of hemoglobin proteins in blood are glycated. Higher percent A1c levels are associated with poor blood sugar control and increased risk of of diabetes-related complications.	14; 26 weeks after initial practice orientation
Count of Participants With Percent A1c Below Benchmark of 7	Count of participants with most recent HbA1c test value (percent A1c) in Electronic Medical Records below target benchmark of 7 at appropriate time point (Count of participants determined with a binary aggregation method; 1= Participant HbA1c test value less than 7; 0= Participant Hb1Ac test value greater than or equal to 7). Percent A1c represents average blood sugar levels as determined by Hemoglobin A1c (HbA1c) test. The HbA1c test measures what percentage of hemoglobin proteins in blood are glycated. A percent A1c level less than 7 is a common treatment target and is associated with with a lower risk of diabetes-related complications.	14; 26 weeks after initial practice orientation
Total Secure Messages Sent by Participant	Total number of messages sent by participant via MyChart Electronic medical records system during the measurement period	(1-14); (15-26) weeks after initial practice orientation
Total Secure Messages Sent by Patient to Primary Care Provider	Total number of MyChart messages sent by patient to the Primary Care Provider (PCP) during the measurement period. Not reported separately from Total number of messages sent by patient, so outcomes not reported here.	(1-14); (15-26) 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	(1-14); (15-26) weeks after initial practice orientation
Total Number of Participant Phone Appointments	Total number of participant phone appointments during the measurement period	(1-14); (1-26) weeks after initial practice orientation
Total Number of Participant In-person Appointments	Total number of participant in-person appointments during the measurement period	(1-14); (1-26) weeks after initial practice orientation
Count of Participants With Changes to Active Medication List	Count of Participants with Changes (Any; Addition; Removal) to list of active medications in EMR during measurement period. Active medication lists is comprised of prescription ordered medications for participants. Count of participants determined with a binary aggregation method: Any Change is defined as medications added or removed from active list ( 1= Participant had medications added to or removed from active medication list; 0= Participant did not have medication added to or removed from active medication list). Medications Added is defined as the addition of medications to active medication list ( 1= Participant had medications added to active medication list; 0= Participant did not have medications added to active medication list). Medications Removed is defined as the removal of medications to active medication list ( 1= Participant had medications removed from active medication list; 0= Participant did not have medications removed from active medication list).	(1-14); (1-26) weeks after initial practice orientation
Prescription Orders	Number of prescription ordered medications for participant during measurement period (Total all; Total new/non-refill; Total diabetes related)	(1-14); (1-26) weeks after initial practice orientation
Flowsheet Entry Values (Descriptive)	Value of blood glucose entered into flowsheet (descriptive analysis). No systematic outcomes recorded to report.	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): September 19, 2024
• Last Update Submitted That Met QC Criteria: May 2, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Electronic Medical Records; Behavioral Economics; Nudge; Self Monitoring of Blood Glucose; Secure Messaging
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus
• 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