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Completed

NCT Number: NCT03542487

Blood Glucose Monitoring in 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.

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Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Inova Heath System

Falls Church, Virginia, 22042, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Practice Orientation

Behavioral

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

Behavioral

Patients receive generic biweekly reminders, addressed from Inova Medical Group, to enter glucose measurements in the electronic flowsheets

Gift Card Reminder

Behavioral

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

Behavioral

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)

Primary outcomes

  1. Count of Participants Entering Flowsheet Data During Measurement Period, Extensive Margin

    Time frame: (1-14) weeks after initial practice orientation

    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)

  2. Participant A1c Test Results (as Percent A1c) at 26 Weeks

    Time frame: 26 weeks after initial practice orientation

    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.

Secondary outcomes

  1. Count of Participants Entering Flowsheet Data During Measurement Period, Extensive Margin

    Time frame: Beginning of week 15 to 26 weeks after initial practice orientation

    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)

  2. Number of Days Participant Used Flowsheet, Intensive

    Time frame: (1-14); (15-26) weeks after initial practice orientation

    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.

  3. Count of Participants With an Open Physician Order for Electronic Glucose Flowsheet

    Time frame: at 14 and 26 weeks after initial practice orientation

    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)

  4. Number of Days Since Last HbA1c Test

    Time frame: 14; 26 weeks after initial practice orientation

    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.

  5. Participant A1c Test Results (as Percent A1c) at 14 Weeks

    Time frame: 14 weeks after initial practice orientation

    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

  6. Count of Participants With Improvement of HbA1c Test Results

    Time frame: 14; 26 weeks after initial practice orientation

    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.

  7. Count of Participants With Percent A1c Below Benchmark of 7

    Time frame: 14; 26 weeks after initial practice orientation

    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.

  8. Total Secure Messages Sent by Participant

    Time frame: (1-14); (15-26) weeks after initial practice orientation

    Total number of messages sent by participant via MyChart Electronic medical records system during the measurement period

  9. Total Secure Messages Sent by Patient to Primary Care Provider

    Time frame: (1-14); (15-26) weeks after initial practice orientation

    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.

  10. Total Secure Messages Sent by PCP to Patient

    Time frame: (1-14); (15-26) weeks after initial practice orientation

    Total number of MyChart messages sent by PCP to the patient during the measurement period

  11. Total Number of Participant Phone Appointments

    Time frame: (1-14); (1-26) weeks after initial practice orientation

    Total number of participant phone appointments during the measurement period

  12. Total Number of Participant In-person Appointments

    Time frame: (1-14); (1-26) weeks after initial practice orientation

    Total number of participant in-person appointments during the measurement period

  13. Count of Participants With Changes to Active Medication List

    Time frame: (1-14); (1-26) weeks after initial practice orientation

    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).

  14. Prescription Orders

    Time frame: (1-14); (1-26) weeks after initial practice orientation

    Number of prescription ordered medications for participant during measurement period (Total all; Total new/non-refill; Total diabetes related)

  15. Flowsheet Entry Values (Descriptive)

    Time frame: 2; 4; 6; 8; 10; 12; 14; 18; 22; 26 weeks after initial orientation meeting

    Value of blood glucose entered into flowsheet (descriptive analysis). No systematic outcomes recorded to report.

Sponsors and collaborators

Lead sponsor

Inova Health Care Services

Other

Collaborators

  • Abdul Latif Jameel Poverty Action Lab
  • Department of Health and Human Services
  • General Services Administration (GSA)
  • University of California, Berkeley

Registry information

Official study title

Integration of Blood Glucose Monitoring Into Electronic Health Records

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
May 31, 2018
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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