Blood Glucose Monitoring in Electronic Health Records

NCT03542487 | Completed Results

• 2 other identifiers: 17-2642Project Code: 1729
• Study Type: interventional
• Target: 7,052
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Diabetes Mellitus

Keywords

Self Monitoring of Blood Glucose; Electronic Medical Records; Nudge; Secure Messaging; Behavioral Economics

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (15)

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

  Beginning of week 15 to 26 weeks after initial practice orientation

• Number of Days Participant Used Flowsheet, Intensive

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

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

  at 14 and 26 weeks after initial practice orientation

• Number of Days Since Last HbA1c Test

  14; 26 weeks after initial practice orientation

• Participant A1c Test Results (as Percent A1c) at 14 Weeks

  14 weeks after initial practice orientation

Study Arms (5)

1: Control

NO INTERVENTION

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.

2a: Practice Orientation- No Reminder

EXPERIMENTAL

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

2b: Practice Orientation- Standard Reminder

EXPERIMENTAL

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; Behavioral: Standard Reminder

2c: Practice Orientation- Gift Card Reminder

EXPERIMENTAL

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; Behavioral: Gift Card Reminder

2d: Practice Orientation- Physician Reminder

EXPERIMENTAL

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; Behavioral: Physician Reminders

Interventions

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.

2a: Practice Orientation- No Reminder; 2b: Practice Orientation- Standard Reminder; 2c: Practice Orientation- Gift Card Reminder; 2d: Practice Orientation- Physician Reminder

Standard Reminder BEHAVIORAL

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

2b: Practice Orientation- Standard Reminder

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.

2c: Practice Orientation- Gift Card Reminder

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)

2d: Practice Orientation- Physician Reminder

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

Inova Heath System

Falls Church, Virginia, 22042, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Mattie Toma
• Organization: Office of Evaluation Sciences, General Services Administration

mattie.toma@gsa.gov

859-621-0517

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Primary care practices will be assigned to a provider-side treatment (physician orientation) or to control. Within treatment assigned practices, individual patients will be assigned to one of four reminder messaging groups (one of which is no messaging).

Study Record Dates

• First Submitted: May 15, 2018
• First Posted: May 31, 2018
• Study Start: May 1, 2018
• Primary Completion: October 31, 2018
• Study Completion: October 31, 2018
• Last Updated: September 19, 2024
• Results First Posted: September 19, 2024

Record last verified: 2024-05

Locations

US (1)