Blood Glucose Monitoring in Electronic Health Records

Study Overview
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Brief Summary
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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.

Official Title
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Integration of Blood Glucose Monitoring Into Electronic Health Records

Conditions
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Diabetes Mellitus

Intervention / Treatment
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* Behavioral: Practice Orientation
* Behavioral: Standard Reminder
* Behavioral: Gift Card Reminder
* Behavioral: Physician Reminders


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: 1: Control<br>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<br>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<br>* 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.<br>|
| Experimental: 2b: Practice Orientation- Standard Reminder<br>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<br>* 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.<br>Behavioral: Standard Reminder<br>* Patients receive generic biweekly reminders, addressed from Inova Medical Group, to enter glucose measurements in the electronic flowsheets<br>|
| Experimental: 2c: Practice Orientation- Gift Card Reminder<br>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<br>* 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.<br>Behavioral: Gift Card Reminder<br>* 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.<br>|
| Experimental: 2d: Practice Orientation- Physician Reminder<br>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<br>* 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.<br>Behavioral: Physician Reminders<br>* 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)<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Self Monitoring of Blood Glucose, Electronic Medical Records, Nudge, Secure Messaging, Behavioral Economics