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临床试验/NCT03542487
NCT03542487已完成不适用

Integration of Blood Glucose Monitoring Into Electronic Health Records

Inova Health Care Services2 个研究点 分布在 1 个国家目标入组 7,052 人开始时间: 2018年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
7,052
试验地点
2
主要终点
Count of Participants Entering Flowsheet Data During Measurement Period, Extensive Margin

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

研究组 & 干预措施

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.

干预措施: Practice Orientation (Behavioral)

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.

干预措施: Practice Orientation (Behavioral)

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.

干预措施: Standard Reminder (Behavioral)

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.

干预措施: Practice Orientation (Behavioral)

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.

干预措施: Gift Card Reminder (Behavioral)

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).

干预措施: Practice Orientation (Behavioral)

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).

干预措施: Physician Reminders (Behavioral)

结局指标

主要结局

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

时间窗: (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)

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

时间窗: 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.

次要结局

  • 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)
  • Count of Participants With Improvement of HbA1c Test Results(14; 26 weeks after initial practice orientation)
  • Count of Participants With Percent A1c Below Benchmark of 7(14; 26 weeks after initial practice orientation)
  • Total Secure Messages Sent by Participant((1-14); (15-26) weeks after initial practice orientation)
  • Total Secure Messages Sent by Patient to Primary Care Provider((1-14); (15-26) weeks after initial practice orientation)
  • Total Secure Messages Sent by PCP to Patient((1-14); (15-26) weeks after initial practice orientation)
  • Total Number of Participant Phone Appointments((1-14); (1-26) weeks after initial practice orientation)
  • Total Number of Participant In-person Appointments((1-14); (1-26) weeks after initial practice orientation)
  • Count of Participants With Changes to Active Medication List((1-14); (1-26) weeks after initial practice orientation)
  • Prescription Orders((1-14); (1-26) weeks after initial practice orientation)
  • Flowsheet Entry Values (Descriptive)(2; 4; 6; 8; 10; 12; 14; 18; 22; 26 weeks after initial orientation meeting)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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