Clinical trial NCT03542487: Blood Glucose Monitoring in Electronic Health Records
Official title: Integration of Blood Glucose Monitoring Into Electronic Health Records
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Keywords: Self Monitoring of Blood Glucose
Electronic Medical Records
Nudge
Secure Messaging
Behavioral Economics
Lead sponsor: Inova Health Care Services
Sponsor class: OTHER
Collaborators: name: University of California, Berkeley
name: Abdul Latif Jameel Poverty Action Lab
name: General Services Administration (GSA)
name: Department of Health and Human Services
First posted: 2018-05-31
Enrollment: 7052
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention 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).
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Count of Participants Entering Flowsheet Data During Measurement Period, Extensive Margin
timeFrame: (1-14) weeks after initial practice orientation
measure: Participant A1c Test Results (as Percent A1c) at 26 Weeks
timeFrame: 26 weeks after initial practice orientation
Secondary outcomes:
measure: Count of Participants Entering Flowsheet Data During Measurement Period, Extensive Margin
timeFrame: Beginning of week 15 to 26 weeks after initial practice orientation
measure: Number of Days Participant Used Flowsheet, Intensive
timeFrame: (1-14); (15-26) weeks after initial practice orientation
measure: Count of Participants With an Open Physician Order for Electronic Glucose Flowsheet
timeFrame: at 14 and 26 weeks after initial practice orientation
measure: Number of Days Since Last HbA1c Test
timeFrame: 14; 26 weeks after initial practice orientation
measure: Participant A1c Test Results (as Percent A1c) at 14 Weeks
timeFrame: 14 weeks after initial practice orientation
measure: Count of Participants With Improvement of HbA1c Test Results
timeFrame: 14; 26 weeks after initial practice orientation
measure: Count of Participants With Percent A1c Below Benchmark of 7
timeFrame: 14; 26 weeks after initial practice orientation
measure: Total Secure Messages Sent by Participant
timeFrame: (1-14); (15-26) weeks after initial practice orientation
measure: Total Secure Messages Sent by Patient to Primary Care Provider
timeFrame: (1-14); (15-26) weeks after initial practice orientation
measure: Total Secure Messages Sent by PCP to Patient
timeFrame: (1-14); (15-26) weeks after initial practice orientation
measure: Total Number of Participant Phone Appointments
timeFrame: (1-14); (1-26) weeks after initial practice orientation
measure: Total Number of Participant In-person Appointments
timeFrame: (1-14); (1-26) weeks after initial practice orientation
measure: Count of Participants With Changes to Active Medication List
timeFrame: (1-14); (1-26) weeks after initial practice orientation
measure: Prescription Orders
timeFrame: (1-14); (1-26) weeks after initial practice orientation
measure: Flowsheet Entry Values (Descriptive)
timeFrame: 2; 4; 6; 8; 10; 12; 14; 18; 22; 26 weeks after initial orientation meeting
Other outcomes:
Locations:
city: Falls Church
country: United States
facility: Inova Heath System
state: Virginia
Study officials:
affiliation: General Services Administration, UC Berkeley
name: Allyson B Root, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: Inova Health Care Services
name: Season Majors, MSN,RN
role: PRINCIPAL_INVESTIGATOR
affiliation: Inova Health Care Services
name: Mary Ann Friesen, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Inova Health Care Services
name: Christopher P Connolly, MD
role: PRINCIPAL_INVESTIGATOR
References: