Clinical trial NCT03826290: Evaluation of a Dashboard for Diabetes Care Integrated With the Electronic Health Record
Official title: Evaluation of an EHR-Integrated Dashboard for Diabetes Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Diabetes Mellitus, Type 2
Keywords: Decision Support Systems, Clinical
Machine Learning
Data Visualization
Lead sponsor: University of Utah
Sponsor class: OTHER
Collaborators: name: Hitachi, Ltd.
First posted: 2019-02-01
Enrollment: 13155
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Clinic randomized trial
Primary purpose: TREATMENT

Brief summary: Diabetes is a significant medical problem in the United States and across the world. Despite significant progress in understanding how to better manage diabetes, there is oftentimes still uncertainty in the optimal management strategy for a specific patient. As a result, providers and patients must often use a trial-and-error approach to identify an effective treatment regimen.

The objective of this research is to evaluate a diabetes dashboard integrated with the electronic health record (EHR) that has been developed as a collaborative project between the University of Utah and Hitachi, Ltd. This dashboard tool provides a graphical overview of the patient's relevant data parameters as well as information on the impact of different treatment options on previous patients with similar characteristics. The different treatment options compare the predicted impact of relevant medication regimens as well as weight loss. Primary care clinics are randomized to either an intervention condition where the tool is available or to a control condition where the tool is not yet available. Patients' hemoglobin A1c levels (a measure of diabetes control) are the main outcome variable. Other secondary analyses will also be conducted. Use of the tool will be encouraged but optional. Following any suggestions made in the tool will also be optional and up to the discretion of the clinician.

Detailed description: This study is a pragmatic clinic-randomized controlled trial of a diabetes dashboard integrated with the electronic health record (EHR). The diabetes dashboard is available as a tab in the EHR and enables clinicians to confirm relevant patient parameters, select treatment goals, and review likely outcomes from alternative treatment strategies through an interactive graphical user interface. In the review process, it enables providers and patients to compare up to three potential therapies side-by side including weight-loss in terms of a) personalized-predicted probability of achieving treatment goals; b) general potential risks, benefits, and medication costs; and c) relevant financial information specific to the patient's insurance. The personalized prediction is performed by a predictive model developed by analyzing a data set of primary care clinic patients with diabetes mellitus. The diabetes dashboard is seamlessly integrated with the EHR using an interoperability standard known as SMART on FHIR (short for Substitutable Medical Apps Reusable Technologies on Fast Healthcare Interoperability Resources).

The study is being conducted at University of Utah primary care clinics. In the intervention group clinics, providers will be introduced to the tool and supported using targeted implementation techniques including education feedback and tailored facilitation. Iterative enhancements will be made to the tool if warranted based on the results of a formative evaluation during the 1-year trial. Use of the tool and associated suggestions will be optional and up to the discretion of the clinician. When patients are seen at clinics randomized to the control arm, clinical providers will not have access to the tool. Following introduction of the tool across intervention clinics, a 1-year trial will be conducted. Use of the tool will be encouraged and supported through targeted implementation strategies. Use of the tool will be regularly monitored, and a mixed-methods evaluation will be conducted of the tool and its impact. The primary outcome measure will be hemoglobin A1c (HbA1c) levels, which are an important physiological marker of diabetes control. Secondary measures will include body mass index (BMI) and the cost of diabetes medications prescribed. Other measures will include usage of the tool and clinical users' opinions of the tool.

The evaluation period will start once all intervention clinics have been educated/trained on use of the tool. The primary study analyses will be limited to adult patients who were seen at least twice in the intervention or control clinics during the evaluation period for office visits with a visit diagnosis of diabetes mellitus, who are known to have diabetes mellitus (but not type-1 diabetes mellitus), who had at least one HbA1c of \>= 7.5% during the evaluation period, and who are not already on maximal diabetes therapy (as defined by the use of short-acting insulin) at the start of the study. Secondary study analyses will be conducted on patient subsets, including a per protocol analysis of cases where the tool was used.

Eligibility criteria: Inclusion Criteria:

* \>= 18 years old
* Are being seen at a University of Utah primary care clinic
* Has diabetes mellitus

Exclusion Criteria:

* None

Note that the primary study analyses will be on a subset of these patients. See the Detailed Description subsection in the Study Description section for details.

Primary outcomes:
measure: Per-patient change in Hemoglobin A1c (HbA1c) levels from beginning to end of evaluation period
timeFrame: Assessed through study completion (estimated to be 1.5 years), for Day 1 and Day 365
Secondary outcomes:
measure: Per-patient change in body mass index (BMI) from beginning to end of evaluation period
timeFrame: Assessed through study completion (estimated to be 1.5 years), for Day 1 and Day 365
measure: Cost of diabetes medications prescribed
timeFrame: Assessed through study completion (estimated to be 1.5 years), for Day 1 through Day 365
Other outcomes:
measure: Use of the diabetes dashboard
timeFrame: Assessed through study completion (estimated to be 1.5 years), for Day 1 through Day 365
measure: User opinions of the diabetes dashboard
timeFrame: Assessed through study completion (estimated to be 1.5 years), for Day 1 through Day 365
Locations:
city: Salt Lake City
country: United States
facility: University of Utah Health
state: Utah
Study officials:
affiliation: University of Utah
name: Kensaku Kawamoto, MD, PhD, MHS
role: PRINCIPAL_INVESTIGATOR
References:
citation: American Diabetes Association. Diagnosis and classification of diabetes mellitus. Diabetes Care. 2004 Jan;27 Suppl 1:S5-S10. doi: 10.2337/diacare.27.2007.s5. No abstract available.
citation: American Diabetes Association. Economic costs of diabetes in the U.S. in 2012. Diabetes Care. 2013 Apr;36(4):1033-46. doi: 10.2337/dc12-2625. Epub 2013 Mar 6.
citation: American Diabetes Association. 7. Approaches to Glycemic Treatment. Diabetes Care. 2016 Jan;39 Suppl 1:S52-9. doi: 10.2337/dc16-S010. No abstract available.