Design, Implementation and Evaluation of Scalable Decision Support for Diabetes Care

This study is a pragmatic pre-post trial of the Diabetes Dashboard integrated with the Disease Manager App. The Disease Manager App is available as a tab in the EHR and enables clinicians to confirm relevant patient parameters. A link to the Diabetes Dashboard will be available from the Disease Manager App diabetes module. In the Diabetes Dashboard, providers can select treatment goals and review likely outcomes from alternative treatment strategies through an interactive graphical user interface. In the review process, the Diabetes Dashboard 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 data sets of patients with diabetes mellitus. The Disease Manager App and the Diabetes Dashboard are 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 all primary care clinics, providers will be provided with access to the Diabetes Dashboard integrated with the Disease Manager App. Iterative enhancements will be made to the tool if warranted based on the results of a formative evaluation during the 1-year pragmatic implementation study. Use of the tool and associated suggestions will be optional and up to the discretion of the clinician. 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 primary study analyses will be limited to adult patients who were seen at least twice in the primary care 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.

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.