Evaluation of a Dashboard for Diabetes Care Integrated With the Electronic Health Record

NCT ID: NCT03826290

Last Updated: 2021-04-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 13155 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-01
• Study Completion Date: 2020-07-01

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.

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention arm

When patients are seen in clinics in this arm, the clinical providers will have access to the intervention (EHR-integrated diabetes dashboard).

Group Type: EXPERIMENTAL

EHR-integrated diabetes dashboard

Intervention Type: OTHER

The diabetes dashboard is available as a tab in the electronic health record (EHR) system 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.

Control arm

When patients are seen in clinics in this arm, the clinical providers will not have access to the intervention (EHR-integrated diabetes dashboard). The providers will have access to the usual decision support tools and information sources.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

EHR-integrated diabetes dashboard

The diabetes dashboard is available as a tab in the electronic health record (EHR) system 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.

Intervention Type: OTHER

Other Intervention Names

Pharmacotherapy decision support system (PDSS)

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hitachi, Ltd.

UNKNOWN

Sponsor Role: collaborator

University of Utah

OTHER

Sponsor Role: lead

Responsible Party

Kensaku Kawamoto, MD, PhD, MHS

Associate Professor, Department of Biomedical Informatics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kensaku Kawamoto, MD, PhD, MHS

Role: PRINCIPAL_INVESTIGATOR

University of Utah

Locations

University of Utah Health

Salt Lake City, Utah, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 14693921 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23468086 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26696682 (View on PubMed)

Other Identifiers

UUtah_00109162

Identifier Type: -

Identifier Source: org_study_id