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

November 2, 2022 updated by: Kensaku Kawamoto, MD, PhD, MHS, University of Utah

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 project team has previously developed a Diabetes Dashboard that summarizes relevant patient information (e.g., medication history and recent hemoglobin A1c trend). This dashboard allows a clinician to select a target hemoglobin A1c level for the patient in 3 or 6 months, then compare and contrast different options for treatment, including weight loss and the use of different medication regimens. Included in this comparison are known benefits and side effects, as well as the likely chances of achieving the treatment target given the experience of past, similar patients. The Diabetes Dashboard is already available as an optional tab in the EHR system.

The project team has also previously developed the Disease Manager App for evidence-based chronic disease management and health maintenance. The Disease Manger Application is fully integrated with the EHR, and it provides care guidance via individual chronic disease modules as well as a unified module that encompasses all relevant modules for chronic diseases and health maintenance. The initial modules that have been developed are for chronic obstructive pulmonary disease, hypertension, diabetes mellitus, and health maintenance.

The objective of this research is to evaluate the Diabetes Dashboard integrated with the Disease Manager App. The Intervention consists of the diabetes module of the Disease Manager App, which incorporates content from the Diabetes Dashboard for pharmacotherapy prediction and provides a link to the Diabetes Dashboard.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

25915

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • University of Utah Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. >= 18 years old
  2. are being seen at a University of Utah primary care clinic
  3. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Diabetes Dashboard integrated with Disease Manager App
When patients are seen in clinics in this arm, the clinical providers will have access to the intervention (EHR-integrated Diabetes Dashboard that is integrated with the diabetes module of the Disease Manager App).
Other: Diabetes Dashboard integrated with Disease Manager App
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. The Diabetes Dashboard is integrated within the diabetes module of the EHR-integrated Disease Manager App, which uses key information from the Diabetes Dashboard and provides a link to the Diabetes Dashboard.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in hemoglobin A1c (HbA1c) levels
Time Frame: Through study completion, an average of 12 months for the intervention period and 12 months for the baseline period
Each patient's HbA1c level will be estimated for day 15 of each month, calculated as follows. If a value exists for that date, use that. Otherwise, estimate the value on that date based on the values immediately before and after that date.
Through study completion, an average of 12 months for the intervention period and 12 months for the baseline period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in body mass index (BMI) levels
Time Frame: Through study completion, an average of 12 months for the intervention period and 12 months for the baseline period
The BMI values will be estimated in a manner similar to HbA1c estimation.
Through study completion, an average of 12 months for the intervention period and 12 months for the baseline period

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of use of the Disease Manager's diabetes module
Time Frame: Through study completion, an average of 12 months for the intervention period
The rate of use of the Disease Manager's diabetes module will be measured. The usage will be measured through system logs and data from the enterprise data warehouse.
Through study completion, an average of 12 months for the intervention period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Utah

Collaborators

Hitachi, Ltd.

Investigators

  • Principal Investigator: Kawamoto Kensaku, MD, PhD, MHS, University of Utah

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 23, 2021

Primary Completion (Actual)

September 22, 2022

Study Completion (Actual)

November 1, 2022

Study Registration Dates

First Submitted

May 25, 2021

First Submitted That Met QC Criteria

June 10, 2021

First Posted (Actual)

June 16, 2021

Study Record Updates

Last Update Posted (Actual)

November 4, 2022

Last Update Submitted That Met QC Criteria

November 2, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB_00134238

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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