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

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ClinicalTrials.gov Identifier: NCT03826290
Recruitment Status : Recruiting
First Posted : February 1, 2019
Last Update Posted : February 1, 2019
Sponsor:
Collaborator:
Hitachi, Ltd.
Information provided by (Responsible Party):
Kensaku Kawamoto, MD, PhD, MHS, University of Utah

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.


Condition or disease Intervention/treatment Phase
Diabetes Mellitus Diabetes Mellitus, Type 2 Other: EHR-integrated diabetes dashboard Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 17000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Clinic randomized trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of an EHR-Integrated Dashboard for Diabetes Care
Actual Study Start Date : January 9, 2019
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : May 2020

Arm Intervention/treatment
Experimental: Intervention arm
When patients are seen in clinics in this arm, the clinical providers will have access to the intervention (EHR-integrated diabetes dashboard).
Other: 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.
Other Name: Pharmacotherapy decision support system (PDSS)

No Intervention: 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.



Primary Outcome Measures :
  1. Per-patient change in Hemoglobin A1c (HbA1c) levels from beginning to end of evaluation period [ Time Frame: Assessed through study completion (estimated to be 1.5 years), for Day 1 and Day 365 ]
    Each patient's HbA1c level will be estimated for the beginning and end of the evaluation period. For each of these time points, the value at that time point will be estimated as follows. If a value exists for that date, use that. Otherwise, for the beginning date, first take the earliest value within the evaluation period (anchor value). If there are no values before the evaluation period, then use the anchor value. Otherwise, take the latest value before the evaluation period, and interpolate with the anchor value to estimate the value. For the value on the end date, first take the latest value within the evaluation period (anchor value). If there are no values after the evaluation period, then use the anchor value. Otherwise, take the earliest value after the evaluation period, and interpolate with the anchor value to estimate the value. Finally, calculate the change in values by comparing the end value to the beginning value.


Secondary Outcome Measures :
  1. Per-patient change in body mass index (BMI) from beginning to end of evaluation period [ Time Frame: Assessed through study completion (estimated to be 1.5 years), for Day 1 and Day 365 ]
    The beginning and end values will be estimated using the same approach used for the primary outcome measure.

  2. Cost of diabetes medications prescribed [ Time Frame: Assessed through study completion (estimated to be 1.5 years), for Day 1 through Day 365 ]
    The cost of diabetes medications prescribed will be estimated using National Average Drug Acquisition Costs


Other Outcome Measures:
  1. Use of the diabetes dashboard [ Time Frame: Assessed through study completion (estimated to be 1.5 years), for Day 1 through Day 365 ]
    Providers' use of the diabetes dashboard will be measured. We will also seek to model patient, provider, and context predictors of tool usage.

  2. User opinions of the diabetes dashboard [ Time Frame: Assessed through study completion (estimated to be 1.5 years), for Day 1 through Day 365 ]
    User opinions of the diabetes dashboard will be solicited during the study to support the implementation and make adjustments to the dashboard as needed. Towards the end of the evaluation period, formal evaluations will be conducted of user opinions of the diabetes dashboard, including through surveys such as the System Usability Scale, user interviews, and focus groups as appropriate.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03826290


Contacts
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Contact: Kensaku Kawamoto, MD, PhD, MHS 801-587-8076 kensaku.kawamoto@utah.edu
Contact: Charlene R Weir, PhD, RN charlene.weir@utah.edu

Locations
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United States, Utah
University of Utah Health Recruiting
Salt Lake City, Utah, United States, 84132
Contact: Kensaku Kawamoto, MD, PhD, MHS    801-587-8076    kensaku.kawamoto@utah.edu   
Contact: Charlene R Weir, PhD, RN       charlene.weir@utah.edu   
Principal Investigator: Kensaku Kawamoto, MD, PhD, MHS         
Principal Investigator: Charlene R Weir, PhD, RN         
Sponsors and Collaborators
University of Utah
Hitachi, Ltd.
Investigators
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Principal Investigator: Kensaku Kawamoto, MD, PhD, MHS University of Utah

Publications:
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Responsible Party: Kensaku Kawamoto, MD, PhD, MHS, Associate Professor, Department of Biomedical Informatics, University of Utah
ClinicalTrials.gov Identifier: NCT03826290     History of Changes
Other Study ID Numbers: UUtah_00109162
First Posted: February 1, 2019    Key Record Dates
Last Update Posted: February 1, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kensaku Kawamoto, MD, PhD, MHS, University of Utah:
Decision Support Systems, Clinical
Machine Learning
Data Visualization
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases