Diabetes MellitusNCT03826290
Evaluation of a Dashboard for Diabetes Care Integrated With the Electronic Health Record
A study testing EHR-integrated diabetes dashboard in people with Diabetes Mellitus and Diabetes Mellitus, Type 2, run by University of Utah at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Diabetes Mellitus, Type 2
- What is being tested?
- EHR-integrated diabetes dashboard
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13,155 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2019to 1 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >= 18 years old
- Are being seen at a University of Utah primary care clinic
- Has diabetes mellitus
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Utah Health
Salt Lake City, Utah, 84132
About this study
Official title: Evaluation of an EHR-Integrated Dashboard for Diabetes Care
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.
Read the 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
- Being tested
- EHR-integrated diabetes dashboard
- Keywords
- Decision Support Systems, Clinical, Machine Learning, Data Visualization
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EHR-integrated diabetes dashboardOther
Also called Pharmacotherapy decision support system (PDSS)
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Experimental | When patients are seen in clinics in this arm, the clinical providers will have access to the intervention (EHR-integrated diabetes dashboard). Receives: Other: EHR-integrated diabetes dashboard |
| Control arm | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Per-patient change in Hemoglobin A1c (HbA1c) levels from beginning to end of evaluation period
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.
Measured: Assessed through study completion (estimated to be 1.5 years), for Day 1 and Day 365
Secondary outcomes (2)
Per-patient change in body mass index (BMI) from beginning to end of evaluation period
The beginning and end values will be estimated using the same approach used for the primary outcome measure.
Measured: Assessed through study completion (estimated to be 1.5 years), for Day 1 and Day 365
Cost of diabetes medications prescribed
The cost of diabetes medications prescribed will be estimated using National Average Drug Acquisition Costs
Measured: Assessed through study completion (estimated to be 1.5 years), for Day 1 through Day 365
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2019
- Study start1 Jan 2019
- Primary completion1 Jan 2020
- Study completion1 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Clinic randomized trial
- Masking
- None (open label)
- Enrolment
- 13,155 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- Hitachi, Ltd.
- Responsible party
- Principal investigator, Kensaku Kawamoto, MD, PhD, MHS, University of Utah
- Investigators
- Kensaku Kawamoto, MD, PhD, MHS, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03826290
- Sponsor's protocol ID
- UUtah_00109162
- Status last verified
- Apr 2021
- First submitted
- 24 Jan 2019
- Last updated
- 27 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 14693921American 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.
PubMed 23468086American Diabetes Association. 7. Approaches to Glycemic Treatment. Diabetes Care. 2016 Jan;39 Suppl 1:S52-9. doi: 10.2337/dc16-S010. No abstract available.
PubMed 26696682
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of an EHR-Integrated Dashboard for Diabetes Care
- ClinicalTrials.gov ID
- NCT03826290
- Acronym / sponsor ID
- UUtah_00109162
- Conditions
- Diabetes Mellitus, Diabetes Mellitus, Type 2
- Keywords
- Decision Support Systems, Clinical, Machine Learning, Data Visualization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13,155 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- Hitachi, Ltd.
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 1 Jul 2020 (actual)
- First posted
- 1 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Clinic randomized trial
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Other: EHR-integrated diabetes dashboardWhen patients are seen in clinics in this arm, the clinical providers will have access to the intervention (EHR-integrated diabetes dashboard). |
| Control arm | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- >= 18 years old
- Are being seen at a University of Utah primary care clinic
- Has diabetes mellitus
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EHR-integrated diabetes dashboardAlso: Pharmacotherapy decision support system (PDSS)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 | Intervention arm |
Primary outcome
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.
2 secondary outcomes
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
Cost of diabetes medications prescribed
Time frame: Assessed through study completion (estimated to be 1.5 years), for Day 1 through Day 365
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2021.
- Background: PubMed 14693921American 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.
- Background: PubMed 23468086American 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.
- Background: PubMed 26696682American Diabetes Association. 7. Approaches to Glycemic Treatment. Diabetes Care. 2016 Jan;39 Suppl 1:S52-9. doi: 10.2337/dc16-S010. No abstract available.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kensaku Kawamoto, MD, PhD, MHS principal investigator
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EHR-integrated diabetes dashboard in people with Diabetes Mellitus and Diabetes Mellitus, Type 2, run by University of Utah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03826290, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2021.