Decision Support Tool for Prediabetes

Overseen By Marielle Bugayong, MSPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Disqualifiers: Diabetes, Non-English, Severe psychiatric, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help individuals with prediabetes avoid developing diabetes by testing the Diabetes Prevention Patient Activation Clinical Decision Support Tool, which supports lifestyle changes. Participants will complete a survey, and their primary care doctors will use the results to guide discussions and recommendations. The study compares this approach with usual care, where patients receive general information about prediabetes. The trial suits those who have prediabetes, are patients at Johns Hopkins Green Spring Station, and use MyChart for their medical records. As an unphased trial, this study offers participants the chance to contribute to innovative research that could shape future diabetes prevention strategies.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this clinical decision support tool is safe for patients?

Research has shown that the Diabetes Prevention Patient Activation Tool helps patients engage more in their care. Studies have found this tool easy to use and effective in improving diabetes care. No safety issues or negative effects have been reported from its use. The tool integrates with the electronic health record system to facilitate discussions between doctors and patients about lifestyle changes to prevent diabetes. It primarily serves as a communication aid and does not involve new medications or procedures. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Diabetes Prevention Patient Activation Clinical Decision Support Tool because it offers a personalized approach to managing prediabetes. Unlike standard care, which often involves general advice on lifestyle changes, this tool uses patient activation surveys to tailor discussions between doctors and patients. This personalized interaction aims to enhance patient engagement and adherence to lifestyle modifications, potentially leading to more effective prevention of diabetes progression. By integrating survey results into medical records, it empowers doctors to make informed decisions and have meaningful conversations with patients about managing their condition.

What evidence suggests that this clinical decision support tool is effective for prediabetes?

Research has shown that tools designed to assist doctors with prediabetes care can enhance management. In this trial, participants in the Intervention Arm will use the Diabetes Prevention Patient Activation Clinical Decision Support Tool. This tool helps doctors have better conversations and provide resources tailored to each patient's needs, aiming to prevent diabetes. Studies have found that such tools can increase patient involvement in managing their health. However, while these tools improve care delivery, they have not yet demonstrated a significant impact on weight loss or diabetes prevention. Overall, they aim to facilitate patient engagement in diabetes prevention. ^{1 2 3 5 6}

Who Is on the Research Team?

Eva Tseng, MD

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

This trial is for patients with prediabetes who have a MyChart account and are seen at the Johns Hopkins General Internal Medicine clinic at Green Spring Station. It aims to help them engage in activities that could prevent diabetes.

Inclusion Criteria

I have been diagnosed with prediabetes.

Patient at Johns Hopkins General Internal Medicine clinic at Green Spring Station

MyChart account

Exclusion Criteria

Non-English speaker

I have a history of diabetes.

Severe intellectual disability or psychiatric comorbidities

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants complete a patient activation survey before each visit. Results are shared with the primary care doctor to use the Diabetes Prevention Patient Activation Clinical Decision Support Tool during the visit.

6 months

At least 2 visits with primary care doctor

Control

Participants receive a handout on pre-diabetes and complete a patient activation survey before each visit, but results are not shared with the doctor.

6 months

At least 2 visits with primary care doctor

Follow-up

Participants are monitored for changes in patient activation, diet, physical activity, and referrals to Diabetes Prevention Program.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Diabetes Prevention Patient Activation Clinical Decision Support Tool

Trial Overview The study is testing a new tool within the electronic health record system designed to activate patients' involvement in their own care. The tool provides tailored communication recommendations for clinicians based on patient responses.

How Is the Trial Designed?

Group I: Intervention Arm (DPACT) Active Control 1 Intervention

In this arm, patients will have at least 2 visits with the participants primary care doctor. Before each visit, participants will complete a patient activation survey. Results of the survey will be shared with the primary care doctor and entered into the medical record so that the Diabetes Prevention Patient Activation Clinical Decision Support Tool can be used by the participants doctor during the visit to discuss lifestyle management.

Group II: Control Arm (Usual Care) Active Control 1 Intervention

Patients in the control arm will follow the same visit schedule as the intervention arm. At the beginning of the study, participants will receive a handout on pre-diabetes which will include information on lifestyle changes and the benefits of joining a Diabetes Prevention Program. Before each visit, participants will complete a patient activation survey but the results will not be shared with the participants primary care doctor

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Published Research Related to This Trial

In a study of 352 adults participating in the Diabetes Prevention Program (DPP), baseline patient activation did not predict attendance or uptake of the program, indicating that initial engagement levels may not influence participation.

However, attending the DPP was linked to a significant increase in patient activation scores, suggesting that the program not only helps with weight loss and health improvements but also empowers participants to take a more active role in their health decisions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diabetes Prevention Program attendance is associated with improved patient activation: Results from the Prediabetes Informed Decisions and Education (PRIDE) study. Skrine Jeffers, K., Castellon-Lopez, Y., Grotts, J., et al.[2020]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9501986/

Development of a novel clinical decision support tool for ... This clinician-facing tool was associated with improvements in processes of prediabetes care. •. Exploratory analyses found small, but nonsignificant weight ...

2. digital.ahrq.gov digital.ahrq.gov/ahrq-funded-projects/prevent-diabetes-mellitus-predm-clinical-decision-support-intervention

Prevent Diabetes Mellitus (PreDM) Clinical Decision Support ... This research showed that it was feasible to develop and implement the PreDM CDS. The tool led to improvements in the processes of diabetes care, but with no ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2211335519301329

Diabetes Prevention Program attendance is associated ... Greene and colleagues examined data from a US health system that collected PAM scores for >10,000 patients during primary care visits in 2010 and again in 2012 ...

4. withpower.com withpower.com/trial/phase-prediabetic-state-5-2024-6d14d

Decision Support Tool for Prediabetes · Info for Participants The study is testing a new tool within the electronic health record system designed to activate patients' involvement in their own care.

5. ama-assn.org ama-assn.org/public-health/prevention-wellness/how-prediabetes-decision-aid-can-help-ease-path-prevention

How a prediabetes decision aid can help ease path to ... The care tool visually displayed the differences in the risk of developing type 2 diabetes ... “Such decision tools that are effective for ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04335331

NCT04335331 | PreDM Clinical Decision Support Intervention The investigators plan to address this critical knowledge gap by developing and evaluating the Prevent Diabetes Mellitus Clinical Decision Support (PreDM CDS) ...