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Study of a Diabetes Prevention Patient Activation Clinical Decision Support Tool

Pilot Study of a Diabetes Prevention Patient Activation Clinical Decision Support Tool

Status
Enrolling by invitation
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06358261
Enrollment
100
Registered
2024-04-10
Start date
2024-07-01
Completion date
2027-02-01
Last updated
2026-09-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Activation, Patient, Lifestyle, Healthy, PreDiabetes

Brief summary

The investigators overarching goal is to increase the percentage of patients engaging in diabetes prevention activities to reduce the incidence of diabetes. The investigators objective is to design and pilot test a prediabetes clinical decision support (CDS) tool in the electronic health record (EHR) that will assess the patient's activation level based on responses to a questionnaire. Based on the patient's assessed level of activation, the tool will generate several communication recommendations to guide clinicians in conversations related to prediabetes/lifestyle change and tailor recommendations about available resources (e.g., care manager, health coach, DPP) to support patient activation.

Detailed description

Patient activation, which incorporates elements of self-efficacy and readiness to change, is particularly important in managing conditions like pre-diabetes, where the mainstay of treatment is behavioral lifestyle change and self-management. Unfortunately, Primary Care Physicians (PCPs) often do not have adequate training on how to promote patient activation. Traditionally, patient decision aids are used in shared decision-making to help elicit patient preferences and guide treatment options. However, the guides primarily focus on reviewing treatment options rather than increasing patient activation, which is key to successful and efficient behavioral counseling. The Patient Activation Measure (PAM) is a widely used and validated patient-reported outcome measure for assessing patient activation. Studies have demonstrated that using PAM to tailor care to a patient's activation level decreased health service utilization while improving clinical outcomes like blood pressure and self-management behaviors. The investigators overarching goal is to increase the percentage of patients engaging in diabetes prevention activities to reduce the incidence of diabetes. The investigators objective is to design and pilot test a pre-diabetes clinical decision support (CDS) tool in the electronic health record (EHR) that will assess the patient's activation level based on responses to a questionnaire. Based on the patient's assessed level of activation, the tool will generate several communication recommendations to guide clinicians in conversations related to pre-diabetes/lifestyle change and tailor recommendations about available resources (e.g., care manager, health coach, DPP) to support patient activation.

Interventions

BEHAVIORALDiabetes Prevention Patient Activation Clinical Decision Support Tool

Diabetes Prevention Patient Activation Clinical Decision Support Tool will be used by the doctor during the visit to discuss lifestyle management

Sponsors

Johns Hopkins University
Lead SponsorOTHER
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Intervention model description

pilot group-randomized controlled trial

Eligibility

Sex/Gender
ALL
Age
25 Years to 75 Years
Healthy volunteers
Yes

Inclusion criteria

* prediabetes * patient at Johns Hopkins General Internal Medicine clinic at Green Spring Station * MyChart account

Exclusion criteria

* history of diabetes * non-English speaker * severe intellectual disability or psychiatric comorbidities

Design outcomes

Primary

MeasureTime frameDescription
patient activation as assessed by the Patient Activation Measure Survey (PAM)baseline, 6 monthsmeasured by Patient Activation Measure (PAM) survey, a 13-item scale with 4 Likert response,s and scores ranging from 0 to 100 (higher score means higher activation level)

Secondary

MeasureTime frameDescription
change in amount and frequency of physical activitybaseline, 6 monthsmeasured using survey developed by study team will assess the change in amount and frequency of physical activity that participants have made
number of participants referred to Diabetes Prevention Programbaseline, 6 monthsmeasured using electronic health record data
number of participants prescribed metforminbaseline, 6 monthsmeasured using electronic health record data
percent of participants who make diet changesbaseline, 6 monthsmeasured using survey developed by study team will assess what diet changes participants have made

Countries

United States

Contacts

PRINCIPAL_INVESTIGATOREva Tseng, MD

Johns Hopkins University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 4, 2026