Study of a Diabetes Prevention Patient Activation Clinical Decision Support Tool

NCT ID: NCT06358261

Last Updated: 2025-07-14

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-01
• Study Completion Date: 2026-04-30

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.

Conditions

PreDiabetes; Lifestyle, Healthy; Activation, Patient

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Intervention Arm (DPACT)

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 Type: ACTIVE_COMPARATOR

Diabetes Prevention Patient Activation Clinical Decision Support Tool

Intervention Type: BEHAVIORAL

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

Control Arm (Usual Care)

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Diabetes 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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

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

NIH

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eva Tseng, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins Internal Medicine at Green Spring Station

Lutherville, Maryland, United States

Countries

United States

Other Identifiers

R03DK135898

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00433279

Identifier Type: -

Identifier Source: org_study_id