Study of a Diabetes Prevention Patient Activation Clinical Decision Support Tool

NCT06358261 | Enrolling By Invitation

• 2 other identifiers: IRB00433279R03DK135898
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

PreDiabetes; Lifestyle, Healthy; Activation, Patient

Outcome Measures

Primary Outcomes (1)

• patient activation as assessed by the Patient Activation Measure Survey (PAM)

  measured 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)

  baseline, 6 months

Secondary Outcomes (4)

• number of participants referred to Diabetes Prevention Program

  baseline, 6 months

• number of participants prescribed metformin

  baseline, 6 months

• percent of participants who make diet changes

  baseline, 6 months

• change in amount and frequency of physical activity

  baseline, 6 months

Study Arms (2)

Intervention Arm (DPACT)

ACTIVE COMPARATOR

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.

Behavioral: Diabetes Prevention Patient Activation Clinical Decision Support Tool

Control Arm (Usual Care)

NO 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

Interventions

Diabetes Prevention Patient Activation Clinical Decision Support Tool BEHAVIORAL

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

Intervention Arm (DPACT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Johns Hopkins Internal Medicine at Green Spring Station

Lutherville, Maryland, 21093, United States

Location

MeSH Terms

Conditions

Prediabetic State; Patient Participation

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Eva Tseng, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: pilot group-randomized controlled trial

Study Record Dates

• First Submitted: April 5, 2024
• First Posted: April 10, 2024
• Study Start: July 1, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)