Study of a Diabetes Prevention Patient Activation Clinical Decision Support Tool

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: PreDiabetes; Lifestyle, Healthy; Activation, Patient
• Intervention / Treatment: Behavioral: Diabetes Prevention Patient Activation Clinical Decision Support Tool

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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Lutherville, Maryland, United States, 21093
      • Johns Hopkins Internal Medicine at Green Spring Station

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Behavioral: 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
No Intervention: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
number of participants referred to Diabetes Prevention Program	measured using electronic health record data	baseline, 6 months
number of participants prescribed metformin	measured using electronic health record data	baseline, 6 months
percent of participants who make diet changes	measured using survey developed by study team will assess what diet changes participants have made	baseline, 6 months
change in amount and frequency of physical activity	measured using survey developed by study team will assess the change in amount and frequency of physical activity that participants have made	baseline, 6 months

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: Eva Tseng, MD, Johns Hopkins University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: April 5, 2024
• First Submitted That Met QC Criteria: April 5, 2024
• First Posted (Actual): April 10, 2024

Study Record Updates

• Last Update Posted (Actual): April 20, 2026
• Last Update Submitted That Met QC Criteria: April 15, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Behavior; Nutritional and Metabolic Diseases; Treatment Adherence and Compliance; Health Behavior; Patient Acceptance of Health Care; Prediabetic State; Patient Participation
• Other Study ID Numbers: IRB00433279; R03DK135898 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No