Study of a Diabetes Prevention Patient Activation Clinical Decision Support Tool

PreDiabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06358261
• Other study ID #: IRB00433279
• Secondary ID: R03DK135898
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2024
• Est. completion date: September 2025

Study information

• Verified date: April 2024
• Source: Johns Hopkins University
• Contact: Eva Tseng, MD
• Phone: 410-614-4396
• Email: etseng3[@]jhmi.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: September 2025
• Est. primary completion date: September 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Activation, Patient
• Lifestyle, Healthy
• PreDiabetes
• Prediabetic State

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	number of participants referred to Diabetes Prevention Program	measured using electronic health record data	baseline, 6 months
Secondary	number of participants prescribed metformin	measured using electronic health record data	baseline, 6 months
Secondary	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
Secondary	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