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Enrolling by Invitation

NCT Number: NCT06358261

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.

Enrolling by Invitation

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins Internal Medicine at Green Spring Station

Lutherville, Maryland, 21093, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

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

    Time frame: baseline, 6 months

    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)

Secondary outcomes

  1. number of participants referred to Diabetes Prevention Program

    Time frame: baseline, 6 months

    measured using electronic health record data

  2. number of participants prescribed metformin

    Time frame: baseline, 6 months

    measured using electronic health record data

  3. percent of participants who make diet changes

    Time frame: baseline, 6 months

    measured using survey developed by study team will assess what diet changes participants have made

  4. change in amount and frequency of physical activity

    Time frame: baseline, 6 months

    measured using survey developed by study team will assess the change in amount and frequency of physical activity that participants have made

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Apr 10, 2024
Registry last updated
Jun 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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