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Enrolling by invitation NCT06358261

Study of a Diabetes Prevention Patient Activation Clinical Decision Support Tool

No phase Interventional PreDiabetes Lifestyle, Healthy Activation, Patient

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Diabetes Prevention Patient Activation Clinical Decision Support Tool.
Who it may be relevant to
Registry conditions: PreDiabetes, Lifestyle, Healthy, Activation, Patient. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • 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

Primary outcome measures

  • patient activation as assessed by the Patient Activation Measure Survey (PAM) [Time frame: baseline, 6 months]
Secondary outcome measures (4)
  • number of participants referred to Diabetes Prevention Program [Time frame: baseline, 6 months]
  • number of participants prescribed metformin [Time frame: baseline, 6 months]
  • percent of participants who make diet changes [Time frame: baseline, 6 months]
  • change in amount and frequency of physical activity [Time frame: baseline, 6 months]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Prevention

Study locations

United States · 1 center
  • Johns Hopkins Internal Medicine at Green Spring Station — Lutherville

Identifiers

NCT: NCT06358261 · IRB00433279 · R03DK135898

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗