Clinical trial NCT06358261: Study of a Diabetes Prevention Patient Activation Clinical Decision Support Tool
Official title: Pilot Study of a Diabetes Prevention Patient Activation Clinical Decision Support Tool
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: PreDiabetes
Lifestyle, Healthy
Activation, Patient
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2024-04-10
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: pilot group-randomized controlled trial
Primary purpose: PREVENTION

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.

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.

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

Primary outcomes:
measure: patient activation as assessed by the Patient Activation Measure Survey (PAM)
timeFrame: baseline, 6 months
Secondary outcomes:
measure: number of participants referred to Diabetes Prevention Program
timeFrame: baseline, 6 months
measure: number of participants prescribed metformin
timeFrame: baseline, 6 months
measure: percent of participants who make diet changes
timeFrame: baseline, 6 months
measure: change in amount and frequency of physical activity
timeFrame: baseline, 6 months
Other outcomes:
Locations:
city: Lutherville
country: United States
facility: Johns Hopkins Internal Medicine at Green Spring Station
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Eva Tseng, MD
role: PRINCIPAL_INVESTIGATOR
References: