Clinical trial NCT06663813: Enhancing Preventative Health Behaviors Among Emergency Department Hyperglycemic Patients
Official title: Enhancing Proactive and Preventative Health Behaviors Among Hyperglycemic Patients Presenting to the Emergency Department
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Type 2 Diabetes
Hyperglycemia
Keywords: Emergency Medicine
Type 2 Diabetes
Hyperglycemia
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
First posted: 2024-10-29
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The goal of this clinical trial is to increase Type 2 Diabetes Mellitus knowledge and awareness among patients who present to the Emergency Department with hyperglycemia. The main questions it aims to answer are:

* How do patients view their risk of developing type 2 diabetes based on their demographics and behaviors?
* Does giving patient education increase patient knowledge, leading to healthier behaviors?

Researchers will assess if the educational intervention increases diabetes knowledge and positive health behaviors among Emergency Department hyperglycemic patients.

Participants will:

* Receive the educational packet (intervention) alongside standard Emergency Care.
* Take pre-survey at time of Emergency Department visit and post- survey two weeks later.

Detailed description: Despite the large prevalence of patients presenting to the Emergency Department (ED) with hyperglycemia or disease manifestations related to Type 2 Diabetes Mellitus (T2DM), there remains a gap in our understanding of rapid educational strategies delivered within the ED itself. As such, the goal of this project is to utilize the Health Belief Model (HBM) framework to target ED patients' perceived susceptibility, severity, benefits, and barriers in an effort to enhance proactive health behaviors, such as primary care physician (PCP) follow-up and utilization of medication assistance programs, among ED patients.

We will recruit 400 English speaking adults who present to the ED with a blood glucose of ≥200 mg/dL. All participants will receive educational materials on diabetes, as well as resources to local primary-care follow up and medication assistance programs. Participants will complete pre- and post-surveys to quantify changes in self-perceived susceptibility, severity, barriers to managing T2DM, and behavioral changes, which include presence of PCP follow-up, establishing a new PCP, and utilizing medication assistance programs.

Quantitative pre- and post-survey responses will be analyzed via regression models and paired t-tests to evaluate for statistically significant changes in perceived susceptibility, severity, benefits, and barriers to T2DM self-management among participants before and after receiving the educational intervention.The expected findings of this research study are increases in patient diabetes knowledge and self-perception of susceptibility and severity, leading to higher rates of PCP follow-up among participants following dissemination of educational materials grounded in the HBM framework. These research outcomes can be utilized to inform future interventions that target further barriers or reduce ED recidivism for hyperglycemic patients in the ED.

Eligibility criteria: Inclusion Criteria:

* Persons 18 years of age or older who present as patients in the Robert Wood Johnson University Hospital Emergency Department with or without a preexisting Type 2 Diabetes Mellitus diagnosis with a blood glucose of ≥200 mg/dL. Participants must speak English to participate in the study.

Exclusion Criteria:

* Age less than 18 years and blood glucose \&lt;200 mg/dL.

Primary outcomes:
measure: Diabetes Knowledge
timeFrame: Initial Emergency Department presentation to follow-up survey (2 weeks later)
Secondary outcomes:
measure: Proactive and Preventative Health Behaviors
timeFrame: Initial Emergency Department presentation to follow-up survey (2 weeks later)
Other outcomes:
Locations:
city: New Brunswick
country: United States
facility: One Robert Wood Johnson Place
state: New Jersey
city: New Brunswick
country: United States
facility: One Robert Wood Johnson Place
state: New Jersey
Study officials:
affiliation: Rutgers Robert Wood Johnson Medical School
name: Sara Heinert, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: