Enhancing Preventative Health Behaviors Among Emergency Department Hyperglycemic Patients

Enhancing Proactive and Preventative Health Behaviors Among Hyperglycemic Patients Presenting to the Emergency Department

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.

Study Overview

• Status: Recruiting
• Conditions: Hyperglycemia; Type 2 Diabetes
• Intervention / Treatment: Behavioral: Educational Intervention

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.

• Study Type: Interventional
• Enrollment (Estimated): 400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Neha V Maddali, BSPH; Phone Number: 9739758066; Email: nvm37@rwjms.rutgers.edu

Study Locations

• United States
  • New Jersey
    • New Brunswick, New Jersey, United States, 08540
      • Recruiting
      • One Robert Wood Johnson Place
      • Contact: Sara Heinert, PhD, MPH; Phone Number: 732-235-7872; Email: sara.heinert@rutgers.edu
    • New Brunswick, New Jersey, United States, 08901
      • Recruiting
      • One Robert Wood Johnson Place
      • Contact: Sara Heinert, PhD, MPH; Phone Number: 732-235-7872; Email: sara.heinert@rutgers.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 <200 mg/dL.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Intervention Arm; Participants in the intervention arm will receive Type 2 Diabetes Mellitus educational materials that includes information regarding Type 2 Diabetes symptoms, risk factors, and resources for further follow-up care alongside standard Emergency Medicine care, which includes discharge instructions provided by ED practitioners along with verbal explanations from their assigned ED nurse.

Behavioral: Educational Intervention; Utilizing the Health Belief model, educational materials detailing diabetes risk factors to address perceived susceptibility, diabetes severity and complications to address perceived severity, and PCP follow-up information and medication assistance programs to address perceived barriers will be provided.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diabetes Knowledge	Changes in self-perceived susceptibility, severity, benefits, and barriers to managing T2DM, aligned with the Health Belief Model	Initial Emergency Department presentation to follow-up survey (2 weeks later)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proactive and Preventative Health Behaviors	Behavioral changes, which include presence of PCP follow-up, establishing a new PCP, and utilizing medication assistance programs.	Initial Emergency Department presentation to follow-up survey (2 weeks later)

Collaborators and Investigators

• Sponsor: Rutgers, The State University of New Jersey
• Investigators: Principal Investigator: Sara Heinert, PhD, MPH, Rutgers Robert Wood Johnson Medical School

Publications and helpful links

General Publications

• Bazargan M, Johnson KH, Stein JA. Emergency department utilization among Hispanic and African-American under-served patients with type 2 diabetes. Ethn Dis. 2003 Summer;13(3):369-75.

Helpful Links

• This research table demonstrates that T2DM is currently the most prevalent chronic disease encountered in the ED.
• Describes the tenants of the Health Belief Model

Study record dates

Study Major Dates

• Study Start (Actual): October 29, 2024
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: October 25, 2024
• First Submitted That Met QC Criteria: October 25, 2024
• First Posted (Actual): October 29, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 13, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Emergency Medicine; Type 2 Diabetes; Hyperglycemia
• Additional Relevant MeSH Terms: Endocrine System Diseases; Pathologic Processes; Disease Attributes; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Emergencies; Diabetes Mellitus, Type 2; Hyperglycemia
• Other Study ID Numbers: Pro2024000602

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: IPD that underlie the results reported in this article, after deidentification (including text, tables, figures, and appendices).
• IPD Sharing Time Frame: Beginning 9 months and ending 36 months following article publication.
• IPD Sharing Access Criteria: Due to the nature of the data being collected, and to ensure participant confidentiality, data will be made available using a tiered request for access system. All tiers of data require a data-use agreement (DUA) at a minimum, additional precautions for restricted-use will be included in data request forms.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No