MEDBRIDGE-Guided NCM/CHW Post-Discharge Support for High-Risk T2D Patients

NCT07599852 | Not Yet Recruiting

• 1 other identifier: IRB-300016482
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 2

Brief Summary

This study tests whether a support program led by a nurse case manager and community health worker can help patients with type 2 diabetes manage their medications after leaving the hospital. Many patients with diabetes take multiple medications, and changes to these medications during hospital stays can cause confusion and lead to missed doses or incorrect use. This is especially common in communities with limited access to healthcare. The study uses a computer-based tool called MEDBRIDGE (MEDication BRIDGE) to identify patients who may be at higher risk for problems after discharge, such as worsening blood sugar control or return visits to the emergency department. Patients identified as high-risk will receive 3 months of support from a nurse case manager and community health worker team, who will help with medication questions, coordinate with their doctor, and provide follow-up check-ins. The main goal is to find out whether this type of support program is practical to deliver and acceptable to patients. The study will also track changes in blood sugar levels and emergency department visits. Forty-five patients will be enrolled over 6 months at the University of Alabama at Birmingham and Cooper Green Mercy Health Services in Jefferson County, Alabama.

Conditions

Type 2 Diabetes; Medication Adherence; Care Transition; Medication Discrepancy

Keywords

Type 2 Diabetes; Medication Management; Care Transitions; Post-Discharge; Nurse Case Manager; Community Health Worker; Risk Stratification; Artificial Intelligence; HbA1c; Social Determinants of Health; Deep South; Underserved Populations

Outcome Measures

Primary Outcomes (4)

• Recruitment Rate

  Number of patient enrollments per month compared against threshold of 6 enrollments per month. Enrollment rate calculated as the percentage of eligible patients (based on MEDBRIDGE recommendations) who enrolled in the intervention (completed first interaction); target 50% or higher.

  6-month recruitment window

• Retention Rate

  Percentage of enrolled patients completing each round of the intervention (first, second, and up to the final round). Target completion rate of 60% or higher. Estimated 85% retention per subsequent interaction, yielding approximately 61% final retention.

  3 months post-enrollment

• Patient Acceptability

  Patient scores on the Acceptability of Intervention Measure (AIM), assessed using a 5-point Likert scale. Target mean score of 4 or higher. Surveys assess comfort with the intervention process and communication with the NCM/CHW team.

  End of 3-month intervention

• Intervention Fidelity

  NCM/CHW self-report logs including interaction start and end timestamps and a checklist of core intervention components performed, compared against adherence threshold of 0.85. Bi-weekly supervision sessions review logs to ensure protocol adherence.

  Throughout 3-month intervention

Secondary Outcomes (3)

• HbA1c Change

  3 months post-discharge

• Diabetes-Related Emergency Department Visits

  3 months post-discharge

• Diabetes-Related Hospitalizations

  3 months post-discharge

Study Arms (1)

MEDBRIDGE-Guided NCM/CHW Support

EXPERIMENTAL

High-risk patients with type 2 diabetes identified by the MEDBRIDGE risk stratification tool receive a 3-month post-discharge support intervention delivered by a nurse case manager (NCM) and community health worker (CHW) team.

Behavioral: MEDBRIDGE-Guided NCM/CHW Post-Discharge Support Intervention

Interventions

MEDBRIDGE-Guided NCM/CHW Post-Discharge Support Intervention BEHAVIORAL

A 3-month post-discharge care coordination intervention delivered by a nurse case manager (NCM) and community health worker (CHW) team, guided by MEDBRIDGE AI-driven risk stratification. The intervention follows a four-phase workflow: (1) Risk Assessment, where the NCM reviews the daily MEDBRIDGE-generated high-risk patient list; (2) Initial Patient Contact, where the NCM/CHW team initiates contact after discharge to review medications and identify discrepancies; (3) Ongoing Support, where the CHW provides monthly check-ins to monitor adherence, address barriers, and coordinate with primary care providers; and (4) Transition to Routine Care, where the team facilitates handoff to the patient's primary care provider with a summary of activities and recommendations. Participants receive a minimum of 3 contacts over the intervention period.

MEDBRIDGE-Guided NCM/CHW Support

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18 years or older
• Diagnosis of type 2 diabetes (HbA1c of 6.5% or higher or relevant ICD-10 codes including E11, E13, E14, R73, L97.509, K31.84)
• Discharged from UAB Hospital or its emergency departments
• Receiving primary care at Cooper Green Mercy Health Services or UAB Post Discharge Clinic
• Identified as high risk by the MEDBRIDGE prediction tool based on elevated risk of HbA1c elevation, diabetes-related emergency department visits, or diabetes-related hospitalizations within 3 months post-discharge

You may not qualify if:

• Under age 18
• No indication of type 2 diabetes
• Not affiliated with Cooper Green Mercy Health Services or UAB Post Discharge Clinic for primary care
• Unable to provide informed consent
• Currently enrolled in another post-discharge intervention study

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (2)

University of Alabama at Birmingham

Birmingham, Alabama, 35223, United States

Location

Cooper Green Mercy Health Services

Birmingham, Alabama, 35233, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Medication Adherence

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Seung-Yup Lee, PhD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Single-arm feasibility pilot. All enrolled participants receive the MEDBRIDGE-guided NCM/CHW post-discharge support intervention for 3 months.

Study Record Dates

• First Submitted: May 14, 2026
• First Posted: May 20, 2026
• Study Start (Estimated): May 1, 2029
• Primary Completion (Estimated): April 30, 2030
• Study Completion (Estimated): April 30, 2031
• Last Updated: May 20, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Beginning 12 months after publication of primary results and available for 5 years.
• Access Criteria: Researchers who provide a methodologically sound proposal and sign a data use agreement. Requests should be directed to the PI (slee9@uab.edu).

Locations

US (2)