MEDBRIDGE-Guided NCM/CHW Post-Discharge Support for High-Risk T2D Patients
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Alabama at Birmingham
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
MEDBRIDGE-Guided NCM/CHW Post-Discharge Support Intervention
BehavioralA 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.
Treatment groups
45 Participants
are divided into 1 treatment groupGroup A: MEDBRIDGE-Guided NCM/CHW SupportExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
6-month recruitment window2
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.
Time frame
3 months post-enrollment3
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.
Time frame
End of 3-month intervention4
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.
Time frame
Throughout 3-month interventionSecondary outcomes
1
HbA1c Change
Continuous variable of HbA1c change calculated for each patient using HbA1c self-check at baseline and 3 months. An indicator variable on whether HbA1c reduction exceeds 0.5% will be created. Values descriptively compared with non-intervention high-risk patients identified by MEDBRIDGE.
Time frame
3 months post-discharge2
Diabetes-Related Emergency Department Visits
Count of diabetes-related emergency department visits identified through retrospective EHR data review. Values descriptively compared with non-intervention high-risk patients identified by MEDBRIDGE.
Time frame
3 months post-discharge3
Diabetes-Related Hospitalizations
Count of diabetes-related hospitalizations identified through retrospective EHR data review. Values descriptively compared with non-intervention high-risk patients identified by MEDBRIDGE.
Time frame
3 months post-dischargeSponsors and contacts
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Source ClinicalTrials.gov
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