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

14. Mai 2026 aktualisiert von: Seung-Yup Lee, University of Alabama at Birmingham

MEDBRIDGE: AI-Driven Risk Stratification and Care Transition Intervention to Improve Diabetes Medication Management

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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

This single-arm feasibility pilot evaluates a MEDBRIDGE-guided nurse case manager (NCM) and community health worker (CHW) post-discharge support intervention for high-risk patients with type 2 diabetes (T2D). MEDBRIDGE is an AI-driven risk stratification tool that integrates medication data, clinical factors, and social determinants of health from electronic health records to identify patients at elevated risk of HbA1c elevation, diabetes-related emergency department visits, and hospitalizations within 3 months post-discharge.

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.

Primary outcomes include feasibility (recruitment rate, retention rate), patient acceptability (Acceptability of Intervention Measure), and intervention fidelity (NCM/CHW contact log adherence). Secondary outcomes include HbA1c change, diabetes-related emergency department visits, and diabetes-related hospitalizations within 3 months post-discharge, analyzed descriptively and compared with non-intervention high-risk patients identified by MEDBRIDGE.

The study is conducted at the University of Alabama at Birmingham (UAB) Hospital and Cooper Green Mercy Health Services, a county-owned safety-net facility serving predominantly low-income and uninsured residents of Jefferson County, Alabama. The patient population is characterized by higher rates of medication complexity, limited health literacy, and social vulnerability. Approximately 20 UAB hospitalizations involve Cooper Green patients with T2D each month, providing a sufficient recruitment base for the target enrollment of 45 patients over a 6-month recruitment window.

Studientyp

Interventionell

Einschreibung (Geschätzt)

45

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Vereinigte Staaten
    • Alabama
      • Birmingham, Alabama, Vereinigte Staaten, 35223
        • University of Alabama at Birmingham
        • Kontakt:
          • Seung-Yup Lee, PhD
          • Telefonnummer: 205-934-4315
          • E-Mail: slee9@uab.edu
        • Hauptermittler:
          • Seung-Yup Lee, PhD
      • Birmingham, Alabama, Vereinigte Staaten, 35233
        • Cooper Green Mercy Health Services
        • Kontakt:
          • Seung-Yup Lee, PhD
          • Telefonnummer: 205-934-4315
          • E-Mail: slee9@uab.edu
        • Hauptermittler:
          • Seung-Yup Lee, PhD

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: N / A
  • Interventionsmodell: Einzelgruppenzuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: MEDBRIDGE-Guided NCM/CHW Support
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.
Verhalten: MEDBRIDGE-Guided NCM/CHW Post-Discharge Support Intervention
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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Recruitment Rate
Zeitfenster: 6-month recruitment window
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
Zeitfenster: 3 months post-enrollment
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
Zeitfenster: End of 3-month intervention
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
Zeitfenster: Throughout 3-month intervention
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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
HbA1c Change
Zeitfenster: 3 months post-discharge
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.
3 months post-discharge
Diabetes-Related Emergency Department Visits
Zeitfenster: 3 months post-discharge
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.
3 months post-discharge
Diabetes-Related Hospitalizations
Zeitfenster: 3 months post-discharge
Count of diabetes-related hospitalizations identified through retrospective EHR data review. Values descriptively compared with non-intervention high-risk patients identified by MEDBRIDGE.
3 months post-discharge

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

University of Alabama at Birmingham

Ermittler

  • Hauptermittler: Seung-Yup Lee, PhD, University of Alabama at Birmingham

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. Mai 2029

Primärer Abschluss (Geschätzt)

30. April 2030

Studienabschluss (Geschätzt)

30. April 2031

Studienanmeldedaten

Zuerst eingereicht

14. Mai 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

14. Mai 2026

Zuerst gepostet (Tatsächlich)

20. Mai 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

20. Mai 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

14. Mai 2026

Zuletzt verifiziert

1. Mai 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • IRB-300016482

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

De-identified individual participant data underlying published results will be made available upon reasonable request.

IPD-Sharing-Zeitrahmen

Beginning 12 months after publication of primary results and available for 5 years.

IPD-Sharing-Zugriffskriterien

Researchers who provide a methodologically sound proposal and sign a data use agreement. Requests should be directed to the PI (slee9@uab.edu).

Art der unterstützenden IPD-Freigabeinformationen

  • STUDIENPROTOKOLL
  • SAFT
  • ICF

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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