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

14. mai 2026 oppdatert av: 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Antatt)

45

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • Alabama
      • Birmingham, Alabama, Forente stater, 35223
        • University of Alabama at Birmingham
        • Ta kontakt med:
          • Seung-Yup Lee, PhD
          • Telefonnummer: 205-934-4315
          • E-post: slee9@uab.edu
        • Hovedetterforsker:
          • Seung-Yup Lee, PhD
      • Birmingham, Alabama, Forente stater, 35233
        • Cooper Green Mercy Health Services
        • Ta kontakt med:
          • Seung-Yup Lee, PhD
          • Telefonnummer: 205-934-4315
          • E-post: slee9@uab.edu
        • Hovedetterforsker:
          • Seung-Yup Lee, PhD

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Atferdsmessig: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Recruitment Rate
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
HbA1c Change
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University of Alabama at Birmingham

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. mai 2029

Primær fullføring (Antatt)

30. april 2030

Studiet fullført (Antatt)

30. april 2031

Datoer for studieregistrering

Først innsendt

14. mai 2026

Først innsendt som oppfylte QC-kriteriene

14. mai 2026

Først lagt ut (Faktiske)

20. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

20. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

14. mai 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • IRB-300016482

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

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

IPD-delingstidsramme

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

Tilgangskriterier for IPD-deling

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

IPD-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • SEVJE
  • ICF

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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