MEDBRIDGE-Guided NCM/CHW Post-Discharge Support for High-Risk T2D Patients (MEDBRIDGE)
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.
연구 개요
상태
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Alabama
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Birmingham, Alabama, 미국, 35223
- University of Alabama at Birmingham
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연락하다:
- Seung-Yup Lee, PhD
- 전화번호: 205-934-4315
- 이메일: slee9@uab.edu
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수석 연구원:
- Seung-Yup Lee, PhD
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Birmingham, Alabama, 미국, 35233
- Cooper Green Mercy Health Services
-
연락하다:
- Seung-Yup Lee, PhD
- 전화번호: 205-934-4315
- 이메일: slee9@uab.edu
-
수석 연구원:
- Seung-Yup Lee, PhD
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: 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.
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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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Recruitment Rate
기간: 6-month recruitment window
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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.
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6-month recruitment window
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Retention Rate
기간: 3 months post-enrollment
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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.
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3 months post-enrollment
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Patient Acceptability
기간: End of 3-month intervention
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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.
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End of 3-month intervention
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Intervention Fidelity
기간: Throughout 3-month intervention
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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.
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Throughout 3-month intervention
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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HbA1c Change
기간: 3 months post-discharge
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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.
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3 months post-discharge
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Diabetes-Related Emergency Department Visits
기간: 3 months post-discharge
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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.
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3 months post-discharge
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Diabetes-Related Hospitalizations
기간: 3 months post-discharge
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Count of diabetes-related hospitalizations identified through retrospective EHR data review.
Values descriptively compared with non-intervention high-risk patients identified by MEDBRIDGE.
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3 months post-discharge
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공동 작업자 및 조사자
수사관
- 수석 연구원: Seung-Yup Lee, PhD, University of Alabama at Birmingham
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- IRB-300016482
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
IPD 공유 기간
IPD 공유 액세스 기준
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- ICF
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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