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.
調査の概要
状態
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Alabama
-
Birmingham、Alabama、アメリカ、35223
- University of Alabama at Birmingham
-
コンタクト：
- Seung-Yup Lee, PhD
- 電話番号：205-934-4315
- メール：slee9@uab.edu
-
主任研究者：
- Seung-Yup Lee, PhD
-
Birmingham、Alabama、アメリカ、35233
- Cooper Green Mercy Health Services
-
コンタクト：
- Seung-Yup Lee, PhD
- 電話番号：205-934-4315
- メール：slee9@uab.edu
-
主任研究者：
- Seung-Yup Lee, PhD
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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.
|
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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Recruitment Rate
時間枠：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
時間枠：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
時間枠：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
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
HbA1c Change
時間枠：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.
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3 months post-discharge
|
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Diabetes-Related Emergency Department Visits
時間枠：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
|
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Diabetes-Related Hospitalizations
時間枠：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
|
協力者と研究者
捜査官
- 主任研究者：Seung-Yup Lee, PhD、University of Alabama at Birmingham
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- IRB-300016482
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
IPD 共有時間枠
IPD 共有アクセス基準
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- ICF
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米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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