Improving Diabetes Care With Strategies For Addressing Health-Related Social Needs and Community Partnerships

Официальное название

THRIVE-DM: Improving Diabetes Care With Strategies For Addressing Health-Related Social Needs and Community Partnerships

Обзор

The goal of this study is to develop, implement, and evaluate a patient-centered triage and referral model designed to improve health outcomes for individuals with uncontrolled type 2 diabetes mellitus (T2DM) and unmet health-related social needs. The intervention builds on the existing THRIVE infrastructure at Boston Medical Center (BMC), which includes screening for social needs and a resource referral guide. It integrates medical and social care by embedding a data-driven triage tool within the EPIC electronic health record system, engaging community health workers trained in population health, and initiating closed-loop EPIC integrated referrals to community-based organizations. This study will use a hybrid type 3 effectiveness-implementation trial design to evaluate the implementation of the THRIVE-DM intervention at the clinic level. Preliminary effectiveness will be assessed by comparing THRIVE-DM to usual care in its ability to increase patient connections to community-based organizations and improve clinical outcomes. Using a stratified randomization approach, the investigators will compare referral closure rates, receipt of social services, hemoglobin A1C levels, and patterns of health service utilization between patients enrolled in THRIVE-DM and those receiving standard care

Вмешательства

• Другое THRIVE-DM
  Low-SS and High-SS will be referred by the CHW to appropriate community-based organizations through the THRIVE Directory. High-SS participants will also receive additional support from a patient navigator (PN), who will follow up to facilitate service connection and address barriers to engagement. CHWs and PNs will coordinate care to ensure services are aligned with the patient's assessed needs.
• Другое Standard of care
  Standard of care may include support from the primary care team, health related social needs (HRSN) screening via the THRIVE screener, printed resource guides, and referrals to community-based organizations initiated at the discretion of clinic staff using the THRIVE Directory.

Первичные конечные точки

• Number of participants that connect to Community-Based Organizations [Срок оценки: 3 months, 6 months, 3 months post intervention]
• Number of participants that are helped by Community-Based Organizations [Срок оценки: 3 months, 6 months, 12 months post intervention]
• Changes in HbA1c [Срок оценки: 3 months, 6 months, 12 months post intervention]

Вторичные конечные точки (2)

• Number of participants hospitalized [Срок оценки: 3 months, 6 months, 12 months post intervention]
• Number of participants that had an emergency department visit [Срок оценки: 3 months, 6 months, 12 months post intervention]

Критерии участия

Критерии включения

• Diagnosis: Must have a diagnosis of Type 2 Diabetes Mellitus (T2DM), confirmed by a current diagnosis in the medical record or at least two billing codes in the last two years, or an HbA1c level ≥6.5% in the last two years.
• Uncontrolled T2DM: Must have an HbA1c ≥9% at the time of screening.
• Health-Related Social Needs: Must have been screened for health related social needs (HRSNs) during a General Internal Medicine (GIM) visit in the last 3 months and screened positive for at least one HRSN.

Критерии исключения

• Patients enrolled in Complex Care Management (CCM).
• Patients receiving hospice care.
• Patients who are deceased
• Patients with Type 1 Diabetes Mellitus (T1DM).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Организация здравоохранения

Центры проведения

США · 1 центр

• Boston Medical Center — Boston

Идентификаторы

NCT: NCT07043426 · H-45851 · 1R01DK140570-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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