Social Needs Screening and Chronic Diseases Study (WE CARE)
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: WE CARE SDOH System, Standard Pediatric Care.
- Кому может быть актуально
- Состояния в реестре: Hyperlipidemias, Diabetes, Depression, Pediatric Asthma. Базовые параметры: Без ограничений · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- США
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Improving Chronic Disease Outcomes Across the Lifespan by Addressing Structural Racism
Обзор
The goal of this clinical trial is to learn if the implementation of the WE CARE social determinants of health (SDOH) screening and referral intervention with an antiracist lens in primary care settings can lead to a meaningful decrease in chronic disease by monitoring conditions such as hypertension, diabetes, depression, hyperlipidemia, and asthma through clinical measures. The main question it aims to answer is: Does the WE CARE SDOH screening and referral intervention applying an antiracism lens informed implementation strategies have the potential to reduce racial/ethnic health inequities in chronic diseases for minoritized patients?
Подробное описание
With a multidisciplinary team of social determinants of health (SDOH), implementation, antiracism, community-engaged, and practice-based researchers, the investigators will apply an antiracism framework to an existing evidence-based SDOH screening and referral system and develop a holistic implementation toolkit aimed at reducing bias and mitigating unequal treatment for families of color. The investigators will first conduct qualitative interviews with adult patients and caregivers to understand their experiences with racism and discrimination within the context of their experiences with screening and referral for SDOH; the investigators will then share their findings with stakeholders (e.g., clinic directors, community agency leaders, health system leaders, Medicaid leaders) and elicit their ideas on how best to address these issues within the systems they lead. Subsequently, the investigators will refine the WE CARE implementation protocol using this stakeholder input with the guidance of antiracism and implementation experts. The investigators will then implement the refined WE CARE protocol in family medicine clinics since adverse SDOH impact the whole family unit; it will also allow them to examine WE CARE's impact on improving health outcomes for racialized groups across the life course. The investigators will conduct a hybrid effectiveness-implementation study with a stepped wedge cluster RCT design in three large family medicine clinics (including 2 health centers) that serve racially/ethnically diverse low-income families from Worcester, Massachusetts. The specific aims are to:
* Aim 1: Refine the WE CARE implementation protocol using an antiracism lens and community engagement approach to: (a) conduct key informant interviews with families to identify racism and discrimination related barriers to SDOH screening/referral; (b) present these barriers to systems-level stakeholders to elicit input on strategies to address patient concerns; and 3) create an antiracist informed toolkit for the implementation of SDOH screening/referral.).\* * Aim 2: Deploy the refined WE CARE protocol in family medicine practices and assess implementation outcomes including equity, appropriateness, and patient-centeredness * Aim 3: Conduct a clinical trial to evaluate the effectiveness of the refined WE CARE protocol on prevalent pediatric and adult chronic diseases (e.g., asthma, diabetes, hyperlipidemia, hypertension, depression) outcomes
Вмешательства
- Другое WE CARE SDOH System
The WE CARE System: A family-centered, highly efficacious approach for addressing adverse SDOH in the clinical setting. Arvin Garg, MD, MPH developed and conceptualized the WE CARE (Well-Child care visit, Evaluation, Community Resources, Advocacy, Referral, Education) intervention in 2005. This approach relies on existing clinical processes and infrastructure and social service resources, thereby making implementation, dissemination, and sustainability feasible. The intervention components inclu - Другое Standard Pediatric Care
Standard pediatric care includes any existing screening practices, which can vary at each clinic.
Первичные конечные точки
- Blood pressure (BP) measurements [Срок оценки: Every 3 months for up to 3 years]
Вторичные конечные точки (4)
- LDL-C measurements [Срок оценки: Every 3 months for up to 3 years]
- HbA1c measurements [Срок оценки: Every 3 months for up to 3 years]
- Emergency department visits [Срок оценки: Every 3 months for up to 3 years]
- Hospitalizations [Срок оценки: Every 3 months for up to 3 years]
Критерии участия
Критерии включения
- Adults and children with diagnosed chronic diseases (hypertension, diabetes mellitus, hyperlipidemia, asthma, or depression) who receive Family Medicine care at one of the study sites.
- Children (<18 years of age) with a diagnosis of asthma.
- Adult patients (18 years or older) with a diagnosis of diabetes mellitus, hypertension, hyperlipidemia and/or depression.
Критерии исключения
- In adults (>18 years of age), those without one or more of the following diagnoses as recorded by ICD-10 codes in their EHR: hypertension, hyperlipidemia, diabetes mellitus, or depression.
- In children (<18 years of age), those without a diagnosis of asthma.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Одна группа
- Маскирование
- Открытое
- Основная цель
- Скрининг
Центры проведения
США · 3 центра
- UMass Memorial Medical Center - Hahnemann Campus — Worcester
- Family Health Center of Worcester — Worcester
- UMass Memorial Medical Center -Benedict Family Medicine Clinic — Worcester
Идентификаторы
NCT: NCT06903897 · STUDY00001499 · 1R01NR020752-01