Меню
Набор по приглашению NCT06831162

Evaluating the Effectiveness of a Multi-level Health-Related Social Needs Initiative

Без фазы С лечением Type 2 Diabetes Hypertension Hyperlipidemia Health-related Social Problems

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: Multi-level HRSN initiative.
Кому может быть актуально
Состояния в реестре: Type 2 Diabetes, Hypertension, Hyperlipidemia, Health-related Social Problems. Базовые параметры: от 18 лет · 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 →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Обзор

The goal of this study is to evaluate the effectiveness of a multi-level health-related social needs (HRSN) initiative among adult patients diagnosed with type 2 diabetes, plus hypertension or hyperlipidemia. The multi-level initiative includes HRSN data collection, training and tools for health care professionals, care coordinator support, and community resources. Patients with type 2 diabetes plus hypertension or hyperlipidemia will be screened for HRSN as part of the primary care clinic intake process to assess if patients have any social needs (like difficulty with getting food, housing, or transportation). If patients screen positive for having social needs, then patients will be offered support, which can include help from primary care providers with adjusting a patient's disease management plan, referrals to care coordinators to provide additional assistance in addressing social needs, and information about community organizations that offer resources for social needs. The initiative will be integrated as a system change across VUMC adult primary care practices. The investigators will use a prospective, single-arm clinical trial to evaluate effects on clinical outcomes for 12 months. Data will be extracted from the EHR on adult patients diagnosed with type 2 diabetes, and either hypertension or hyperlipidemia. The investigators hypothesize that the initiative will reduce the impact of HRSN on clinical outcomes over the study period. The investigators will also administer surveys to a subgroup of patients to examine trends in self-reported psychosocial and behavioral measures over the course of the initiative.

Вмешательства

  • Другое Multi-level HRSN initiative
    The multi-level health-related social needs (HRSN) initiative includes multiple components aimed at assessing and addressing HRSN in clinical practice: HRSN screening, EHR tools for clinical decision support, training and tools for health care providers to address HRSN, care coordinator support for patient outreach, and community resources for referral and support.

Первичные конечные точки

  • Change in glycemic control [Срок оценки: Baseline and 12 months post-baseline]
Вторичные конечные точки (2)
  • Change in cholesterol [Срок оценки: Baseline and 12 months post-baseline]
  • Change in blood pressure [Срок оценки: Baseline and 12 months post-baseline]

Критерии участия

ELIGIBILITY CRITERIA FOR EHR DATA EXTRACTION

Критерии включения

  • 18 years of age or older
  • Completed the health-related social needs (HRSN) screener as part of a primary care visit
  • Diagnosed with type 2 diabetes, plus hypertension and/or hyperlipidemia as reflected by ICD-10 billing codes
  • Receive care at one of six partner Vanderbilt University Medical Center primary care clinics: South One Hundred Oaks, North One Hundred Oaks, Green Hills, Hillsboro Medical Group, Melrose, Bellevue

ELIGIBILITY CRITERIA FOR PATIENT SURVEYS (subset of EHR data)

Критерии включения

  • 18 years of age or older
  • Completed the HRSN screener as part of a primary care visit
  • Diagnosed with type 2 diabetes
  • Receive care at one of six partner Vanderbilt University Medical Center primary care clinics: South One Hundred Oaks, North One Hundred Oaks, Green Hills, Hillsboro Medical Group, Melrose, Bellevue
  • English-speaking

Критерии исключения

  • Blindness
  • Hearing impairment
  • Conditions that would interfere with survey completion (e.g., significant dementia, active psychosis or mania)
  • Being near the end of life (hospice or home hospice)

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Организация здравоохранения

Центры проведения

США · 1 центр
  • Vanderbilt University Medical Center — Nashville

Идентификаторы

NCT: NCT06831162 · 241778 · P50MD017347-03S3

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗