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Набор по приглашению NCT05208450

Actions to Decrease Disparities in Risk and Engage in Shared Support for Blood Pressure Control (ADDRESS-BP) in Blacks

Без фазы С лечением Hypertension (HTN)

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: Practice support And Community Engagement (PACE).
Кому может быть актуально
Состояния в реестре: Hypertension (HTN). 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 →

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Обзор

To use practice facilitation (PF) + community health worker (CHW) facilitation as a practical and sustainable implementation strategy to support the implementation and evaluation of three multi-level evidence-based interventions \[nurse case management (NCM), remote blood pressure monitoring (RBPM), and social determinants of health (SDOH) support\] delivered as an integrated community-clinic linkage model \[Practice support And Community Engagement (PACE) to address patient-, physician-, health system-, and community-level barriers to hypertension (HTN) control in Blacks across 25 primary practices within NYU Langone Health in New York City (NYC) and, in partnership with an established Community-Clinic-Academic Advisory Board and HealthFirst (NYC's largest Medicaid payer). The goal for the UH3 Implementation Phase (Years 4-7, Intervention) is to evaluate a stepped-wedge cluster RCT of 25 primary care practices in Black patients with uncontrolled hypertension (HTN)

Вмешательства

  • Другое Practice support And Community Engagement (PACE)
    A practical and sustainable implementation strategy, referred to as Practice Facilitation And social deTerminants of health support utilizing CHWs (PATCH), to support the implementation and evaluation of three multi-level evidence-based interventions: \[nurse case management (NCM) + remote blood pressure monitoring (RBPM) + social determinants of health (SDOH) support\] delivered as an integrated community-clinic linkage model \[Practice support And Community Engagement (PACE)\]

Первичные конечные точки

  • Number of Nurses who adopt the PACE intervention [Срок оценки: Month 12]

Критерии участия

UH3 IMPLEMENTATION PHASE (Years 4 - 7): INTERVENTION

Критерии включения

Patients are eligible if he/she:

  • identifies as Black (through EHR code or self-report)
  • is 18+ years of age
  • has a diagnosis of HTN (identified by ICD-10 codes for HTN)
  • prescribed an antihypertensive medication(s)
  • has a clinic BP > 130/80 mmHg

Критерии исключения

Patients will be ineligible for the study if they:

  • are deemed unable to comply with the study protocol (either self-selected or by indicating during screening that s/he could not complete all requested tasks)
  • participate in other hypertension-related clinical trials
  • have significant psychiatric comorbidity or reports of substance abuse (as documented in the EHR)
  • plan to discontinue care at the site within the next 12 months; or
  • are pregnant or planning to become pregnant in the next 12 months

IMPLEMENTATION EVALUATION

  • NYULH Primary care provider (MD/DO, NP), Clinical Director, Site Administrator, Medical Assistant, or administrative staff employed at the participating practices and interacts with at least five patients with a diagnosis of hypertension; or
  • NYULH Nurse case manager within centralized service; or
  • Staff and leadership of community- and faith-based organizations serving the Black community; or
  • NYULH Organizational leadership; or
  • NYULH Project Staff: Community Health Workers/CHW Supervisor/Practice Facilitators; and
  • Able and willing to provide consent

Критерии исключения

1\. Refusal to participate

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Перекрёстный дизайн
Маскирование
Простое слепое
Основная цель
Организация здравоохранения

Центры проведения

США · 1 центр
  • NYU Langone Health — New York

Публикации

  • Gyamfi J, Cooper C, Barber A, Onakomaiya D, Lee WY, Zanowiak J, Mansu M, Diaz L, Thompson L, Abrams R, Schoenthaler A, Islam N, Ogedegbe G. Needs assessment and planning for a clinic-community-based implementation program for hypertension control among blacks in New York City: a protocol paper. Implement Sci Commun. 2022 Sep 6;3(1):96. doi: 10.1186/s43058-022-00340-z. PMID 36068611

Идентификаторы

NCT: NCT05208450 · 20-01114

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗