Improving Hypertension Control in Safety-Net Settings: The Boston Hypertension Equity Alliance in Treatment
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: RBPM, MII.
- Кому может быть актуально
- Состояния в реестре: Hypertension, Hypertension Complicated. 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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Официальное название
Comparative Effectiveness of Interventions to Improve Hypertension Control in Safety-Net Settings: The Boston Hypertension Equity Alliance in Treatment
Обзор
High blood pressure (BP) or hypertension (HTN) affects over 100 million individuals in the US, increasing the risk of adverse outcomes, including stroke, myocardial infarction (MI), and chronic kidney disease (CKD). Effective therapies include non-pharmacologic approaches and multiple medication classes. Successful HTN management requires ongoing patient engagement for BP monitoring and treatment intensification. Reaching this goal is challenging, and many patients with HTN do not have controlled BP. Using a collaborative partnership between patients, clinicians, health system and public health stakeholders, and the research team the investigators plan to overcome barriers to widespread implementation of evidence-based health system strategies to improve BP control in a large, urban, primary care-based safety-net setting for diverse populations experiencing disparities in HTN-related outcomes.
Подробное описание
A hybrid type 1 effectiveness-implementation study will be implemented to evaluate the comparative impact of each intervention on clinical outcomes while also assessing implementation at each site. The multi-site cluster randomized stepped-wedge design allows for feasible resource allocation and sequential roll out of the interventions for comparison, ensuring each site has the opportunity to benefit from both approaches. Data will be collected for multiple patient reported outcomes (PROs) to understand the range of impacts of the interventions from the patient perspective.
The specific aims are to:
* Assess comparative effectiveness of remote BP monitoring (RBPM) versus RBPM + multilevel intensification intervention (MII) on HTN control and quality of care. Prior research has demonstrated the effectiveness of each of these interventions yet the optimal approach to achieve equity in HTN control in safety net practices remains unknown. * Use mixed methods, guided by the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework, to assess implementation of the two comparators as measured by reach, adoption, implementation (fidelity) and maintenance. Using a convergent parallel design, the investigators will use concurrent quantitative and qualitative data to obtain perspectives across multiple levels to understand the reasons for success or failure of implementation of each comparator. By merging these data, integration can be achieved by using qualitative themes related to implementation to support or refute quantitative findings of reach and fidelity. * Evaluate the comparative impacts of each intervention on PROs assessed with validated measures of patient activation, medication adherence, and trust in medical settings. The study intervention approaches were informed by direct feedback from the targeted diverse patients and clinical providers to address patient-reported barriers to HTN control: lack of activation, adherence to medications, and trust in their care providers.
Вмешательства
- Поведенческое RBPM
Standardized blood pressure measurement and treatment protocols in clinical practice. - Другое MII
Team-based interventions including multiple evidence-proven interventions such as clinician decision support, monitoring medication non-adherence, use of combination pills, and formulary modifications.
Первичные конечные точки
- Systolic blood pressure (SBP) improvement [Срок оценки: Baseline, every 3 months up to 54 months]
- Interventions received [Срок оценки: Baseline, 54 months]
- Patient activation [Срок оценки: Baseline, 18 months, 30 months, 36 months, 42 months, 54 months]
Вторичные конечные точки (6)
- Blood pressure control [Срок оценки: Baseline, 18 months, 30 months, 36 months, 42 months, 54 months]
- Medication intensification [Срок оценки: Baseline, 18 months, 30 months, 36 months, 42 months, 54 months]
- BP monitoring [Срок оценки: Baseline, 18 months, 30 months, 36 months, 42 months, 54 months]
- Fidelity of interventions [Срок оценки: Baseline, 18 months, 30 months, 36 months, 42 months, 54 months]
- Medication adherence [Срок оценки: Baseline, 18 months, 30 months, 36 months, 42 months, 54 months]
- Trust in primary care [Срок оценки: Baseline, 18 months, 30 months, 36 months, 42 months, 54 months]
Критерии участия
Критерии включения
- Adult (age>18) patients receiving primary care at one of the 9 participating sites, with primary care provider (PCP) visit in the preceding year
- Presence of HTN defined by one or more of: 1) diagnosis included on active problem list, 2) active HTN medications in prior year, 3) 3 separate elevated BP measurements
- Uncontrolled HTN defined as systolic blood pressure (SBP)>140
Критерии исключения
- Not meeting the inclusion criteria
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Последовательный дизайн
- Маскирование
- Открытое
- Основная цель
- Организация здравоохранения
Центры проведения
США · 7 центров
- Boston Healthcare for the Homeless (BHCHP) — Boston
- Boston Medical Center Family Medicine — Boston
- Boston Medical Center, General Internal Medicine primary care — Boston
- Neighborhood Health — Boston
- Mattapan Community Health Center — Boston
- Manet Community Health Center — Quincy
- Greater Roslindale Medical and Dental Center (GRMDC) — Roslindale
Идентификаторы
NCT: NCT06948838 · H-45398 · HMC-2023C2-33345