Evaluation of a Novel Technology to Support Tailored Health Behavior Counseling in Rural Primary Care Clinics
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: Wait-List Control, PREVENT Tool.
- Кому может быть актуально
- Состояния в реестре: Cardiovascular Diseases, Obesity. Базовые параметры: 18 лет — 64 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
This project will conduct a pilot hybrid study that examines the implementation (Aims 1 \& 2) and preliminary effectiveness (Aim 3) of PREVENT, a digital health intervention, among patients with overweight/obesity (N=100) using a clinic-randomized design. The central hypothesis of the study is that PREVENT will be feasible and show improvements in health behavior counseling and the patient experience that will improve patients' motivation to change, and their CVH health behaviors and outcomes.
Подробное описание
Cardiovascular disease (CVD) prevalence is 40% higher among rural than urban residents in the United States. Maintaining healthy weight, physical activity, and food intake behaviors promotes cardiovascular health (CVH) and prevents CVD. The Health Resources and Services Administration requires health behavior counseling and follow-up care for patients with elevated body mass index. Counseling is most effective when developed with and tailored to the patient and offered with resources that support healthy food intake and physical activity. Healthcare teams are challenged by the lack of accessible evidence-based, tailored recommendations and limited awareness of patient health behaviors and community resources, all of which are compounded by lack of time within the clinical workflow. Yet, digital health tools that can facilitate quality counseling and follow-up are not readily available for primary care teams - particularly those in low-resourced rural settings. The investigators will leverage our existing digital health tool (PREVENT) for healthcare teams, including Community Health Workers (CHWs), to use at the point-of-care with rural low-income patients who are overweight or obese and often have more severe social needs. PREVENT visually displays patient-reported and electronic health record data to facilitate counseling and deliver tailored physical activity and healthy food intake goals and resources. The investigators have been working with the Missouri Highlands Health Care, a federally-qualified health center with 10 clinics across 7 rural counties that has an existing CHW network, to adapt our tool to meet the needs of their health care teams and patients. This project will examine the implementation (Aims 1 \& 2) and preliminary effectiveness (Aim 3) of PREVENT among patients with overweight/obesity (N=100) using a clinic-randomized design in four clinics. The investigators believe that PREVENT will be feasible and show improvements in health behavior counseling and the patient experience that will improve patients' motivation to change, CVH health behaviors, and outcomes. The investigators will seek to understand factors impacting implementation and sustainment of this approach to streamline the translation of this tool into routine care. Our ultimate goal is to improve CVH with enhanced health behavior counseling and follow-up using a multi-level approach that targets health behaviors and unmet social needs to give everyone an equal opportunity for health.
Вмешательства
- Поведенческое Wait-List Control
Will receive routine clinical care. After completion of follow-up measures, control participants will receive a behavior change prescription via the PREVENT tool - Поведенческое PREVENT Tool
PREVENT is a novel Health Information Technology tool designed to promote physical activity and healthy food intake among overweight/obese patients at the point of care. PREVENT automates the delivery of personalized, evidence-based behavior change recommendations and provides an interactive map of community resources to help the care team link patients to resources in their community. PREVENT follows up with patients electronically and communicates progress on behavior change to the care team.
Первичные конечные точки
- Healthcare team member confidence [Срок оценки: baseline, at study completion (3 years)]
- Quality counseling [Срок оценки: Within 48 hours of clinic visit]
Вторичные конечные точки (12)
- Provider satisfaction [Срок оценки: at study completion (3 years)]
- Shared Decision Making [Срок оценки: 3 months into study]
- Resource Offering [Срок оценки: 6-months]
- Patient satisfaction [Срок оценки: Within 48 hours of clinic visit]
- Patient motivation to change [Срок оценки: At baseline, 3 months and 6-months]
- Change in patients knowledge of CVH [Срок оценки: At baseline, 3 months and 6-months]
- Change in food intake behaviors [Срок оценки: At baseline, 3 months and 6-months]
- Change in physical activity behaviors [Срок оценки: At baseline, 3 months and 6-months]
- Change in body mass index (BMI) index z-score [Срок оценки: At baseline, and 6-months]
- Change on patient's average systolic and diastolic blood pressure [Срок оценки: At baseline, and 6-months]
- Change in patient's cholesterol at baseline and at study completion [Срок оценки: At baseline, and 6-months]
- Change in patient's blood glucose at baseline and at study completion [Срок оценки: At baseline, and 6-months]
Критерии участия
Patient Inclusion Criteria:
- Aged 18-64 years at baseline
- At risk for poor CVH (body mass index greater than or equal to 30)
- Receiving care from the Missouri Highlands Healthcare
- Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable)
Provider Inclusion Criteria:
- All providers and clinic staff (physicians, nurses, community health workers, clinic staff, clinic research associates) in the Missouri Highlands Healthcare Clinics are eligible to participate.
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
- Простое слепое
- Основная цель
- Организация здравоохранения
Центры проведения
США · 1 центр
- Washington University in St. Louis — St Louis
Идентификаторы
NCT: NCT06397729 · 202309157