IMPACT: Improving Maternal Postpartum Access to Care Through Telemedicine
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: Intensive Education, Enhanced Virtual Care.
- Кому может быть актуально
- Состояния в реестре: Postpartum Complication. Базовые параметры: от 18 лет · Женщины.
- 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
The purpose of this study is to compare two complex, multi-component evidence-based postpartum interventions in underserved populations of lower socioeconomic status in an effort to reduce maternal morbidity and mortality.
Подробное описание
This large, multi-center randomized controlled trial will compare two multi-component postpartum care models via hybrid type 1 design conducted in two phases. An initial phase (phase 1) will collect baseline data and ensure patient input into final study. In phase 2, women will be randomized. Comparators are evidenced- based approaches: (1) an intensive in-person education with virtual education via push notifications using an electronic health record web portal; (2) a telehealth model using serial encounters. The "push" approach using notifications directly contrasts with the "pull" approach using telehealth visits. Both models include home visit programs. The study population includes patients delivering in two urban, inner-city health systems: Parkland (Dallas, TX) and Grady Memorial (Atlanta, GA). The primary outcome is time from hospital discharge to diagnosis and treatment of a composite of complications in the first 6 weeks. Based upon pilot data, 2349 women will demonstrate a 40% reduction (9 to 5.4 days) with 80% power and two-sided alpha of 0.05. 3500 women will be enrolled (1000 in phase 1; 2500 in phase 2) with anticipated \<5% attrition at 6 weeks. Inclusion will be women who deliver liveborn infants. Secondary outcomes include mental health disorders, emergency room visits, hospital admissions, patient knowledge, quality of life and satisfaction, provider satisfaction, and social determinants of health. Women will be followed for one year postpartum.
Вмешательства
- Другое Intensive Education
Intervention will consist of virtual education and communication through scheduled push notifications - Другое Enhanced Virtual Care
Intervention will utilize a telehealth model consisting of "pull" approach of patient engagement.
Первичные конечные точки
- Composite Healthcare Outcome - time to diagnosis and treatment of postpartum complications after hospital discharge [Срок оценки: Up to one year postpartum]
Вторичные конечные точки (12)
- Edinburgh Postnatal Depression Scale [Срок оценки: enrollment, 1 week, 6 weeks, 3 months, 6 months, 1 year postpartum]
- Generalized Anxiety Disorder 7 [Срок оценки: enrollment, 1 week, 6 weeks, 3 months, 6 months, 1 year postpartum]
- Number of patients requiring emergency room visits, % preventable [Срок оценки: Up to one year postpartum]
- Number of patients requiring hospital admissions, % preventable [Срок оценки: Up to one year postpartum]
- Postpartum warning signs knowledge assessment, based on AWOHHN criteria [Срок оценки: enrollment, 1 week, 6 weeks, 3 months, 6 months, 1 year postpartum]
- PROMIS-29 questionnaire v 2.1 [Срок оценки: 6 weeks and 1 year postpartum]
- Healthy People 2030 questionnaire [Срок оценки: 6 weeks and 1 year postpartum]
- PRAPARE questionnaire [Срок оценки: 6 weeks and 1 year postpartum]
- Short Assessment of Patient Satisfaction (SAPS) [Срок оценки: 6 weeks and 1 year postpartum]
- Provider Satisfaction Survey (Quantitative) [Срок оценки: Every 6 months throughout the study period]
- Systolic Blood Pressure [Срок оценки: enrollment, 1 week, 6 weeks, 3 months, 6 months, 1 year postpartum]
- Diastolic Blood Pressure [Срок оценки: enrollment, 1 week, 6 weeks, 3 months, 6 months, 1 year postpartum]
Критерии участия
Критерии включения
- Postpartum women who deliver a live born infant at Parkland Hospital or Grady Health and receive postpartum care at dedicated community clinics.
- Due to the nature of the study, all will be women, and all will be postpartum, thus of reproductive age. Postpartum women 18 years of age and older will be considered for inclusion if informed consent can be obtained.
Критерии исключения
- Postpartum women who do not deliver at Parkland Hospital or Grady Health will not receive postpartum care in the pre-specified community clinics for Parkland health systems.
- Patients with a primary language other than English or Spanish.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Открытое
- Основная цель
- Профилактика
Центры проведения
США · 2 центра
- Emory University School of Medicine — Atlanta
- University of Texas Southwestern Medical Center — Dallas
Публикации
- Zhang R, Boulet SL, Nelson DB, Goedken P, Catchings J, McIntire D, Platner M, Martin RB, Spong CY, Duryea EL. Improving Maternal Postpartum Access to Care through Telemedicine (IMPACT): A multi-center randomized controlled trial of postpartum interventions to improve access and outcome. Contemp Clin Trials. 2025 May;152:107882. doi: 10.1016/j.cct.2025.107882. Epub 2025 Mar 14. PMID 40090665
Идентификаторы
NCT: NCT06218355 · STU-2023-0332 · PCORI-MMM-2022C2-27680