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Идёт набор NCT06541951

Scaling up Maternal Health Equity Best Practices

Без фазы С лечением Maternal Mortality Disparities Maternal Morbidity Disparities

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: Services as usual, Scale-up implementation approach.
Кому может быть актуально
Состояния в реестре: Maternal Mortality Disparities, Maternal Morbidity Disparities. 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 →
Официальное название

Scale-up Implementation Approaches to Ending Pregnancy-related and -Associated Morbidity and Mortality (MIRACLE Center Project 3)

Обзор

This study works with prenatal and postnatal care providers in 12 Michigan counties to scale up best practices for maternal health equity.

Подробное описание

The project recruits prenatal and postnatal care providers in 12 Michigan counties. his project will develop and test a scale-up focused implementation approach for addressing pregnancy-related and -associated morbidity and mortality (PRAMM) disparities. Previous efforts have shown that use of hospital- focused maternal safety bundles are an important part of successful efforts to reduce PRAMM. However, overall quality of obstetric care improved in these efforts without any effect on disparities. Thus, unlike previous efforts, the proposed project will implement quality improvement bundles that: (1) focus on PRAMM disparities; and (2) focus on community care (i.e., care provided outside the hospital in outpatient and other community settings) and coordination among care settings. Given that 83% of U.S. pregnancy-related and pregnancy-associated deaths occur during pregnancy or postpartum (rather than around the time of delivery), outpatient and community efforts are vital. Bundles (the evidence-based practices to be implemented) are developed by the national Alliance for Innovation on Maternal Health Community Care Initiative (AIM-CCI), and include "Community care for postpartum safety and wellness," and "Community care for maternal mental health," "Chronic conditions," and "Intimate partner violence" bundles. All bundles target PRAMM disparities. • Aim 1 of the proposed project will analyze bundle implementation experiences in 2 counties to develop a county-wide scale-up focused implementation approach for the bundles in partnership with stakeholders date to create and manualize a scale-up implementation intervention. • Aim 2 will evaluate the effectiveness and cost-effectiveness of the scale-up implementation intervention using a stepped wedge design in 12 Michigan counties with a total population of nearly 6 million people. PRAMM outcomes (individual level) will be extracted from a pre-existing statewide linked dataset. The sample for these analyses will include all Medicaid insured individuals in the 12 counties observed during pregnancy, at birth, and up to 1 year postpartum during the project period (\~151,920 births, including \~49,110 births to African American and/or Hispanic mothers). Implementation outcomes (provider-level) include scale-up (penetration, reach, control for delivery, and intervention effectiveness at scale) and sustainment (maintenance of fidelity to core elements, health benefits, and capacity to deliver core elements over time). This project is innovative because it: (1) is the first controlled implementation trial to test approaches to implementing quality improvement bundles that: (a) specifically target PRAMM disparities; and (b) focus on community care; (2) advances the science of scale-up (it is the first study to test scale- up or sustainment implementation approaches to addressing maternal morbidity/mortality disparities); and (3) works to improve services across many (vs. a single) health systems. The project is significant because the field needs to reach pregnant people at scale, and scale-up is an understudied aspect of implementation science.

Вмешательства

  • Другое Services as usual
    During this phase of the stepped wedge design, agencies offering prenatal and postnatal care will follow their standard procedures
  • Другое Scale-up implementation approach
    An implementation approach for scaling up bundled equity-focused maternal health safety guidelines in community care settings county-wide, co-developed with partners. It may involve implementation approaches such as training, facilitation, learning collaboratives, coalitions, and other activities.

Первичные конечные точки

  • African-American and Hispanic pregnancy-related and associated morbidity and mortality (PRAMM) [Срок оценки: Continuous for 6 years]
Вторичные конечные точки (10)
  • Scale-up: Penetration [Срок оценки: Assessed annually for 6 years]
  • Scale-up: Reach [Срок оценки: Assessed annually for 6 years]
  • Scale-up: Control for delivery [Срок оценки: Assessed annually for 6 years]
  • Scale-up: Effectiveness [Срок оценки: Assessed annually for 6 years]
  • Sustainment: Fidelity [Срок оценки: Annually for 6 years]
  • Sustainment: Health benefits [Срок оценки: Annually for 6 years]
  • Sustainment: Capacity [Срок оценки: Annually for 6 years]
  • Cost of implementation approaches [Срок оценки: Continuous over 6 years]
  • Cost-effectiveness of implementation approaches [Срок оценки: Continuous over 6 years]
  • Index (y/n) that is yes if there is any African-American and Hispanic severe maternal morbidity or pregnancy-associated mortality [Срок оценки: Continuous for 6 years]

Критерии участия

Provider Inclusion Criteria:

-Be a provider or staff person at agencies offering prenatal and/or postnatal services in Wayne, Oakland, Ingham, Isabella, Macomb, Muskegon, Calhoun, Jackson, Saginaw, Kalamazoo, Barrien, or Washtenaw counties in Michigan.

Provider Exclusion Criteria:

  • None

Patient outcomes are assessed through population-level Medicaid data, without direct recruitment.

Patient Inclusion criteria:

-All pregnant or postpartum (up to 12 months) people receiving Medicaid in Michigan

Patient Exclusion criteria:

-None

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Последовательный дизайн
Маскирование
Простое слепое
Основная цель
Профилактика

Центры проведения

США · 1 центр
  • Michigan State University on behalf on 12 Michigan counties — Flint

Публикации

  • Johnson JE, Clement J, Sikorskii A, Loree A, Meulen MV, Roman L, Dearing JW, Bolder H, White JM, Sokol R, Meghea C. A cluster randomized stepped wedge implementation trial of scale-up approaches to ending pregnancy-related and -associated morbidity and mortality disparities in 12 Michigan counties: rationale and study protocol. Implement Sci Commun. 2025 Feb 20;6(1):19. doi: 10.1186/s43058-024-006 PMID 39980059

Идентификаторы

NCT: NCT06541951 · STUDY00009307 · U54HD113291

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗