Healing, Equity, Advocacy and Respect for Mamas

Официальное название

Comparing Standard of Care Versus a Technology-Based Approach To Reduce Postpartum Emergency Department Visits

Обзор

The goal of the proposed research is to test the comparative effectiveness of AIM safety bundles for post-partum women delivered in-person vs. via text/phone to improve early detection of and timely care for complications during the first six weeks postpartum for women experiencing significant health disparities.

Подробное описание

The purpose of the study is to learn if a program for newborn mom's can improve detection of complications after delivery and help women get medical care quickly and easily. Participants will be asked to complete a survey at the time of enrollment and at 3 additional times. All surveys can be completed via cell-phone or email. All women will be followed for 1-year after delivery. Women that enroll will be assigned to one of two groups: usual in person care OR usual in-person care PLUS a text message-based program that will ask about sign and symptoms of complications that may occur after delivery. If there is a concern, a nurse advocate will call on the phone to discuss options and help refer to care if needed. Participants will be paid for their time in completing surveys.

Вмешательства

• Другое H.E.A.R. for Mamas
  H.E.A.R. for Mamas is a patient and provider informed, multicomponent intervention that uses simple text/phone-based screenings to systematically and frequently monitor women for postpartum complications, chronic conditions and SDoH (Social Determinants of Health) and provides patients with immediate feedback and recommendations based on their screenings.

Первичные конечные точки

• Emergency Department (ED) visits within six weeks postpartum [Срок оценки: Within six weeks following the delivery]

Вторичные конечные точки (1)

• Patient Reported Outcomes (PROs) [Срок оценки: time of study enrollment (baseline=0), and 3, 6, and 12 months postpartum]

Критерии участия

Inclusion Criteria for Postpartum Women

• Postpartum woman within approximately 2 weeks of delivering a baby of gestational age ≥ 26 weeks in South Carolina.
• Aged 16-49 years old.
• Insured by Medicaid.

Exclusion Criteria for Postpartum Women

• Plans to relocate outside of SC anytime during the postpartum year.
• Plans to discontinue Medicaid health insurance during the postpartum year.
• Speaks a language other than English or Spanish.
• Incarcerated/pending incarceration during peripartum period.
• Currently institutionalized.
• Enrolled in current MUSC study funded by PCORI (#Pro00123833)
• Does not have and/or does not wish to use their personal cell phone for the study.

Inclusion Criteria for Obstetric Providers and Hospital Administrators

\- OB provider working at a delivery hospital in SC and directly involved in the care of postpartum women; or hospital administrator working in a delivery hospital in SC and job responsibilities relate to the postpartum unit.

Exclusion Criteria for Obstetric Providers and Hospital Administrators

• Less than 1 month of HEAR 4 Mamas experience if involved in the hospital where participants are recruited from.
• Unable or unwilling to commit to completing surveys or an interview.
• Speaking a language other than English.

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

Открытое

Основная цель

Профилактика

Центры проведения

США · 1 центр

• Medical University of South Carolina — Charleston

Идентификаторы

NCT: NCT06273436 · Pro00130902

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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