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临床试验/NCT06273436
NCT06273436招募中不适用

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

Medical University of South Carolina1 个研究点 分布在 1 个国家目标入组 2,894 人开始时间: 2024年5月28日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
2,894
试验地点
1
主要终点
Emergency Department (ED) visits within six weeks postpartum

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
16 Years 至 49 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

Usual Care

No Intervention

AIM (AIM Alliance for Innovation on Maternal Health) safety bundles delivered in-person

Usual Care plus H.E.A.R. for Mamas

Experimental

H.E.A.R. for Mamas is designed to provide the AIM (Alliance for Innovation on Maternal Health) Postpartum Discharge Transition education systematically and to frequently monitor women for signs and symptoms of postpartum complications using simple, patient-centered technology (text/phone).

干预措施: H.E.A.R. for Mamas (Other)

结局指标

主要结局

Emergency Department (ED) visits within six weeks postpartum

时间窗: Within six weeks following the delivery

Percent of postpartum women with an ED visit that occurs within six weeks following delivery

次要结局

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

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Constance Guille

Professor - Faculty

Medical University of South Carolina

研究点 (1)

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