Baby Steps to Care

Официальное название

Baby Steps to Care - Improving Access to Prenatal Care From the Emergency Department

Обзор

The purpose of this research study is to understand if receipt of extra prenatal resources from the ED visit improves i) the patient's ability to engage in prenatal services after the ED visit, and ii) how it impacts the patient's pregnancy knowledge and confidence. If participant's consent to this study, the participants will receive standard of care and additionally be randomized, like flipping a coin, to receive either i) extra prenatal care resources in the form of a 'care box' during this ED visit, or ii) the extra prenatal care resources in the form of a 'care box" two weeks from today. All participants will also receive a follow-up survey asking about the patient's engagement in prenatal services following ED visit, perceptions of pregnancy knowledge and confidence, the usefulness of the resources received, and what additional resources might have been helpful during the early stages of pregnancy. Participation in this study will not require any additional clinic or hospital visits. The total time involved is approximately 20 minutes during the initial ED visit and less than 20 minutes to complete the follow-up survey. Investigators hope to enroll a total of 50 participants in this study.

Вмешательства

• Поведенческое Care Box
  The resources in the care box include a water bottle, pocket calendar (monthly planner) and pen, recorder in the shape of a heart, bus pass, mini stuffed animal, and a welcome insert (includes descriptions for the items and a QR code with additional resources) additionally, the QR code will be on the inside of the box's top as well as on the insert.

Первичные конечные точки

• Change in number of OBGYN follow up appointments as measured by medical record review [Срок оценки: 1 week, 1 month, 3 months, 6 months, 9 months]

Вторичные конечные точки (6)

• Number of participants with a pregnancy outcome of 1 as measured by medical record review [Срок оценки: Up to 9 months]
• Number of participants with a pregnancy outcome of 2 as measured by medical record review [Срок оценки: Up to 9 months]
• Number of participants with a pregnancy outcome of 3 as measured by medical record review [Срок оценки: Up to 9 months]
• Number of participants with a pregnancy outcome of 4 as measured by medical record review [Срок оценки: Up to 9 months]
• Number of participants with a pregnancy outcome of 5 as measured by medical record review [Срок оценки: Up to 9 months]
• Number of participants who affirmed the care box supported the pregnancy as measured by patient survey [Срок оценки: Up to 1 week]

Критерии участия

Критерии включения

• Found to be pregnant in the CMC Emergency Department through serum or urine pregnancy testing (hcg) or point of care (POC) urine testing
• Ability to provide verbal consent to this study

Критерии исключения

• Prisoners
• Non-Ohio residents
• Serious medical conditions (severe cardiovascular disease, infections, trauma) or critical illness requiring urgent hospitalization
• Nonpregnant persons including men

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

Поддерживающая терапия

Центры проведения

США · 1 центр

• University University Cleveland Medical Center — Cleveland

Идентификаторы

NCT: NCT07499648 · STUDY20251517

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗