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临床试验/NCT05159726
NCT05159726已完成不适用

YOU MATTER: Using Video Education to Improve Patient Knowledge of Severe Maternal Morbidity (SMM) Warning Signs

Yale University2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2022年7月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
200
试验地点
2
主要终点
Change in baseline and post-education questionnaire score

研究概览

简要总结

This is a prospective, single-center, randomized control study to determine if video education at the time of postpartum discharge improves patient knowledge on the warning signs for the top three causes of severe maternal morbidity (infection, hemorrhage, and blood pressure disorders) in the first seven days following delivery. Participants will be randomized to written discharge education + video education (intervention) vs standard discharge education (control). They will complete a baseline questionnaire and a post-discharge education questionnaire during their postpartum stay to assess for knowledge improvement. The investigators hypothesize that video education will improve patient's knowledge of severe maternal morbidity warning signs.

详细描述

Prior to the day of postpartum discharge, a designated staff person will approach eligible patients and review the objectives of the study. If patients are willing to participate, they will complete a consent form and the baseline questionnaire. The baseline questionnaire will assess patient knowledge on postpartum hemorrhage, infection, hypertensive disorders of pregnancy, and depression.

Following delivery, patients will be randomized. Randomization will be done in a 1:1 allocation ratio between written discharge instructions + video education vs. written discharge instructions (standard of care at YNHH). A computer algorithm will assign participant based on random permuted blocks design with block size between 2-4. Each participant will have an assigned Study ID number that is linked to their random assignment. Group 1 will be the written discharge + video education group (intervention group). Group 2 will be the written discharge education (control group).

On the day of discharge, the nursing staff will provide discharge education based on their randomized group:

Group 1 will be the written discharge education + video education group (intervention group). These patients will view a 12-minute educational video on SMM warning signs, in addition to the written discharge instructions provided by nursing staff. At the completion of the video, they will complete a post-video questionnaire to assess their knowledge on the covered topics.

Group 2 will be the written discharge instruction group (control group). They will receive the written discharge instructions provided by nursing staff and complete the post-discharge instruction questionnaire.

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
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Age >18 years
  • Speaks English or Spanish
  • Informed and written consent
  • Delivered at Yale New Haven Hospital (YNHH)
  • Received prenatal, and will receive postpartum, care through a YNHH-affiliated obstetric and/or midwifery practice

排除标准

  • Patients who do not plan to receive postpartum care within the YNHH system
  • Patients who experience an intrauterine fetal demise
  • Patients who have a pregnancy with multiple severe congenital anomalies with an anticipated poor prognosis
  • Patients who speak a primary language other than English or Spanish

结局指标

主要结局

Change in baseline and post-education questionnaire score

时间窗: Baseline, discharge (up to one week)

Patients will complete a baseline and post-discharge education 15 item questionnaire that will assess knowledge on postpartum hemorrhage, infection, hypertensive disorders of pregnancy, and depression. The questionnaire will be scored 0-15 based on the number of correct responses. A lower score indicates lower knowledge, while a higher score indicates a better knowledge of the subject items. Outcome will be binary based on whether or not the patient improved their score between the two questionnaires.

次要结局

  • Patient satisfaction(Baseline, post-education)
  • Change in post-education and post-discharge questionnaire score(3-7 days)
  • Compliance with Postpartum Care(6 weeks)
  • Healthcare utilization(6 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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