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临床试验/NCT06899737
NCT06899737已完成不适用

Monitoring and Outreach for Maternal Safety Postpartum

KDH Research & Communication1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2025年3月5日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
120
试验地点
1
主要终点
Knowledge Pretest Score

研究概览

简要总结

Two arm study, intervention and control, to explore the impact of an online training program to help community health workers (CHWs) conduct effective outreach to support postpartum mothers, particularly those at higher risk for complications.

详细描述

The investigators will use a randomized, two-group, pretest/posttest design to test the efficacy of the MOMS Postpartum course and explore the following research question: To what extent does exposure to the MOMS Postpartum course increase CHWs' knowledge, skills, attitudes/beliefs, self-efficacy, and intentions to provide support to postpartum mothers?

MOMS Postpartum course is set in context of imperative need of assisting postpartum mothers in the U.S. and working with CHWs after pregnancy to have better maternal outcomes, particularly among high-risk mothers. Researchers worked with subject matter experts, CHWs, and the intended audience to ensure the MOMS Postpartum course reflects the specific needs of postpartum mothers; minimize counter-productive duplications of services and resource expenditure; and create empowered opportunities for CHWs to conduct outreach with high-risk postpartum mothers. MOMS Postpartum course will provide an effective, low-cost, evidence-based, professional development curriculum to train CHWs to provide support to postpartum mothers and fill a gap in care.

The Principal Investigator (PI), with input from the subject matter experts and CHWs, developed necessary research materials, including the recruitment protocols, evaluation instrumentation, and human subjects consent materials . The PI also outlined the appropriate statistical analysis methods. All procedure documents were reviewed by the KDHRC Institutional Review Board before the evaluation launch.

Investigators will recruit participants through evaluation partners who will disseminate the study information to CHWs via electronic notifications and flyers. Evaluation partners include CHW Association of Rochester, Center for Health Innovation, and other CHW organizations. The notifications and flyers provide information about the goal of the study, participant eligibility, and a link to an eligibility form. Once a potential participant completes the eligibility form and s/he is eligible for the study, they will receive a link to a consent form located on a secure online platform.

After consent and enrollment into the study, CHWs will complete a pretest survey and be randomly assigned to the intervention or control group. The intervention group will be exposed to MOMS Postpartum course and will complete an online posttest survey after completing the online modules. The control group participants will not be exposed to the MOMS Postpartum course and will complete a posttest one week after completing the pretest. Participant responses to pretest and posttest survey measures will be linked using non-personal identifiers.

研究设计

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

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Must be at least 18 years old.
  • •Must self-identify as a community health worker (CHW).
  • •Must live in the United States.
  • •Must have six months of field experience. KDHRC defines "field experience" as conducting outreach activities in their community, for example, working with clients in a clinic, conducting home visits, or educating clients at health fairs or community events.
  • •Must be an active CHW. KDHRC defines "active" as conducting outreach activities, such as working with clients in a clinic, conducting home visits, or educating clients at health fairs or community events, in the last six months.
  • •Must have Internet access either at home or at work to access the lessons and/or online surveys.

排除标准

  • 未提供

研究组 & 干预措施

Treatment: MOMS Postpartum course

Experimental

Community health workers (CHWs) in the treatment group will complete the MOMS Postpartum course online training program. They will engage with the training materials, apply learned concepts, and complete pretest and posttest assessments to measure changes in their knowledge, skills, attitudes, intentions and self-efficacy.

干预措施: MOMS Postpartum Course (Other)

Control

No Intervention

Community health workers (CHWs) in the control group will not receive access to the MOMS Postpartum course training during the study period. Their will continue their usual work without the additional training while also completing pretest and posttest assessments to allow for comparison with the treatment group.

结局指标

主要结局

Knowledge Pretest Score

时间窗: Pretest (Baseline)

Multiple-choice questions on content related to postpartum care, self-care practices, and needs of postpartum mothers based on information from the MOMS Postpartum course lessons. The score is reported on a scale of 0 to 100, calculated as the percentage of correctly answered questions. Higher scores indicate greater knowledge.

Knowledge Posttest Score

时间窗: Posttest (1 week after baseline)

Multiple-choice questions on content related to postpartum care, self-care practices, and needs of postpartum mothers based on information from the MOMS Postpartum course lessons. The score is reported on a scale of 0 to 100, calculated as the percentage of correctly answered questions. Higher scores indicate greater knowledge.

Skills Pretest Score

时间窗: Pretest (Baseline)

Likert scale ranging from 1 (no experience) to 10 (extensive experience), with a higher score being a better outcome, on conducting education and outreach to postpartum mothers and how to support postpartum mothers

Skills Posttest Score

时间窗: Posttest (1 week after baseline)

Likert scale ranging from 1 (no experience) to 10 (extensive experience), with a higher score being a better outcome, on conducting education and outreach to postpartum mothers and how to support postpartum mothers

Self-efficacy Pretest Score

时间窗: Pretest (Baseline)

Likert scale ranging from 1 (strongly disagree) to 10 (strongly agree) to measure CHWs' beliefs that they can effectively support postpartum mothers

Self-efficacy Posttest Score

时间窗: Posttest (1 week after baseline)

Likert scale ranging from 1 (no experience) to 10 (extensive experience), with a higher score being a better outcome, to measure CHWs' beliefs that they can effectively support postpartum mothers

Attitudes Pretest Score

时间窗: Pretest (Baseline)

Likert scale ranging from 1 (strongly disagree) to 10 (strongly agree) on attitudes conducting education and outreach to postpartum mothers and how to support postpartum mothers

Attitudes Posttest Score

时间窗: Posttest (1 week after baseline)

Likert scale ranging from 1 (strongly disagree) to 10 (strongly agree) on attitudes conducting education and outreach to postpartum mothers and how to support postpartum mothers

Intentions Pretest Score

时间窗: Pretest (Baseline)

Likert scale ranging from 1 (extremely unlikely) to 10 (extremely likely) on intentions conducting education and outreach to postpartum mothers and how to support postpartum mothers

Intentions Posttest Score

时间窗: Posttest (1 week after baseline)

Likert scale ranging from 1 (extremely unlikely) to 10 (extremely likely) on intentions conducting education and outreach to postpartum mothers and how to support postpartum mothers

次要结局

  • Satisfaction at Posttest(Posttest (1 weeks after baseline))

研究者

发起方
KDH Research & Communication
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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