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Completed

NCT Number: NCT06899737

Monitoring and Outreach for Maternal Safety Postpartum

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.

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Key information

Conditions

Postpartum Attitude Behavior Community Health Workers High-risk Intention Knowledge Self Efficacy Women

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

KDH Research & Communication

Atlanta, Georgia, 30309, United States

About this study

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.

The investigators will download and export the data from Alchemer into an encrypted Excel file and import the raw data into STATA. The investigators will match the pretest and posttest responses using the random assigned identifiers and conduct analyses to test for the effect of MOMS Postpartum course exposure on changes in CHWs' knowledge, skills, attitudes/beliefs, perceived self-efficacy, and intentions to conduct outreach to postpartum mothers.

The initial feasibility criterion is: Statistically significant (p<0.05) and positive relationship between exposure to MOMS Postpartum course and increased knowledge among the intervention group in comparison to the control group.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • None

Treatment and study plan

MOMS Postpartum Course

Other

Online professional development training for CHWs on outreach and support for high-risk postpartum mothers

Primary outcomes

  1. Knowledge Pretest Score

    Time frame: 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.

  2. Knowledge Posttest Score

    Time frame: 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.

  3. Skills Pretest Score

    Time frame: 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

  4. Skills Posttest Score

    Time frame: 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

  5. Self-efficacy Pretest Score

    Time frame: Pretest (Baseline)

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

  6. Self-efficacy Posttest Score

    Time frame: 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

  7. Attitudes Pretest Score

    Time frame: 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

  8. Attitudes Posttest Score

    Time frame: 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

  9. Intentions Pretest Score

    Time frame: 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

  10. Intentions Posttest Score

    Time frame: 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

Secondary outcomes

  1. Satisfaction at Posttest

    Time frame: Posttest (1 weeks after baseline)

    Likert scale ranging from 1 (strongly disagree) to 10 (strongly agree), with a higher score being a better outcome, to measure CHWs' satisfaction with the course, interactive experiences, and offline resources and measure the extent to which CHWs would recommend the course

Other outcomes

  1. Change in Knowledge Scores From Pretest to Posttest

    Time frame: From pretest to posttest (1 week)

    At both pretest and posttest, we asked all participants the same multiple choice knowledge questions on content related to postpartum care, self-care practices, and needs of postpartum mothers based on information from the MOMS Postpartum course lessons, which we will average to create a composite knowledge score for each participant ranging from 0 to 100. A score of 0 meant a participant got zero questions correct while a score of 100 meant a participant got all questions correct. We will average these composite scores across all participants for both groups to create mean scores. We then subtracted pretest scores from posttest scores and will average these changes for all participants. Positive scores mean a gain in knowledge and a higher scores mean higher gains from baseline to posttest.

  2. Change in Skills Scores From Pretest to Posttest

    Time frame: From pretest to posttest (1 week)

    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. We will average ratings from each question to create an average composite rating for each participant, then average these composite scores for both groups. We will then subtract pretest scores from posttest scores and averaged these changes for all participants. Positive scores mean a gain in skills and higher scores mean higher gains from baseline to posttest.

  3. Change in Self-Efficacy Scores From Pretest to Posttest

    Time frame: From pretest to posttest (1 week)

    Likert scale ranging from 1 (strongly disagree) to 10 (strongly agree), with a higher score being a better outcome, on conducting education and outreach to postpartum mothers and how to support postpartum women. We will average ratings from each question to create an average composite rating for each participant, then average these composite scores for both groups. We will then subtract pretest scores from posttest scores and average these changes for all participants. Positive scores mean a gain in self-efficacy and higher scores mean higher gains from baseline to posttest.

  4. Change in Attitudes Scores From Pretest to Posttest

    Time frame: From pretest to posttest (1 week)

    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. We will average ratings from each question to create an average composite rating for each participant, then average these composite scores for both groups. We will then subtract pretest scores from posttest scores and averaged these changes for all participants. Positive scores mean a gain in attitudes and higher scores mean higher gains from baseline to posttest.

  5. Change in Intention Scores From Pretest to Posttest

    Time frame: From pretest to posttest (1 week)

    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. We averaged ratings from each question to create an average composite rating for each participant, then averaged these composite scores for both groups. We then subtracted pretest scores from posttest scores and averaged these changes for all participants. Positive scores mean a gain in intentions and higher scores mean higher gains from baseline to posttest.

Sponsors and collaborators

Lead sponsor

KDH Research & Communication

Industry

Collaborators

  • National Institute on Minority Health and Health Disparities (NIMHD)

Registry information

Acronym: MOMSPostpartum

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 28, 2025
Registry last updated
Jul 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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