Monitoring and Outreach for Maternal Safety Postpartum

NCT ID: NCT06899737

Last Updated: 2025-07-23

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-05

Study Completion Date

2025-04-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Community health workers will be randomly assigned to either the treatment group, which will complete the MOMS Postpartum course, or the control group, which will not receive the training during the study period. Both groups will complete pretest and posttest assessments.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Treatment: MOMS Postpartum course

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.

Group Type EXPERIMENTAL

MOMS Postpartum Course

Intervention Type OTHER

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

Control

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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MOMS Postpartum Course

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Minority Health and Health Disparities (NIMHD)

NIH

Sponsor Role collaborator

KDH Research & Communication

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dexter L Cooper, MPH

Role: PRINCIPAL_INVESTIGATOR

KDH Research & Communication

Locations

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KDH Research & Communication

Atlanta, Georgia, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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1R43MD019206-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2025-02-03

Identifier Type: -

Identifier Source: org_study_id

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