Clinical trial NCT06899737: Monitoring and Outreach for Maternal Safety Postpartum
Official title: Monitoring and Outreach for Maternal Safety Postpartum
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Postpartum
Women
Community Health Workers
Knowledge
High-risk
Self Efficacy
Intention
Attitude
Keywords: Community health workers
Postpartum
Support for high risk postpartum women
Women
Lead sponsor: KDH Research & Communication
Sponsor class: INDUSTRY
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2025-03-28
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: SUPPORTIVE_CARE

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Knowledge Pretest Score
timeFrame: Pretest (Baseline)
measure: Knowledge Posttest Score
timeFrame: Posttest (1 week after baseline)
measure: Skills Pretest Score
timeFrame: Pretest (Baseline)
measure: Skills Posttest Score
timeFrame: Posttest (1 week after baseline)
measure: Self-efficacy Pretest Score
timeFrame: Pretest (Baseline)
measure: Self-efficacy Posttest Score
timeFrame: Posttest (1 week after baseline)
measure: Attitudes Pretest Score
timeFrame: Pretest (Baseline)
measure: Attitudes Posttest Score
timeFrame: Posttest (1 week after baseline)
measure: Intentions Pretest Score
timeFrame: Pretest (Baseline)
measure: Intentions Posttest Score
timeFrame: Posttest (1 week after baseline)
Secondary outcomes:
measure: Satisfaction at Posttest
timeFrame: Posttest (1 weeks after baseline)
Other outcomes:
measure: Change in Knowledge Scores From Pretest to Posttest
timeFrame: From pretest to posttest (1 week)
measure: Change in Skills Scores From Pretest to Posttest
timeFrame: From pretest to posttest (1 week)
measure: Change in Self-Efficacy Scores From Pretest to Posttest
timeFrame: From pretest to posttest (1 week)
measure: Change in Attitudes Scores From Pretest to Posttest
timeFrame: From pretest to posttest (1 week)
measure: Change in Intention Scores From Pretest to Posttest
timeFrame: From pretest to posttest (1 week)
Locations:
city: Atlanta
country: United States
facility: KDH Research & Communication
state: Georgia
Study officials:
affiliation: KDH Research & Communication
name: Dexter L Cooper, MPH
role: PRINCIPAL_INVESTIGATOR
References: