- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00536159
Medicaid Enhanced Prenatal/Postnatal Services Using a Nurse-Community Health Worker Team
Improving the Health and Development of Low-Income Pregnant Women
Study Overview
Status
Intervention / Treatment
Detailed Description
Impoverished pregnant and parenting women have greater exposure to environmental stress with adverse effects for their own mental and physical health that may have long term consequences for their children's health and development. The mental health consequences of stress are pervasive in low income pregnant women and mothers with almost half screening positive for depressive symptoms and a quarter meeting diagnostic criteria for major or minor depression. While national home visiting models have demonstrated improvement in health, developmental, and parenting outcomes for women willing to participate, they have had less success in reducing depressive symptoms during pre and postnatal periods, and often programs struggle to engage women with unmet mental health needs.
We conducted a community-based, multi-site, randomized, controlled trial that included longitudinal assessment on five occasions during pregnancy and infancy to determine temporal program effects. We used a CC comparison group because Medicaid insured women in Michigan are eligible for home visiting through enhanced prenatal and infant services, and our goal was to determine if there was any advantage to the team approach when compared to community implementation of the state-sponsored home visiting program.
Pregnant women, who telephoned one of five public clinics in Kent County, Michigan, a county that includes urban (Grand Rapids) and rural areas, were contacted and invited to participate in the trial. We enrolled women considered harder to reach with cultural, language, and literacy barriers to participation and with chronic or current medical problems-populations traditionally served by state-sponsored programs. Participation was not dependent on women coming to a research or health facility, participating in prenatal or child health care or the enhanced services, having reliable transportation, consistent phone service, or stable housing.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Michigan
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Grand Rapids, Michigan, United States, 49503
- Spectrum Health Hospitals
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Medicaid eligible
- residency in the county and no plans to move within 18 months
- at least 16 years of age
- speaks Spanish or English
Exclusion Criteria:
- no pre-existing relationship with a home visiting nurse
- no diagnosis or treatment for a pre-existing mental health condition within the last two years
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Active Comparator: Community Care
Medicaid eligible/insured pregnant women and their infants are eligible for risk assessment and up to 18 home visits (9/pregnancy and 9/infancy) from community professional providers as part of a state-sponsored enhanced prenatal and postnatal Medicaid program.
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Enhanced services include home visiting, transportation, psychosocial counseling, multidisciplinary planning, case management, nutritional guidance, and pregnancy and parenting education during pregnancy and infancy.
The services are delivered primarily by nurses with occasional visits by social workers or nutritionists.
In the county of the study (Kent), women who were assessed were provided intervention services.
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Experimental: Nurse-CHW Team
Nurse-CHW team provided both nursing care, with additional focus on mental health and stress, and intensive relationship-based support from a CHW similar in characteristics to women served in the context of state-sponsored Medicaid program.
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A nurse and two CHWs functioned as a team, using visit and clinical guidelines that detailed expected care.
Each team provided services for approximately 50-60 families.
While occasional visits were made by both providers, most visits were made by either provider alone.
Nurses guided the CHW care, led a multidisciplinary team assessment (with social workers, nutritionists, and others), provided crisis intervention and case management, assessed and managed health problems (including screening for depression and mental health care), and had periodic office visits with prenatal providers.
CHWs provided relationship-based support by attempting weekly prenatal contact that alternated phone and face-to-face visits and used peer role modeling and personal empowerment approaches.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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depressive symptoms
Time Frame: <24 weeks gestation to 12 months post birth
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<24 weeks gestation to 12 months post birth
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perceived stress
Time Frame: <24 weeks gestation to 12 months post birth
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<24 weeks gestation to 12 months post birth
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mastery
Time Frame: <24 weeks gestation to 12 months postbirth
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<24 weeks gestation to 12 months postbirth
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self esteem
Time Frame: <24 weeks gestation to 12 months post birth
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<24 weeks gestation to 12 months post birth
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social support
Time Frame: <24 weeks gestation to 12 months postbirth
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<24 weeks gestation to 12 months postbirth
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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infant motor, mental development
Time Frame: 6 and 12 months postbirth
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6 and 12 months postbirth
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maternal-infant interaction
Time Frame: 6 and 12 months postbirth
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6 and 12 months postbirth
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Medicaid (maternal and infant)and program costs
Time Frame: <24 weeks gestation to 12 months
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<24 weeks gestation to 12 months
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health risk behaviors (smoking, drug, alcohol)
Time Frame: <24 weeks gestation to 12 months postbirth
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<24 weeks gestation to 12 months postbirth
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Lee Anne Roman, MSN, PhD, Michigan State University
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- R50 MC00045-04 R2
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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