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OpenTrials
Completed

NCT Number: NCT00536159

Medicaid Enhanced Prenatal/Postnatal Services Using a Nurse-Community Health Worker Team

Our objective was to test whether there were advantages to Nurse-CHW team home visiting designed to combine the strengths of both visitors, with a focus on maternal stress and mental health, when compared with standard of Community Care (CC) that included professional home visitors in a state-sponsored Medicaid program. We conducted the study under usual community conditions in a population of women eligible for state-sponsored Medicaid programs. We predicted that during pregnancy and infancy, women in the Nurse-CHW team intervention would report 1) less perceived stress; 2) fewer depressive symptoms; and 3) increased levels of psychosocial resources (self-esteem, mastery, and social support) than women in CC. Benefits were expected to be most pronounced for women with low psychosocial resources and high stress at enrollment.

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Key information

Age range

16 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Spectrum Health Hospitals

Grand Rapids, Michigan, 49503, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Medicaid Maternal and Infant Support Services

Other

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.

Nurse-CHW team

Other

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.

Primary outcomes

  1. depressive symptoms

    Time frame: <24 weeks gestation to 12 months post birth

  2. perceived stress

    Time frame: <24 weeks gestation to 12 months post birth

  3. mastery

    Time frame: <24 weeks gestation to 12 months postbirth

  4. self esteem

    Time frame: <24 weeks gestation to 12 months post birth

  5. social support

    Time frame: <24 weeks gestation to 12 months postbirth

Secondary outcomes

  1. infant motor, mental development

    Time frame: 6 and 12 months postbirth

  2. maternal-infant interaction

    Time frame: 6 and 12 months postbirth

  3. Medicaid (maternal and infant)and program costs

    Time frame: <24 weeks gestation to 12 months

  4. health risk behaviors (smoking, drug, alcohol)

    Time frame: <24 weeks gestation to 12 months postbirth

Sponsors and collaborators

Lead sponsor

Michigan State University

Other

Collaborators

  • Corewell Health West

Registry information

Official study title

Improving the Health and Development of Low-Income Pregnant Women

Important dates

Study start
1997
Study completion
2000
First posted
Sep 27, 2007
Registry last updated
Sep 27, 2007

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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