Medicaid Enhanced Prenatal/Postnatal Services Using a Nurse-Community Health Worker Team
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|ClinicalTrials.gov Identifier: NCT00536159|
Recruitment Status : Completed
First Posted : September 27, 2007
Last Update Posted : September 27, 2007
|Condition or disease||Intervention/treatment||Phase|
|Perinatal Depression Stress Prenatal Health Risk Behaviors Child Development||Other: Medicaid Maternal and Infant Support Services Other: Nurse-CHW team||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||613 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Improving the Health and Development of Low-Income Pregnant Women|
|Study Start Date :||January 1997|
|Actual Study Completion Date :||August 2000|
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.
Other: Medicaid Maternal and Infant Support Services
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.
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.
Other: Nurse-CHW team
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.
- depressive symptoms [ Time Frame: <24 weeks gestation to 12 months post birth ]
- perceived stress [ Time Frame: <24 weeks gestation to 12 months post birth ]
- mastery [ Time Frame: <24 weeks gestation to 12 months postbirth ]
- self esteem [ Time Frame: <24 weeks gestation to 12 months post birth ]
- social support [ Time Frame: <24 weeks gestation to 12 months postbirth ]
- infant motor, mental development [ Time Frame: 6 and 12 months postbirth ]
- maternal-infant interaction [ Time Frame: 6 and 12 months postbirth ]
- Medicaid (maternal and infant)and program costs [ Time Frame: <24 weeks gestation to 12 months ]
- health risk behaviors (smoking, drug, alcohol) [ Time Frame: <24 weeks gestation to 12 months postbirth ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00536159
|United States, Michigan|
|Spectrum Health Hospitals|
|Grand Rapids, Michigan, United States, 49503|
|Principal Investigator:||Lee Anne Roman, MSN, PhD||Michigan State University|