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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00536159
Recruitment Status : Completed
First Posted : September 27, 2007
Last Update Posted : September 27, 2007
Spectrum Health Hospitals
Information provided by:
Michigan State University

Brief Summary:
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.

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

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 613 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Improving the Health and Development of Low-Income Pregnant Women
Study Start Date : January 1997
Actual Study Completion Date : August 2000

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Medicaid

Arm Intervention/treatment
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.

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00536159

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United States, Michigan
Spectrum Health Hospitals
Grand Rapids, Michigan, United States, 49503
Sponsors and Collaborators
Michigan State University
Spectrum Health Hospitals
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Principal Investigator: Lee Anne Roman, MSN, PhD Michigan State University
Layout table for additonal information Identifier: NCT00536159    
Other Study ID Numbers: R50 MC00045-04 R2
First Posted: September 27, 2007    Key Record Dates
Last Update Posted: September 27, 2007
Last Verified: September 2007
Keywords provided by Michigan State University:
nurse-community health worker team
perinatal depression
Medicaid enhanced prenatal programs
Additional relevant MeSH terms:
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Behavioral Symptoms