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

This study has been completed.
Sponsor:
Collaborator:
Spectrum Health Hospitals
Information provided by:
Michigan State University
ClinicalTrials.gov Identifier:
NCT00536159
First received: September 18, 2007
Last updated: September 26, 2007
Last verified: September 2007
  Purpose

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 Intervention
Perinatal Depression
Stress
Prenatal Health Risk Behaviors
Child Development
Other: Medicaid Maternal and Infant Support Services
Other: Nurse-CHW team

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Improving the Health and Development of Low-Income Pregnant Women

Resource links provided by NLM:


Further study details as provided by Michigan State University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 613
Study Start Date: January 1997
Study Completion Date: August 2000
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00536159

Locations
United States, Michigan
Spectrum Health Hospitals
Grand Rapids, Michigan, United States, 49503
Sponsors and Collaborators
Michigan State University
Spectrum Health Hospitals
Investigators
Principal Investigator: Lee Anne Roman, MSN, PhD Michigan State University
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00536159     History of Changes
Other Study ID Numbers: R50 MC00045-04 R2
Study First Received: September 18, 2007
Last Updated: September 26, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by Michigan State University:
nurse-community health worker team
perinatal depression
stress
Medicaid enhanced prenatal programs

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 22, 2014