Clinical trial NCT00536159: Medicaid Enhanced Prenatal/Postnatal Services Using a Nurse-Community Health Worker Team
Official title: Improving the Health and Development of Low-Income Pregnant Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Perinatal Depression
Stress
Prenatal Health Risk Behaviors
Child Development
Keywords: nurse-community health worker team
perinatal depression
stress
Medicaid enhanced prenatal programs
Lead sponsor: Michigan State University
Sponsor class: OTHER
Collaborators: name: Spectrum Health Hospitals
First posted: 2007-09-27
Enrollment: 613
Sex: FEMALE
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: depressive symptoms
timeFrame: <24 weeks gestation to 12 months post birth
measure: perceived stress
timeFrame: <24 weeks gestation to 12 months post birth
measure: mastery
timeFrame: <24 weeks gestation to 12 months postbirth
measure: self esteem
timeFrame: <24 weeks gestation to 12 months post birth
measure: social support
timeFrame: <24 weeks gestation to 12 months postbirth
Secondary outcomes:
measure: infant motor, mental development
timeFrame: 6 and 12 months postbirth
measure: maternal-infant interaction
timeFrame: 6 and 12 months postbirth
measure: Medicaid (maternal and infant)and program costs
timeFrame: <24 weeks gestation to 12 months
measure: health risk behaviors (smoking, drug, alcohol)
timeFrame: <24 weeks gestation to 12 months postbirth
Other outcomes:
Locations:
city: Grand Rapids
country: United States
facility: Spectrum Health Hospitals
state: Michigan
Study officials:
affiliation: Michigan State University
name: Lee Anne Roman, MSN, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Roman LA, Lindsay JK, Moore JS, Duthie PA, Peck C, Barton LR, Gebben MR, Baer LJ. Addressing mental health and stress in Medicaid-insured pregnant women using a nurse-community health worker home visiting team. Public Health Nurs. 2007 May-Jun;24(3):239-48. doi: 10.1111/j.1525-1446.2007.00630.x.