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

Sponsors and Collaborators:	Michigan State University Spectrum Health Hospitals
Information provided by:	Michigan State University
ClinicalTrials.gov Identifier:	NCT00536159

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

MedlinePlus related topics: Child Development Depression Infant and Toddler Development Medicaid Mental Health Prenatal Care

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Active Control, Parallel Assignment
Official Title:	Improving the Health and Development of Low-Income Pregnant Women

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
Community Care: Active Comparator 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.
Nurse-CHW Team: Experimental 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.

Arms

Assigned Interventions

Community Care: Active Comparator

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.

Nurse-CHW Team: Experimental

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

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:

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.

Study ID Numbers:	R50 MC00045-04 R2
Study First Received:	September 18, 2007
Last Updated:	September 26, 2007
ClinicalTrials.gov Identifier:	NCT00536159 History of Changes
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

Study placed in the following topic categories:

Depression
Mental Disorders
Mood Disorders

Stress
Depressive Disorder
Behavioral Symptoms

Additional relevant MeSH terms:

Depression
Mental Disorders
Mood Disorders
Depressive Disorder
Behavioral Symptoms

ClinicalTrials.gov processed this record on May 06, 2009