upREACH Home Visitation for Pregnancy
(upREACH Trial)
Recruiting in Palo Alto (17 mi)
Age: Any Age
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Baylor College of Medicine
Disqualifiers: Non-English/Spanish speakers, others
No Placebo Group
Trial Summary
What is the purpose of this trial?This trial tests a new home visitation program where non-nurse visitors help pregnant women by providing resources and support during multiple home visits. The goal is to see if this program improves their connection to community resources, boosts their health confidence, and reduces stress compared to typical care.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It seems focused on home visitation services rather than medication changes.
What data supports the effectiveness of the upREACH Home Visitation Program treatment?
Research shows that home visitation programs can improve health behaviors during pregnancy, increase birth weight, and reduce child abuse and emergency visits. Programs that start during pregnancy and involve frequent visits by nurses are particularly effective, especially for families facing social and economic challenges.
12345Is the upREACH Home Visitation Program safe for participants?
Research on home visitation programs, including those similar to upREACH, shows they can improve health behaviors during pregnancy and reduce risks like child abuse and emergency visits, suggesting they are generally safe for participants.
34678How is the upREACH Home Visitation Program treatment different from other treatments for pregnancy?
The upREACH Home Visitation Program is unique because it involves home visits by healthcare professionals during pregnancy, focusing on improving maternal and child health by addressing behavioral and psychosocial factors. This approach is different from standard prenatal care as it provides personalized support and aims to build a strong relationship with families, especially those at higher risk due to socioeconomic challenges.
13459Eligibility Criteria
This trial is for pregnant or postpartum women within 3 weeks after giving birth, who are patients at Harris Health Clinic obstetric clinics and can speak and read English or Spanish. Women not receiving care from these clinics, those not pregnant or over 4 weeks postpartum, or unable to understand English/Spanish cannot join.Inclusion Criteria
I can speak and read either English or Spanish.
You are currently receiving care for pregnancy at Harris Health Clinic.
You are pregnant or gave birth within the past 3 weeks.
Exclusion Criteria
I cannot speak or read English or Spanish.
Women that do not receive perinatal or postpartum care at Harris Health obstetric clinics
I am not pregnant or it has been more than 4 weeks since I gave birth.
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Intervention
Participants in the intervention group receive at least 1 prenatal and 1 postpartum home visit by a non-nurse home visitor to provide resources and tools for preparing for their baby.
2 months
At least 2 home visits
Postpartum Survey
All participants complete a second round of electronic surveys at approximately 2 months postpartum.
1 week
Follow-up
Participants are monitored for health self-efficacy, trust in institutions, appointment adherence, linkages to community resources, and maternal stress.
5 months
Participant Groups
The study tests a new home visitation program called upREACH against standard clinic care. It aims to connect participants with community resources, boost health confidence, and reduce stress. Outcomes like infant health and service use will be compared between the two groups.
2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention GroupExperimental Treatment1 Intervention
Demographic and baseline measures will be obtained from the participants electronically. The participant will receive at least 1 prenatal home visit and at least 1 postpartum home visit. During the visits, the home visitor will review the screening assessments that were completed at baseline, identify health and social needs (including but not limited to referrals to substance use treatment providers, domestic violence hotline/shelters, mental health providers, applications for public assistance, and basic needs provision),work with the client to prioritize their needs, assist with applications and connections to community resources, support the participant in communicating with medical and social service providers, and provide education to help the participant advocate for their health, think ahead for after delivery (prenatal), and understand infant health and safety. At 2 months postpartum, both intervention and control groups will receive a post- survey through REDCap.
Group II: Control GroupActive Control1 Intervention
Demographic and baseline measures will be obtained from the participants electronically through REDCap surveys. The participants will receive standard care from the obstetric clinic. At approximately 2 months postpartum, both intervention and control groups will receive a post- survey through REDCap.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Harris Health/Baylor College of MedicineHouston, TX
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Who Is Running the Clinical Trial?
Baylor College of MedicineLead Sponsor
Texas Department of Family Protective ServicesCollaborator
References
Client experiences in a prenatal home visiting program: A prenatal care coordination program evaluation. [2020]Prenatal home visiting programs are a strategy to promote positive birth outcomes. Ongoing evaluations of these programs are important to promote fidelity and quality. The goal of this program evaluation was to gain clients' perspectives of their experiences in one Wisconsin Health Department's Prenatal Care Coordination program including: (a) why clients entered the program, (b) whether client expectations were met, and (c) how expectations impacted client retention.
A statewide Medicaid enhanced prenatal care program: impact on birth outcomes. [2021]Policy makers and practitioners need rigorous evaluations of state-based Medicaid enhanced prenatal care programs that provide home visiting to guide improvements and inform future investments. Effects on adverse birth outcomes are of particular interest.
Effect of prenatal and infancy home visitation by nurses on pregnancy outcomes, childhood injuries, and repeated childbearing. A randomized controlled trial. [2022]Interest in home-visitation services as a way of improving maternal and child outcomes has grown out of the favorable results of a trial in semirural New York. The findings have not been replicated in other populations.
Can home visitation improve the health of women and children at environmental risk? [2022]We reviewed randomized trials of prenatal and infancy home-visitation programs for socially disadvantaged women and children. Some home-visitation programs were effective in improving women's health-related behaviors during pregnancy, the birth weight and length of gestation of babies born to smokers and young adolescents, parents' interaction with their children, and children's developmental status; reducing the incidence of child abuse and neglect, childhood behavioral problems, emergency department visits and hospitalizations for injury, and unintended subsequent pregnancies; and increasing mothers' participation in the work force. The more effective programs employed nurses who began visiting during pregnancy, who visited frequently and long enough to establish a therapeutic alliance with families, and who addressed the systems of behavioral and psychosocial factors that influence maternal and child outcomes. They also targeted families at greater risk for health problems by virtue of the parents' poverty and lack of personal and social resources.
Women and children. Infant mortality, urban programs, and home care. [2005]Infant mortality and morbidity has remained a national problem in the United States, directly related to a complex interrelationship between behavioral risk factors and psychosocial, socioeconomic, and biologic variables. This article examines recent urban home care programs that have begun to provide a comprehensive approach to prenatal and infancy home visitation by home care agencies. These programs provide a link between home and the community and improve maternal-child family health and function.
Factors predicting completion of a home visitation program by high-risk pregnant women: the North Carolina Maternal Outreach Worker Program. [2019]This study sought to identify characteristics of high-risk pregnant women that predicted long-term participation in a home visitation program.
WITHDRAWN: Home-based social support for socially disadvantaged mothers. [2020]Epidemiologic studies indicate that babies born to socio-economically disadvantaged mothers are at higher risk of injury, abuse and neglect, health problems in infancy, and are less likely to have regular well-child care. Home visitation programs have long been advocated as a strategy for improving the health of disadvantaged children. Over the past two decades, a number of randomised trials have examined the effect of home visitation programs on a range of maternal and child health outcomes. The studies in this review evaluate programs which offer additional home based support for socially disadvantaged mothers and their children.
Home-based social support for socially disadvantaged mothers. [2018]Epidemiologic studies indicate that babies born to socio-economically disadvantaged mothers are at higher risk of injury, abuse and neglect, health problems in infancy, and are less likely to have regular well-child care. Home visitation programs have long been advocated as a strategy for improving the health of disadvantaged children. Over the past two decades, a number of randomised trials have examined the effect of home visitation programs on a range of maternal and child health outcomes. The studies in this review evaluate programs which offer additional home based support for socially disadvantaged mothers and their children.
Long-term effects of home visitation on maternal life course and child abuse and neglect. Fifteen-year follow-up of a randomized trial. [2022]Home-visitation services have been promoted as a means of improving maternal and child health and functioning. However, long-term effects have not been examined.