upREACH Home Visitation for Pregnancy

(upREACH Trial)

Overseen By Cary M Cain, PhD

Age: Any Age

Sex: Female

Trial Phase: Academic

Sponsor: Baylor College of Medicine

Disqualifiers: Non-English/Spanish speakers, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

450 Participants Needed

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. ^{1 2 3 4 5}

Is 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. ^{3 4 6 7 8}

How 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. ^{1 3 4 5 9}

Research Team

Cary M Cain, PhD

Principal Investigator

Baylor College of Medicine

Eligibility 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.

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

Treatment Details

Interventions

• upREACH Home Visitation Program

Trial Overview 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.

Participant Groups

Group I: Intervention Group Experimental Treatment 1 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 Group Active Control 1 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.

Who Is Running the Clinical Trial?

Baylor College of Medicine

Lead Sponsor

Trials

1,044

Recruited

6,031,000+

Texas Department of Family Protective Services

Collaborator

Trials

1

Recruited

450+

Findings from Research

Clients in the Wisconsin Health Department's Prenatal Care Coordination program reported high satisfaction with the services, primarily valuing the supportive nurse-client relationship and the information provided.

Most clients entered the program without specific expectations, indicating that the program's effectiveness may rely more on the quality of support and resources rather than pre-defined goals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Client experiences in a prenatal home visiting program: A prenatal care coordination program evaluation. Heitzman, M., Weitzel, J., Kroll, S., et al.[2020]

Participation in Michigan's Maternal Infant Health Program (MIHP) significantly reduced the odds of low birth weight and preterm births among black women, particularly when they enrolled and were screened by the second trimester and had at least three additional prenatal contacts.

The MIHP also showed similar benefits for participants of other races, indicating that enhanced prenatal care programs can effectively improve birth outcomes in diverse, disadvantaged populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A statewide Medicaid enhanced prenatal care program: impact on birth outcomes. Roman, L., Raffo, JE., Zhu, Q., et al.[2021]

Home visits by nurses during pregnancy significantly reduced the incidence of pregnancy-induced hypertension among low-income women, with 13% of those receiving visits affected compared to 20% in the control group.

The program also led to fewer healthcare encounters for childhood injuries and lower rates of subsequent pregnancies, indicating positive outcomes for maternal and child health, although it did not impact preterm delivery, low birth weight, or children's developmental and behavioral outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of prenatal and infancy home visitation by nurses on pregnancy outcomes, childhood injuries, and repeated childbearing. A randomized controlled trial. Kitzman, H., Olds, DL., Henderson, CR., et al.[2022]

Home-visitation programs for socially disadvantaged women and children can significantly improve maternal health behaviors, birth outcomes, and child development, while also reducing child abuse and hospital visits.

The most effective programs involved nurses who started visits during pregnancy, maintained frequent contact, and focused on addressing behavioral and psychosocial factors, particularly for families at higher risk due to poverty.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can home visitation improve the health of women and children at environmental risk? Olds, DL., Kitzman, H.[2022]

Recent urban home care programs have been developed to address infant mortality and morbidity in the U.S. by providing comprehensive prenatal and infancy home visitation services.

These programs enhance maternal-child health and family functioning by creating a supportive link between families and their communities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Women and children. Infant mortality, urban programs, and home care. Struk, CM.[2005]

Long-term participants in a home visitation program for high-risk pregnant women were more likely to be African American, married, nonsmokers, and enrolled during their second trimester, indicating specific demographic factors that influence program retention.

Women who had greater emotional and instrumental support needs were more likely to continue participating in the program, suggesting that addressing social support can enhance engagement in home visitation services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Factors predicting completion of a home visitation program by high-risk pregnant women: the North Carolina Maternal Outreach Worker Program. Navaie-Waliser, M., Martin, SL., Campbell, MK., et al.[2019]

Postnatal home-based support programs for socially disadvantaged mothers show potential benefits, such as a trend towards reduced child injury rates and increased likelihood of complete well-child immunizations, based on a review of 11 studies involving 2992 families.

While the results suggest no significant risks associated with these programs, the findings on child abuse and neglect were inconclusive due to differences in how families were monitored, indicating a need for careful interpretation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

WITHDRAWN: Home-based social support for socially disadvantaged mothers. Hodnett, ED., Roberts, I.[2020]

Postnatal home-based support programs for socially disadvantaged mothers show a trend towards reduced child injury rates, although this finding was not statistically significant, indicating potential benefits in safety.

These programs also appear to improve health outcomes, as babies receiving additional support were more likely to have complete well-child immunizations, suggesting enhanced access to healthcare.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home-based social support for socially disadvantaged mothers. Hodnett, ED., Roberts, I.[2018]

A program of prenatal and early childhood home visitation by nurses significantly reduced verified reports of child abuse and neglect among participating women, with 0.29 reports compared to 0.54 in the comparison group over 15 years (P<.001).

The intervention also led to fewer subsequent births and reduced reliance on welfare, with nurse-visited women having an average of 1.3 subsequent births compared to 1.6 in the comparison group, and significantly fewer arrests reported (0.18 vs 0.58) over the same period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term effects of home visitation on maternal life course and child abuse and neglect. Fifteen-year follow-up of a randomized trial. Olds, DL., Eckenrode, J., Henderson, CR., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Client experiences in a prenatal home visiting program: A prenatal care coordination program evaluation. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

A statewide Medicaid enhanced prenatal care program: impact on birth outcomes. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Effect of prenatal and infancy home visitation by nurses on pregnancy outcomes, childhood injuries, and repeated childbearing. A randomized controlled trial. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Can home visitation improve the health of women and children at environmental risk? [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Women and children. Infant mortality, urban programs, and home care. [2005]

6. United States pubmed.ncbi.nlm.nih.gov

Factors predicting completion of a home visitation program by high-risk pregnant women: the North Carolina Maternal Outreach Worker Program. [2019]

7. England pubmed.ncbi.nlm.nih.gov

WITHDRAWN: Home-based social support for socially disadvantaged mothers. [2020]

8. England pubmed.ncbi.nlm.nih.gov

Home-based social support for socially disadvantaged mothers. [2018]

9. United States pubmed.ncbi.nlm.nih.gov

Long-term effects of home visitation on maternal life course and child abuse and neglect. Fifteen-year follow-up of a randomized trial. [2022]