upREACH Perinatal Home Visitation Program

Baylor College of Medicine

Status: Enrolling

Conditions: Postpartum; Pregnancy

Treatments: Behavioral: upREACH Home Visitation Program

Study type: Interventional

Funder types: Other

Identifiers

NCT06133829

62823-S1 (Other Grant/Funding Number)

H-53998

Details and patient eligibility

About

The purpose of this study is to assess the effectiveness of a new brief home visitation program delivered by non-nurse home visitors to 1) improve connections to community resources based on reported and assessed needs, 2) increase health self-efficacy, and 3) reduce maternal stress compared to a control group that receives standard care from an obstetric clinic.

Secondary administrative data on infant birth outcomes, health care use during the first year of life (appointment adherence), and interaction with government services (such as public assistance or child welfare) will be compared between the groups.

For the intervention group, we will secondarily also assess home visit compliance and satisfaction with the intervention.

Participants will be asked to complete questionnaires that include questions about the participant, their pregnancy, their feelings, their family, and their use of social/community services. Half of the women in this study will be randomly offered free home visitation services and the other half of women in this study will receive standard services from the clinic. The intervention group will be offered at least two free home visits with a non-nurse home visitor. During these visits, the home visitor will provide them with resources and tools to help the participant prepare for their baby. All participants will complete a second round of electronic surveys at approximately 2 months postpartum.

Intervention participant outcomes will be compared to a control group that receive standard care from an obstetric clinic.

Enrollment: 450 estimated patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion criteria

• Pregnant or postpartum women within 3 weeks postpartum (at enrollment)
• Receiving prenatal or postpartum care from Harris Health Clinic obstetric clinics
• Speak and read English or Spanish language.

Exclusion criteria

• Unable to speak or read English or Spanish language
• Women that do not receive perinatal or postpartum care at Harris Health obstetric clinics
• Women that are not pregnant or greater than 4 weeks postpartum (at enrollment)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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450 participants in 2 patient groups

Intervention Group

Experimental group

Description:

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.

Treatment:

Behavioral: upREACH Home Visitation Program

Control Group

No Intervention group

Description:

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.