The Social Determinants of Health Screening and Referral Project

University of Massachusetts, Worcester

Status: Invitation-only

Conditions: Preterm Birth

Treatments: Other: Implementation of social determinants of health screening and referral

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06582147

STUDY00000543

5R01HD104772 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

Up to a quarter of the families with preterm infants have unmet social needs, such as housing or job insecurity, which represent adverse social determinants of health (SDOH). Preterm infants are especially vulnerable to the social conditions they grow up in, with sustained impacts on function across multiple organ systems. The goal of this study is to translate an established model of SDOH screening and referral from the outpatient setting to the NICU, thereby maximizing the potential to offset the effects of adverse SDOH on vulnerable mother-preterm infant dyads.

Full description

The goal of this study is to implement SDOH screening and referral models in 7 safety net NICUs, examining their potential to offset the effects of adverse SDOH for a highly vulnerable population at the earliest stages of life. The investigators propose a hybrid effectiveness-implementation stepped wedge cluster randomized trial using the Proctor Conceptual Model of Implementation Research. The investigators will follow a cohort of 882 mother-infant dyads longitudinally for 12 months after NICU discharge to examine family, maternal, and infant outcomes. Each site will participate in three phases: usual, experimental, and sustainment.

The study aims are to:

Aim 1: Examine the implementation of SDOH screening and referral models into the NICU (acceptability, feasibility, penetration, equity, and sustainability).

Aim 2: Examine the effectiveness and equity of SDOH screening and referral models in the NICU setting on parental receipt of community resources for unmet social needs 3 months post-NICU discharge.

Aim 3: Explore the effectiveness of SDOH screening and referral models in the NICU to improve (a) maternal mental health (depression) and (b) health and developmental outcomes of preterm infants (quality of life, growth, development, and respiratory disease) during the 12 months post-NICU discharge.

Enrollment: 882 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Infant gestational age <34 weeks' gestation; singleton or multiple.
• Infant hospitalized for at least 14 days of life (to allow for SDOH screening/referral and contact with resources if applicable).
• Mother and infant are alive.
• Mother speaks and reads English or Spanish.
• Infant will be discharged home from the NICU (to allow for follow-up).
• Mother will care for her infant(s) at home in the US for at least 12 months after discharge from the NICU.

Exclusion criteria

• Mothers or infants who die before anticipated infant discharge.
• Infant discharged after 52 weeks postmenstrual age.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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882 participants in 1 patient group

Social needs screening and referral care

Other group

Description:

As a step wedge cluster randomized trial all sites will be assigned to receive the intervention in a randomized order. There is no difference in the intervention by site, the only difference is the timing of the beginning of the intervention. Therefore, we have only identified one arm.

Treatment:

Other: Implementation of social determinants of health screening and referral