The Social Determinants of Health Screening and Referral Project
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Implementation of social determinants of health screening and referral.
- Who it may be relevant to
- Registry conditions: Preterm Birth. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Implementing a Social Determinants of Health Screening and Referral Care Model in the Neonatal Intensive Care Unit
Overview
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.
Detailed 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.
Interventions
- Other Implementation of social determinants of health screening and referral
WE CARE is a relatively simple, low-intensity intervention that has two key components: (1) screening individuals using the WE CARE SDOH Screener for unmet social needs, and (2) providing individuals who have unmet social needs with SDOH Community Resource sheets
Primary outcome measures
- Penetration of SDOH intervention [Time frame: Monthly for approximately 12 months]
- Receipt of ANY Community Resource [Time frame: 3 months Post-NICU discharge]
Secondary outcome measures (12)
- Acceptability of SDOH intervention [Time frame: Approximately 7, 9, and 12 months]
- Feasibility of SDOH intervention [Time frame: Approximately 7, 9, and 12 months.]
- Sustainability of SDOH intervention [Time frame: Monthly for approximately 6 months.]
- Equity of implementation [Time frame: Monthly for approximately 18 months (during both penetration and sustainability).]
- Equity of receipt of community resources [Time frame: 3 months Post-NICU discharge]
- SDOH Risk [Time frame: Baseline, 3 months, 6 months, and 12 months Post-NICU discharge]
- SDOH Desire Assistance [Time frame: Baseline, 3 months, 6 months, and 12 months Post-NICU discharge]
- SDOH Community Resource [Time frame: Baseline, 3 months, 6 months, and 12 months Post-NICU discharge]
- Family Economic Pressure [Time frame: Baseline, 3 months, 6 months, and 12 months Post-NICU discharge]
- Maternal Wellbeing [Time frame: Baseline, 3 months, 6 months, and 12 months Post-NICU discharge]
- Postpartum maternal primary care utilization [Time frame: 3 months, 6 months, and 12 months Post-NICU discharge]
- Maternal Postpartum Obstetric Care Utilization [Time frame: 3 months, 6 months, and 12 months Post-NICU discharge]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Health services research
Study locations
United States · 7 centers
- Denver Health Hospital Authority — Denver
- Shands Jacksonville Medical Center, Inc. DBA UF Health Jacksonville — Jacksonville
- Children's Hospital of Michigan — Detroit
- University of Mississippi Medical Center — Jackson
- Children's Hospital at Montefiore — The Bronx
- Cincinnati Children's Hospital Medical Center — Cincinnati
- Temple University Hospital — Philadelphia
Identifiers
NCT: NCT06582147 · STUDY00000543 · 5R01HD104772