Clinical trial NCT06582147: The Social Determinants of Health Screening and Referral Project
Official title: Implementing a Social Determinants of Health Screening and Referral Care Model in the Neonatal Intensive Care Unit
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Preterm Birth
Keywords: Neonatal intensive care unit (NICU)
Social determinants of health (SDOH)
WE CARE
SDoH screening and referral
Mother-infant dyads
Maternal depression
Safety net hospitals
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2024-09-03
Enrollment: 882
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Hybrid effectiveness- implementation stepped wedge cluster randomized trial (SW-CRT) using the Proctor Conceptual Model of Implementation Research.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

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.

Primary outcomes:
measure: Penetration of SDOH intervention
timeFrame: Monthly for approximately 12 months
measure: Receipt of ANY Community Resource
timeFrame: 3 months Post-NICU discharge
Secondary outcomes:
measure: Acceptability of SDOH intervention
timeFrame: Approximately 7, 9, and 12 months
measure: Feasibility of SDOH intervention
timeFrame: Approximately 7, 9, and 12 months.
measure: Sustainability of SDOH intervention
timeFrame: Monthly for approximately 6 months.
measure: Equity of implementation
timeFrame: Monthly for approximately 18 months (during both penetration and sustainability).
measure: Equity of receipt of community resources
timeFrame: 3 months Post-NICU discharge
measure: SDOH Risk
timeFrame: Baseline, 3 months, 6 months, and 12 months Post-NICU discharge
measure: SDOH Desire Assistance
timeFrame: Baseline, 3 months, 6 months, and 12 months Post-NICU discharge
measure: SDOH Community Resource
timeFrame: Baseline, 3 months, 6 months, and 12 months Post-NICU discharge
measure: Family Economic Pressure
timeFrame: Baseline, 3 months, 6 months, and 12 months Post-NICU discharge
measure: Maternal Wellbeing
timeFrame: Baseline, 3 months, 6 months, and 12 months Post-NICU discharge
measure: Postpartum maternal primary care utilization
timeFrame: 3 months, 6 months, and 12 months Post-NICU discharge
measure: Maternal Postpartum Obstetric Care Utilization
timeFrame: 3 months, 6 months, and 12 months Post-NICU discharge
measure: Maternal emergency room utilization
timeFrame: 3 months, 6 months, and 12 months Post-NICU discharge
measure: Maternal hospital readmission
timeFrame: 3 months, 6 months, and 12 months Post-NICU discharge
measure: Maternal Depression
timeFrame: Baseline, 3 months, 6 months, and 12 months Post-NICU discharge
measure: Length of Lactation
timeFrame: Baseline, 3 months, 6 months, and 12 months Post-NICU discharge
measure: Infant primary care utilization
timeFrame: 3 months, 6 months, and 12 months Post-NICU discharge
measure: Infant utilization of emergency care
timeFrame: 3 months, 6 months, and 12 months Post-NICU discharge
measure: Infant hospital readmission
timeFrame: 3 months, 6 months, and 12 months Post-NICU discharge
measure: Receipt of necessary infant services and equipment
timeFrame: 3 months, 6 months, and 12 months Post-NICU discharge
measure: Infant Respiratory Symptoms (shortness of breath, wheezing, coughing, clinically demonstrated need for oral corticosteroids)
timeFrame: 3 months, 6 months, and 12 months Post-NICU discharge
measure: Infant growth
timeFrame: Baseline, 3 months, 6 months, and 12 months Post-NICU discharge
measure: Infant Quality of Life
timeFrame: 3 months, 6 months, and 12 months Post-NICU discharge
Other outcomes:
Locations:
city: Denver
country: United States
facility: Denver Health Hospital Authority
state: Colorado
city: Jacksonville
country: United States
facility: Shands Jacksonville Medical Center, Inc. DBA UF Health Jacksonville
state: Florida
city: Detroit
country: United States
facility: Children's Hospital of Michigan
state: Michigan
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
city: Bronx
country: United States
facility: Children's Hospital at Montefiore
state: New York
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
city: Philadelphia
country: United States
facility: Temple University Hospital
state: Pennsylvania
Study officials:
affiliation: University of Massachusetts Chan Medical School
name: Margaret Parker, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Boston University Chobanian and Avedisian School of Medicine
name: Mari-Lynn Drainoni, PhD, MEd
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Massachusetts Chan Medical School
name: Arvin Garg, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: