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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
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
Denver Health Hospital Authority
Denver, Colorado, United States
Shands Jacksonville Medical Center, Inc. DBA UF Health Jacksonville
Jacksonville, Florida, United States
Children's Hospital of Michigan
Detroit, Michigan, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Penetration of SDOH intervention
Penetration is the rate of administration of social needs screener and appropriate referral for community resources to eligible families.
Time frame: Monthly for approximately 12 months
Receipt of ANY Community Resource
Receipt of any community resource as collected via participant survey specifying receipt of the resource.
Time frame: 3 months Post-NICU discharge
Acceptability of SDOH intervention
Mean score on Acceptability of Intervention Measure (AIM), which is a 4-item measure of perceived intervention acceptability. Items are measured on a 5-point Likert scale (Completely Disagree-Completely Agree). The score is calculated mean, and higher scores are associated with better acceptability. (Minimum score is 4, maximum score is 20).
Time frame: Approximately 7, 9, and 12 months
Feasibility of SDOH intervention
Mean score on Feasibility of Intervention Measure (FIM) is A 4-item instrument to assess perceived intervention feasibility. Items are measured on a 5-point Likert scale (Completely Disagree-Completely Agree). Score is calculated mean, and higher scores are associated with better feasibility. (Minimum score is 4, maximum score is 20).
Time frame: Approximately 7, 9, and 12 months.
Sustainability of SDOH intervention
Number of individuals who continued to get screened after active intervention is complete.
Time frame: Monthly for approximately 6 months.
Equity of implementation
Penetration rate by maternal demographics.
Time frame: Monthly for approximately 18 months (during both penetration and sustainability).
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882
Children's Hospital at Montefiore
The Bronx, New York, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Temple University Hospital
Philadelphia, Pennsylvania, United States
Equity of receipt of community resources
Rate of receipt of community resources by maternal demographics
Time frame: 3 months Post-NICU discharge
SDOH Risk
Any social need or change in social need for housing, food, utilities, childcare, employment, transportation, or education was collected via participant survey.
Time frame: Baseline, 3 months, 6 months, and 12 months Post-NICU discharge
SDOH Desire Assistance
Any desired assistance or change in desired assistance for housing, food, utilities, childcare, employment, transportation, and education was collected via participant survey.
Time frame: Baseline, 3 months, 6 months, and 12 months Post-NICU discharge
SDOH Community Resource
Number of individuals who received any community resource (housing, food, utilities, education, employment, childcare, transportation).
Time frame: Baseline, 3 months, 6 months, and 12 months Post-NICU discharge
Family Economic Pressure
The Family Economic Pressure scale is a 2-item measure that is scored and summed together. Scores on Measures A and B are from the Economic Pressure Scale. Higher levels indicate higher economic hardship. (Minimum score is 6, maximum score is 30).
Time frame: Baseline, 3 months, 6 months, and 12 months Post-NICU discharge
Maternal Wellbeing
Rating of current overall health
Time frame: Baseline, 3 months, 6 months, and 12 months Post-NICU discharge
Postpartum maternal primary care utilization
Number of appointments with a primary care provider
Time frame: 3 months, 6 months, and 12 months Post-NICU discharge
Maternal Postpartum Obstetric Care Utilization
Number of appointments with a maternal postpartum obstetric provider
Time frame: 3 months, 6 months, and 12 months Post-NICU discharge
Maternal emergency room utilization
Number of emergency room visits.
Time frame: 3 months, 6 months, and 12 months Post-NICU discharge
Maternal hospital readmission
Number of overnight hospital readmissions
Time frame: 3 months, 6 months, and 12 months Post-NICU discharge
Maternal Depression
Overall score on Personal Health Questionnaire Depression Scale (PHQ8), an 8-item instrument with 4 category Likert scale responses from 0 to 4 where 0=not at all and 4=daily. Scores can range from 0 to 32. Higher scores are associated with greater levels of maternal depression.
Time frame: Baseline, 3 months, 6 months, and 12 months Post-NICU discharge
Length of Lactation
Duration of milk production in months
Time frame: Baseline, 3 months, 6 months, and 12 months Post-NICU discharge
Infant primary care utilization
Number of appointments with a primary care provider
Time frame: 3 months, 6 months, and 12 months Post-NICU discharge
Infant utilization of emergency care
Number of emergency room visits
Time frame: 3 months, 6 months, and 12 months Post-NICU discharge
Infant hospital readmission
Number of overnight hospital readmissions
Time frame: 3 months, 6 months, and 12 months Post-NICU discharge
Receipt of necessary infant services and equipment
The proportion of individuals who receive services and equipment among those individuals who indicate needing services and equipment on the national survey of children with special healthcare needs
Time frame: 3 months, 6 months, and 12 months Post-NICU discharge
Infant Respiratory Symptoms (shortness of breath, wheezing, coughing, clinically demonstrated need for oral corticosteroids)
Overall score on Test for Respiratory and Asthma Control in Kids. Each item is scored from 0 to 20 points on a 5-point Likert-type scale for a total score ranging from 0 to 100. Higher scores indicate better respiratory control.
Time frame: 3 months, 6 months, and 12 months Post-NICU discharge
Infant growth
Weight for age z-score change
Time frame: Baseline, 3 months, 6 months, and 12 months Post-NICU discharge
Infant Quality of Life
Overall score on the Infant Toddler Quality of Life Questionnaire™ (ITQOL) is a 47-item short form that is scored on a scale from 0 (worst health) to 100 (best health). Higher scores indicate a better quality of life.
Time frame: 3 months, 6 months, and 12 months Post-NICU discharge