The Social Determinants of Health Screening and Referral Project

Implementing a Social Determinants of Health Screening and Referral Care Model in the Neonatal Intensive Care Unit

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Preterm Birth
• Intervention / Treatment: Other: Implementation of social determinants of health screening and referral

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.

• Study Type: Interventional
• Enrollment (Estimated): 882
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Denver, Colorado, United States, 80204
      • Denver Health Hospital Authority
  • Florida
    • Jacksonville, Florida, United States, 32209
      • Shands Jacksonville Medical Center, Inc. DBA UF Health Jacksonville
  • Michigan
    • Detroit, Michigan, United States, 48201
      • Children's Hospital of Michigan
  • Mississippi
    • Jackson, Mississippi, United States, 39216
      • University of Mississippi Medical Center
  • New York
    • Bronx, New York, United States, 10467
      • Children's Hospital at Montefiore
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Cincinnati Children's Hospital Medical Center
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19140
      • Temple University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Social needs screening and referral care; 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.	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; Other Names: WE CARE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Penetration of SDOH intervention	Penetration is the rate of administration of social needs screener and appropriate referral for community resources to eligible families.	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.	3 months Post-NICU discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sustainability of SDOH intervention	Number of individuals who continued to get screened after active intervention is complete.	Monthly for approximately 6 months.
Equity of implementation	Penetration rate by maternal demographics.	Monthly for approximately 18 months (during both penetration and sustainability).
Equity of receipt of community resources	Rate of receipt of community resources by maternal demographics	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.	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.	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).	Baseline, 3 months, 6 months, and 12 months Post-NICU discharge
Maternal Wellbeing	Rating of current overall health	Baseline, 3 months, 6 months, and 12 months Post-NICU discharge
Postpartum maternal primary care utilization	Number of appointments with a primary care provider	3 months, 6 months, and 12 months Post-NICU discharge
Maternal Postpartum Obstetric Care Utilization	Number of appointments with a maternal postpartum obstetric provider	3 months, 6 months, and 12 months Post-NICU discharge
Maternal emergency room utilization	Number of emergency room visits.	3 months, 6 months, and 12 months Post-NICU discharge
Maternal hospital readmission	Number of overnight hospital readmissions	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.	Baseline, 3 months, 6 months, and 12 months Post-NICU discharge
Length of Lactation	Duration of milk production in months	Baseline, 3 months, 6 months, and 12 months Post-NICU discharge
Infant primary care utilization	Number of appointments with a primary care provider	3 months, 6 months, and 12 months Post-NICU discharge
Infant utilization of emergency care	Number of emergency room visits	3 months, 6 months, and 12 months Post-NICU discharge
Infant hospital readmission	Number of overnight hospital readmissions	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	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.	3 months, 6 months, and 12 months Post-NICU discharge
Infant growth	Weight for age z-score change	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.	3 months, 6 months, and 12 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).	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).	Approximately 7, 9, and 12 months.
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).	Baseline, 3 months, 6 months, and 12 months Post-NICU discharge

Collaborators and Investigators

• Sponsor: University of Massachusetts, Worcester
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Investigators: Principal Investigator: Margaret Parker, MD, MPH, University of Massachusetts Chan Medical School; Principal Investigator: Mari-Lynn Drainoni, PhD, MEd, Boston University Chobanian and Avedisian School of Medicine; Principal Investigator: Arvin Garg, MD, MPH, University of Massachusetts Chan Medical School

Study record dates

Study Major Dates

• Study Start (Actual): December 6, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: August 14, 2024
• First Submitted That Met QC Criteria: August 29, 2024
• First Posted (Actual): September 3, 2024

Study Record Updates

• Last Update Posted (Actual): May 7, 2025
• Last Update Submitted That Met QC Criteria: May 2, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: WE CARE; Maternal depression; Neonatal intensive care unit (NICU); Social determinants of health (SDOH); SDoH screening and referral; Safety net hospitals; Mother-infant dyads
• Additional Relevant MeSH Terms: Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Premature Birth
• Other Study ID Numbers: STUDY00000543; 5R01HD104772 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data requests can be submitted to the MPIs after study completion.
• IPD Sharing Time Frame: Data requests can be submitted to the MPIs 6 months after study completion.
• IPD Sharing Access Criteria: Access to data can be requested by qualified researchers engaging in independent scientific research. Requests must include review and approval of the research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Statement (DSA).
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No