The Social Determinants of Health Screening and Referral Project
NCT Number: NCT06582147
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Preterm Birth
Interventions: OTHER: Implementation of social determinants of health screening and referral
Sponsor: University of Massachusetts, Worcester
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Sex: FEMALE
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 882
Study Design: Allocation: RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2024-10-01
Completion Date: 2027-12
Locations: Denver Health Hospital Authority, Denver, Colorado, 80204, United States|Shands Jacksonville Medical Center, Inc. DBA UF Health Jacksonville, Jacksonville, Florida, 32209, United States|Children's Hospital of Michigan, Detroit, Michigan, 48201, United States|University of Mississippi Medical Center, Jackson, Mississippi, 39216, United States|Children's Hospital at Montefiore, Bronx, New York, 10467, United States|Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, 45229, United States|Temple University Hospital, Philadelphia, Pennsylvania, 19140, United States

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.

Primary Outcome Measures: 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: 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., 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., Approximately 7, 9, and 12 months.|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|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., 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