NCT Number: NCT06582147
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.
Interested in participating?
Request Info18 year and older
Female
Interventional
Not applicable
Denver Health Hospital Authority, Denver, Colorado, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: Monthly for approximately 12 months
Penetration is the rate of administration of social needs screener and appropriate referral for community resources to eligible families.
Time frame: 3 months Post-NICU discharge
Receipt of any community resource as collected via participant survey specifying receipt of the resource.
Time frame: Approximately 7, 9, and 12 months
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.
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: Monthly for approximately 6 months.
Number of individuals who continued to get screened after active intervention is complete.
Time frame: Monthly for approximately 18 months (during both penetration and sustainability).
Penetration rate by maternal demographics.
Time frame: 3 months Post-NICU discharge
Rate of receipt of community resources by maternal demographics
Time frame: Baseline, 3 months, 6 months, and 12 months Post-NICU discharge
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
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
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
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
Rating of current overall health
Time frame: 3 months, 6 months, and 12 months Post-NICU discharge
Number of appointments with a primary care provider
Time frame: 3 months, 6 months, and 12 months Post-NICU discharge
Number of appointments with a maternal postpartum obstetric provider
Time frame: 3 months, 6 months, and 12 months Post-NICU discharge
Number of emergency room visits.
Time frame: 3 months, 6 months, and 12 months Post-NICU discharge
Number of overnight hospital readmissions
Time frame: Baseline, 3 months, 6 months, and 12 months Post-NICU discharge
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
Duration of milk production in months
Time frame: 3 months, 6 months, and 12 months Post-NICU discharge
Number of appointments with a primary care provider
Time frame: 3 months, 6 months, and 12 months Post-NICU discharge
Number of emergency room visits
Time frame: 3 months, 6 months, and 12 months Post-NICU discharge
Number of overnight hospital readmissions
Time frame: 3 months, 6 months, and 12 months Post-NICU discharge
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
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: Baseline, 3 months, 6 months, and 12 months Post-NICU discharge
Weight for age z-score change
Time frame: 3 months, 6 months, and 12 months Post-NICU discharge
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.
University of Massachusetts, Worcester
Other
Implementing a Social Determinants of Health Screening and Referral Care Model in the Neonatal Intensive Care Unit
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