Preterm Birth
Conditions
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
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.
Interventions
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
Sponsors
University of Massachusetts, Worcester
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Masking description
None (Open Label)
Intervention model description
Hybrid effectiveness- implementation stepped wedge cluster randomized trial (SW-CRT) using the Proctor Conceptual Model of Implementation Research.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Penetration of SDOH intervention | Monthly for approximately 12 months | Penetration is the rate of administration of social needs screener and appropriate referral for community resources to eligible families. |
| Receipt of ANY Community Resource | 3 months Post-NICU discharge | Receipt of any community resource as collected via participant survey specifying receipt of the resource. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability of SDOH intervention | 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). |
| Feasibility of SDOH intervention | 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). |
| Sustainability of SDOH intervention | Monthly for approximately 6 months. | Number of individuals who continued to get screened after active intervention is complete. |
| Equity of implementation | Monthly for approximately 18 months (during both penetration and sustainability). | Penetration rate by maternal demographics. |
| Equity of receipt of community resources | 3 months Post-NICU discharge | Rate of receipt of community resources by maternal demographics |
| SDOH Risk | 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. |
| SDOH Desire Assistance | 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. |
| SDOH Community Resource | 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). |
| Family Economic Pressure | 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). |
| Maternal Wellbeing | Baseline, 3 months, 6 months, and 12 months Post-NICU discharge | Rating of current overall health |
| Postpartum maternal primary care utilization | 3 months, 6 months, and 12 months Post-NICU discharge | Number of appointments with a primary care provider |
| Maternal Postpartum Obstetric Care Utilization | 3 months, 6 months, and 12 months Post-NICU discharge | Number of appointments with a maternal postpartum obstetric provider |
| Maternal emergency room utilization | 3 months, 6 months, and 12 months Post-NICU discharge | Number of emergency room visits. |
| Maternal hospital readmission | 3 months, 6 months, and 12 months Post-NICU discharge | Number of overnight hospital readmissions |
| Maternal Depression | 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. |
| Length of Lactation | Baseline, 3 months, 6 months, and 12 months Post-NICU discharge | Duration of milk production in months |
| Infant primary care utilization | 3 months, 6 months, and 12 months Post-NICU discharge | Number of appointments with a primary care provider |
| Infant utilization of emergency care | 3 months, 6 months, and 12 months Post-NICU discharge | Number of emergency room visits |
| Infant hospital readmission | 3 months, 6 months, and 12 months Post-NICU discharge | Number of overnight hospital readmissions |
| Receipt of necessary infant services and equipment | 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 |
| Infant Respiratory Symptoms (shortness of breath, wheezing, coughing, clinically demonstrated need for oral corticosteroids) | 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. |
| Infant growth | Baseline, 3 months, 6 months, and 12 months Post-NICU discharge | Weight for age z-score change |
| Infant Quality of Life | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMargaret Parker, MD, MPH
University of Massachusetts, Worcester
PRINCIPAL_INVESTIGATORMari-Lynn Drainoni, PhD, MEd
Boston University Chobanian and Avedisian School of Medicine
PRINCIPAL_INVESTIGATORArvin Garg, MD, MPH
University of Massachusetts, Worcester
Outcome results
None listed