Ignite Creation Date:
2024-10-25 @ 7:52 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06582147
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-14
Brief Title:
The Social Determinants of Health Screening and Referral Project
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Implementing a Social Determinants of Health Screening and Referral Care Model in the Neonatal Intensive Care Unit
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 8 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 800 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None