The Social Determinants of Health Screening and Referral Project

NCT06582147 | Enrolling By Invitation DMC

• 2 other identifiers: STUDY000005435R01HD104772
• Study Type: interventional
• Target: 882
• Locations: 1 country
• Sites: 7

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.

Conditions

Preterm Birth

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (23)

• Acceptability of SDOH intervention

  Approximately 7, 9, and 12 months

• Feasibility of SDOH intervention

  Approximately 7, 9, and 12 months.

• Sustainability of SDOH intervention

  Monthly for approximately 6 months.

• Equity of implementation

  Monthly for approximately 18 months (during both penetration and sustainability).

• Equity of receipt of community resources

  3 months Post-NICU discharge

Study Arms (1)

Social needs screening and referral care

OTHER

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

Interventions

Implementation of social determinants of health screening and referral OTHER

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

Also known as: WE CARE

Social needs screening and referral care

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Mothers or infants who die before anticipated infant discharge.
• Infant discharged after 52 weeks postmenstrual age.

Sponsors & Collaborators

• University of Massachusetts, Worcester: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (7)

Denver Health Hospital Authority

Denver, Colorado, 80204, United States

Location

Shands Jacksonville Medical Center, Inc. DBA UF Health Jacksonville

Jacksonville, Florida, 32209, United States

Location

Children's Hospital of Michigan

Detroit, Michigan, 48201, United States

Location

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

Children's Hospital at Montefiore

The Bronx, New York, 10467, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Temple University Hospital

Philadelphia, Pennsylvania, 19140, United States

Location

MeSH Terms

Conditions

Premature Birth

Interventions

Referral and Consultation

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Professional Practice; Organization and Administration; Health Services Administration

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: None (Open Label)
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Hybrid effectiveness- implementation stepped wedge cluster randomized trial (SW-CRT) using the Proctor Conceptual Model of Implementation Research.

Study Record Dates

• First Submitted: August 14, 2024
• First Posted: September 3, 2024
• Study Start: December 6, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: May 7, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Data requests can be submitted to the MPIs 6 months after study completion.
• 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).

Locations

US (7)