Preterm BirthNCT06582147
The Social Determinants of Health Screening and Referral Project
A study testing Implementation of social determinants of health screening and referral in people with Preterm Birth, run by University of Massachusetts, Worcester at 7 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Preterm Birth
- What is being tested?
- Implementation of social determinants of health screening and referral
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 882 participants
- Where
- 7 sitesUnited States
- Study dates
- 6 Dec 2024to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Mothers or infants who die before anticipated infant discharge.
- Infant discharged after 52 weeks postmenstrual age.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
United States7 sites
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Denver Health Hospital Authority
Denver, Colorado, 80204
Children's Hospital of Michigan
Detroit, Michigan, 48201
University of Mississippi Medical Center
Jackson, Mississippi, 39216
Shands Jacksonville Medical Center, Inc. DBA UF Health Jacksonville
Jacksonville, Florida, 32209
Temple University Hospital
Philadelphia, Pennsylvania, 19140
Children's Hospital at Montefiore
The Bronx, New York, 10467
About this study
Official title: Implementing a Social Determinants of Health Screening and Referral Care Model in the Neonatal Intensive Care Unit
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.
Read the 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.
- Conditions
- Preterm Birth
- Being tested
- Implementation of social determinants of health screening and referral
- 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
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implementation of social determinants of health screening and referralOther
Also called WE CARE
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Implementation of social determinants of health screening and referral |
What is being measured
The primary outcome is the main question the study is designed to answer.
Penetration of SDOH intervention
Penetration is the rate of administration of social needs screener and appropriate referral for community resources to eligible families.
Measured: 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.
Measured: 3 months Post-NICU discharge
Secondary outcomes (23)
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. (Minimum score is 4, maximum score is 20).
Measured: 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. (Minimum score is 4, maximum score is 20).
Measured: Approximately 7, 9, and 12 months.
Sustainability of SDOH intervention
Number of individuals who continued to get screened after active intervention is complete.
Measured: Monthly for approximately 6 months.
Equity of implementation
Penetration rate by maternal demographics.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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. (Minimum score is 6, maximum score is 30).
Measured: Baseline, 3 months, 6 months, and 12 months Post-NICU discharge
Maternal Wellbeing
Rating of current overall health
Measured: Baseline, 3 months, 6 months, and 12 months Post-NICU discharge
Postpartum maternal primary care utilization
Number of appointments with a primary care provider
Measured: 3 months, 6 months, and 12 months Post-NICU discharge
Maternal Postpartum Obstetric Care Utilization
Number of appointments with a maternal postpartum obstetric provider
Measured: 3 months, 6 months, and 12 months Post-NICU discharge
Maternal emergency room utilization
Number of emergency room visits.
Measured: 3 months, 6 months, and 12 months Post-NICU discharge
Maternal hospital readmission
Number of overnight hospital readmissions
Measured: 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.
Measured: Baseline, 3 months, 6 months, and 12 months Post-NICU discharge
Length of Lactation
Duration of milk production in months
Measured: Baseline, 3 months, 6 months, and 12 months Post-NICU discharge
Infant primary care utilization
Number of appointments with a primary care provider
Measured: 3 months, 6 months, and 12 months Post-NICU discharge
Infant utilization of emergency care
Number of emergency room visits
Measured: 3 months, 6 months, and 12 months Post-NICU discharge
Infant hospital readmission
Number of overnight hospital readmissions
Measured: 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
Measured: 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.
Measured: 3 months, 6 months, and 12 months Post-NICU discharge
Infant growth
Weight for age z-score change
Measured: 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.
Measured: 3 months, 6 months, and 12 months Post-NICU discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2024
- Study start6 Dec 2024
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm BirthStudies of the same condition, open and under way.
- More trials run by University of Massachusetts, WorcesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Hybrid effectiveness- implementation stepped wedge cluster randomized trial (SW-CRT) using the Proctor Conceptual Model of Implementation Research.
- Masking
- None (open label)
- Enrolment
- 882 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Worcester
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Margaret Parker, University of Massachusetts, Worcester
- Investigators
- Margaret Parker, MD, MPH, Principal investigator, University of Massachusetts, WorcesterMari-Lynn Drainoni, PhD, MEd, Principal investigator, Boston University Chobanian and Avedisian School of MedicineArvin Garg, MD, MPH, Principal investigator, University of Massachusetts, Worcester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06582147
- Sponsor's protocol ID
- STUDY00000543
- Other IDs
- 5R01HD104772
- Status last verified
- May 2026
- First submitted
- 14 Aug 2024
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data requests can be submitted to the MPIs after study completion.
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing a Social Determinants of Health Screening and Referral Care Model in the Neonatal Intensive Care Unit
- ClinicalTrials.gov ID
- NCT06582147
- Acronym / sponsor ID
- STUDY00000543
- 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
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 882 participants (estimated)
- Lead sponsor
- University of Massachusetts, WorcesterUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 6 Dec 2024 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 3 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Hybrid effectiveness- implementation stepped wedge cluster randomized trial (SW-CRT) using the Proctor Conceptual Model of Implementation Research.
| Arm | Type | Receives |
|---|---|---|
| Social needs screening and referral care | Other | Other: Implementation of social determinants of health screening and referralAs 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (2 listed)
- Mothers or infants who die before anticipated infant discharge.
- Infant discharged after 52 weeks postmenstrual age.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Implementation of social determinants of health screening and referralAlso: WE CAREWE 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 | Social needs screening and referral care |
Primary outcome
Penetration of SDOH intervention
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.
Receipt of ANY Community Resource
Time frame: 3 months Post-NICU discharge
Receipt of any community resource as collected via participant survey specifying receipt of the resource.
23 secondary outcomes
Acceptability of SDOH intervention
Time frame: Approximately 7, 9, and 12 months
Feasibility of SDOH intervention
Time frame: Approximately 7, 9, and 12 months.
Sustainability of SDOH intervention
Time frame: Monthly for approximately 6 months.
Equity of implementation
Time frame: Monthly for approximately 18 months (during both penetration and sustainability).
Equity of receipt of community resources
Time frame: 3 months Post-NICU discharge
SDOH Risk
Time frame: Baseline, 3 months, 6 months, and 12 months Post-NICU discharge
SDOH Desire Assistance
Time frame: Baseline, 3 months, 6 months, and 12 months Post-NICU discharge
SDOH Community Resource
Time frame: Baseline, 3 months, 6 months, and 12 months Post-NICU discharge
Family Economic Pressure
Time frame: Baseline, 3 months, 6 months, and 12 months Post-NICU discharge
Maternal Wellbeing
Time frame: Baseline, 3 months, 6 months, and 12 months Post-NICU discharge
Postpartum maternal primary care utilization
Time frame: 3 months, 6 months, and 12 months Post-NICU discharge
Maternal Postpartum Obstetric Care Utilization
Time frame: 3 months, 6 months, and 12 months Post-NICU discharge
Maternal emergency room utilization
Time frame: 3 months, 6 months, and 12 months Post-NICU discharge
Maternal hospital readmission
Time frame: 3 months, 6 months, and 12 months Post-NICU discharge
Maternal Depression
Time frame: Baseline, 3 months, 6 months, and 12 months Post-NICU discharge
Length of Lactation
Time frame: Baseline, 3 months, 6 months, and 12 months Post-NICU discharge
Infant primary care utilization
Time frame: 3 months, 6 months, and 12 months Post-NICU discharge
Infant utilization of emergency care
Time frame: 3 months, 6 months, and 12 months Post-NICU discharge
Infant hospital readmission
Time frame: 3 months, 6 months, and 12 months Post-NICU discharge
Receipt of necessary infant services and equipment
Time frame: 3 months, 6 months, and 12 months Post-NICU discharge
Infant Respiratory Symptoms (shortness of breath, wheezing, coughing, clinically demonstrated need for oral corticosteroids)
Time frame: 3 months, 6 months, and 12 months Post-NICU discharge
Infant growth
Time frame: Baseline, 3 months, 6 months, and 12 months Post-NICU discharge
Infant Quality of Life
Time frame: 3 months, 6 months, and 12 months Post-NICU discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
- Individual participant dataSharing planned: Yes. Data requests can be submitted to the MPIs after study completion.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Margaret Parker, MD, MPH principal investigator
University of Massachusetts, Worcester
Mari-Lynn Drainoni, PhD, MEd principal investigator
Boston University Chobanian and Avedisian School of Medicine
Arvin Garg, MD, MPH principal investigator
University of Massachusetts, Worcester
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implementation of social determinants of health screening and referral in people with Preterm Birth, run by University of Massachusetts, Worcester at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Penetration of SDOH intervention (time frame: Monthly for approximately 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026.