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| ID | Type | Description | Link |
|---|---|---|---|
| 5R01HD104772 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Approximately 7, 9, and 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Margaret Parker, MD, MPH | University of Massachusetts, Worcester | Principal Investigator |
| Mari-Lynn Drainoni, PhD, MEd | Boston University Chobanian and Avedisian School of Medicine | Principal Investigator |
| Arvin Garg, MD, MPH | University of Massachusetts, Worcester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Denver Health Hospital Authority | Denver | Colorado | 80204 | United States | ||
| Shands Jacksonville Medical Center, Inc. DBA UF Health Jacksonville |
Data requests can be submitted to the MPIs after study completion.
Data requests can be submitted to the MPIs 6 months after study completion.
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).
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Hybrid effectiveness- implementation stepped wedge cluster randomized trial (SW-CRT) using the Proctor Conceptual Model of Implementation Research.
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None (Open Label)
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| 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). | Approximately 7, 9, and 12 months. |
| Sustainability of SDOH intervention | Number of individuals who continued to get screened after active intervention is complete. | Monthly for approximately 6 months. |
| Equity of implementation | Penetration rate by maternal demographics. | 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 | 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. | 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. | 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). | 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). | Baseline, 3 months, 6 months, and 12 months Post-NICU discharge |
| Maternal Wellbeing | Rating of current overall health | Baseline, 3 months, 6 months, and 12 months Post-NICU discharge |
| Postpartum maternal primary care utilization | Number of appointments with a primary care provider | 3 months, 6 months, and 12 months Post-NICU discharge |
| Maternal Postpartum Obstetric Care Utilization | Number of appointments with a maternal postpartum obstetric provider | 3 months, 6 months, and 12 months Post-NICU discharge |
| Maternal emergency room utilization | Number of emergency room visits. | 3 months, 6 months, and 12 months Post-NICU discharge |
| Maternal hospital readmission | Number of overnight hospital readmissions | 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. | Baseline, 3 months, 6 months, and 12 months Post-NICU discharge |
| Length of Lactation | Duration of milk production in months | Baseline, 3 months, 6 months, and 12 months Post-NICU discharge |
| Infant primary care utilization | Number of appointments with a primary care provider | 3 months, 6 months, and 12 months Post-NICU discharge |
| Infant utilization of emergency care | Number of emergency room visits | 3 months, 6 months, and 12 months Post-NICU discharge |
| Infant hospital readmission | Number of overnight hospital readmissions | 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 | 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. | 3 months, 6 months, and 12 months Post-NICU discharge |
| Infant growth | Weight for age z-score change | 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. | 3 months, 6 months, and 12 months Post-NICU discharge |
| Jacksonville |
| Florida |
| 32209 |
| United States |
| Children's Hospital of Michigan | Detroit | Michigan | 48201 | United States |
| University of Mississippi Medical Center | Jackson | Mississippi | 39216 | United States |
| Children's Hospital at Montefiore | The Bronx | New York | 10467 | United States |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | United States |
| Temple University Hospital | Philadelphia | Pennsylvania | 19140 | United States |
| ID | Term |
|---|---|
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D012017 | Referral and Consultation |
| ID | Term |
|---|---|
| D011364 | Professional Practice |
| D009934 | Organization and Administration |
| D006298 | Health Services Administration |
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