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Clinical Trials/NCT02451059
NCT02451059
Completed
N/A

Reducing Socioeconomic Disparities in Health at Pediatric Visits

Boston Medical Center6 sites in 1 country1,205 target enrollmentSeptember 2015

Overview

Phase
N/A
Intervention
Not specified
Conditions
Asthma
Sponsor
Boston Medical Center
Enrollment
1205
Locations
6
Primary Endpoint
Health care utilization
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

This research project is aimed to assess the effectiveness and impact of a pediatric-based intervention aimed at reducing low-income families' unmet material needs (food, housing, employment, childcare, household heat, education and learning the English language ) on child health.

Detailed Description

This project builds upon the PI's prior studies including a recently completed cluster randomized controlled trial (RCT) at community health centers in Boston, which demonstrated a positive impact on provider referrals, discussion, and family receipt of resources. This study will specifically test the effectiveness of a further strengthened intervention "WE CARE 2.0" on provider referrals and family receipt of resources, along with its impact on child health, health care utilization, and developmental outcomes. Finally, we will gather information from stakeholders at the health centers in order to learn more about the facilitators and barriers to implementation of the model. The study will take place at six community health centers in the Greater Boston area. The centers will be randomized to either an intervention or control site. Data will be collected on referrals, receipt of resources, and child outcomes from the child's electronic medical record (EMR) from birth to age 3. Focus groups will be used to gather implementation data from intervention health center personnel. The WE CARE 2.0 intervention consists of: 1) WE CARE surveys which parents complete prior to their child's well-child visits; 2) information technology (IT) generated provider referrals which providers use to provide families with resource information sheets; 3) peer patient navigators who assist families in connecting to available resources and updating providers; and 4) training sessions for providers and office staff. Families attending the control health centers will receive standard of care. Of note, since the health centers share a common EMR and for ethical reasons, control sites will have access to the IT generated referral mechanism.

Registry
clinicaltrials.gov
Start Date
September 2015
End Date
December 29, 2020
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Child is on Medicaid insurance
  • Is attending routine newborn visit

Exclusion Criteria

  • Premature (less than or equal to 32 weeks GA)
  • Has a chronic disease
  • Has Neonatal Abstinence Syndrome
  • Has a foster parent

Outcomes

Primary Outcomes

Health care utilization

Time Frame: Throughout child's enrollment in study (0 years through 3 years of age)

Investigators will measure whether child is up to date with well child visits between 0-3 years of age. Investigators will measure whether child is up to date on their immunizations between 0-3 years of age. Investigators will measure if and how many times child has been hospitalized or had a visit to the emergency department (ED) between 0-3 years of age.

Secondary Outcomes

  • Family receipt of community based resource(Throughout child's enrollment in study (0 years through 3 years of age))
  • Provider referrals(Throughout child's enrollment in study (0 years through 3 years of age))
  • Developmental delay(Throughout child's enrollment in study (0 years through 3 years of age))
  • Asthma(Throughout child's enrollment in study (0 years through 3 years of age))
  • Obesity(Measured at 2-year, 30-month, and 3-year well child care visits (as recommended by the American Academy of Pediatrics))
  • Blood pressure(Measured at 3-year well child care visits)
  • Focus group data gathered by audio recordings then transcribed and coded(During 1st month pilot phase and again after investigators have enrolled our the cohort, approximately 3 years after the first focus groups and the study initiation)
  • Child maltreatment(Throughout child's enrollment in study (0 years through 3 years of age))

Study Sites (6)

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