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Reducing Socioeconomic Disparities in Health at Pediatric Visits (WECARE01)

Boston Medical Center (BMC) logo

Boston Medical Center (BMC)

Status

Completed

Conditions

Asthma
Basic Unmet Social Needs
Child Development
Health Care Disparities
Obesity
Health Care Utilization
Child Maltreatment
Blood Pressure

Treatments

Behavioral: Patient Navigator
Behavioral: WE CARE Community Resource Handout
Behavioral: WE CARE survey

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT02451059
1R01MD007793-01A1 (U.S. NIH Grant/Contract)
H-33061

Details and patient eligibility

About

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.

Full 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.

Enrollment

1,205 patients

Sex

All

Ages

1 day to 1 month old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

1,205 participants in 2 patient groups

Intervention-WE CARE
Experimental group
Description:
1. The WE CARE survey is used to identify unmet material needs; it will be administered with patient's developmental screening forms at all health supervision visits from birth to two years of age. 2. Providers will be trained to review the WE CARE survey at health supervision visits and generate our WE CARE community resource handouts (referrals) through the EMR. 3. A peer patient navigator will offer personalized guidance to families with accessing community resources. The patient navigator will be available for at least a 1/2 day per week at each intervention health center to meet with families and offer guidance. Providers can communicate the patient navigator to refer families via the electronic medical record and families will also have the opportunity to contact the peer navigator at any time via the hotline number listed on the referral information sheets.
Treatment:
Behavioral: Patient Navigator
Behavioral: WE CARE Community Resource Handout
Behavioral: WE CARE survey
Control-Standard of Care
No Intervention group
Description:
Participants in the delayed-intervention control group will receive standard pediatric care. However, since the health centers share a common EMR, and for ethical reasons, investigators will also embed the health IT referral mechanism into the EMR at the control sites. Control providers will be made aware of this prior to the start of the study. Although this may potentially reduce the effect size, the investigator's prior study found that the impact on referral rates of provider access to resource information was minimal. Families at control health centers will not receive the WE CARE surveys at health supervision visits and will not have access to the peer patient navigators

Trial contacts and locations

6

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Data sourced from clinicaltrials.gov

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