Clinical trial NCT02451059: Reducing Socioeconomic Disparities in Health at Pediatric Visits
Official title: Reducing Socioeconomic Disparities in Health at Pediatric Visits
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Obesity
Health Care Utilization
Health Care Disparities
Basic Unmet Social Needs
Blood Pressure
Child Maltreatment
Child Development
Keywords: community resource
well-child care visit
low-income
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
Collaborators: name: Center for Community Health Education Research and Service, Inc.
name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2015-05-21
Enrollment: 1205
Sex: ALL
Minimum age (years): 1
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Health care utilization
timeFrame: Throughout child's enrollment in study (0 years through 3 years of age)
Secondary outcomes:
measure: Child maltreatment
timeFrame: Throughout child's enrollment in study (0 years through 3 years of age)
measure: Developmental delay
timeFrame: Throughout child's enrollment in study (0 years through 3 years of age)
measure: Obesity
timeFrame: Measured at 2-year, 30-month, and 3-year well child care visits (as recommended by the American Academy of Pediatrics)
measure: Asthma
timeFrame: Throughout child's enrollment in study (0 years through 3 years of age)
measure: Blood pressure
timeFrame: Measured at 3-year well child care visits
measure: Provider referrals
timeFrame: Throughout child's enrollment in study (0 years through 3 years of age)
measure: Family receipt of community based resource
timeFrame: Throughout child's enrollment in study (0 years through 3 years of age)
measure: Focus group data gathered by audio recordings then transcribed and coded
timeFrame: 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
Other outcomes:
Locations:
city: Boston
country: United States
facility: South End Community Health Center
state: Massachusetts
city: Boston
country: United States
facility: Dorchester House Multi-Service Center
state: Massachusetts
city: Boston
country: United States
facility: Codman Square Health Center
state: Massachusetts
city: Dorchester
country: United States
facility: Uphams Corner Health Center
state: Massachusetts
city: Mattapan
country: United States
facility: Mattapan Community Health Center
state: Massachusetts
city: Roslindale
country: United States
facility: Greater Roslindale Medical and Dental Center
state: Massachusetts
Study officials:
affiliation: Boston University
name: Arvin Garg, MD MPH
role: PRINCIPAL_INVESTIGATOR
References: