WECARE01: Reducing Socioeconomic Disparities in Health at Pediatric Visits

Sponsor
Boston Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT02451059
Collaborator
Center for Community Health Education Research and Service, Inc. (Other), National Institute on Minority Health and Health Disparities (NIMHD) (NIH)
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: WE CARE survey
  • Behavioral: WE CARE Community Resource Handout
  • Behavioral: Patient Navigator
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
1205 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Reducing Socioeconomic Disparities in Health at Pediatric Visits
Actual Study Start Date :
Sep 1, 2015
Actual Primary Completion Date :
Dec 29, 2020
Actual Study Completion Date :
Dec 29, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention-WE CARE

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. 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. 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.

Behavioral: WE CARE survey
The WE CARE survey, consists of 14 questions used to identify seven unmet material needs (education, employment, food security, housing, childcare, household heat, language). The survey will be administered with patient's developmental screening forms at all health supervision visits from birth to two years of age. The office staff will instruct parents to give the WE CARE survey, along with the developmental screening tool, to their child's provider at the visit.

Behavioral: WE CARE Community Resource Handout
Providers will be trained to review the WE CARE survey at health supervision visits and generate referrals thru the EMR. Specifically, they will receive a one-hour teaching session one week prior to the study implementation. The goals for the session will include providing an overview of pediatric practice guidelines, introducing the WE CARE survey, reviewing the referral process, and discussing the role of peer patient navigators. Study staff will conduct periodic booster sessions; study staff will also train new providers should there be staff turnover
Other Names:
  • Resource Referral
  • Behavioral: Patient Navigator
    The peer patient navigator will offer guidance to families with accessing community resources. They will be available at least .5 days per week at intervention health centers to meet with families and offer guidance as well as be available via a hotline number. The navigator will speak with families and offer guidance on community resources and offer assistance with completing applications. In addition, they will offer to schedule and, if desired, accompany parents to the agencies. Interpreter services will be utilized at the health centers in case the navigator does not speak the parent's language. The navigator will also place an update note in the EMR within 1-month post-visit and one week after any contact with families.

    No Intervention: Control-Standard of Care

    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

    Outcome Measures

    Primary Outcome Measures

    1. Health care utilization [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 Outcome Measures

    1. Child maltreatment [Throughout child's enrollment in study (0 years through 3 years of age)]

      Investigators will measure in the child's EMR whether or not there are any reports of child maltreatment and/or involvement with the Department of Child and Families, at any point, from age 0-3 years of age.

    2. Developmental delay [Throughout child's enrollment in study (0 years through 3 years of age)]

      Investigators will measure whether a developmental delay has been added to the child's problem list in their EMR or if provider has noted a concern of a developmental delay in their routine well-child care notes, at any point, from age 0-3 years of age.

    3. Obesity [Measured at 2-year, 30-month, and 3-year well child care visits (as recommended by the American Academy of Pediatrics)]

      Investigators will record the child's reported BMI at their 2-year, 30-month, and 3-year well child care visits from the EMR

    4. Asthma [Throughout child's enrollment in study (0 years through 3 years of age)]

      Investigators will record whether asthma or concerns about asthma have been added to child's problem list in the EMR or noted in the EMR by child's provider at any point, from age 0-3 years of age.

    5. Blood pressure [Measured at 3-year well child care visits]

      We will record the child's reported blood pressure number as measured at their 3-year well child care visit. We will gather this information from the EMR.

    6. Provider referrals [Throughout child's enrollment in study (0 years through 3 years of age)]

      Investigators will measure if and how many times a provider made a referral/printed out a community resource handout for patients during their enrollment in the study at any point, from age 0-3 years of age.

    7. Family receipt of community based resource [Throughout child's enrollment in study (0 years through 3 years of age)]

      Investigators will determine whether families who were printed out community resource handouts had been able to receive services from a community based resource organization. This will be recorded in the EMR by the patient navigator at anytime from age 0-3 years of age.

    8. 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]

      Investigators will gain insight into the context and implementation of the augmented WE CARE model from providers and administrative staff at the intervention sites

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Day to 1 Month
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 South End Community Health Center Boston Massachusetts United States 02118
    2 Dorchester House Multi-Service Center Boston Massachusetts United States 02122
    3 Codman Square Health Center Boston Massachusetts United States 02124
    4 Uphams Corner Health Center Dorchester Massachusetts United States 02125
    5 Mattapan Community Health Center Mattapan Massachusetts United States 02126
    6 Greater Roslindale Medical and Dental Center Roslindale Massachusetts United States 02131

    Sponsors and Collaborators

    • Boston Medical Center
    • Center for Community Health Education Research and Service, Inc.
    • National Institute on Minority Health and Health Disparities (NIMHD)

    Investigators

    • Principal Investigator: Arvin Garg, MD MPH, Boston University Medical Campus

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Boston Medical Center
    ClinicalTrials.gov Identifier:
    NCT02451059
    Other Study ID Numbers:
    • H-33061
    • 1R01MD007793-01A1
    First Posted:
    May 21, 2015
    Last Update Posted:
    May 18, 2021
    Last Verified:
    May 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Boston Medical Center

    Study Results

    No Results Posted as of May 18, 2021