NCT02451059

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,205

participants targeted

Target at P75+ for not_applicable asthma

Timeline
Completed

Started Sep 2015

Longer than P75 for not_applicable asthma

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 14, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 21, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 29, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 29, 2020

Completed
Last Updated

May 18, 2021

Status Verified

May 1, 2021

Enrollment Period

5.3 years

First QC Date

May 14, 2015

Last Update Submit

May 14, 2021

Conditions

Keywords

community resourcewell-child care visitlow-income

Outcome Measures

Primary Outcomes (1)

  • Health care utilization

    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.

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

Secondary Outcomes (8)

  • Child maltreatment

    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)

  • Obesity

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

  • Asthma

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

  • Blood pressure

    Measured at 3-year well child care visits

  • +3 more secondary outcomes

Study Arms (2)

Intervention-WE CARE

EXPERIMENTAL

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.

Behavioral: WE CARE surveyBehavioral: WE CARE Community Resource HandoutBehavioral: Patient Navigator

Control-Standard of Care

NO INTERVENTION

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

Interventions

WE CARE surveyBEHAVIORAL

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.

Intervention-WE CARE

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

Also known as: Resource Referral
Intervention-WE CARE

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.

Intervention-WE CARE

Eligibility Criteria

Age1 Day - 1 Month
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

South End Community Health Center

Boston, Massachusetts, 02118, United States

Location

Dorchester House Multi-Service Center

Boston, Massachusetts, 02122, United States

Location

Codman Square Health Center

Boston, Massachusetts, 02124, United States

Location

Uphams Corner Health Center

Dorchester, Massachusetts, 02125, United States

Location

Mattapan Community Health Center

Mattapan, Massachusetts, 02126, United States

Location

Greater Roslindale Medical and Dental Center

Roslindale, Massachusetts, 02131, United States

Location

MeSH Terms

Conditions

AsthmaObesityPatient Acceptance of Health Care

Interventions

Patient Navigation

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsTreatment Adherence and ComplianceHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

Patient-Centered CarePrimary Health CareComprehensive Health CarePatient Care ManagementHealth Services Administration

Study Officials

  • Arvin Garg, MD MPH

    Boston University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 14, 2015

First Posted

May 21, 2015

Study Start

September 1, 2015

Primary Completion

December 29, 2020

Study Completion

December 29, 2020

Last Updated

May 18, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations