Transforming Care and Payment Priorities for Vulnerable Families

This will be a randomized control trial of 800 children admitted to the Pediatric Hospital Medicine service at Texas Children's Hospital. Each eligible participant will give informed consent prior to enrollment. Study participants will be randomized into an intervention (400 participants) or control group (400 participants). The intervention group will receive a survey (WE CARE HOUSTON) that has been designed to assess family need for community resources that address the SDH (such as food insecurity, housing insecurity, etc.). The intervention group will receive referrals to community resources based on their responses to the WE CARE HOUSTON survey.

Study Overview

• Status: Completed
• Conditions: Social Stress
• Intervention / Treatment: Other: Screening survey and accompanying handout for resources

Detailed Description

This will be a randomized control trial of 800 children admitted to the Pediatric Hospital Medicine service at Texas Children's Hospital. Each eligible participant will give informed consent prior to enrollment.

Study participants will be randomized into an intervention (400 participants) or control group (400 participants). The intervention group will receive a survey (WE CARE HOUSTON) that has been designed to assess family need for community resources that address the SDH (such as food insecurity, housing insecurity, etc.). The intervention group will receive referrals to community resources based on their responses to the WE CARE HOUSTON survey. The intervention group will receive a phone call within 3 months of discharge to ask if they have had trouble following up with resources.

Both the intervention and the control groups will be followed for 6 months. Study investigators will obtain outcome data through structured telephone interviews at 6 months and also through medical record review.

This research has been designed to test our hypotheses:

1. The use of the WE CARE HOUSTON screening tool and subsequent referral to community resources will result in increased family participation in community resources that address the SDH; i.e. we believe that the intervention group will enroll in more community resources than the control group over the 6 month study period.
2. The use of the WE CARE HOUSTON screening tool and subsequent referral to community resources will result in improved health outcomes, i.e. children in the intervention group will have fewer emergency department visits, fewer readmissions, improved BMI and improved parent perception of child's health during the study period.

• Study Type: Interventional
• Enrollment (Actual): 430
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Texas Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 18 years (ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Children admitted to pediatric hospital medicine service

Exclusion Criteria:

• Children in child protective service custody
• Children residing outside of the greater Houston area

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SCREENING
• Allocation: RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: Control; To obtain baseline socioeconomic data on all children (intervention and control), study participants will utilize the Children's HealthWatch Survey (www.childrenshealthwatch.org), which is a standardized, validated survey designed to collect demographics and information on child health and development, parental health, and socioeconomic factors income, education level, financial literacy, childcare, and government assistance). The control group will not complete the WE CARE HOUSTON survey and will not receive any referrals to community resources from the study team at the time of enrollment (they may be referred to resources by their medical/clinical team as per standard of care during their hospitalization at Texas Children's Hospital). The study investigators will offer control participants information on community resources at the end of the study. Study participants will be called for a 6 month follow up structure telephone survey.
EXPERIMENTAL: Intervention; The intervention group will complete a short survey called the WE CARE HOUSTON survey. The WE CARE HOUSTON survey has been designed to quickly assess patient need for local services that address the social determinants of health. The WE CARE HOUSTON survey will be administered on paper or verbally if family is not able to read. Based on the parent's responses to the screening survey, the study investigators will use an algorithm to direct families to appropriate services and community resources. Families who screen positive for social needs will receive a handout on resources. For the families that screen positive for depression/ mental health needs, domestic violence, or alcohol and drug abuse, the study investigators will notify the medical/clinical team and recommend an inpatient social work prior to discharge. Intervention participants will be called 1 week-2 months after enrollment to follow up on resources and will be called for a 6 month follow up structured telephone survey.	Other: Screening survey and accompanying handout for resources; Intervention group will be completing a survey of social determinants of health and providing resources based on caregiver responses.; Other Names: Addressing social needs

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Enrollment (yes/no) in social determinant of health resources based on answer to questionnaire	We will assess whether study participants followed up with the resources provided and were able to enroll in needed resources with follow up phone call.	6 months after study enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Decreased emergency department revisits and hospital readmissions	We will assess whether children in the intervention group will have fewer quantity of all cause emergency department visits, fewer quantity of hospital readmissions on chart review.	6 months after study enrollment
Improved parental perception of child's health	We will compare caregiver's baseline and 6 month self-rating of their child's health in categories of "excellent", "good", "fair" or "poor".	study enrollment to 6 months after enrollment
Child's immunization status	Self report of compliance with vaccinations by parents on follow up survey	6 months after study enrollment
Child's growth	Weight and height will be combined to report BMI in kg/m^2. If height is unavailable, weight will be used and reported in kilograms.	6 months after study enrollment

Collaborators and Investigators

• Sponsor: Baylor College of Medicine

Publications and helpful links

General Publications

• Garg A, Toy S, Tripodis Y, Silverstein M, Freeman E. Addressing social determinants of health at well child care visits: a cluster RCT. Pediatrics. 2015 Feb;135(2):e296-304. doi: 10.1542/peds.2014-2888. Epub 2015 Jan 5.
• Garg A, Butz AM, Dworkin PH, Lewis RA, Thompson RE, Serwint JR. Improving the management of family psychosocial problems at low-income children's well-child care visits: the WE CARE Project. Pediatrics. 2007 Sep;120(3):547-58. doi: 10.1542/peds.2007-0398.
• Garg A, Butz AM, Dworkin PH, Lewis RA, Serwint JR. Screening for basic social needs at a medical home for low-income children. Clin Pediatr (Phila). 2009 Jan;48(1):32-6. doi: 10.1177/0009922808320602. Epub 2008 Jun 19.

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 13, 2016
• Primary Completion (ACTUAL): October 1, 2018
• Study Completion (ACTUAL): October 1, 2018

Study Registration Dates

• First Submitted: October 3, 2017
• First Submitted That Met QC Criteria: January 24, 2018
• First Posted (ACTUAL): January 31, 2018

Study Record Updates

• Last Update Posted (ESTIMATE): February 14, 2023
• Last Update Submitted That Met QC Criteria: February 11, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Social Determinants of Health
• Other Study ID Numbers: H-38428

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No