Transforming Care and Payment Priorities for Vulnerable Families

NCT03416712 | Completed

• 1 other identifier: H-38428
• Study Type: interventional
• Target: 430
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Social Stress

Keywords

Social Determinants of Health

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Decreased emergency department revisits and hospital readmissions

  6 months after study enrollment

• Improved parental perception of child's health

  study enrollment to 6 months after enrollment

• Child's immunization status

  6 months after study enrollment

• Child's growth

  6 months after study enrollment

Study Arms (2)

Control

NO INTERVENTION

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.

Intervention

EXPERIMENTAL

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

Interventions

Screening survey and accompanying handout for resources OTHER

Intervention group will be completing a survey of social determinants of health and providing resources based on caregiver responses.

Also known as: Addressing social needs

Intervention

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Children admitted to pediatric hospital medicine service

You may not qualify if:

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

Sponsors & Collaborators

• Baylor College of Medicine: lead

Study Sites (1)

Texas Children's Hospital

Houston, Texas, 77030, United States

Location

Related Publications (4)

• 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.

  PMID: 25560448 BACKGROUND

• 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.

  PMID: 17766528 BACKGROUND

• 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.

  PMID: 18566347 BACKGROUND

• Lopez MA, Yu X, Hetrick R, Raman S, Lee J, Hall J, Tran K, Vonasek B, Garg A, Raphael J, Bocchini C. Social Needs Screening in Hospitalized Pediatric Patients: A Randomized Controlled Trial. Hosp Pediatr. 2023 Feb 1;13(2):95-114. doi: 10.1542/hpeds.2022-006815.

  PMID: 36594231 DERIVED

MeSH Terms

Interventions

Health Resources

Intervention Hierarchy (Ancestors)

Health Planning; Health Care Economics and Organizations; Delivery of Health Care; Health Care Quality, Access, and Evaluation

Study Officials

• Michelle Lopez, MD, MPH

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Quantify unmet socioeconomic determinants of health (SDH) needs using a screening tool in the inpatient settings at Texas Children's Hospital (TCH). Screen will assess educational attainment, employment, literacy, language skills, substance dependence, childcare and child behavior, mental health, domestic violence, housing insecurity and conditions, medical insurance, access to primary care, transportation to medical appointments, ability to pay for prescriptions, legal issues and immigration services. 2. Increase vulnerable family enrollment in community resources to decrease unmet psychosocial and economic needs in the study population 3. Evaluate impact of this intervention on health outcome indicators and hospital resource utilization (body mass index (BMI), return visit to ED, hospital readmission, and parent's perception of child's health).

Study Record Dates

• First Submitted: October 3, 2017
• First Posted: January 31, 2018
• Study Start: June 13, 2016
• Primary Completion: October 1, 2018
• Study Completion: October 1, 2018
• Last Updated: February 14, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)