Clinical trial NCT03416712: Transforming Care and Payment Priorities for Vulnerable Families
Official title: Transforming Care and Payment Priorities for Vulnerable Families
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Social Stress
Keywords: Social Determinants of Health
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
First posted: 2018-01-31
Enrollment: 430
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: 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).
Primary purpose: SCREENING

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Enrollment (yes/no) in social determinant of health resources based on answer to questionnaire
timeFrame: 6 months after study enrollment
Secondary outcomes:
measure: Decreased emergency department revisits and hospital readmissions
timeFrame: 6 months after study enrollment
measure: Improved parental perception of child's health
timeFrame: study enrollment to 6 months after enrollment
measure: Child's immunization status
timeFrame: 6 months after study enrollment
measure: Child's growth
timeFrame: 6 months after study enrollment
Other outcomes:
Locations:
city: Houston
country: United States
facility: Texas Children's Hospital
state: Texas
Study officials:
affiliation: Baylor College of Medicine
name: Michelle Lopez, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.