Transforming Care and Payment Priorities for Vulnerable Families

Social Stress Clinical Trial

Official title:

Transforming Care and Payment Priorities for Vulnerable Families

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03416712
• Other study ID #: H-38428
• Status: Completed
• Phase: N/A
• Start date: June 13, 2016
• Est. completion date: October 1, 2018

Study information

• Verified date: February 2023
• Source: Baylor College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 430
• Est. completion date: October 1, 2018
• Est. primary completion date: October 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Social Stress

Intervention

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.

Locations

Country	Name	City	State
United States	Texas Children's Hospital	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Baylor College of Medicine

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Child's immunization status	Self report of compliance with vaccinations by parents on follow up survey	6 months after study enrollment
Secondary	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