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Transforming Care and Payment Priorities for Vulnerable Families

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03416712
Recruitment Status : Completed
First Posted : January 31, 2018
Last Update Posted : March 5, 2019
Sponsor:
Information provided by (Responsible Party):
Michelle Lopez, Baylor College of Medicine

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.

Condition or disease Intervention/treatment Phase
Social Stress Other: Screening survey and accompanying handout for resources Not Applicable

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 ED visits, fewer readmissions, improved BMI and improved parent perception of child's health during the study period.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 430 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
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).
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Transforming Care and Payment Priorities for Vulnerable Families
Actual Study Start Date : June 13, 2016
Actual Primary Completion Date : October 1, 2018
Actual Study Completion Date : October 1, 2018

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 Name: Addressing social needs




Primary Outcome Measures :
  1. Enrollment (yes/no) in social determinant of health resources based on answer to questionnaire [ Time Frame: 6 months after study enrollment ]
    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.


Secondary Outcome Measures :
  1. Decreased emergency department revisits and hospital readmissions [ Time Frame: 6 months after study enrollment ]
    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.

  2. Improved parental perception of child's health [ Time Frame: study enrollment to 6 months after enrollment ]
    We will compare caregiver's baseline and 6 month self-rating of their child's health in categories of "excellent", "good", "fair" or "poor".

  3. Child's immunization status [ Time Frame: 6 months after study enrollment ]
    Self report of compliance with vaccinations by parents on follow up survey

  4. Child's growth [ Time Frame: 6 months after study enrollment ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03416712


Locations
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United States, Texas
Texas Children's Hospital
Houston, Texas, United States, 77030
Sponsors and Collaborators
Baylor College of Medicine
Investigators
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Principal Investigator: Michelle Lopez, MD, MPH Baylor College of Medicine
Publications:
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Responsible Party: Michelle Lopez, Assistant Professor, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT03416712    
Other Study ID Numbers: H-38428
First Posted: January 31, 2018    Key Record Dates
Last Update Posted: March 5, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Michelle Lopez, Baylor College of Medicine:
Social Determinants of Health