Social StressNCT03416712
Transforming Care and Payment Priorities for Vulnerable Families
A study testing Screening survey and accompanying handout for resources in people with Social Stress, run by Baylor College of Medicine at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages Up to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Social Stress
- What is being tested?
- Screening survey and accompanying handout for resources
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 430 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jun 2016to 1 Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Children admitted to pediatric hospital medicine service
Who cannot join
- Children in child protective service custody
- Children residing outside of the greater Houston area
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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:
- 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.
- 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.
- Conditions
- Social Stress
- Being tested
- Screening survey and accompanying handout for resources
- Keywords
- Social Determinants of Health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Screening survey and accompanying handout for resourcesOther
Also called Addressing social needs
Intervention group will be completing a survey of social determinants of health and providing resources based on caregiver responses.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Screening survey and accompanying handout for resources |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months after study enrollment
Secondary outcomes (4)
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.
Measured: 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".
Measured: study enrollment to 6 months after enrollment
Child's immunization status
Self report of compliance with vaccinations by parents on follow up survey
Measured: 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.
Measured: 6 months after study enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2018
- Study start13 Jun 2016
- Primary completion1 Oct 2018
- Study completion1 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Social StressStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Single group
- 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)
- Enrolment
- 430 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michelle Lopez, Baylor College of Medicine
- Investigators
- Michelle Lopez, MD, MPH, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03416712
- Sponsor's protocol ID
- H-38428
- Status last verified
- Feb 2023
- First submitted
- 3 Oct 2017
- Last updated
- 14 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 25560448Garg 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.
PubMed 17766528Garg 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.
PubMed 18566347Lopez 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.
PubMed 36594231
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transforming Care and Payment Priorities for Vulnerable Families
- ClinicalTrials.gov ID
- NCT03416712
- Acronym / sponsor ID
- H-38428
- Conditions
- Social Stress
- Keywords
- Social Determinants of Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 430 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Study start
- 13 Jun 2016 (actual)
- Primary completion
- 1 Oct 2018 (actual)
- Study completion
- 1 Oct 2018 (actual)
- First posted
- 31 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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 design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: Screening survey and accompanying handout for resourcesThe 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. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Children admitted to pediatric hospital medicine service
Key exclusion criteria (2 listed)
- Children in child protective service custody
- Children residing outside of the greater Houston area
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Screening survey and accompanying handout for resourcesAlso: Addressing social needsIntervention group will be completing a survey of social determinants of health and providing resources based on caregiver responses. | Other | Intervention |
Primary outcome
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.
4 secondary outcomes
Decreased emergency department revisits and hospital readmissions
Time frame: 6 months after study enrollment
Improved parental perception of child's health
Time frame: study enrollment to 6 months after enrollment
Child's immunization status
Time frame: 6 months after study enrollment
Child's growth
Time frame: 6 months after study enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2023.
- Background: PubMed 25560448Garg 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.
- Background: PubMed 17766528Garg 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.
- Background: PubMed 18566347Garg 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.
- Derived from this study: PubMed 36594231Lopez 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michelle Lopez, MD, MPH principal investigator
Baylor College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Screening survey and accompanying handout for resources in people with Social Stress, run by Baylor College of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Enrollment (yes/no) in social determinant of health resources based on answer to questionnaire (time frame: 6 months after study enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03416712, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2023.