Implementing an Intervention to Address Social Determinants of Health in Pediatric Practices

Patient Satisfaction Clinical Trial

— PROSWECARE  

Official title:

Implementing an Intervention to Address Social Determinants of Health in Pediatric Practices

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02918435
• Other study ID #: H-35482
• Secondary ID: R01HD090191
• Status: Completed
• Phase: N/A
• Start date: October 7, 2019
• Est. completion date: November 1, 2023

Study information

• Verified date: January 2024
• Source: University of Massachusetts, Worcester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This research project is aimed to assess the implementation, effectiveness, and sustainability of a pediatric-based intervention aimed at reducing families' unmet material needs (food, housing, employment, childcare, household utilities, education) in pediatric practices throughout the United States.

Description:

The investigators prior work has focused on developing a pediatric primary care-based intervention, WE CARE (Well-child care visit, Evaluation, Community Resources, Advocacy, Referral, Education), aimed at addressing poor families' material needs - food security, employment, parental education, housing stability, household heat, and childcare - by systematically screening for these needs and referring families to existing community-based services. To date, the investigators have tested WE CARE primarily in community health centers (CHCs); their randomized controlled trial (RCT) demonstrated WE CARE's efficacy on parental receipt of community-based resources. However, over 80% of low-income children receive care from providers in traditional pediatric practices (i.e. non-CHCs). The investigators therefore will conduct a large-scale, Hybrid Type 2 effectiveness-implementation trial in eighteen pediatric practices in the US. A stepped wedge study cluster RCT design will be used to implement WE CARE in all practices using two common strategies used to integrate systems-based interventions into primary care - a previously facilitated "on-site" strategy in which content experts provide training sessions and on-going consultation; and a self-directed "web-based" method modeled after the American Academy of Pediatrics' practice transformation strategy. The proposed study's specific aims are to: 1) demonstrate the non-inferiority of the self-directed, web-based strategy for implementing WE CARE, in comparison to the facilitated on-site strategy; 2) demonstrate WE CARE's effectiveness on increasing parental receipt of community resources; and 3) assess the sustainability of WE CARE in pediatric practices. The investigators hypothesize that WE CARE will have equivalent fidelity via the two strategies. Based on prior work, the investigators hypothesize that WE CARE will significantly increase parental receipt of community resources three months post-visit compared to usual care. The investigators also expect WE CARE to be sustained 1.5-, 2-, and 2.5-years post-implementation; they expect to gather data from over 2,700 chart reviews, 2,520 parent-child dyads, and 360 providers and office staff. This proposal has significant public health implications for the delivery of primary care to low-income children.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1872
• Est. completion date: November 1, 2023
• Est. primary completion date: September 26, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Months to 10 Years

Eligibility

Inclusion Criteria:

• Parents/legal guardians (aged at least 18 years) of children aged 2 months through 10 years whose child presents for a health supervision visit

Exclusion Criteria:

• Foster parents, parents who speak neither English or Spanish, and previously enrolled parents

Related Conditions & MeSH terms

• Basic Unmet Material Needs
• Patient Satisfaction
• Provider Referrals
• Receipt of Community Resources

Intervention

Behavioral:
• WE CARE
The WE CARE (Well-child care visit, Evaluation, Community Resources, Advocacy, Referral, Education) survey consists of 12 questions used to identify six unmet material needs (education, employment, food security, housing, childcare, household utilities). It will be administered at health supervision visits during the WE CARE phase at each study site. The Family Resource Book will contain resource information sheets for each of these needs listing available community resources. A physician champion will conduct regular booster sessions every 4 months and train new providers should there be staff turnover.

Locations

Country	Name	City	State
United States	Boston Medical Center	Boston	Massachusetts

Sponsors (5)

Lead Sponsor	Collaborator
University of Massachusetts, Worcester	Boston University, Continuity Research Network, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Pediatric Research in Office Settings

Country where clinical trial is conducted

United States, 

References & Publications (2)

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	Receipt of Community Resources	Effectiveness outcome of WE CARE (Well-child care visit, Evaluation, Community Resources, Advocacy, Referral, Education) on parental receipt of community resources	3 months post-index visit
Primary	Provider Referrals for Unmet Material Needs at Visit	Implementation outcome of WE CARE on provider referrals	Baseline at Index visit
Secondary	WE CARE survey distribution	Sustainability of WE CARE- office staff outcome	1.5-,2-,and 2.5- years post-implementation of WE CARE
Secondary	Appropriate referrals made by providers	Sustainability of WE CARE- provider outcome	1.5-,2-,and 2.5- years post-implementation of WE CARE
Secondary	Patient satisfaction measured via the CAHPS Clinician and Group Survey (Child)	Parental assessment of satisfaction of pediatric care received	3 months post-index visit
Secondary	Family centeredness measured via the National Survey of Children's Health (2016)	Parental assessment of family centeredness of pediatric care received	3 months post-index visit
Secondary	Care coordination measured via the National Survey of Children's Health (2016)	Parental assessment of the care coordination of pediatric care received	3 months post-index visit
Secondary	Acceptability of WE CARE measured via questionnaires	Providers and Office staff acceptability views on WE CARE	Through study completion; baseline and 12-15 months into WE CARE phase at all sites
Secondary	Whether Discussion of Unmet Needs (e.g., food insecurity) occurred at child's well-child care visit	Measurement of whether discussion of unmet social needs occurred during pediatric visit	Baseline at index visit
Secondary	Appropriateness of WE CARE measured via questionnaire	Providers and Office staff appropriateness views on WE CARE	Through study completion; baseline and 12-15 months into WE CARE phase at all sites