Clinical trial NCT02918435: Implementing an Intervention to Address Social Determinants of Health in Pediatric Practices
Official title: Implementing an Intervention to Address Social Determinants of Health in Pediatric Practices
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Basic Unmet Material Needs
Patient Satisfaction
Receipt of Community Resources
Provider Referrals
Keywords: WE CARE
Pediatric practices
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
Collaborators: name: Pediatric Research in Office Settings
name: Continuity Research Network
name: Boston University
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2016-09-29
Enrollment: 1872
Sex: ALL
Minimum age (years): 2
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SCREENING

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Receipt of Community Resources
timeFrame: 3 months post-index visit
measure: Provider Referrals for Unmet Material Needs at Visit
timeFrame: Baseline at Index visit
Secondary outcomes:
measure: WE CARE survey distribution
timeFrame: 1.5-,2-,and 2.5- years post-implementation of WE CARE
measure: Appropriate referrals made by providers
timeFrame: 1.5-,2-,and 2.5- years post-implementation of WE CARE
measure: Patient satisfaction measured via the CAHPS Clinician and Group Survey (Child)
timeFrame: 3 months post-index visit
measure: Family centeredness measured via the National Survey of Children's Health (2016)
timeFrame: 3 months post-index visit
measure: Care coordination measured via the National Survey of Children's Health (2016)
timeFrame: 3 months post-index visit
measure: Acceptability of WE CARE measured via questionnaires
timeFrame: Through study completion; baseline and 12-15 months into WE CARE phase at all sites
measure: Whether Discussion of Unmet Needs (e.g., food insecurity) occurred at child's well-child care visit
timeFrame: Baseline at index visit
measure: Appropriateness of WE CARE measured via questionnaire
timeFrame: Through study completion; baseline and 12-15 months into WE CARE phase at all sites
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
Study officials:
affiliation: University of Massachusets Medical School
name: Arvin Garg, 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.