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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02918435
Acronym
PROSWECARE
Enrollment
1872
Registered
2016-09-29
Start date
2019-10-07
Completion date
2023-11-01
Last updated
2024-10-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

WE CARE, Pediatric practices

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.

Interventions

BEHAVIORALWE 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.

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SCREENING
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
2 Months to 10 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Receipt of Community Resources3 months post-index visitEffectiveness outcome of WE CARE (Well-child care visit, Evaluation, Community Resources, Advocacy, Referral, Education) on parental receipt of community resources
Provider Referrals for Unmet Material Needs at VisitBaseline at Index visitImplementation outcome of WE CARE on provider referrals

Secondary

MeasureTime frameDescription
Patient satisfaction measured via the CAHPS Clinician and Group Survey (Child)3 months post-index visitParental assessment of satisfaction of pediatric care received
Family centeredness measured via the National Survey of Children's Health (2016)3 months post-index visitParental assessment of family centeredness of pediatric care received
Care coordination measured via the National Survey of Children's Health (2016)3 months post-index visitParental assessment of the care coordination of pediatric care received
WE CARE survey distribution1.5-,2-,and 2.5- years post-implementation of WE CARESustainability of WE CARE- office staff outcome
Whether Discussion of Unmet Needs (e.g., food insecurity) occurred at child's well-child care visitBaseline at index visitMeasurement of whether discussion of unmet social needs occurred during pediatric visit
Appropriateness of WE CARE measured via questionnaireThrough study completion; baseline and 12-15 months into WE CARE phase at all sitesProviders and Office staff appropriateness views on WE CARE
Acceptability of WE CARE measured via questionnairesThrough study completion; baseline and 12-15 months into WE CARE phase at all sitesProviders and Office staff acceptability views on WE CARE
Appropriate referrals made by providers1.5-,2-,and 2.5- years post-implementation of WE CARESustainability of WE CARE- provider outcome

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026