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Clinical Trials/NCT02918435
NCT02918435
Completed
Not Applicable

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

University of Massachusetts, Worcester1 site in 1 country1,872 target enrollmentOctober 7, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Basic Unmet Material Needs
Sponsor
University of Massachusetts, Worcester
Enrollment
1872
Locations
1
Primary Endpoint
Receipt of Community Resources
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 7, 2019
End Date
November 1, 2023
Last Updated
last year
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Sponsor
University of Massachusetts, Worcester
Responsible Party
Principal Investigator
Principal Investigator

Arvin Garg

Principal Investigator

University of Massachusetts, Worcester

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

Outcomes

Primary Outcomes

Receipt of Community Resources

Time Frame: 3 months post-index visit

Effectiveness 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 Visit

Time Frame: Baseline at Index visit

Implementation outcome of WE CARE on provider referrals

Secondary Outcomes

  • Appropriate referrals made by providers(1.5-,2-,and 2.5- years post-implementation of WE CARE)
  • Acceptability of WE CARE measured via questionnaires(Through study completion; baseline and 12-15 months into WE CARE phase at all sites)
  • WE CARE survey distribution(1.5-,2-,and 2.5- years post-implementation of WE CARE)
  • Family centeredness measured via the National Survey of Children's Health (2016)(3 months post-index visit)
  • Care coordination measured via the National Survey of Children's Health (2016)(3 months post-index visit)
  • Patient satisfaction measured via the CAHPS Clinician and Group Survey (Child)(3 months post-index visit)
  • Whether Discussion of Unmet Needs (e.g., food insecurity) occurred at child's well-child care visit(Baseline at index visit)
  • Appropriateness of WE CARE measured via questionnaire(Through study completion; baseline and 12-15 months into WE CARE phase at all sites)

Study Sites (1)

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