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

Not Applicable

Completed

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

Interventions: Behavioral: WE CARE

Registration Number: NCT02918435

Lead Sponsor: University of Massachusetts, Worcester

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 1872

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Self-directed web-based WE CARE implementation arm	WE CARE	WE CARE will be implemented in the study site using a web-based implementation strategy. 1. Participants will receive the WE CARE survey at health supervision visits; this survey will be used to identify unmet material needs. 2. Providers will be trained on WE CARE via web-based tools (e.g., web-based seminar) which will teach them how to review the survey and provide referrals (community resource information sheets) from a Family Resource Book located in each exam room
On-site WE CARE implementation arm	WE CARE	WE CARE will be implemented in the study site using a facilitated "on-site" strategy. 1. Participants will receive the WE CARE survey at health supervision visits; this survey will be used to identify unmet material needs. 2. Providers will be trained on WE CARE via an on-site team which will teach them how to review the survey and provide referrals (community resource information sheets) from a Family Resource Book located in each exam room.

Primary Outcome Measures

Name	Time	Method
Receipt of Community Resources	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	Baseline at Index visit	Implementation outcome of WE CARE on provider referrals

Secondary Outcome Measures

Name	Time	Method
Appropriate referrals made by providers	1.5-,2-,and 2.5- years post-implementation of WE CARE	Sustainability of WE CARE- provider outcome
Acceptability of WE CARE measured via questionnaires	Through study completion; baseline and 12-15 months into WE CARE phase at all sites	Providers and Office staff acceptability views on WE CARE
Patient satisfaction measured via the CAHPS Clinician and Group Survey (Child)	3 months post-index visit	Parental assessment of satisfaction of pediatric care received
WE CARE survey distribution	1.5-,2-,and 2.5- years post-implementation of WE CARE	Sustainability of WE CARE- office staff outcome
Family centeredness measured via the National Survey of Children's Health (2016)	3 months post-index visit	Parental assessment of family centeredness of pediatric care received
Care coordination measured via the National Survey of Children's Health (2016)	3 months post-index visit	Parental assessment of the care coordination of pediatric care received
Whether Discussion of Unmet Needs (e.g., food insecurity) occurred at child's well-child care visit	Baseline at index visit	Measurement of whether discussion of unmet social needs occurred during pediatric visit
Appropriateness of WE CARE measured via questionnaire	Through study completion; baseline and 12-15 months into WE CARE phase at all sites	Providers and Office staff appropriateness views on WE CARE