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

University of Massachusetts, Worcester

Status: Completed

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

Treatments: Behavioral: WE CARE

Study type: Interventional

Funder types: Other; NETWORK; NIH

Identifiers

NCT02918435

H-35482

R01HD090191 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,872 patients

Sex: All

Ages: 2 months to 10 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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1,872 participants in 3 patient groups

Usual Care-Control

No Intervention group

Description:

Participants in the usual care group will receive standard pediatric care.

On-site WE CARE implementation arm

Experimental group

Description:

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.

Treatment:

Behavioral: WE CARE

Self-directed web-based WE CARE implementation arm

Experimental group

Description:

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

Treatment:

Behavioral: WE CARE