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

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Behavioral: WE CARE


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Months
Maximum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual Care-Control<br>Participants in the usual care group will receive standard pediatric care. | |
| Experimental: On-site WE CARE implementation arm<br>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. | Behavioral: WE CARE<br>* 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.<br>|
| Experimental: Self-directed web-based WE CARE implementation arm<br>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 | Behavioral: WE CARE<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Receipt of Community Resources | Effectiveness outcome of WE CARE (Well-child care visit, Evaluation, Community Resources, Advocacy, Referral, Education) on parental receipt of community resources | 3 months post-index visit | 
| Provider Referrals for Unmet Material Needs at Visit | Implementation outcome of WE CARE on provider referrals | Baseline at Index visit | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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WE CARE, Pediatric practices