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OpenTrials
Completed

NCT Number: NCT02918435

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

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.

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Key information

Age range

2 month–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Boston Medical Center

Boston, Massachusetts, 02118, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

WE CARE

Behavioral

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.

Primary outcomes

  1. 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

  2. Provider Referrals for Unmet Material Needs at Visit

    Time frame: Baseline at Index visit

    Implementation outcome of WE CARE on provider referrals

Secondary outcomes

  1. WE CARE survey distribution

    Time frame: 1.5-,2-,and 2.5- years post-implementation of WE CARE

    Sustainability of WE CARE- office staff outcome

  2. Appropriate referrals made by providers

    Time frame: 1.5-,2-,and 2.5- years post-implementation of WE CARE

    Sustainability of WE CARE- provider outcome

  3. Patient satisfaction measured via the CAHPS Clinician and Group Survey (Child)

    Time frame: 3 months post-index visit

    Parental assessment of satisfaction of pediatric care received

  4. Family centeredness measured via the National Survey of Children's Health (2016)

    Time frame: 3 months post-index visit

    Parental assessment of family centeredness of pediatric care received

  5. Care coordination measured via the National Survey of Children's Health (2016)

    Time frame: 3 months post-index visit

    Parental assessment of the care coordination of pediatric care received

  6. Acceptability of WE CARE measured via questionnaires

    Time frame: Through study completion; baseline and 12-15 months into WE CARE phase at all sites

    Providers and Office staff acceptability views on WE CARE

  7. Whether Discussion of Unmet Needs (e.g., food insecurity) occurred at child's well-child care visit

    Time frame: Baseline at index visit

    Measurement of whether discussion of unmet social needs occurred during pediatric visit

  8. Appropriateness of WE CARE measured via questionnaire

    Time frame: Through study completion; baseline and 12-15 months into WE CARE phase at all sites

    Providers and Office staff appropriateness views on WE CARE

Sponsors and collaborators

Lead sponsor

University of Massachusetts, Worcester

Other

Collaborators

  • Boston University
  • Continuity Research Network
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • Pediatric Research in Office Settings

Registry information

Acronym: PROSWECARE

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Sep 29, 2016
Registry last updated
Oct 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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