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

NCT ID: NCT02918435

Last Updated: 2024-10-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1872 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-07
• Study Completion Date: 2023-11-01

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Usual Care-Control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

On-site WE CARE implementation arm

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.

Group Type: EXPERIMENTAL

WE CARE

Intervention Type: 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.

Self-directed web-based WE CARE implementation arm

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

Group Type: EXPERIMENTAL

WE CARE

Intervention Type: 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.

Interventions

WE CARE

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 2 Months
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pediatric Research in Office Settings

NETWORK

Sponsor Role: collaborator

Continuity Research Network

NETWORK

Sponsor Role: collaborator

Boston University

OTHER

Sponsor Role: collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: collaborator

University of Massachusetts, Worcester

OTHER

Sponsor Role: lead

Responsible Party

Arvin Garg

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Arvin Garg, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Massachusets Medical School

Locations

Boston Medical Center

Boston, Massachusetts, United States

Countries

United States

References

Garg A, Toy S, Tripodis Y, Silverstein M, Freeman E. Addressing social determinants of health at well child care visits: a cluster RCT. Pediatrics. 2015 Feb;135(2):e296-304. doi: 10.1542/peds.2014-2888. Epub 2015 Jan 5.

Reference Type: BACKGROUND

PMID: 25560448 (View on PubMed)

Garg A, Butz AM, Dworkin PH, Lewis RA, Thompson RE, Serwint JR. Improving the management of family psychosocial problems at low-income children's well-child care visits: the WE CARE Project. Pediatrics. 2007 Sep;120(3):547-58. doi: 10.1542/peds.2007-0398.

Reference Type: BACKGROUND

PMID: 17766528 (View on PubMed)

Other Identifiers

R01HD090191

Identifier Type: NIH

Identifier Source: secondary_id

View Link

H-35482

Identifier Type: -

Identifier Source: org_study_id