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

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.

Study Overview

• Status: Completed
• Conditions: Patient Satisfaction; Basic Unmet Material Needs; Receipt of Community Resources; Provider Referrals
• Intervention / Treatment: Behavioral: WE CARE

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.

• Study Type: Interventional
• Enrollment (Actual): 1872
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Margaret Parker, MD; Phone Number: 617-414-3655; Email: Margaret.Parker@bmc.org
• Study Contact Backup: Name: Annelise Brochiere, MPH; Phone Number: (617) 414-3630; Email: Annelise.Brochier@bmc.org

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Boston Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 8 years (Child)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual Care-Control; Participants in the usual care group will receive standard pediatric care.
Experimental: 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.	Behavioral: 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.
Experimental: 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	Behavioral: 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Massachusetts, Worcester
• Collaborators: Boston University; Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); Pediatric Research in Office Settings; Continuity Research Network
• Investigators: Principal Investigator: Arvin Garg, MD, MPH, University of Massachusets Medical School

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 7, 2019
• Primary Completion (Actual): September 26, 2023
• Study Completion (Actual): November 1, 2023

Study Registration Dates

• First Submitted: September 26, 2016
• First Submitted That Met QC Criteria: September 27, 2016
• First Posted (Estimated): September 29, 2016

Study Record Updates

• Last Update Posted (Actual): January 5, 2024
• Last Update Submitted That Met QC Criteria: January 3, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: WE CARE; Pediatric practices
• Other Study ID Numbers: H-35482; R01HD090191 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No