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

• ClinicalTrials.gov Identifier: NCT02918435
• Recruitment Status: Recruiting
• First Posted: September 29, 2016
• Last Update Posted: December 19, 2022
• Sponsor: Boston Medical Center
• Collaborators: Pediatric Research in Office Settings; Continuity Research Network; Boston University; Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Information provided by (Responsible Party): Boston Medical Center

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Basic Unmet Material Needs; Patient Satisfaction; Receipt of Community Resources; Provider Referrals	Behavioral: WE CARE	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 2520 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Screening
• Official Title: Implementing an Intervention to Address Social Determinants of Health in Pediatric Practices
• Actual Study Start Date: October 7, 2019
• Estimated Primary Completion Date: June 2023
• Estimated Study Completion Date: June 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 2 Months to 10 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Contacts

Contact: Margaret Parker, MD; 617-414-3655; Margaret.Parker@bmc.org

Contact: Annelise Brochiere, MPH; (617) 414-3630; Annelise.Brochier@bmc.org

Locations

United States, Massachusetts

Arvin Garg; Recruiting

Boston, Massachusetts, United States, 02118

Principal Investigator: Arvin Garg, MD

Sponsors and Collaborators

Boston Medical Center

Pediatric Research in Office Settings

Continuity Research Network

Boston University

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

Investigators

• Principal Investigator: Arvin Garg, MD, MPH; University of Massachusets Medical School

More Information

Publications:

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.

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.

• Responsible Party: Boston Medical Center
• ClinicalTrials.gov Identifier: NCT02918435
• Other Study ID Numbers: H-35482; R01HD090191 ( U.S. NIH Grant/Contract )
• First Posted: September 29, 2016
• Last Update Posted: December 19, 2022
• Last Verified: December 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Boston Medical Center:

WE CARE; Pediatric practices