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

NCT02918435 | Completed

• 2 other identifiers: H-35482R01HD090191
• Study Type: interventional
• Target: 1,872
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

WE CARE; Pediatric practices

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• WE CARE survey distribution

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

• Appropriate referrals made by providers

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

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

  3 months post-index visit

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

  3 months post-index visit

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

  3 months post-index visit

Study Arms (3)

Usual Care-Control

NO INTERVENTION

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

On-site WE CARE implementation arm

EXPERIMENTAL

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

Self-directed web-based WE CARE implementation arm

EXPERIMENTAL

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

Interventions

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.

On-site WE CARE implementation arm; Self-directed web-based WE CARE implementation arm

Eligibility Criteria

• Age: 2 Months - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Parents/legal guardians (aged at least 18 years) of children aged 2 months through 10 years whose child presents for a health supervision visit

You may not qualify if:

• Foster parents, parents who speak neither English or Spanish, and previously enrolled parents

Sponsors & Collaborators

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

Study Sites (1)

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Related Publications (2)

• 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.

  PMID: 25560448 BACKGROUND

• 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.

  PMID: 17766528 BACKGROUND

MeSH Terms

Conditions

Patient Satisfaction

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Arvin Garg, MD, MPH

  University of Massachusets Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 26, 2016
• First Posted: September 29, 2016
• Study Start: October 7, 2019
• Primary Completion: September 26, 2023
• Study Completion: November 1, 2023
• Last Updated: October 2, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)