NCT03239041

Brief Summary

Social determinants of health affect patients throughout the life course. They may be particularly relevant for pediatric emergency department (ED) patients. Computerized screening for social and behavioral determinants of health has been deemed effective and acceptable. This pilot study will characterize the cumulative burden of health related social problems experienced by patients and families in a pediatric ED. It will specifically examine those patients with a subset of 9 high-risk chief complaints, patients with obesity, patients with poor asthma control, and patients with a high number of non-urgent visits, who may be at particularly high risk for health related social problems. Our analysis will compare these subsets of patients with the general ED population, hypothesizing that these groups will have a higher number of health related social problems than the general ED population. Parent and adolescent participants will be approached during ED visits and administered a computerized screening tool. For patients aged 0-13, a survey administered to parents will test for thirteen distinct health related social problems. Two surveys will be administered to adolescent-parent dyads. The adolescent survey will test for thirteen health related social problems, seven of which overlap with those on the parent survey. The average total number of health related social problems in patient groups hypothesized to be at high risk will be compared to the average total number of HRSPs in the general ED population. For adolescent patients, an intervention group will receive social navigation consisting of rapid referrals to community resources based on survey responses by a community health liaison. Their ED recidivism, community resource use and number of unmet social needs at 12-month follow up will be compared with that of a control group that receives screening and written resources only.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
395

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 1, 2017

Completed
Same day until next milestone

Study Start

First participant enrolled

August 1, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 3, 2017

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
Last Updated

July 29, 2024

Status Verified

July 1, 2024

Enrollment Period

5.4 years

First QC Date

August 1, 2017

Last Update Submit

July 26, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Emergency Department Recidivism

    Number of ED visits

    12 months

Secondary Outcomes (1)

  • Community Resource Use

    12 months

Study Arms (2)

Intervention Arm

ACTIVE COMPARATOR

The intervention group will have access to the services of a social navigation team. The social navigation team will consist of trained community health liaisons, a clinician and a social worker. The social navigation team will function as follows: The research assistant will then instruct the community health intern to review the results of the completed computerized survey. The community health intern will review the results, create a plan of action, i.e. specific referrals to community agencies and next steps needed by the caregiver and or adolescent (e.g., documents to gather, appointments to make, etc.), following pre-developed protocols for each risk area. Each plan will be reviewed with the social worker prior to presentation to the family. Each family will also receive a packet of community resources relevant to each social domain covered in the screening survey, similar to that provided to the enhanced usual care group.

Behavioral: Social navigation team

Enhanced Usual Care Arm

NO INTERVENTION

The enhanced usual care arm will only receive printed information regarding community resources.

Interventions

Social navigation team

Intervention Arm

Eligibility Criteria

Age0 Years - 21 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • between 13 and 21 years of age for intervention and control arms
  • English or Spanish speaking

You may not qualify if:

  • Not English or Spanish speaking
  • Caregiver or adolescent developmentally delayed or altered mental status
  • Patient in custody of police or child protective services

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's National Health System

Washington D.C., District of Columbia, 20010, United States

Location

Related Publications (1)

  • Rucker A, Watson A, Badolato G, Jarvis L, Patel SJ, Goyal MK. Social Navigation for Adolescent Emergency Department Patients: A Randomized Clinical Trial. J Adolesc Health. 2024 Feb;74(2):292-300. doi: 10.1016/j.jadohealth.2023.08.030. Epub 2023 Oct 7.

MeSH Terms

Conditions

Adolescent BehaviorEmergencies

Condition Hierarchy (Ancestors)

BehaviorDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Alexandra C Rucker, MD

    Children's National Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Pediatrics

Study Record Dates

First Submitted

August 1, 2017

First Posted

August 3, 2017

Study Start

August 1, 2017

Primary Completion

December 30, 2022

Study Completion

December 30, 2022

Last Updated

July 29, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations