Evaluating Models for Dissemination of Injury Prevention Information in the Pediatric Emergency Department Setting

Injuries Clinical Trial

Official title:

Evaluating Models for Dissemination of Injury Prevention Information in the PED

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00476255
• Other study ID #: 0080-06
• Status: Withdrawn
• Phase: N/A
• First received: May 18, 2007
• Last updated: November 5, 2014
• Start date: December 2011

Study information

• Verified date: April 2010
• Source: Rhode Island Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This study examines the Pediatric Emergency Department as a location for increasing safe car seat practices by parents who are not restraining their children appropriately in motor vehicles. Three different intervention will be tested to determine their effectiveness in increasing safe car seat practices: usual emergency department care; provision of printed materials; and a brief motivational intervention in the emergency department.

Description:

The long-term goal of the present research program is to enhance the utilization of evidence-based injury prevention strategies and to encourage medical practitioners to disseminate focused information regarding injury prevention in the Pediatric Emergency Department (ED). This study examines the Pediatric Emergency Department as a location for increasing safe car seat practices by parents who are not restraining their children appropriately in motor vehicles. Three different intervention will be tested to determine their effectiveness in increasing safe car seat practices. The proposed research plan: 1. examines the efficacy of a Brief Motivational Intervention to enhance automobile safety restraint-specific injury prevention behaviors in parents/caregivers of younger children; and 2. examines the efficacy of focused, behavior-specific, injury prevention discharge instruction supplements (Enhanced Standard Care) in increasing safety restraint-specific injury prevention behaviors in parents/caregivers of younger children. We will conduct a randomized, controlled trial of parent/caregivers of children being evaluated in the Hasbro Children's Hospital Emergency Department in Providence, Rhode Island. Eligible, consenting participants will be screened with an injury assessment tool for inappropriate use of motor vehicle child safety restraints. High risk participants will be randomized into three intervention groups: Standard Care (SC), Enhanced Standard Care (ESC) and Brief Motivational Intervention (BMI). All participants will then be contacted three months following enrollment and surveyed regarding child safety restraint practices, attitudes and knowledge. The following main effects will be evaluated with relation to child safety restraint practice and attitude change: 1. Intervention (SC vs. ESC vs. BMI); 2. Injury status of child (Injured vs. non-injured). In addition, we will monitor re-injury rates of the index children of all enrolled parent/caregivers for one year from the time of enrollment and compare on the bases of the above main effects.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: November 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Parents/primary caregivers of children ages 0-7 years who are being seen in the Pediatric ED for a non life-threatening injury or non-injury related complaint

• Parents/primary caregivers whose children are medically stable

• Parent/primary caregiver has legal custody of the index child and is able to provide informed consent for participation

• Parent/primary caregiver speaks English or Spanish

• Parent/primary caregiver must have access to a motor vehicle in which the child is transported

Exclusion Criteria:

• parents/primary caregivers who are cognitively unable to take part in the intervention

• those whose children are suspected by the clinical staff of being victims of child abuse

• those whose children are medically or surgically unstable

• those whose children are being evaluated for possible psychiatric disorders or suicidal ideation

• those who do not speak English or Spanish, and those without a telephone

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Car Seats
• Injuries

Intervention

Behavioral:
• Enhanced Standard Care (ESC)
Reading material
• Brief Motivational Intervention (BMI)
Motivational interview with trained therapist

Locations

Country	Name	City	State
United States	Hasbro Children's Hospital	Providence	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
Rhode Island Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Self-reported child safety restraint practices, attitudes and knowledge		3 months post intervention	No