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

November 5, 2014 updated by: Rhode Island Hospital

Evaluating Models for Dissemination of Injury Prevention Information in the PED

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.

Study Overview

Detailed 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.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Hasbro Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Enhanced Standard Care
Instructional materials
Reading material
Experimental: Motivational Intervention
Motivational interview
Motivational interview with trained therapist

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Self-reported child safety restraint practices, attitudes and knowledge
Time Frame: 3 months post intervention
3 months post intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: James G Linakis, PhD, MD, Rhode Island Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2011

Primary Completion (Actual)

November 1, 2014

Study Registration Dates

First Submitted

May 18, 2007

First Submitted That Met QC Criteria

May 18, 2007

First Posted (Estimate)

May 21, 2007

Study Record Updates

Last Update Posted (Estimate)

November 7, 2014

Last Update Submitted That Met QC Criteria

November 5, 2014

Last Verified

April 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0080-06

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Injuries

Clinical Trials on Enhanced Standard Care (ESC)

3
Subscribe