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

This study is not yet open for participant recruitment.
Verified April 2010 by Rhode Island Hospital
Sponsor:
Information provided by:
Rhode Island Hospital
ClinicalTrials.gov Identifier:
NCT00476255
First received: May 18, 2007
Last updated: May 4, 2010
Last verified: April 2010

May 18, 2007
May 4, 2010
December 2011
November 2014   (final data collection date for primary outcome measure)
Self-reported child safety restraint practices, attitudes and knowledge [ Time Frame: 3 months post intervention ] [ Designated as safety issue: No ]
Self-reported child safety restraint practices, attitudes and knowledge [ Time Frame: 3 months post intervention ]
Complete list of historical versions of study NCT00476255 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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Evaluating Models for Dissemination of Injury Prevention Information in the Pediatric Emergency Department Setting
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
  • Car Seats
  • Injuries
  • Behavioral: Standard Care
    Usual ED care
  • Behavioral: Enhanced Standard Care (ESC)
    Reading material
  • Behavioral: Brief Motivational Intervention (BMI)
    Motivational interview with trained therapist
  • No Intervention: Standard Care
    Standard emergency department care
    Intervention: Behavioral: Standard Care
  • Active Comparator: Enhanced Standard Care
    Instructional materials
    Intervention: Behavioral: Enhanced Standard Care (ESC)
  • Experimental: Motivational Intervention
    Motivational interview
    Intervention: Behavioral: Brief Motivational Intervention (BMI)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
555
Not Provided
November 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact: James G Linakis, PhD, MD 401-444-6680 James_Linakis_PhD@brown.edu
United States
 
NCT00476255
0080-06
Yes
James G. Linakis, PhD, MD, Principal Investigator, Rhode Island Hospital
Rhode Island Hospital
Not Provided
Principal Investigator: James G Linakis, PhD, MD Rhode Island Hospital
Rhode Island Hospital
April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP