NCT00959478

Brief Summary

Carbon Monoxide (CO) exposure kills and injures thousands of children and families each year. Although there is growing concern about the need to increase carbon monoxide detector use, little is known about how best to do so, especially for low-income families. The objective of this research is to determine whether a brief intervention, Project Carbon Monoxide Detector Education (Project CODE), will increase CO detector use. For this study, parents of children, 18 years or younger, will be randomly assigned to receive Project CODE (an educational tool and a CO detector) or usual care (a flyer on CO poisoning); both of which will be delivered in the Pediatric Emergency Department (PED) examination rooms. The use of a CO detector and the participant's current stage in the theory of stage-based behavior change-the Precaution Adoption Process Model (PAPM), will be assessed at enrollment and then again at the home visits which will occur two-weeks and six-months following the PED visit. The investigators hypothesize that parents receiving Project CODE will have working CO detectors and will be further along in the PAPM than parents in the control group at the two-week and six-month home visits. The long term goal of this research is to reduce the number of injuries and deaths from CO poisoning.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2009

Typical duration 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 13, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 14, 2009

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

January 30, 2014

Status Verified

January 1, 2014

Enrollment Period

1.3 years

First QC Date

August 13, 2009

Last Update Submit

January 29, 2014

Conditions

Keywords

Carbon Monoxide (CO)Carbon Monoxide PoisoningCarbon Monoxide Alarm/DetectorPrecaution Adoption Process Model (PAPM)Injury PreventionEmergency Department

Outcome Measures

Primary Outcomes (1)

  • Observation of working carbon monoxide alarms

    Two-weeks and six-months following enrollment

Secondary Outcomes (1)

  • Behavioral profile and Precaution Adoption Process Model(PAPM)stage

    Two-weeks and six-months following enrollment

Study Arms (1)

Educational tool & Carbon Monoxide Alarm

EXPERIMENTAL

Parents will be randomly assigned into a control and intervention group. Both groups will complete a computer based survey at enrollment and at their home visits occuring two weeks and approximately six months following enrollment. Participants will be given the following materials at enrollment. Intervention: * Fast Facts about Carbon Monoxide Educational Tool * Kidde Nighthawk Carbon Monoxide Alarm Control: \- Central Ohio Poison Control Center Flyer

Behavioral: Educational Tool & Carbon Monoxide Alarm

Interventions

Based on the recommendations from the expert panel and focus group meetings, Fast Facts about Carbon Monoxide was developed to be an educational tool aimed at helping parents understand the dangers of CO and the need CO alarms in every home. In addition, this tool will help parents select and purchase the correct CO alarm, as well as properly install and maintain the alarm in their home. Each parent assigned to the intervention group will be given a Fast Facts about Carbon Monoxide educational tool and a Kidde Nighthawk Carbon Monoxide Alarm at enrollment.

Also known as: Fast Facts about Carbon Monoxide Educational Tool
Educational tool & Carbon Monoxide Alarm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age: The child being treated in the PED must be 18 years old or younger. The parent/guardian of the child being treated must be at least 18 years of age.
  • Current/Previous Enrollment: The participant must only enroll in the study once. A participant may not re-enroll in the study after completing any step of the study nor can they enroll as a result of an additional trip to the PED with the same child or a sibling of that child.
  • English speaking: Participants must feel comfortable answering survey questions that are written in English to be eligible for Project CODE.
  • Parent/Guardian: The parent/guardian is the actual study participant, not the child, even if the child is eighteen years-old. The child treated in the PED must be accompanied by an English-speaking adult and that adult must be the person responsible for ensuring the child's safety in his/her home. The child must live with the adult most of the time.
  • Reason for PED visit: Information regarding the nature of the child's visit will be obtained by reviewing PED triage information via EPIC and must be for an injury or a medical complaint.
  • Place of Residence: Study participants must live in Franklin County (Columbus, Ohio and surrounding area).

You may not qualify if:

  • Children being seen for possible sexual or physical abuse, neglect, behavioral problems, self inflicted harm or a suicide attempt.
  • Children that must see a doctor immediately or are presenting with a critical condition.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Research Institute at Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

Related Publications (1)

  • McKenzie LB, Roberts KJ, Kaercher RM, Collins CL, Comstock RD, Fernandez S, Abdel-Rasoul M, Casavant MJ, Mihalov L. Paediatric emergency department-based carbon monoxide detector intervention: a randomised trial. Inj Prev. 2017 Oct;23(5):314-320. doi: 10.1136/injuryprev-2016-042039. Epub 2016 Dec 22.

Related Links

MeSH Terms

Conditions

Carbon Monoxide PoisoningEmergencies

Condition Hierarchy (Ancestors)

Gas PoisoningPoisoningChemically-Induced DisordersDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Lara B. McKenzie, PhD

    Center for Inury Research and Policy, The Research Institute at Nationwide Children's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 13, 2009

First Posted

August 14, 2009

Study Start

June 1, 2009

Primary Completion

September 1, 2010

Study Completion

March 1, 2012

Last Updated

January 30, 2014

Record last verified: 2014-01

Locations