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Emergency Department Brief Intervention to Increase Carbon Monoxide Detector Use (ProjectCODE)

Primary Purpose

Intervention-carbon Monoxide Alarm + Educational Tool, Control- Usual Care Flyer on Carbon Monoxide

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Educational Tool & Carbon Monoxide Alarm
Sponsored by
Lara McKenzie
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Intervention-carbon Monoxide Alarm + Educational Tool focused on measuring Carbon Monoxide (CO), Carbon Monoxide Poisoning, Carbon Monoxide Alarm/Detector, Precaution Adoption Process Model (PAPM), Injury Prevention, Emergency Department

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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.

Sites / Locations

  • The Research Institute at Nationwide Children's Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Educational tool & Carbon Monoxide Alarm

Arm Description

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

Outcomes

Primary Outcome Measures

Observation of working carbon monoxide alarms

Secondary Outcome Measures

Behavioral profile and Precaution Adoption Process Model(PAPM)stage

Full Information

First Posted
August 13, 2009
Last Updated
January 29, 2014
Sponsor
Lara McKenzie
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1. Study Identification

Unique Protocol Identification Number
NCT00959478
Brief Title
Emergency Department Brief Intervention to Increase Carbon Monoxide Detector Use
Acronym
ProjectCODE
Official Title
Emergency Department Brief Intervention to Increase Carbon Monoxide Detector Use
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
March 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Lara McKenzie

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Poisoning from Carbon Monoxide (CO) is among the leading causes of non-fatal injuries treated in US hospital emergency departments and accounts for approximately 500 unintentional deaths each year. Known effective countermeasures to detect CO and reduce CO poisoning exist, yet are not routinely utilized. Although there is increasing concern about the need to increase CO detector use, little is known about how best to do so, especially for low income families. This research aims to address this gap, by applying a theory of stage-based behavior change-the Precaution Adoption Process Model PAPM)-to a brief intervention feasible for a busy emergency department setting. A randomized trial will be conducted involving 300 families with children 18 years or younger. In the Pediatric Emergency Department (PED), eligible parents will randomly be assigned to receive the Project CODE intervention (an educational tool and a CO detector) or usual care (a flyer on CO poisoning). The use of a CO detector and participant's PAPM stage will be assessed at enrollment and again at follow-up home visits occurring two-weeks and six-months following the PED visit. We 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 a two-week and six-month follow-up home visits. By examining the extent to which the intervention increases CO detector use, these findings will also demonstrate how innovative health communications (brief interventions delivered in the PED) can reduce the risk of injuries among vulnerable children. This research builds on and extends the investigators' previous work on behavioral theory, injury prevention interventions delivered in the PED, and development and evaluation of interactive educational tools for safety practices. The specific aims of this project are as follows: Aim 1-Determine whether a brief intervention will increase CO detector use and PAPM stage among parents whose children are being seen in a PED compared to parents of children receiving routine care CO flyer; and Aim 2-Determine whether and to what extent socioeconomic status moderates the effect of the intervention. Findings from this research study will have both theoretical and practical applications for improving injury prevention services in PEDs. This single-site efficacy trial is the first step in determining whether a brief intervention in the PED will successfully increase CO detector use.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intervention-carbon Monoxide Alarm + Educational Tool, Control- Usual Care Flyer on Carbon Monoxide
Keywords
Carbon Monoxide (CO), Carbon Monoxide Poisoning, Carbon Monoxide Alarm/Detector, Precaution Adoption Process Model (PAPM), Injury Prevention, Emergency Department

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
300 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Educational tool & Carbon Monoxide Alarm
Arm Type
Experimental
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
Educational Tool & Carbon Monoxide Alarm
Other Intervention Name(s)
Fast Facts about Carbon Monoxide Educational Tool
Intervention Description
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.
Primary Outcome Measure Information:
Title
Observation of working carbon monoxide alarms
Time Frame
Two-weeks and six-months following enrollment
Secondary Outcome Measure Information:
Title
Behavioral profile and Precaution Adoption Process Model(PAPM)stage
Time Frame
Two-weeks and six-months following enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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). Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lara B. McKenzie, PhD
Organizational Affiliation
Center for Inury Research and Policy, The Research Institute at Nationwide Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Research Institute at Nationwide Children's Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
28007971
Citation
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.
Results Reference
derived
Links:
URL
http://www.injurycenter.org
Description
The Center for Injury Research and Policy, The Research Institute at Nationwide Children's Hospital

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Emergency Department Brief Intervention to Increase Carbon Monoxide Detector Use

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