Emergency Department Brief Intervention to Increase Carbon Monoxide Detector Use (ProjectCODE)
This study has been completed.
Information provided by (Responsible Party):
Lara McKenzie, Nationwide Children's Hospital
First received: August 13, 2009
Last updated: January 29, 2014
Last verified: January 2014
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.
Intervention-carbon Monoxide Alarm + Educational Tool
Control- Usual Care Flyer on Carbon Monoxide
Behavioral: Educational Tool & Carbon Monoxide Alarm
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
||Emergency Department Brief Intervention to Increase Carbon Monoxide Detector Use
Primary Outcome Measures:
- Observation of working carbon monoxide alarms [ Time Frame: Two-weeks and six-months following enrollment ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Behavioral profile and Precaution Adoption Process Model(PAPM)stage [ Time Frame: Two-weeks and six-months following enrollment ] [ Designated as safety issue: No ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||September 2010 (Final data collection date for primary outcome measure)
Experimental: Educational tool & Carbon Monoxide Alarm
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.
- Fast Facts about Carbon Monoxide Educational Tool
- Kidde Nighthawk Carbon Monoxide Alarm
- Central Ohio Poison Control Center Flyer
Behavioral: Educational Tool & Carbon Monoxide Alarm
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.
Other Name: Fast Facts about Carbon Monoxide Educational Tool
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.
|Ages Eligible for Study:
||18 Years and older (Adult, Senior)
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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).
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00959478
|The Research Institute at Nationwide Children's Hospital
|Columbus, Ohio, United States, 43205 |
||Lara B. McKenzie, PhD
||Center for Inury Research and Policy, The Research Institute at Nationwide Children's Hospital
||Lara McKenzie, Principal Investigator, Nationwide Children's Hospital
History of Changes
|Other Study ID Numbers:
Grant No.: R01HD057155
|Study First Received:
||August 13, 2009
||January 29, 2014
||United States: Institutional Review Board
Keywords provided by Nationwide Children's Hospital:
Carbon Monoxide (CO)
Carbon Monoxide Poisoning
Carbon Monoxide Alarm/Detector
Precaution Adoption Process Model (PAPM)
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on December 02, 2016
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs