Control- Usual Care Flyer on Carbon Monoxide Clinical Trial
— ProjectCODEOfficial title:
Emergency Department Brief Intervention to Increase Carbon Monoxide Detector Use
Verified date | January 2014 |
Source | Nationwide Children's Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 300 |
Est. completion date | March 2012 |
Est. primary completion date | September 2010 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
United States | The Research Institute at Nationwide Children's Hospital | Columbus | Ohio |
Lead Sponsor | Collaborator |
---|---|
Lara McKenzie |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Observation of working carbon monoxide alarms | Two-weeks and six-months following enrollment | No | |
Secondary | Behavioral profile and Precaution Adoption Process Model(PAPM)stage | Two-weeks and six-months following enrollment | No |