Intervention-carbon Monoxide Alarm + Educational ToolProjectCODENCT00959478
Emergency Department Brief Intervention to Increase Carbon Monoxide Detector Use
A study testing Educational Tool & Carbon Monoxide Alarm in people with Intervention-carbon Monoxide Alarm + Educational Tool and Control- Usual Care Flyer on Carbon Monoxide, run by Lara McKenzie at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Intervention-carbon Monoxide Alarm + Educational Tool, Control- Usual Care Flyer on Carbon Monoxide
- What is being tested?
- Educational Tool & Carbon Monoxide Alarm
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2009to Mar 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Research Institute at Nationwide Children's Hospital
Columbus, Ohio, 43205
About this study
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.
Read the 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.
- Conditions
- Intervention-carbon Monoxide Alarm + Educational Tool, Control- Usual Care Flyer on Carbon Monoxide
- Being tested
- Educational Tool & Carbon Monoxide Alarm
- Keywords
- Carbon Monoxide (CO), Carbon Monoxide Poisoning, Carbon Monoxide Alarm/Detector, Precaution Adoption Process Model (PAPM), Injury Prevention, Emergency Department
- Medical subject headings
- Carbon Monoxide Poisoning, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational Tool & Carbon Monoxide AlarmBehavioural
Also called Fast Facts about Carbon Monoxide Educational Tool
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Educational Tool & Carbon Monoxide Alarm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Observation of working carbon monoxide alarms
Measured: Two-weeks and six-months following enrollment
Secondary outcomes (1)
Behavioral profile and Precaution Adoption Process Model(PAPM)stage
Measured: Two-weeks and six-months following enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2009 (estimated)
- Study startJun 2009
- Primary completionSep 2010
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intervention-carbon Monoxide Alarm + Educational ToolStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lara McKenzie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lara McKenzie, Nationwide Children's Hospital
- Investigators
- Lara B. McKenzie, PhD, Principal investigator, Center for Inury Research and Policy, The Research Institute at Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00959478
- Sponsor's protocol ID
- HD057155
- Other IDs
- Grant No.: R01HD057155
- Acronym
- ProjectCODE
- Status last verified
- Jan 2014
- First submitted
- 13 Aug 2009
- Last updated
- 30 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 28007971
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emergency Department Brief Intervention to Increase Carbon Monoxide Detector Use
- ClinicalTrials.gov ID
- NCT00959478
- Acronym / sponsor ID
- ProjectCODE / HD057155
- Conditions
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Lara McKenzieUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Sep 2010 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 14 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Educational tool & Carbon Monoxide Alarm | Experimental | Behavioral: Educational Tool & Carbon Monoxide AlarmParents 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational Tool & Carbon Monoxide AlarmAlso: Fast Facts about Carbon Monoxide Educational ToolBased 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. | Behavioural | Educational tool & Carbon Monoxide Alarm |
Primary outcome
Observation of working carbon monoxide alarms
Time frame: Two-weeks and six-months following enrollment
1 secondary outcome
Behavioral profile and Precaution Adoption Process Model(PAPM)stage
Time frame: Two-weeks and six-months following enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2014.
- Derived from this study: PubMed 28007971McKenzie 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.
- The Center for Injury Research and Policy, The Research Institute at Nationwide Children's HospitalLink provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lara B. McKenzie, PhD principal investigator
Center for Inury Research and Policy, The Research Institute at Nationwide Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational Tool & Carbon Monoxide Alarm in people with Intervention-carbon Monoxide Alarm + Educational Tool and Control- Usual Care Flyer on Carbon Monoxide, run by Lara McKenzie at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Observation of working carbon monoxide alarms (time frame: Two-weeks and six-months following enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00959478, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2014.