Injury in the HomeH3CNCT01740622
Healthy Homes Healthy Children (H3C)
A study testing Injury Prevention Measures in people with Injury in the Home, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial summary
Aim To evaluate the efficacy of a CCHMC Human Resources Benefits program to reduce exposure to injury hazards and subsequent injury-related medical claims for their children. Hypothesis H1: The investigators anticipate, based on our recently completed trial, that the installation of multiple, passive safety devices in… Read more about this study
- Who is it for?
- Ages 6 to 36 monthsHealthy volunteers can take part
- Conditions the study is for
- Injury in the Home
- What is being tested?
- Injury Prevention Measures
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 520 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to Feb 2017
- 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 6 to 36 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Current CCHMC qualified beneficiaries (non-contract workers)
- Child is both covered by a CCHMC health insurance plan and is less than 8 months of age at the time of screening
- Employees must be at least 18 years of age
- Employee must have no plans to leave CCHMC employment within next 12 months
- Employee must have no plans to relocate greater than 90 minutes away from CCHMC in the next 12 months
- Employees must speak fluent English
Who cannot join
- The child is greater than 8 months of age at time of screening
- Employee is non-English speaking
- Not a current CCHMC employee
- Child not covered by CCHMC health insurance plan
- Employees who are not 18 years of age
- Live beyond a 90-minute driving radius from Cincinnati Children's Hospital or have plans to relocate outside of a 90-minute driving radius from Cincinnati Children's Hospital in the next 12 months at the time of screening
- Have plans to leave employment at Cincinnati Children's Hospital in the next 12 months at the time of screening
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229-3039
About this study
Aim
To evaluate the efficacy of a CCHMC Human Resources Benefits program to reduce exposure to injury hazards and subsequent injury-related medical claims for their children.
Read more
Hypothesis
H1: The investigators anticipate, based on our recently completed trial, that the installation of multiple, passive safety devices in the homes of children 6- to 36-month old children of CCHMC non-contract employees randomized to the intervention group will reduce childhood injuries and medical claims by 50% compared to children of CCHMC non-contract employees who do not receive the home safety program.
H2: Cincinnati Children's Hospital Medical Center Employees whose children are randomized to the intervention will have 30% less lost work days compared to employees whose children are assigned control group.
Read the detailed description
Injury is the leading cause of morbidity and mortality for US children; the home is the leading location of injury for younger US children. Unintentional injuries in the home environment account for more than 4 million visits to emergency departments, with over 74,000 hospitalizations and 2,800 deaths each year in US children at a cost in excess of $3 billion annually and $800 per emergency visit. Ambulatory visit rates for injury in US Children are more than 3-fold higher than emergency visit rates and account for more than 13 million visits to offices and clinics each year in the U.S.
There is increasing interest in developing systems to improve the health of populations of children residing in the Cincinnati Children's Hospital Medical Center (CCHMC) primary service area. Emerging payment models are fostering programs that can improve proactive population health management including preventive measures to reduce morbidity and improve the value of health services provided by insurers and accountable care organizations. This project will test the efficacy of an intervention to reduce exposure to injury hazards in the home and subsequent preventable and medically attended injury in young children.
Experimental Group: In homes of children randomized to the intervention arm of the trial, a comprehensive observational survey of living spaces will be undertaken. The study will examine living spaces to which a child may be exposed including 5 high-exposure, high-risk areas (main activity room, kitchen, child's bedroom and bathrooms, and stairways). In addition to quantifying hazards, the area of rooms will be obtained allowing for determination of both the number and density of injury hazards.
The hazards identified by the intervention team will be reviewed with the parent and the proposed interventions will be presented. Intervention options are designed and prioritized so that the most passive and durable interventions are recommended first and progressively less 'passive' and less durable options last. After consent is obtained, passive measures will be installed across the living space as indicated.
Control Group: Participants who are assigned to the control group will have their medical claims examined related to injury in the home. Households in this control condition will also be provided with information sheets on child safety developed by the American Academy of Pediatrics, The Injury Prevention Program (TIPP). These age-based recommendations for child safety are provided as standard of care at many pediatric offices.
- Conditions
- Injury in the Home
- Being tested
- Injury Prevention Measures
- Keywords
- Injury, Injury Prevention, Cincinnati Home Injury Prevention, Injury Hazards, Modifiable Injury Hazards
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Injury Prevention MeasuresOther
Also called Injury in the Home, Injury, Injury Prevention, Cincinnati Home Injury Prevention
The hazards identified in the home will be reviewed with the parent and the proposed interventions will be presented. Intervention options are designed and prioritized so that the most passive and durable interventions are recommended first (e.g. self-closing, self-locking stair gate) and progressively less 'passive' and less durable options last (e.g. area gate, pressure mounted gate, or refusal of intervention).
| Study group | Role | What they receive |
|---|---|---|
| Injury Intervention Group | Experimental | In homes of children who are randomized to the injury intervention arm of the trial, a comprehensive survey of injury hazards in living spaces will be undertaken. In addition to quantifying hazards, the area of living spaces will be obtained to allow the determination of both the number and density (number of hazards per 100 sq.ft.) of injury hazards. If one or more injury hazards are identified, they will be removed and/or modified to reduce exposure and injury risk. The intervention is focused on areas in living spaces below 1-meter (~39 inches) in height from (the 75th percentile in height or eye-level for a 3-year old US male toddler) which might be easily reached or climbed on by children less than 4 years. Receives: Other: Injury Prevention Measures |
| Control Group | No intervention | Participants who are assigned to the control group will have their medical claims examined related to injury in the home. Households in this control condition will also be provided with information sheets on child safety developed by the American Academy of Pediatrics, The Injury Prevention Program (TIPP). These age-based recommendations for child safety are provided as standard of care at many pediatric offices. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Any modifiable and medically-attended injury in enrolled children sustained in the home
The primary outcome measure will be claims for medically-attended injury sustained in the home environment. This composite outcome includes any medical claims from phone calls, office, clinic, and emergency department (ED) visits by enrolled children in the home for injuries whose exposure was modified by the installed safety devices (i.e. falls, cuts/pierces, struck/strike, burns, poisonings).
Measured: Quarterly ( quarterly online surveys) (up to 24 months)
Secondary outcomes (1)
Presenteeism / Absenteeism at work due to child's injury
Furthermore, the investigators will attempt to capture work loss, presenteeism and absenteeism associated with medical treatment for a child's injury.
Measured: Quarterly (online surveys) (up to 2 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2012 (estimated)
- Study startOct 2012
- Primary completionFeb 2017
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Injury in the HomeStudies of the same condition, open and under way.
- More trials run by Children's Hospital Medical Center, CincinnatiThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 520 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kiernan Phelan, MD, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01740622
- Sponsor's protocol ID
- 2012-2903
- Acronym
- H3C
- Status last verified
- Jan 2018
- First submitted
- 19 Oct 2012
- Last updated
- 29 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healthy Homes Healthy Children (H3C)
- ClinicalTrials.gov ID
- NCT01740622
- Acronym / sponsor ID
- H3C / 2012-2903
- Conditions
- Injury in the Home
- Keywords
- Injury, Injury Prevention, Cincinnati Home Injury Prevention, Injury Hazards, Modifiable Injury Hazards
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 520 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 4 Dec 2012 (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.
Aim
To evaluate the efficacy of a CCHMC Human Resources Benefits program to reduce exposure to injury hazards and subsequent injury-related medical claims for their children.
Hypothesis
H1: The investigators anticipate, based on our recently completed trial, that the installation of multiple, passive safety devices in the homes of children 6- to 36-month old children of CCHMC non-contract employees randomized to the intervention group will reduce childhood injuries and medical claims by 50% compared to children of CCHMC non-contract employees who do not receive the home safety program.
H2: Cincinnati Children's Hospital Medical Center Employees whose children are randomized to the intervention will have 30% less lost work days compared to employees whose children are assigned control group.
Detailed description
Injury is the leading cause of morbidity and mortality for US children; the home is the leading location of injury for younger US children. Unintentional injuries in the home environment account for more than 4 million visits to emergency departments, with over 74,000 hospitalizations and 2,800 deaths each year in US children at a cost in excess of $3 billion annually and $800 per emergency visit. Ambulatory visit rates for injury in US Children are more than 3-fold higher than emergency visit rates and account for more than 13 million visits to offices and clinics each year in the U.S.
There is increasing interest in developing systems to improve the health of populations of children residing in the Cincinnati Children's Hospital Medical Center (CCHMC) primary service area. Emerging payment models are fostering programs that can improve proactive population health management including preventive measures to reduce morbidity and improve the value of health services provided by insurers and accountable care organizations. This project will test the efficacy of an intervention to reduce exposure to injury hazards in the home and subsequent preventable and medically attended injury in young children.
Experimental Group: In homes of children randomized to the intervention arm of the trial, a comprehensive observational survey of living spaces will be undertaken. The study will examine living spaces to which a child may be exposed including 5 high-exposure, high-risk areas (main activity room, kitchen, child's bedroom and bathrooms, and stairways). In addition to quantifying hazards, the area of rooms will be obtained allowing for determination of both the number and density of injury hazards.
The hazards identified by the intervention team will be reviewed with the parent and the proposed interventions will be presented. Intervention options are designed and prioritized so that the most passive and durable interventions are recommended first and progressively less 'passive' and less durable options last. After consent is obtained, passive measures will be installed across the living space as indicated.
Control Group: Participants who are assigned to the control group will have their medical claims examined related to injury in the home. Households in this control condition will also be provided with information sheets on child safety developed by the American Academy of Pediatrics, The Injury Prevention Program (TIPP). These age-based recommendations for child safety are provided as standard of care at many pediatric offices.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Injury Intervention Group | Experimental | Other: Injury Prevention MeasuresIn homes of children who are randomized to the injury intervention arm of the trial, a comprehensive survey of injury hazards in living spaces will be undertaken. In addition to quantifying hazards, the area of living spaces will be obtained to allow the determination of both the number and density (number of hazards per 100 sq.ft.) of injury hazards. If one or more injury hazards are identified, they will be removed and/or modified to reduce exposure and injury risk. The intervention is focused on areas in living spaces below 1-meter (~39 inches) in height from (the 75th percentile in height or eye-level for a 3-year old US male toddler) which might be easily reached or climbed on by children less than 4 years. |
| Control Group | No intervention | –Participants who are assigned to the control group will have their medical claims examined related to injury in the home. Households in this control condition will also be provided with information sheets on child safety developed by the American Academy of Pediatrics, The Injury Prevention Program (TIPP). These age-based recommendations for child safety are provided as standard of care at many pediatric offices. |
Who may qualify
- Ages
- 6 to 36 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Current CCHMC qualified beneficiaries (non-contract workers)
- Child is both covered by a CCHMC health insurance plan and is less than 8 months of age at the time of screening
- Employees must be at least 18 years of age
- Employee must have no plans to leave CCHMC employment within next 12 months
- Employee must have no plans to relocate greater than 90 minutes away from CCHMC in the next 12 months
Key exclusion criteria (7 listed)
- The child is greater than 8 months of age at time of screening
- Employee is non-English speaking
- Not a current CCHMC employee
- Child not covered by CCHMC health insurance plan
- Employees who are not 18 years of age
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 |
|---|---|---|
| Injury Prevention MeasuresAlso: Injury in the Home, Injury, Injury Prevention, Cincinnati Home Injury PreventionThe hazards identified in the home will be reviewed with the parent and the proposed interventions will be presented. Intervention options are designed and prioritized so that the most passive and durable interventions are recommended first (e.g. self-closing, self-locking stair gate) and progressively less 'passive' and less durable options last (e.g. area gate, pressure mounted gate, or refusal of intervention). | Other | Injury Intervention Group |
Primary outcome
Any modifiable and medically-attended injury in enrolled children sustained in the home
Time frame: Quarterly ( quarterly online surveys) (up to 24 months)
The primary outcome measure will be claims for medically-attended injury sustained in the home environment. This composite outcome includes any medical claims from phone calls, office, clinic, and emergency department (ED) visits by enrolled children in the home for injuries whose exposure was modified by the installed safety devices (i.e. falls, cuts/pierces, struck/strike, burns, poisonings).
1 secondary outcome
Presenteeism / Absenteeism at work due to child's injury
Time frame: Quarterly (online surveys) (up to 2 years)
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 29 Jan 2018.
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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.
Kiernan Phelan, MD principal investigator
Children's Hospital Medical Center, Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Injury Prevention Measures in people with Injury in the Home, run by Children's Hospital Medical Center, Cincinnati 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 7 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 29 Jan 2018. 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?
Any modifiable and medically-attended injury in enrolled children sustained in the home (time frame: Quarterly ( quarterly online surveys) (up to 24 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Jan 2018.