Clinical trial NCT01740622: Healthy Homes Healthy Children (H3C)
Official title: Healthy Homes Healthy Children (H3C)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Injury in the Home
Keywords: Injury
Injury Prevention
Cincinnati Home Injury Prevention
Injury Hazards
Modifiable Injury Hazards
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
First posted: 2012-12-04
Enrollment: 520
Sex: ALL
Minimum age (years): 6
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Any modifiable and medically-attended injury in enrolled children sustained in the home
timeFrame: Quarterly ( quarterly online surveys) (up to 24 months)
Secondary outcomes:
measure: Presenteeism / Absenteeism at work due to child's injury
timeFrame: Quarterly (online surveys) (up to 2 years)
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Kiernan Phelan, MD
role: PRINCIPAL_INVESTIGATOR
References: