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Injury in the Home | Healthy Homes Healthy Children (H3C)

Injury in the Home research study

What is the primary objective of 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. 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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Injury in the Home

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Other:Injury Prevention MeasuresThe 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 Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Injury Intervention GroupIn 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 GroupParticipants 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 Status

Active, not recruiting

Start Date: October 2012

Completed Date: February 2017

Phase: N/A

Type: Interventional

Design:

Primary Outcome: Any modifiable and medically-attended injury in enrolled children sustained in the home

Secondary Outcome: Presenteeism / Absenteeism at work due to child's injury

Study sponsors, principal investigator, and references

Principal Investigator: Kiernan Phelan, MD

Lead Sponsor: Children's Hospital Medical Center, Cincinnati

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01740622

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