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Healthy Homes Healthy Children (H3C) (H3C)

25. ledna 2018 aktualizováno: Children's Hospital Medical Center, Cincinnati

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.

Přehled studie

Postavení

Dokončeno

Detailní popis

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.

Typ studie

Intervenční

Zápis (Aktuální)

520

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

    • Ohio
      • Cincinnati, Ohio, Spojené státy, 45229-3039
        • Cincinnati Children's Hospital Medical Center

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

6 měsíců až 3 roky (Dítě)

Přijímá zdravé dobrovolníky

Ano

Pohlaví způsobilá ke studiu

Všechno

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Prevence
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: Injury Intervention Group
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.
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).
Ostatní jména:
  • Prevence zranění
  • Injury in the Home
  • Injury
  • Cincinnati Home Injury Prevention
  • Injury Hazards
  • Modifiable Injury Hazards
Žádný zásah: 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.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Any modifiable and medically-attended injury in enrolled children sustained in the home
Časové okno: 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).
Quarterly ( quarterly online surveys) (up to 24 months)

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Presenteeism / Absenteeism at work due to child's injury
Časové okno: Quarterly (online surveys) (up to 2 years)
Furthermore, the investigators will attempt to capture work loss, presenteeism and absenteeism associated with medical treatment for a child's injury.
Quarterly (online surveys) (up to 2 years)

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Vyšetřovatelé

  • Vrchní vyšetřovatel: Kiernan Phelan, MD, Children's Hospital Medical Center, Cincinnati

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia

1. října 2012

Primární dokončení (Aktuální)

1. února 2017

Dokončení studie (Aktuální)

1. února 2017

Termíny zápisu do studia

První předloženo

19. října 2012

První předloženo, které splnilo kritéria kontroly kvality

30. listopadu 2012

První zveřejněno (Odhad)

4. prosince 2012

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

29. ledna 2018

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

25. ledna 2018

Naposledy ověřeno

1. ledna 2018

Více informací

Termíny související s touto studií

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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