title: A cluster-randomized controlled trial of a multicomponent intervention protocol for pneumonia prevention among nursing home elders.
abstract: BACKGROUND
  Pneumonia remains an important public health problem among elderly nursing home residents. This clinical trial sought to determine if a multicomponent intervention protocol, including manual tooth/gum brushing plus 0.12% chlorhexidine oral rinse, twice per day, plus upright positioning during feeding, could reduce the incidence of radiographically documented pneumonia among nursing home residents, compared with usual care.
  
  
  METHODS
  This cluster-randomized clinical trial was conducted in 36 nursing homes in Connecticut. Eligible residents >65 years with at least 1 of 2 modifiable risk factors for pneumonia (ie, impaired oral hygiene, swallowing difficulty) were enrolled. Nursing homes were randomized to the multicomponent intervention protocol or usual care. Participants were followed for up to 2.5 years for development of the primary outcome, a radiographically documented pneumonia, and secondary outcome, a lower respiratory tract infection (LRTI) without radiographic documentation.
  
  
  RESULTS
  A total of 834 participants were enrolled: 434 to intervention and 400 to usual care. The trial was terminated for futility. The number of participants in the intervention vs control arms with first pneumonia was 119 (27.4%) vs 94 (23.5%), respectively, and with first LRTI, 125 (28.8%) vs 100 (25.0%), respectively. In a multivariable Cox regression model, the hazard ratio in the intervention vs control arms, respectively, was 1.12 (95% confidence interval [CI], .84-1.50; P = .44) for first pneumonia and 1.07 (95% CI, .79-1.46, P = .65) for first LRTI.
  
  
  CONCLUSIONS
  The multicomponent intervention protocol did not significantly reduce the incidence of first radiographically confirmed pneumonia or LRTI compared with usual care in nursing home residents.
  
  
  BACKGROUND
  NCT00975780.
authors.affiliation: Sections of Infectious Diseases.
authors.forename: Manisha
authors.initials: M
authors.lastname: Juthani-Mehta
authors.affiliation: Geriatrics, Department of Internal Medicine, Yale School of Medicine.
authors.forename: Peter H
authors.initials: PH
authors.lastname: Van Ness
authors.affiliation: Geriatrics, Department of Internal Medicine, Yale School of Medicine.
authors.forename: Joanne
authors.initials: J
authors.lastname: McGloin
authors.affiliation: Geriatrics, Department of Internal Medicine, Yale School of Medicine.
authors.forename: Stephanie
authors.initials: S
authors.lastname: Argraves
authors.affiliation: Geriatrics, Department of Internal Medicine, Yale School of Medicine.
authors.forename: Shu
authors.initials: S
authors.lastname: Chen
authors.affiliation: Geriatrics, Department of Internal Medicine, Yale School of Medicine.
authors.forename: Peter
authors.initials: P
authors.lastname: Charpentier
authors.affiliation: Geriatrics, Department of Internal Medicine, Yale School of Medicine.
authors.forename: Laura
authors.initials: L
authors.lastname: Miller
authors.affiliation: Geriatrics, Department of Internal Medicine, Yale School of Medicine.
authors.forename: Kathleen
authors.initials: K
authors.lastname: Williams
authors.affiliation: Geriatrics, Department of Internal Medicine, Yale School of Medicine.
authors.forename: Diane
authors.initials: D
authors.lastname: Wall
authors.affiliation: Geriatrics, Department of Internal Medicine, Yale School of Medicine.
authors.forename: Dorothy
authors.initials: D
authors.lastname: Baker
authors.affiliation: Geriatrics, Department of Internal Medicine, Yale School of Medicine.
authors.forename: Mary
authors.initials: M
authors.lastname: Tinetti
authors.affiliation: Yale Center for Analytical Sciences, Department of Biostatistics, Yale School of Public Health, New Haven, Connecticut.
authors.forename: Peter
authors.initials: P
authors.lastname: Peduzzi
authors.affiliation: Sections of Infectious Diseases.
authors.forename: Vincent J
authors.initials: VJ
authors.lastname: Quagliarello
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D002710:Chlorhexidine; D003237:Connecticut / Q000453:epidemiology; D005260:Female; D005500:Follow-Up Studies; D006707:Homes for the Aged; D006801:Humans; D015994:Incidence; D008297:Male; D009067:Mouthwashes; D009735:Nursing Homes; D011014:Pneumonia / Q000000981:diagnostic imaging / Q000453:epidemiology / Q000401:mortality / Q000517:prevention & control*; D011859:Radiography; D012307:Risk Factors; D014099:Toothbrushing
chemical_list: D009067:Mouthwashes; D002710:Chlorhexidine
keywords: chlorhexidine; nursing homes; oral care; pneumonia; prevention