The primary aim of this proposal is to test a multicomponent intervention for its effectiveness in reducing the cumulative rate of radiographically documented pneumonia in nursing home residents, compared to usual care. This aim will be achieved by conducting a randomized controlled trial of the intervention, determined in pilot studies to be feasible and adhered to by nursing home staff, in a cohort of residents with modifiable pneumonia risk factors, in New Haven, CT, area nursing homes. The primary hypothesis is that the multicomponent intervention will reduce the cumulative rate of pneumonia by 25%, compared to usual care. The secondary aims are to test the hypotheses that the multicomponent intervention will reduce the cumulative rate of: 1) lower respiratory tract infections by 25%, including those that are not radiographically documented, compared to usual care; and 2) total pneumonia episodes by 25%, including recurrent pneumonia episodes, compared to usual care. The tertiary aims are to explore the impact of the intervention on reduction of the targeted pneumonia risk factors (i.e., impaired oral hygiene, swallowing difficulty), and the relationship of risk factor reduction to the effectiveness of the intervention in reducing pneumonia. The setting for the trial will be 20 New Haven area nursing homes. The design will consist of a stratified clustered randomization of nursing homes in which intervention and control participants will be followed for a 2.5-year surveillance period for the primary outcome, a radiographically documented pneumonia. The participants will be long-term care nursing home residents, over 65 years in age, who have at least one of the two modifiable risk factors for pneumonia (i.e., impaired oral hygiene and/or swallowing difficulty). [The target sample size is 860 participants to detect a 25% reduction in the 2.5 year cumulative pneumonia rate, between intervention and control groups with 80% power.] The multicomponent intervention will consist of manual brushing of teeth and gums (twice per day) plus 0.12% chlorhexidine oral rinse (twice per day) plus upright feeding positioning during and after meals. Interim data monitoring will focus on participant accrual, protocol adherence, data quality, safety, efficacy and futility with periodic presentation to a Data and Safety Monitoring Board. All primary treatment comparisons will be based on the intent-to-treat principle. The trial will utilize the experienced personnel of the Yale Program on Aging to test the effectiveness of a feasible intervention to reduce pneumonia in thi vulnerable population of citizens.
NIH ExPorter
NIH ExPorter