122. A Cluster Randomized Trial to Test an Enhanced Oral Care Intervention for Prevention of Pneumonia in Nursing Home Residents
Session: Oral Abstract Session: Epidemiology of Respiratory Infections
Thursday, October 3, 2013: 11:00 AM
Room: The Moscone Center: 300
Background:

Nursing home acquired pneumonia (NHAP) remains a major public health problem.  Impaired oral hygiene and swallowing difficulty are modifiable risk factors for NHAP.  Published data indicates that a multicomponent intervention emphasizing enhanced oral care was feasible, adhered to by nursing home staff, and effective in risk factor reduction.  A clinical trial was conducted to test the efficacy of the multicomponent intervention in preventing NHAP compared to usual care.

Methods:

36 nursing homes (i.e., clusters) in the greater New Haven, CT area were randomized to adopt either the intervention protocol (i.e., oral brushing BID + topical oral chlorhexidine BID + upright feeding positioning) or continue usual care.  Eligibility criteria included age > 65, and either impaired oral hygiene (defined as an oral plaque score >1) or swallowing difficulty.  Planned study surveillance was for up to 2.5 years post enrollment. The primary outcome was first CXR documented pneumonia; lower respiratory infections (LRI), deaths, hospitalizations and adverse events were secondary outcomes. 

Results:

834 residents were enrolled in 36 randomized nursing homes (18 intervention; 18 usual care). Participant baseline characteristics included: mean age 86.3 years (SD 8.15), 93.5% white, 76.3% women, median of 4 (IQR 3-5) comorbid illnesses, 100% with plaque score >1; 19.8% with swallowing difficulty.  Enrollment began in 10/2009 and the study was terminated in 10/2012 because futility guidelines were met. Using the intent-to-treat principle, there were no significant differences between intervention (N=434) vs. control (N=400) group in first pneumonias (119 [27.4%] vs. 94 [23.5%]), LRI (128 [29.5%] vs. 101 [25.3%]), hospitalizations (124 [28.6%] vs. 100 [25.0%]), or deaths (122 [28.1%] vs. 89 [22.3%]). The incidence rate of first pneumonias in intervention vs. control group was 0.282 vs. 0.257 per person-year of follow-up. In an unadjusted Cox regression model accounting for nursing home clustering of participants, the hazard ratio of first pneumonias for the intervention vs. control group was 1.13 (95% CI 0.78, 1.62; p = 0.52). 

Conclusion:

A multicomponent intervention protocol, emphasizing enhanced oral care, did not prevent CXR documented first pneumonias or any secondary outcomes compared to usual care.

Manisha Juthani-Mehta, MD1, Peter Van Ness2, Joanne Mcgloin2, Diane Wall2, Kathleen Williams2, Laura Miller, DDS2, Stephanie Argraves2, Shu Chen, MS2, Peter Charpentier2, Dorothy Baker2, Mary Tinetti, MD3, Peter Peduzzi2 and Vincent Quagliarello, MD, FIDSA1, (1)Internal Medicine, Infectious Diseases, Yale University School of Medicine, New Haven, CT, (2)Yale University School of Medicine, New Haven, CT, (3)Internal Medicine, Geriatrics, Yale University School of Medicine, New Haven, CT

Disclosures:

M. Juthani-Mehta, None

P. Van Ness, None

J. Mcgloin, None

D. Wall, None

K. Williams, None

L. Miller, None

S. Argraves, None

S. Chen, None

P. Charpentier, None

D. Baker, None

M. Tinetti, None

P. Peduzzi, None

V. Quagliarello, None

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