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.

Clinical trials registration: NCT00975780.

Keywords: chlorhexidine; nursing homes; oral care; pneumonia; prevention.

Figure 1.

Flow diagram of nursing homes and participants. ^aNursing home population mostly younger mental health residents, did not meet eligibility criteria, administrative reasons, or enrollment met; ^bTwo participants randomized to the intervention arm were identified after enrollment as having met a previously unidentified exclusion criterion: one participant had an existing pneumonia within 6 weeks and one participant was hospitalized (and had not resided in the nursing home for at least one month) prior to randomization. Both participants remained in the analyses; ^cPrevalent participants were those residents who were housed in the nursing home and recruited for the study at the time of initiation of the study at the home. Incident participants were recruited in subsequent waves of recruitment after the study was initiated at the home, approximately every three months; ^dWithdrew due to administrative leadership decision; ^eWithdrew due to foreclosure; ^fReasons for lost to follow-up included discharged from facility, facility withdrew from the study, and death.

Figure 2.

A, Cumulative incidence of first pneumonia by treatment (1 – Kaplan–Meier estimates). The number of participants at risk at 30 months represents participants who were censored after they completed the 30 months of follow-up as specified in the study protocol. B, Cumulative incidence of first lower respiratory tract infection by treatment (1 – Kaplan–Meier estimates). The number of participants at risk at 30 months represents participants who were censored after they completed the 30 months of follow-up as specified in the study protocol. The cumulative percentages in (A and B) are calculated by dividing the number of outcome events in each treatment arm at each time point by the total number of participants enrolled in the respective treatment arm (ie, 400 in the control arm and 434 in the intervention arm), and then by multiplying by 100; 95% confidence intervals (CIs) for the percentages account for the clustering of participants within nursing homes.