A Trial to Reduce Pneumonia in Nursing Home Residents (PRIDE)

Yale University

Status and phase: Completed; Phase 3

Conditions: Lower Respiratory Tract Infection; Pneumonia

Treatments: Other: Usual oral care; Other: Enhanced Oral Care

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00975780

0609001783

R01AG030575 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The purpose of this study is to test the effectiveness of an enhanced oral hygiene protocol in preventing pneumonia among nursing home residents.

Enrollment: 834 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• long term care resident of nursing home
• residents age >65
• residents of nursing home for at least one month
• residents having at least one of two modifiable risk factors for pneumonia (i.e., impaired oral hygiene, swallowing difficulty)

Exclusion criteria

• residents housed in nursing home for short term rehabilitation
• residents who receive nourishment by tube feeding
• residents who have a life expectancy < 3 months
• residents who have been diagnosed with pneumonia within the previous 6 weeks
• residents who are currently using oral chlorhexidine
• residents who have previously been enrolled in the study
• residents, or their designated proxies, who are unwilling to give informed consent
• residents who have tracheostomy
• residents who are non-english speaking
• residents who the administrator leadership of the home felt were not appropriate for the study

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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834 participants in 2 patient groups

enhanced oral care

Experimental group

Treatment:

Other: Enhanced Oral Care

Usual care

Active Comparator group

Description:

The usual oral care provided at the nursing home

Treatment:

Other: Usual oral care