Lower Respiratory Tract Infection, Pneumonia
Conditions
Keywords
Pneumonia, Lower respiratory tract infection, Lower respiratory tract infection other than pneumonia
Brief summary
The purpose of this study is to test the effectiveness of an enhanced oral hygiene protocol in preventing pneumonia among nursing home residents.
Interventions
OTHEREnhanced Oral Care
oral brushing plus oral chlorhexidine plus upright feeding positioning
OTHERUsual oral care
Usual oral care and feeding positioning
Sponsors
National Institute on Aging (NIA)
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pneumonia | 2.5 years | The number of participants that recorded a 'first pneumonia' during the 2.5 years timeframe. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lower Respiratory Tract Infection Other Than Pneumonia | 2.5 years | The number of participants that recorded a 'lower respiratory tract infection other than pneumonia' during the 2.5 years timeframe. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Enhanced Oral Care Study participants receiving 'Enhanced Oral Care' in the study | 434 |
| Usual Oral Care Study participants receiving 'Usual Oral Care' in the study. | 400 |
| Total | 834 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Follow Up | Death | 88 | 122 |
| Follow Up | Discharged from Facility | 7 | 12 |
| Follow Up | Facility Withdrawal | 7 | 23 |
Baseline characteristics
| Characteristic | Enhanced Oral Care | Usual Oral Care | Total |
|---|---|---|---|
| Age, Continuous | 86.5 years STANDARD_DEVIATION 8 | 86.1 years STANDARD_DEVIATION 8.3 | 86.3 years STANDARD_DEVIATION 8.1 |
| Sex: Female, Male Female | 329 Participants | 307 Participants | 636 Participants |
| Sex: Female, Male Male | 105 Participants | 93 Participants | 198 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 391 / 434 | 371 / 400 |
| serious Total, serious adverse events | 204 / 434 | 153 / 400 |
Outcome results
Primary
Pneumonia
The number of participants that recorded a 'first pneumonia' during the 2.5 years timeframe.
Time frame: 2.5 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Enhanced Oral Care | Pneumonia | 119 participants |
| Usual Oral Care | Pneumonia | 94 participants |
Secondary
Lower Respiratory Tract Infection Other Than Pneumonia
The number of participants that recorded a 'lower respiratory tract infection other than pneumonia' during the 2.5 years timeframe.
Time frame: 2.5 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Enhanced Oral Care | Lower Respiratory Tract Infection Other Than Pneumonia | 125 participants |
| Usual Oral Care | Lower Respiratory Tract Infection Other Than Pneumonia | 100 participants |