Clinical trial NCT01498601: Improving Oral Care to Reduce Hospital-Acquired Pneumonia (HAP) in the Acute Neurologically Impaired Adult
Official title: Improving Oral Care to Reduce Hospital Acquired Pneumonia (HAP) in the Acute, Non-Intubated, Care Dependent, Neurologically Impaired Adult Patient Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pneumonia
Keywords: oral hygiene
tracheostomy
deglutition disorders
enteral nutrition
brain injury
coma
Lead sponsor: Fraser Health
Sponsor class: OTHER
First posted: 2011-12-23
Enrollment: 32
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Hypothesis: The investigators hypothesize that the current oral protocol is sub-optimal and an enhanced protocol will decrease the incidence of hospital acquired pneumonia (HAP)in the acute, non-intubated, care-dependent, neurologically impaired, adult patient.

Detailed description: Overview Problem: Hospital-acquired pneumonia (HAP) is the second most common nosocomial infection and is a significant cause of morbidity and mortality. In the surgical population, HAP is associated with a 55% increase in length of stay and increased costs of approximately $31,000.00 per case. Neurologically impaired patients (those with brain injury causing alterations in mental status, immobility, impaired swallowing and cough, and increased risk of aspiration) are particularly vulnerable to HAP. HAP negatively impacts patient comfort and satisfaction, increases costs associated with diagnostic tests and treatments, increases risk for sepsis, and potential for higher level of care. It is estimated 95% of care-dependent patients on the Royal Columbian Hospital (RCH) neuroscience unit acquire HAP during their stay.

Gap: Research studies have shown improving oral hygiene in critical care, neuroscience intensive care units and cardiac surgery reduces the incidence of HAP. However, in the acutely ill neuroscience population outside critical care areas, this relationship has not been determined. Current oral care protocols, products and practitioner practice on medical/surgical units such as the RCH neuroscience unit do not consider recent evidence or recent increases in patient acuity and complexity.

Goal: The goal of this study is to test the efficacy of an improved, evidence-based oral care protocol in reducing HAP in this population on the medical/surgical neuroscience unit at RCH.

Research question: Does implementing an enhanced oral care protocol reduce rates of HAP in the acute, non-intubated, care-dependent, neurologically impaired, adult patient on a neuroscience unit?

Objective: To measure and compare the incidence of HAP among medical/surgical patients who had the current standard of oral care with those receiving an improved, preventative-based, oral hygiene protocol including regular teeth brushing, mouth and tongue inspection, swabbing and moisturizing, elevation of head of the bed (HOB), changing of suction equipment, and universal precautions.

Relevance: This study may identify the importance of standardizing oral hygiene protocols to the evidence, and heighten awareness among care providers in the prevention of HAP. If proven successful, the oral care protocol could be considered for implementation on acute units outside the RCH neuro unit.

Eligibility criteria: Inclusion Criteria:

* Adult (\> 19 years)
* Admitted to RCH neuroscience unit
* Primary diagnosis is neurological (brain injury/insult)
* Non-intubated
* Dependent for oral care and unable to direct their own oral care

Exclusion Criteria:

* \< 19 years
* Off service patients
* Intubated, on bilevel positive airway pressure or continuous positive airway pressure devices, (respiratory assistive devices)
* Palliative
* Capable of directing their own oral care
* Unable to receive oral care due to: oral tubes, nasal/oral airways, wired jaws, or behaviours such as resistiveness, combativeness, non-compliance, etc.

Primary outcomes:
measure: Hospital Acquired Pneumonia Occurrences
timeFrame: 10 months
Secondary outcomes:
Other outcomes:
Locations:
city: New Westminster
country: Canada
facility: Royal Columbian Hospital
state: British Columbia
Study officials:
affiliation: Fraser Health Authority
name: Trudy L. Robertson, MSN
role: PRINCIPAL_INVESTIGATOR
affiliation: Fraser Health Authority
name: Dulcie J. Carter, MMedSci
role: PRINCIPAL_INVESTIGATOR
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