Improving Oral Care to Reduce Hospital-Acquired Pneumonia (HAP) in the Acute Neurologically Impaired Adult
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Pneumonia |
Other: Enhanced oral care protocol |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Improving Oral Care to Reduce Hospital Acquired Pneumonia (HAP) in the Acute, Non-Intubated, Care Dependent, Neurologically Impaired Adult Patient Population |
- Hospital Acquired Pneumonia Occurrences [ Time Frame: 10 months ] [ Designated as safety issue: Yes ]Hospital acquired pneumonia is acquired greater than 48 hours after admission and is diagnosed by a positive chest x-ray plus 2 of the following 3 symptoms: presence of fever, elevated serum white blood cells count, and positive sputum specimen.
| Estimated Enrollment: | 35 |
| Study Start Date: | January 2012 |
| Estimated Study Completion Date: | October 2012 |
| Estimated Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Oral care treatment group
All subjects in the prospective intervention group will receive the same enhanced oral care protocol
|
Other: Enhanced oral care protocol
Other Name: Sage oral care products
|
|
No Intervention: Retrospective chart review
For comparison purposes, a retrospective chart review of matched in-patient population will reveal pneumonia rates in the same population who did not receive the enhanced oral care protocol.
|
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| Ages Eligible for Study: | 19 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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 (Bipap) or continuous positive airway pressure (CPAP) 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.
Contacts and Locations| Contact: Trudy L. Robertson, MSN | (604) 520-4715 | Trudy.Robertson@fraserhealth.ca |
| Contact: Dulcie J. Carter, MMedSci | (604) 520-4510 | Dulcie.Carter@fraserhealth.ca |
| Canada, British Columbia | |
| Royal Columbian Hospital | |
| New Westminster, British Columbia, Canada, V3L 3W7 | |
| Principal Investigator: | Trudy L. Robertson, MSN | Fraser Health Authority |
| Principal Investigator: | Dulcie J. Carter, MMedSci | Fraser Health Authority |
More Information
Publications:
| Responsible Party: | Fraser Health |
| ClinicalTrials.gov Identifier: | NCT01498601 History of Changes |
| Other Study ID Numbers: | FDAAA |
| Study First Received: | December 13, 2011 |
| Last Updated: | December 22, 2011 |
| Health Authority: | Canada: Health Canada |
Keywords provided by Fraser Health:
|
oral hygiene tracheostomy deglutition disorders |
enteral nutrition brain injury coma |
Additional relevant MeSH terms:
|
Pneumonia Lung Diseases Respiratory Tract Diseases Respiratory Tract Infections |
ClinicalTrials.gov processed this record on May 23, 2013