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Improving Oral Care to Reduce Hospital-Acquired Pneumonia (HAP) in the Acute Neurologically Impaired Adult

Primary Purpose

Pneumonia

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Enhanced oral care protocol
Sponsored by
Fraser Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pneumonia focused on measuring oral hygiene, tracheostomy, deglutition disorders, enteral nutrition, brain injury, coma

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Royal Columbian Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Oral care treatment group

Retrospective study group

Arm Description

All subjects in the prospective intervention group will receive the same enhanced oral care protocol

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.

Outcomes

Primary Outcome Measures

Hospital Acquired Pneumonia Occurrences
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.

Secondary Outcome Measures

Full Information

First Posted
December 13, 2011
Last Updated
August 19, 2015
Sponsor
Fraser Health
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1. Study Identification

Unique Protocol Identification Number
NCT01498601
Brief Title
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

2. Study Status

Record Verification Date
December 2011
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fraser Health

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumonia
Keywords
oral hygiene, tracheostomy, deglutition disorders, enteral nutrition, brain injury, coma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Oral care treatment group
Arm Type
Experimental
Arm Description
All subjects in the prospective intervention group will receive the same enhanced oral care protocol
Arm Title
Retrospective study group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Enhanced oral care protocol
Other Intervention Name(s)
Sage oral care products
Intervention Description
Changing mouth suction equipment every 24 hours Mouth assessment every 2-4 hours Cleansing mouth with toothbrush every 12 hours Cleansing oral mucosa with oral rinse solution every 2-4 hours Moisturize mouth/lips with swab and standard mouth moisturizer every 4 hours Suction mouth and throat as needed Head of the bed elevated to a minimum of 30° during oral care
Primary Outcome Measure Information:
Title
Hospital Acquired Pneumonia Occurrences
Description
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.
Time Frame
10 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Trudy L. Robertson, MSN
Organizational Affiliation
Fraser Health Authority
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dulcie J. Carter, MMedSci
Organizational Affiliation
Fraser Health Authority
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Columbian Hospital
City
New Westminster
State/Province
British Columbia
ZIP/Postal Code
V3L 3W7
Country
Canada

12. IPD Sharing Statement

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Improving Oral Care to Reduce Hospital-Acquired Pneumonia (HAP) in the Acute Neurologically Impaired Adult

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