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A Clinical Pathway for Nursing Home Acquired Pneumonia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00157612
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : October 29, 2018
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
McMaster University

Brief Summary:
Nursing home residents are frequently transferred to hospital for management of pneumonia. This often leads to hospital related complications and is a burden on the acute care health system. The purpose of this study is to assess whether managing residents with pneumonia and lower respiratory tract infection on site in the nursing home can reduce hospital admissions and can reduce complications and improve quality of life for residents. We have randomized residents with nursing home acquired pneumonia to on-site management, using a clinical pathway, versus usual care.

Condition or disease Intervention/treatment Phase
Pneumonia Lower Respiratory Tract Infection Procedure: a clinical pathway nursing home acquired pneumonia Not Applicable

Detailed Description:
We conducted a cluster-randomized controlled trial where nursing homes were randomized to either use of a clinical pathway or usual care for management of nursing home acquired pneumonia. The clinical pathway included chest radiographs performed on-site in the nursing home by a mobile x-ray unit, use of hypodermocylysis (subcutaneous infusion) for re-hydration, administration of an oral antimicrobials, and use of pulse oximetry to assess oxygenation. The main outcomes were hospital admission rate and length of stay. Secondary outcomes included health related quality of life, rates of both infectious and non-infectious complications within four weeks of onset of symptoms; mortality rate of residents with pneumonia (death from all causes within 30 days of onset of symptoms. Time to stabilization of vital signs, as well as functional status at four weeks, were assessed.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 680 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Control Trial of a Clinical Pathway for Nursing Home Pneumonia.
Study Start Date : January 2001
Actual Primary Completion Date : July 2005
Actual Study Completion Date : July 2005

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
use of oral anti-microbials, portable chest radiographs, oxygen saturation monitoring, re-hydration and close monitoring by a research nurse
Procedure: a clinical pathway nursing home acquired pneumonia
treatment in nursing homes according to a clinical pathway, which included use of oral anti-microbials, portable chest radiographs, oxygen saturation monitoring, rehydrations and close monitoring by research nurse
Other Name: Nursing Home Residents with Pneumonia

No Intervention: Comparator
usual care

Primary Outcome Measures :
  1. Hospital admission, length of stay

Secondary Outcome Measures :
  1. Health related quality of life,
  2. complication rates,
  3. mortality,
  4. functional status,
  5. time to stabilization of vital signs

Information from the National Library of Medicine

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Ages Eligible for Study:   64 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Symptoms or signs of lower respiratory tract infection as defined by standardized criteria.

Exclusion Criteria:

  • Residents were excluded if they were not expected to live longer than 30 days from the date of enrollment, had a previous anaphylactic or serious allergic reaction to quinolones, had advanced directives that they are not be transferred to hospital for treatment.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00157612

Sponsors and Collaborators
McMaster University
Canadian Institutes of Health Research (CIHR)
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Principal Investigator: Mark B Loeb, MD MSc FRCPC McMaster University

Publications of Results:
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Responsible Party: McMaster University Identifier: NCT00157612     History of Changes
Other Study ID Numbers: 00-1848
long term care ( Other Identifier: McMaster University )
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: October 29, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by McMaster University:
lower respiratory tract infection
clinical pathway
nursing home
long-term care
randomized control trial
Additional relevant MeSH terms:
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Respiratory Tract Infections
Lung Diseases
Respiratory Tract Diseases