A Clinical Pathway for Nursing Home Acquired Pneumonia
October 25, 2018 updated by: McMaster University
A Randomized Control Trial of a Clinical Pathway for Nursing Home Pneumonia.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
680
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
64 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Intervention
use of oral anti-microbials, portable chest radiographs, oxygen saturation monitoring, re-hydration and close monitoring by a research nurse
|
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 Names:
|
|
No Intervention: Comparator
usual care
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
|---|
|
Hospital admission, length of stay
|
Secondary Outcome Measures
Outcome Measure |
|---|
|
Health related quality of life,
|
|
complication rates,
|
|
mortality,
|
|
functional status,
|
|
time to stabilization of vital signs
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2001
Primary Completion (Actual)
July 1, 2005
Study Completion (Actual)
July 1, 2005
Study Registration Dates
First Submitted
September 7, 2005
First Submitted That Met QC Criteria
September 7, 2005
First Posted (Estimate)
September 12, 2005
Study Record Updates
Last Update Posted (Actual)
October 29, 2018
Last Update Submitted That Met QC Criteria
October 25, 2018
Last Verified
October 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 00-1848
- long term care (Other Identifier: McMaster University)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.