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A Clinical Pathway for Nursing Home Acquired Pneumonia

Primary Purpose

Pneumonia, Lower Respiratory Tract Infection

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
a clinical pathway nursing home acquired pneumonia
Sponsored by
McMaster University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pneumonia focused on measuring pneumonia, lower respiratory tract infection, clinical pathway, nursing home, long-term care, randomized control trial

Eligibility Criteria

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

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    No Intervention

    Arm Label

    Intervention

    Comparator

    Arm Description

    use of oral anti-microbials, portable chest radiographs, oxygen saturation monitoring, re-hydration and close monitoring by a research nurse

    usual care

    Outcomes

    Primary Outcome Measures

    Hospital admission, length of stay

    Secondary Outcome Measures

    Health related quality of life,
    complication rates,
    mortality,
    functional status,
    time to stabilization of vital signs

    Full Information

    First Posted
    September 7, 2005
    Last Updated
    October 25, 2018
    Sponsor
    McMaster University
    Collaborators
    Canadian Institutes of Health Research (CIHR)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00157612
    Brief Title
    A Clinical Pathway for Nursing Home Acquired Pneumonia
    Official Title
    A Randomized Control Trial of a Clinical Pathway for Nursing Home Pneumonia.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2001 (undefined)
    Primary Completion Date
    July 2005 (Actual)
    Study Completion Date
    July 2005 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    McMaster University
    Collaborators
    Canadian Institutes of Health Research (CIHR)

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pneumonia, Lower Respiratory Tract Infection
    Keywords
    pneumonia, lower respiratory tract infection, clinical pathway, nursing home, long-term care, randomized control trial

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    680 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention
    Arm Type
    Other
    Arm Description
    use of oral anti-microbials, portable chest radiographs, oxygen saturation monitoring, re-hydration and close monitoring by a research nurse
    Arm Title
    Comparator
    Arm Type
    No Intervention
    Arm Description
    usual care
    Intervention Type
    Procedure
    Intervention Name(s)
    a clinical pathway nursing home acquired pneumonia
    Other Intervention Name(s)
    Nursing Home Residents with Pneumonia
    Intervention Description
    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
    Primary Outcome Measure Information:
    Title
    Hospital admission, length of stay
    Secondary Outcome Measure Information:
    Title
    Health related quality of life,
    Title
    complication rates,
    Title
    mortality,
    Title
    functional status,
    Title
    time to stabilization of vital signs

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    64 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mark B Loeb, MD MSc FRCPC
    Organizational Affiliation
    McMaster University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    16757722
    Citation
    Loeb M, Carusone SC, Goeree R, Walter SD, Brazil K, Krueger P, Simor A, Moss L, Marrie T. Effect of a clinical pathway to reduce hospitalizations in nursing home residents with pneumonia: a randomized controlled trial. JAMA. 2006 Jun 7;295(21):2503-10. doi: 10.1001/jama.295.21.2503.
    Results Reference
    result

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    A Clinical Pathway for Nursing Home Acquired Pneumonia

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