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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00157612
Other study ID # 00-1848
Secondary ID long term care
Status Completed
Phase N/A
First received
Last updated
Start date January 2001
Est. completion date July 2005

Study information

Verified date October 2018
Source McMaster University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 680
Est. completion date July 2005
Est. primary completion date July 2005
Accepts healthy volunteers No
Gender All
Age group 64 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
McMaster University Canadian Institutes of Health Research (CIHR)

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Hospital admission, length of stay
Secondary Health related quality of life,
Secondary complication rates,
Secondary mortality,
Secondary functional status,
Secondary time to stabilization of vital signs
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