Clinical trial NCT00157612: 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
Overall status: COMPLETED
Phase: NA
Conditions: Pneumonia
Lower Respiratory Tract Infection
Keywords: pneumonia
lower respiratory tract infection
clinical pathway
nursing home
long-term care
randomized control trial
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2005-09-12
Enrollment: 680
Sex: ALL
Minimum age (years): 64
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Hospital admission, length of stay
Secondary outcomes:
measure: Health related quality of life,
measure: complication rates,
measure: mortality,
measure: functional status,
measure: time to stabilization of vital signs
Other outcomes:
Locations:
Study officials:
affiliation: McMaster University
name: Mark B Loeb, MD MSc FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
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.