A Clinical Pathway for Nursing Home Acquired Pneumonia

Sponsor

McMaster University (Other)

Overall Status

Completed

CT.gov ID

NCT00157612

Collaborator

Canadian Institutes of Health Research (CIHR) (Other)

680

Enrollment

Arms

53.9

Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Pneumonia Lower Respiratory Tract Infection	Procedure: a clinical pathway nursing home acquired pneumonia	N/A

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 Design

Study Type:

Interventional

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 :

Jan 1, 2001

Actual Primary Completion Date :

Jul 1, 2005

Actual Study Completion Date :

Jul 1, 2005

Arms and Interventions

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	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 Names: Nursing Home Residents with Pneumonia
No Intervention: Comparator usual care

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

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 Names:

Nursing Home Residents with Pneumonia

No Intervention: Comparator

usual care

Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

64 Years and Older

Sexes Eligible for Study:

All

Accepts 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.