NCT00157612

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
680

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2001

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2001

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 7, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
Last Updated

October 29, 2018

Status Verified

October 1, 2018

Enrollment Period

4.5 years

First QC Date

September 7, 2005

Last Update Submit

October 25, 2018

Conditions

Keywords

pneumonialower respiratory tract infectionclinical pathwaynursing homelong-term carerandomized control trial

Outcome Measures

Primary Outcomes (1)

  • Hospital admission, length of stay

Secondary Outcomes (5)

  • Health related quality of life,

  • complication rates,

  • mortality,

  • functional status,

  • time to stabilization of vital signs

Study Arms (2)

Intervention

OTHER

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

Comparator

NO INTERVENTION

usual care

Interventions

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

Also known as: Nursing Home Residents with Pneumonia
Intervention

Eligibility Criteria

Age64 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Symptoms or signs of lower respiratory tract infection as defined by standardized criteria.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related 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. doi: 10.1001/jama.295.21.2503.

MeSH Terms

Conditions

Pneumonia

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Mark B Loeb, MD MSc FRCPC

    McMaster University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 7, 2005

First Posted

September 12, 2005

Study Start

January 1, 2001

Primary Completion

July 1, 2005

Study Completion

July 1, 2005

Last Updated

October 29, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share