PneumoniaNCT00157612
A Clinical Pathway for Nursing Home Acquired Pneumonia
A study testing a clinical pathway nursing home acquired pneumonia in people with Pneumonia and Lower Respiratory Tract Infection, run by McMaster University.
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. Read more about this study
- Who is it for?
- Ages 64 years and older
- Conditions the study is for
- Pneumonia, Lower Respiratory Tract Infection
- What is being tested?
- a clinical pathway nursing home acquired pneumonia
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 680 participants
- Where
- No sites listed yet
- Study dates
- Jan 2001to Jul 2005
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 64 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Symptoms or signs of lower respiratory tract infection as defined by standardized criteria.
Who cannot join
- 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.
About this study
Official title: A Randomized Control Trial of a Clinical Pathway for Nursing Home Pneumonia.
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.
Read the 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.
- Conditions
- Pneumonia, Lower Respiratory Tract Infection
- Being tested
- a clinical pathway nursing home acquired pneumonia
- Keywords
- pneumonia, lower respiratory tract infection, clinical pathway, nursing home, long-term care, randomized control trial
- Medical subject headings
- Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
a clinical pathway nursing home acquired pneumoniaProcedure or surgery
Also called Nursing Home Residents with 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
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Other | use of oral anti-microbials, portable chest radiographs, oxygen saturation monitoring, re-hydration and close monitoring by a research nurse Receives: Procedure: a clinical pathway nursing home acquired pneumonia |
| Comparator | No intervention | usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital admission, length of stay
Secondary outcomes (5)
Health related quality of life,
complication rates,
mortality,
functional status,
time to stabilization of vital signs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startJan 2001
- Primary completionJul 2005
- Study completionJul 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PneumoniaStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 680 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor
- Investigators
- Mark B Loeb, MD MSc FRCPC, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00157612
- Sponsor's protocol ID
- 00-1848
- Other IDs
- long term care
- Status last verified
- Oct 2018
- First submitted
- 7 Sep 2005
- Last updated
- 29 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 16757722
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Control Trial of a Clinical Pathway for Nursing Home Pneumonia.
- ClinicalTrials.gov ID
- NCT00157612
- Acronym / sponsor ID
- 00-1848
- Conditions
- Pneumonia, Lower Respiratory Tract Infection
- Keywords
- pneumonia, lower respiratory tract infection, clinical pathway, nursing home, long-term care, randomized control trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 680 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- Jan 2001
- Primary completion
- Jul 2005 (actual)
- Study completion
- Jul 2005 (actual)
- First posted
- 12 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Other | Procedure: a clinical pathway nursing home acquired pneumoniause of oral anti-microbials, portable chest radiographs, oxygen saturation monitoring, re-hydration and close monitoring by a research nurse |
| Comparator | No intervention | –usual care |
Who may qualify
- Ages
- 64 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Symptoms or signs of lower respiratory tract infection as defined by standardized criteria.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| a clinical pathway nursing home acquired pneumoniaAlso: Nursing Home Residents with Pneumoniatreatment 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 | Procedure or surgery | Intervention |
Primary outcome
Hospital admission, length of stay
5 secondary outcomes
Health related quality of life,
complication rates,
mortality,
functional status,
time to stabilization of vital signs
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2018.
- Results publication: PubMed 16757722Loeb 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark B Loeb, MD MSc FRCPC principal investigator
McMaster University
Questions about this trial
What is this clinical trial studying?
A study testing a clinical pathway nursing home acquired pneumonia in people with Pneumonia and Lower Respiratory Tract Infection, run by McMaster University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospital admission, length of stay. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00157612, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2018.