PneumoniaPIANONCT04121182
Prevention of pneumonIA in Nursing hOme
A study testing On-line training and Usual practice in people with Pneumonia, run by University Hospital, Toulouse at 1 site in France.
Trial summary
Infections in nursing home are associated with high morbidity and mortality. Pulmonary infections are known to be the most problematic. In our INCUR observational study of 773 residents, 20.13% of residents had pneumonia during the year of follow-up. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Pneumonia
- What is being tested?
- On-line training and Usual practice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,818 participants
- Where
- 1 siteFrance
- Study dates
- 19 Oct 2020to 5 Jun 2023
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Living in a nursing home for at least 30 days at the start of inclusions,
- Having received information concerning the study and having not expressed opposition to participate,
- For which an agreement in principle of the attending physician has been obtained.
Who cannot join
- Refusal of the resident (or of his legal representative) or of his treating physician after given information,
- Resident at the end of life (life expectancy evaluated within one month by the coordinating physician),
- Resident whose attending physician is already involved in the PIANO study under a resident of another nursing home.
Trial locations and contacts
1 site in 1 country.
About this study
Infections in nursing home are associated with high morbidity and mortality. Pulmonary infections are known to be the most problematic. In our INCUR observational study of 773 residents, 20.13% of residents had pneumonia during the year of follow-up. On average, the extra cost of pneumopathies was 4,467 euros / patient for the long-term care facility and 3,044 euros for the hospital.
Read the detailed description
The pneumopathies in nursing home are the main cause of hospitalization of residents. Depending on the series, 9 to 50% of residents with pneumonia should be transferred. This reflects the difficulties faced by nursing home care teams in these situations. The respiratory symptomatology of nursing home residents is difficult to grasp and the prescribed antibiotic therapy is often considered inappropriate (25% to 75% of cases). Prevention of resident pneumonia, such as vaccination against pneumococcus remains poorly practiced, influenza vaccination teams or vitamin D supplementation.
In addition to the risk of mortality, lung diseases are often the cause of a rapid functional decline. Preventing pneumonia in nursing homes is therefore an important issue in the prevention of dependence, the quality of life, the health care system (use of hospitalization and transfer to emergencies) and health expenditure. In this vulnerable population, a prevention intervention seems particularly relevant.
In this research project, the investigators hypothesize that a multi-domain prevention intervention for pneumonia carried out by nursing teams in nursing homes can reduce the incidence of pneumonia. They also believe that this action would reduce emergency transfers and health expenditures.
- Conditions
- Pneumonia
- Being tested
- On-line training, Usual practice
- Keywords
- Nursing home, Prevention
- Medical subject headings
- Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
On-line trainingOther
Nursing teams randomized in the intervention group will benefit from an intervention in the form of a specific training "online" on the prevention of pneumonia and their management in the nursing home This training focuses on prevention, and management during the infectious period (the false food route and the management of pneumonia).
Usual practiceOther
Nursing home with usual practice : The act of comparison is defined by the usual care, as they are performed in the nursing home at the time of the study. No restrictions are placed on residents or caregivers of any kind in the care of the resident.
| Study group | Role | What they receive |
|---|---|---|
| Nursing home with On-line training | Experimental | 25 randomized residents will be included by nursing home Half of the institutions (randomized too) will benefit from an "on-line" training on the prevention and management of resident lung diseases Receives: Other: On-line training |
| Nursing home with usual practice | Active comparator | This group of Institutions continue their usual practice (routine care) and will not benefit from training during the study period. Receives: Other: Usual practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
The comparison of the incidence of lung disease number between the two groups
After the one-year : to compare of the incidence of lung disease between the two groups of Nursing home (the on-line formation/casual care) The diagnosis of pneumopathy will be defined on the criteria of the Infectious Risk Observatory in Geriatrics that are appropriate for nursing home residents, with at least two of the criteria defined for pneumonia
Measured: 1 year
Number of Medical evidence of rattles or crepitates
Medical evidence of rattles or crepitates on chest auscultation : rattles or crepitates are criteria for the diagnosis of pneumopathy
Measured: 1 year
Secondary outcomes (5)
Establish a differential cost-effectiveness ratio at 1 year of the care of the residents in nursing home
Establish a differential cost-effectiveness ratio at 1 year of the care of the residents in nursing home by a healthcare team trained in the management of pneumonia in the context of E-learning training versus usual care.
The medico-economic analysis will consist in a cost-effectiveness evaluation of a training in the prevention of pneumopathies aimed at the carers in nursing homes, compared to the usual practice.
Measured: 1 year
Evaluation of the time spent by the health care team to support the patient between two groups
Perform an evaluation of the time spent by the health care team to support the patient for Basic Activities of Daily Living (ADL), Instrumental Activities of Daily Living, supervision of care and patient monitoring. They will use the Questionnaire adapted from Resource Utilization in Dementia - Formal Care (RUD-FOCA)
Measured: 1 year
Evaluating the incidence of all-cause hospitalizations
Evaluating the incidence of number of all-cause hospitalizations to compare with the hospitalizations due to pneumonia
Measured: 1 year
Evaluate the evolution of quality of care indicators in the nursing home
Indicators of quality of care in the nursing home related to the risk of pneumonia will be reported at T-2 months and T12 months. These indicators will be provided by the coordinating physician :
- Vaccination rate (Residents; Staff).
- Presence in the nursing home of a protocol for taking care of the false route
- In case of pneumopathy, the use of antibiotic therapy will be indicated
Measured: 1 year
Functional decline of residents
The degree of dependence of the residents will be evaluated by the carers of the nursing home by the Scale ADL (Basic Activity Daily Living) of Katz during 12 months On this scale of 0 (totally dependent) to 6 points (independent), a difference of 0.5 points would be considered clinically relevant.
Measured: 1year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2019
- Study start19 Oct 2020
- Primary completion5 Jun 2023
- Study completion5 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PneumoniaStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Seven thousand residents will be recruited by 280 nursing home in 2 major regions in France and followed for 1 year. At the end of the randomization, half of the institutions will benefit from an "on-line" training on the prevention and management of pulmonary disease in residents. Other institutions will continue their usual practice (routine care) and will not benefit from training during the study period.
- Masking
- None (open label)
- Enrolment
- 3,818 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France
- Responsible party
- Sponsor
- Investigators
- Yves Rolland, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04121182
- Sponsor's protocol ID
- RC31/17/0452
- Acronym
- PIANO
- Status last verified
- Jun 2023
- First submitted
- 19 Aug 2019
- Last updated
- 18 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of pneumonIA in Nursing hOme
- ClinicalTrials.gov ID
- NCT04121182
- Acronym / sponsor ID
- PIANO / RC31/17/0452
- Conditions
- Pneumonia
- Keywords
- Nursing home, Prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,818 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Collaborators
- Ministry of Health, France
- Study start
- 19 Oct 2020 (actual)
- Primary completion
- 5 Jun 2023 (actual)
- Study completion
- 5 Jun 2023 (actual)
- First posted
- 9 Oct 2019 (actual)
- 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.
Infections in nursing home are associated with high morbidity and mortality. Pulmonary infections are known to be the most problematic. In our INCUR observational study of 773 residents, 20.13% of residents had pneumonia during the year of follow-up. On average, the extra cost of pneumopathies was 4,467 euros / patient for the long-term care facility and 3,044 euros for the hospital.
Detailed description
The pneumopathies in nursing home are the main cause of hospitalization of residents. Depending on the series, 9 to 50% of residents with pneumonia should be transferred. This reflects the difficulties faced by nursing home care teams in these situations. The respiratory symptomatology of nursing home residents is difficult to grasp and the prescribed antibiotic therapy is often considered inappropriate (25% to 75% of cases). Prevention of resident pneumonia, such as vaccination against pneumococcus remains poorly practiced, influenza vaccination teams or vitamin D supplementation.
In addition to the risk of mortality, lung diseases are often the cause of a rapid functional decline. Preventing pneumonia in nursing homes is therefore an important issue in the prevention of dependence, the quality of life, the health care system (use of hospitalization and transfer to emergencies) and health expenditure. In this vulnerable population, a prevention intervention seems particularly relevant.
In this research project, the investigators hypothesize that a multi-domain prevention intervention for pneumonia carried out by nursing teams in nursing homes can reduce the incidence of pneumonia. They also believe that this action would reduce emergency transfers and health expenditures.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Seven thousand residents will be recruited by 280 nursing home in 2 major regions in France and followed for 1 year. At the end of the randomization, half of the institutions will benefit from an "on-line" training on the prevention and management of pulmonary disease in residents. Other institutions will continue their usual practice (routine care) and will not benefit from training during the study period.
| Arm | Type | Receives |
|---|---|---|
| Nursing home with On-line training | Experimental | Other: On-line training25 randomized residents will be included by nursing home Half of the institutions (randomized too) will benefit from an "on-line" training on the prevention and management of resident lung diseases |
| Nursing home with usual practice | Active comparator | Other: Usual practiceThis group of Institutions continue their usual practice (routine care) and will not benefit from training during the study period. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Living in a nursing home for at least 30 days at the start of inclusions,
- Having received information concerning the study and having not expressed opposition to participate,
- For which an agreement in principle of the attending physician has been obtained.
Key exclusion criteria (3 listed)
- Refusal of the resident (or of his legal representative) or of his treating physician after given information,
- Resident at the end of life (life expectancy evaluated within one month by the coordinating physician),
- Resident whose attending physician is already involved in the PIANO study under a resident of another nursing home.
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 |
|---|---|---|
| On-line trainingNursing teams randomized in the intervention group will benefit from an intervention in the form of a specific training "online" on the prevention of pneumonia and their management in the nursing home This training focuses on prevention, and management during the infectious period (the false food route and the management of pneumonia). | Other | Nursing home with On-line training |
| Usual practiceNursing home with usual practice : The act of comparison is defined by the usual care, as they are performed in the nursing home at the time of the study. No restrictions are placed on residents or caregivers of any kind in the care of the resident. | Other | Nursing home with usual practice |
Primary outcome
The comparison of the incidence of lung disease number between the two groups
Time frame: 1 year
After the one-year : to compare of the incidence of lung disease between the two groups of Nursing home (the on-line formation/casual care) The diagnosis of pneumopathy will be defined on the criteria of the Infectious Risk Observatory in Geriatrics that are appropriate for nursing home residents, with at least two of the criteria defined for pneumonia
Number of Medical evidence of rattles or crepitates
Time frame: 1 year
Medical evidence of rattles or crepitates on chest auscultation : rattles or crepitates are criteria for the diagnosis of pneumopathy
5 secondary outcomes
Establish a differential cost-effectiveness ratio at 1 year of the care of the residents in nursing home
Time frame: 1 year
Evaluation of the time spent by the health care team to support the patient between two groups
Time frame: 1 year
Evaluating the incidence of all-cause hospitalizations
Time frame: 1 year
Evaluate the evolution of quality of care indicators in the nursing home
Time frame: 1 year
Functional decline of residents
Time frame: 1year
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 18 Jun 2023.
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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.
Yves Rolland, MD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing On-line training and Usual practice in people with Pneumonia, run by University Hospital, Toulouse at 1 site in France.
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 3 inclusion and 3 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 18 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The comparison of the incidence of lung disease number between the two groups (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Jun 2023.