IatrogenesisCORRESPAGENCT05936515
Evaluation of the Impact of a Paramedical Training Program for Nurses and Nursing Assistants on the Length of Stay and Prevention of Hospital Iatrogenic Complications in Elderly Patients
An observational study of Iatrogenesis, run by Hospices Civils de Lyon at 5 sites in France.
Trial summary
In France, hospitalised elderly patients (EP) aged >75 years are expected to represent 1/3 of patients by 2030 (22% in 2015). In acute care wards outside geriatrics, the average length of stay increases with age, i.e. 8.5 days after the age of 90 compared with 5.5 days for younger patients. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Iatrogenesis
- What is being tested?
- Training of nurses and nursing assistants
- How many people
- 2,671 participants
- Where
- 5 sitesFrance
- Study dates
- 1 May 2023to 1 Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: This study covers patients aged 75 and over hospitalised in participating specialitist wards (excluding geriatrics) (medicine, rheumatology, neurology, pneumology, orthopaedic surgery, digestive surgery, ENT and facial surgery)
Who may be able to join
- Patients aged 75 years and over hospitalised in a participating specialtist wards
- not objecting to the study,
- including those under guardianship or curatorship.
Who cannot join
- Patient not affiliated to a social security scheme
- Patient at the end of life
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
France5 sites, 5 recruiting
- Recruiting
Centre Hospitalier de Bourg en Bresse
Bourg-en-Bresse, 01012
Christophe VAITON, cvaiton@ch-bourg01.fr
- Recruiting
Croix Rousse Hospital
Lyon, 69004
- Not yet recruiting
CH Annecy Genevois
Metz-Tessy, 74370
DUSSEL Anne Sophie, MD, addussel@ch-annecygenevois.fr
- Recruiting
service de court séjour gériatrique, Hôpital Lyon Sud
Pierre-Bénite, 69495
Thomas GILBERT, MD, thomas.gilbert@chu-lyon.fr
- Not yet recruiting
Hôpital Nord-Ouest
Villefranche-sur-Saône
Frederique COSTA PATRY, MD, fcostapatry@hno.fr
About this study
In France, hospitalised elderly patients (EP) aged >75 years are expected to represent 1/3 of patients by 2030 (22% in 2015). In acute care wards outside geriatrics, the average length of stay increases with age, i.e. 8.5 days after the age of 90 compared with 5.5 days for younger patients. Dependence related to hospitalisation, partly avoidable, occurs in 30 to 60% of patients aged over 70. Faced with this situation Geriatric Mobile Teams (GMT) were created in 2002 to meet the need for geriatric expertise in hospitals and in the community by making punctual evaluations. Expert and multidisciplinary, the GMTs are a referring team for "advice, information and training for health care teams" for the care of vulnerable EPs. The GMTs are dependent on an exclusively medical demand system. The lack of knowledge of a specific care for EPs by nurses and nursing assistants and the occasional contribution of GMTs prevents a systematic targeted a for EP. Over the past 30 years, an American nursing programme (NICHE) aimed at improving the overall care of EPs in hospitals has shown that the training of geriatric resource nurses in speciality wards brought about a significant change in hospital geriatric culture. The training is based on evidence based practice including the HELP programme targeting confusion. The HELP programme has shown that nurses and nursing assistants play a pivotal role in reducing the incidence of hospital confusion. In the USA, the implementation of NICHE begins with the creation of a team of nursing leaders (geriatric/education/clinical care experts), dedicated to the coordination of the training and the companionship of geriatric resource nurses. Within the framework of the targets of the Ségur de la santé 2020 and Ma Santé 2022, our hypothesis is that an adaptation of NICHE to the French health context could improve specific care for EP in specialist wards, reduce the occurrence of complications and reduce the length of stay. Indeed, the GMT would ensure this coordination role in the training and support of a nurse and nursing assistant duo, based on the model of hygiene correspondents, in order to disseminate good geriatric practices.
- Conditions
- Iatrogenesis
- Being tested
- Training of nurses and nursing assistants
- Keywords
- Care of the elderly, training of paramedical duo, specialtist wards, geriatric resource nurse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Training of nurses and nursing assistantsOther
Training of nurses and nursing assistants, based on the model of hygiene correspondents, in order to disseminate good geriatric practices
| Study group | Role | What they receive |
|---|---|---|
| Post-intervention group (Training course group) | The experimental group will be composed of patients aged 75 and over hospitalised in specialised departments after the establishment of geriatric correspondents trained in the specific care for the elderly. Receives: Other: Training of nurses and nursing assistants | |
| Pre-intervention group (Control group) | The control group will be composed of patients aged 75 years and over hospitalised in specialised departments before the introduction of geriatric correspondents trained in the specific care for the elderly. Their care will be conducted in accordance with usual practices. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of stay
Length of stay compared between groups according to whether or not geriatric correspondents are in place. This criterion has the advantage of being easy to measure, robust and a reflection of overall care. It depends on the occurrence of complications that can be prevented by the intervention of paramedical staff.
Measured: The length of stay is calculated as the number of days between admission to the inclusion service and discharge documented in the medical record, assessed up to one month.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2023
- Study start1 May 2023
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IatrogenesisStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 2,671 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05936515
- Sponsor's protocol ID
- 22-5125
- Acronym
- CORRESPAGE
- Status last verified
- Jun 2023
- First submitted
- 22 Jun 2023
- Last updated
- 7 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Impact of a Paramedical Training Program for Nurses and Nursing Assistants on the Length of Stay and Prevention of Hospital Iatrogenic Complications in Elderly Patients
- ClinicalTrials.gov ID
- NCT05936515
- Acronym / sponsor ID
- CORRESPAGE / 22-5125
- Conditions
- Iatrogenesis
- Keywords
- Care of the elderly, training of paramedical duo, specialtist wards, geriatric resource nurse
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,671 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 7 Jul 2023 (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.
In France, hospitalised elderly patients (EP) aged >75 years are expected to represent 1/3 of patients by 2030 (22% in 2015). In acute care wards outside geriatrics, the average length of stay increases with age, i.e. 8.5 days after the age of 90 compared with 5.5 days for younger patients. Dependence related to hospitalisation, partly avoidable, occurs in 30 to 60% of patients aged over 70. Faced with this situation Geriatric Mobile Teams (GMT) were created in 2002 to meet the need for geriatric expertise in hospitals and in the community by making punctual evaluations. Expert and multidisciplinary, the GMTs are a referring team for "advice, information and training for health care teams" for the care of vulnerable EPs. The GMTs are dependent on an exclusively medical demand system. The lack of knowledge of a specific care for EPs by nurses and nursing assistants and the occasional contribution of GMTs prevents a systematic targeted a for EP. Over the past 30 years, an American nursing programme (NICHE) aimed at improving the overall care of EPs in hospitals has shown that the training of geriatric resource nurses in speciality wards brought about a significant change in hospital geriatric culture. The training is based on evidence based practice including the HELP programme targeting confusion. The HELP programme has shown that nurses and nursing assistants play a pivotal role in reducing the incidence of hospital confusion. In the USA, the implementation of NICHE begins with the creation of a team of nursing leaders (geriatric/education/clinical care experts), dedicated to the coordination of the training and the companionship of geriatric resource nurses. Within the framework of the targets of the Ségur de la santé 2020 and Ma Santé 2022, our hypothesis is that an adaptation of NICHE to the French health context could improve specific care for EP in specialist wards, reduce the occurrence of complications and reduce the length of stay. Indeed, the GMT would ensure this coordination role in the training and support of a nurse and nursing assistant duo, based on the model of hygiene correspondents, in order to disseminate good geriatric practices.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Post-intervention group (Training course group) | – | Other: Training of nurses and nursing assistantsThe experimental group will be composed of patients aged 75 and over hospitalised in specialised departments after the establishment of geriatric correspondents trained in the specific care for the elderly. |
| Pre-intervention group (Control group) | – | –The control group will be composed of patients aged 75 years and over hospitalised in specialised departments before the introduction of geriatric correspondents trained in the specific care for the elderly. Their care will be conducted in accordance with usual practices. |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- This study covers patients aged 75 and over hospitalised in participating specialitist wards (excluding geriatrics) (medicine, rheumatology, neurology, pneumology, orthopaedic surgery, digestive surgery, ENT and facial surgery)
Key inclusion criteria (3 listed)
- Patients aged 75 years and over hospitalised in a participating specialtist wards
- not objecting to the study,
- including those under guardianship or curatorship.
Key exclusion criteria (2 listed)
- Patient not affiliated to a social security scheme
- Patient at the end of life
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 |
|---|---|---|
| Training of nurses and nursing assistantsTraining of nurses and nursing assistants, based on the model of hygiene correspondents, in order to disseminate good geriatric practices | Other | Post-intervention group (Training course group) |
Primary outcome
Length of stay
Time frame: The length of stay is calculated as the number of days between admission to the inclusion service and discharge documented in the medical record, assessed up to one month.
Length of stay compared between groups according to whether or not geriatric correspondents are in place. This criterion has the advantage of being easy to measure, robust and a reflection of overall care. It depends on the occurrence of complications that can be prevented by the intervention of paramedical staff.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Iatrogenesis, run by Hospices Civils de Lyon at 5 sites 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 2 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: looking for participants now, as of the sponsor's last update on 7 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eleonore BROCARD, MD (00 33 4 72 11 95 61, eleonore.brocard@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of stay (time frame: The length of stay is calculated as the number of days between admission to the inclusion service and discharge documented in the medical record, assessed up to one month.). 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 7 Jul 2023.