Frail ElderlyFINENCT02677272
Factors Predisposing to Inappropriate Transfers of Nursing Home Residents to Emergency Departments
An observational study of Frail Elderly, run by University Hospital, Toulouse at 16 sites in France.
Trial summary
According to the data of our nursing homes (NH) research network (REHPA - Gérontopôle Toulouse, 345 nursing home in France), 13.5% of NH residents are hospitalized every 3 months or about 50% per year. These hospitalizations concern for half, transfers to emergency department (ED). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Frail Elderly
- What is being tested?
- Appropriateness of NH resident's transfer to ED
- How many people
- 1,040 participants
- Where
- 16 sitesFrance
- Study dates
- 1 Jan 2016to 31 Jul 2018
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients living in Nursing Home admitted in Emergency Department of the hospitals participating in the study during the inclusion period will be included in the study.
Who may be able to join
- to live in a Nursing Home
- to be directly transferred from the NH to ED
- to have not previously been included in FINE study
Who cannot join
- to live in structures other than Nursing Home (i.e. sheltered housing, seniors' residences, housing homes, retirement homes, long-term care units)
- to live in the community
- to be transferred to ED from elsewhere than the NH
- to have previously been included in FINE study
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
France16 sites
CH d'Albi
Albi
CH d'Auch
Auch
CH de Cahors
Cahors
CHI Castres Mazamet
Castres
CH Ariège Couserans
Foix
CH de Gourdon
Gourdon
CH Lannemezan
Lannemezan
CH Lavaur
Lavaur
CH de Lourdes
Lourdes
CH Castelsarrasin Moissac
Moissac
CH Montauban
Montauban
CH Rodez
Rodez
CH Saint Gaudens
Saint-Gaudens
CHI Val d'Ariège
Saint-Girons
Toulouse University Hospital (CHU de Toulouse)
Toulouse, 31059
CH de Bigorre
Vic-en-Bigorre
About this study
According to the data of our nursing homes (NH) research network (REHPA - Gérontopôle Toulouse, 345 nursing home in France), 13.5% of NH residents are hospitalized every 3 months or about 50% per year. These hospitalizations concern for half, transfers to emergency department (ED). Data from the literature and the PLEIAD study, conducted with 300 NH in France, confirm that intense flows between NH and ED. These studies also support the idea that these transfers to ED potentially expose some NH residents to iatrogenic complications, a risk of functional decline, an increased risk of mortality, and generate additional health costs. To transfer to ED residents who will benefit from emergency care and not to transfer to ED residents for whom this transfer generates a higher risk than the expected benefit is the goal to reach to guarantee the better quality of care for NH residents.
Inappropriate transfer to ED may be defined by the absence of somatic emergency and / or palliative care known before transferring to ED and / or the presence of advance directives of non-hospitalization in the resident's file. This is a clinical situation that could be managed by other means that the transfer to ED without loss of opportunity for the patient.
Read more
The primary objective of our study is to determine the factors predisposing NH residents to inappropriate transfer to ED.
Our hypothesis is that inappropriate transfers to the ED of NH residents are conditioned by factors accessible to interventions such as the organization of the NH care system or by improving the management of some diseases in NH. Investigators also hypothesize that the cost of inappropriate transfers to the ED is considerable. Acknowledgement of costs generated by inappropriate transfers to ED would allow policy makers to make strategic decisions to improve care system.
Read the detailed description
This is a retroprospective study conducted in sixteen hospitals in south-west of France. Inclusion will last one year, including 4 periods (one per season) of 7 days (24h / 24, including necessarily each day of the week). All the NH residents admitted in ED will be included. For each resident included, medical and non-medical data will be collected in 4 times: retrospectively before transfer to ED (=T0); and prospectively : at ED (= T1), in hospital services in case the patient is hospitalized (=T2) and at the patient's return to NH (=T3).
At T0 data collected will concern the NH and resident basis medical state, resident's medical state the week before transfer and resident medical state before transfer to ED.
At T3 data collected will concern the resident's return modality and his/her autonomy 7 days after his/her return
Time frame:
between T1 and T3 : mean expected duration will variate from few hours if the resident isn't hospitalized (ED visit) to an average 12.4 days, which is the average length of hospital stay of NH resident hospitalized after a transfer to ED (cf Pleiad study, Rolland 2012) plus 7 days as Investigators will collect T3's data 7 days after the NH resident's return to NH
- Conditions
- Frail Elderly
- Being tested
- Appropriateness of NH resident's transfer to ED
- Keywords
- Nursing home, emergency department, inappropriate transfer, elderly
- Medical subject headings
- Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Appropriateness of NH resident's transfer to EDOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Inappropriate transfer to ED of NH residents
Inappropriateness of the NH residents' transfers to ED : the inappropriateness of ED transfers will be determined by the opinion of a group of experts composed of geriatricians, emergency physicians, general practitioners and pharmacists. Inappropriate transfer to ED is defined by the absence of somatic emergency and / or palliative care known before decision to transfer and / or the presence of advance directives of non-hospitalization in the resident's file. This is a clinical situation that could be managed by other means that the transition to ED without loss of opportunity for the resident. To judge the inappropriateness of the transfer to ED, the group of experts will use a rating scale of usual emergencies. Individual and independent rating divergences will lead to a concerted evaluation of the clinical situation by the group.
Analyse retro-prospectively by the group of experts.
Measured: Baseline (T1 = inclusion at ED): retro-prospectively by the group of experts
Secondary outcomes (4)
Cost of the NH resident transfer to ED
The cost of ED transfers (i.e. appropriate and inappropriate transfers) and the direct medical costs of residents 6 months before and 6 months after the first transfer will be calculated.This work will be lead in partnership with the Regional Direction of the Medical Service of the region and the medico-economic cell of the Medical Information Department of Toulouse University Hospital
Measured: 6 months before to 6 months after the transfer
Avoidability of the NH resident transfer to ED
Potentially avoidable transfers to ED: When a transfer is considered appropriate it also can be considered as potentially avoidable if adequate preventive measures were implemented. The Ambulatory Care Sensitive Diagnosis usually used in the literature will be used to characterize the transfers as potentially avoidable. When a transfer is considered inappropriate it is always considered as potentially avoidable. Analyse retro-prospectively by the group of experts.
Measured: Baseline (T1 = inclusion at ED)
NH resident's autonomy using Katz'ADL
- Residents' autonomy will be assessed using Katz'ADL at the NH before transfer (T0); at the end of the hospitalization if the resident is concerned (T2), and at the resident's return to ED (T3)
Measured: Change at different time points: T0, T2 (up to 12 days,if concerned) and T3 (7 days after return to NH)
Analysis of Medical prescription, with a focus on psychotropic drug
- Medical prescriptions will be collected at inclusion (T1), at the end of the hospitalization if the resident is concerned (T2), and at the resident's return to ED (T3)
Measured: Change at different time points: T1 (baseline), T2 (up to 12 days,if concerned) and T3 (7 days after return to NH)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2016 (estimated)
- Study start1 Jan 2016
- Primary completion31 Jul 2018
- Study completion31 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Frail ElderlyStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 1,040 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Collaborators
- Agence Régionale de la Santé - Midi Pyrénées, Ministry of Health, France
- Responsible party
- Sponsor
- Investigators
- Yves ROLLAND, MD PhD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02677272
- Sponsor's protocol ID
- RC31/15/7464
- Other IDs
- 2015-A00723-46
- Acronym
- FINE
- Status last verified
- Feb 2024
- First submitted
- 8 Jan 2016
- Last updated
- 23 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Perrin A, Tavassoli N, Mathieu C, Hermabessiere S, Houles M, McCambridge C, Magre E, Fernandez S, Caquelard A, Charpentier S, Lauque D, Azema O, Bismuth S, Chicoulaa B, Oustric S, Costa N, Molinier L, Vellas B, Berard E, Rolland Y. Factors predisposing nursing home resident to inappropriate transfer to emergency department. The FINE study protocol. Contemp Clin Trials Commun. 2017 Jul 21;7:217-223. doi: 10.1016/j.conctc.2017.07.005. eCollection 2017 Sep.
PubMed 29696189Rolland Y, Mathieu C, Tavassoli N, Berard E, Laffon de Mazieres C, Hermabessiere S, Houles M, Perrin A, Krams T, Qassemi S, Cambon A, Magre E, Cantet C, Charpentier S, Lauque D, Azema O, Chicoulaa B, Oustric S, McCambridge C, Gombault-Datzenko E, Molinier L, Costa N, De Souto Barreto P. Factors Associated with Potentially Inappropriate Transfer to the Emergency Department among Nursing Home Residents. J Am Med Dir Assoc. 2021 Dec;22(12):2579-2586.e7. doi: 10.1016/j.jamda.2021.04.002. Epub 2021 May 5.
PubMed 33964225Bouzid W, Cantet C, Berard E, Mathieu C, Hermabessiere S, Houles M, Krams T, Qassemi S, Cambon A, McCambridge C, Tavassoli N, Rolland Y. Exploring Predictive Factors for Potentially Avoidable Emergency Department Transfers: Findings From the FINE Study. J Am Med Dir Assoc. 2024 Apr;25(4):572-579.e1. doi: 10.1016/j.jamda.2023.11.017. Epub 2023 Dec 27.
PubMed 38159914Dubucs X, Balen F, Charpentier S, Lauque D, De Souto Barreto P, Tavassoli N, Houze-Cerfon CH, Rolland Y. Factors associated with Emergency Medical Dispatcher request and residents' inappropriate transfers from Nursing Homes to Emergency Department. Eur Geriatr Med. 2022 Apr;13(2):351-357. doi: 10.1007/s41999-021-00574-5. Epub 2021 Oct 15.
PubMed 34652784Gombault-Datzenko E, Costa N, Mounie M, Tavassoli N, Mathieu C, Roussel H, Lagarrigue JM, Berard E, Rolland Y, Molinier L. Cost of care pathways before and after appropriate and inappropriate transfers to the emergency department among nursing home residents: results from the FINE study. BMC Geriatr. 2024 Apr 19;24(1):353. doi: 10.1186/s12877-024-04946-x.
PubMed 38641801
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors Predisposing to Inappropriate Transfers of Nursing Home Residents to Emergency Departments
- ClinicalTrials.gov ID
- NCT02677272
- Acronym / sponsor ID
- FINE / RC31/15/7464
- Conditions
- Frail Elderly
- Keywords
- Nursing home, emergency department, inappropriate transfer, elderly
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,040 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Collaborators
- Agence Régionale de la Santé - Midi Pyrénées, Ministry of Health, France
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 31 Jul 2018 (actual)
- Study completion
- 31 Jul 2018 (actual)
- First posted
- 9 Feb 2016 (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.
According to the data of our nursing homes (NH) research network (REHPA - Gérontopôle Toulouse, 345 nursing home in France), 13.5% of NH residents are hospitalized every 3 months or about 50% per year. These hospitalizations concern for half, transfers to emergency department (ED). Data from the literature and the PLEIAD study, conducted with 300 NH in France, confirm that intense flows between NH and ED. These studies also support the idea that these transfers to ED potentially expose some NH residents to iatrogenic complications, a risk of functional decline, an increased risk of mortality, and generate additional health costs. To transfer to ED residents who will benefit from emergency care and not to transfer to ED residents for whom this transfer generates a higher risk than the expected benefit is the goal to reach to guarantee the better quality of care for NH residents.
Inappropriate transfer to ED may be defined by the absence of somatic emergency and / or palliative care known before transferring to ED and / or the presence of advance directives of non-hospitalization in the resident's file. This is a clinical situation that could be managed by other means that the transfer to ED without loss of opportunity for the patient.
The primary objective of our study is to determine the factors predisposing NH residents to inappropriate transfer to ED.
Our hypothesis is that inappropriate transfers to the ED of NH residents are conditioned by factors accessible to interventions such as the organization of the NH care system or by improving the management of some diseases in NH. Investigators also hypothesize that the cost of inappropriate transfers to the ED is considerable. Acknowledgement of costs generated by inappropriate transfers to ED would allow policy makers to make strategic decisions to improve care system.
Detailed description
This is a retroprospective study conducted in sixteen hospitals in south-west of France. Inclusion will last one year, including 4 periods (one per season) of 7 days (24h / 24, including necessarily each day of the week). All the NH residents admitted in ED will be included. For each resident included, medical and non-medical data will be collected in 4 times: retrospectively before transfer to ED (=T0); and prospectively : at ED (= T1), in hospital services in case the patient is hospitalized (=T2) and at the patient's return to NH (=T3).
At T0 data collected will concern the NH and resident basis medical state, resident's medical state the week before transfer and resident medical state before transfer to ED.
At T3 data collected will concern the resident's return modality and his/her autonomy 7 days after his/her return
Time frame:
between T1 and T3 : mean expected duration will variate from few hours if the resident isn't hospitalized (ED visit) to an average 12.4 days, which is the average length of hospital stay of NH resident hospitalized after a transfer to ED (cf Pleiad study, Rolland 2012) plus 7 days as Investigators will collect T3's data 7 days after the NH resident's return to NH
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients living in Nursing Home admitted in Emergency Department of the hospitals participating in the study during the inclusion period will be included in the study.
Key inclusion criteria (3 listed)
- to live in a Nursing Home
- to be directly transferred from the NH to ED
- to have not previously been included in FINE study
Key exclusion criteria (4 listed)
- to live in structures other than Nursing Home (i.e. sheltered housing, seniors' residences, housing homes, retirement homes, long-term care units)
- to live in the community
- to be transferred to ED from elsewhere than the NH
- to have previously been included in FINE study
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 |
|---|---|---|
| Appropriateness of NH resident's transfer to ED | Other | – |
Primary outcome
Inappropriate transfer to ED of NH residents
Time frame: Baseline (T1 = inclusion at ED): retro-prospectively by the group of experts
Inappropriateness of the NH residents' transfers to ED : the inappropriateness of ED transfers will be determined by the opinion of a group of experts composed of geriatricians, emergency physicians, general practitioners and pharmacists. Inappropriate transfer to ED is defined by the absence of somatic emergency and / or palliative care known before decision to transfer and / or the presence of advance directives of non-hospitalization in the resident's file. This is a clinical situation that could be managed by other means that the transition to ED without loss of opportunity for the resident. To judge the inappropriateness of the transfer to ED, the group of experts will use a rating scale of usual emergencies. Individual and independent rating divergences will lead to a concerted evaluation of the clinical situation by the group. Analyse retro-prospectively by the group of experts.
4 secondary outcomes
Cost of the NH resident transfer to ED
Time frame: 6 months before to 6 months after the transfer
Avoidability of the NH resident transfer to ED
Time frame: Baseline (T1 = inclusion at ED)
NH resident's autonomy using Katz'ADL
Time frame: Change at different time points: T0, T2 (up to 12 days,if concerned) and T3 (7 days after return to NH)
Analysis of Medical prescription, with a focus on psychotropic drug
Time frame: Change at different time points: T1 (baseline), T2 (up to 12 days,if concerned) and T3 (7 days after return to NH)
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 23 Feb 2024.
- Background: PubMed 29696189Perrin A, Tavassoli N, Mathieu C, Hermabessiere S, Houles M, McCambridge C, Magre E, Fernandez S, Caquelard A, Charpentier S, Lauque D, Azema O, Bismuth S, Chicoulaa B, Oustric S, Costa N, Molinier L, Vellas B, Berard E, Rolland Y. Factors predisposing nursing home resident to inappropriate transfer to emergency department. The FINE study protocol. Contemp Clin Trials Commun. 2017 Jul 21;7:217-223. doi: 10.1016/j.conctc.2017.07.005. eCollection 2017 Sep.
- Results publication: PubMed 33964225Rolland Y, Mathieu C, Tavassoli N, Berard E, Laffon de Mazieres C, Hermabessiere S, Houles M, Perrin A, Krams T, Qassemi S, Cambon A, Magre E, Cantet C, Charpentier S, Lauque D, Azema O, Chicoulaa B, Oustric S, McCambridge C, Gombault-Datzenko E, Molinier L, Costa N, De Souto Barreto P. Factors Associated with Potentially Inappropriate Transfer to the Emergency Department among Nursing Home Residents. J Am Med Dir Assoc. 2021 Dec;22(12):2579-2586.e7. doi: 10.1016/j.jamda.2021.04.002. Epub 2021 May 5.
- Results publication: PubMed 38159914Bouzid W, Cantet C, Berard E, Mathieu C, Hermabessiere S, Houles M, Krams T, Qassemi S, Cambon A, McCambridge C, Tavassoli N, Rolland Y. Exploring Predictive Factors for Potentially Avoidable Emergency Department Transfers: Findings From the FINE Study. J Am Med Dir Assoc. 2024 Apr;25(4):572-579.e1. doi: 10.1016/j.jamda.2023.11.017. Epub 2023 Dec 27.
- Results publication: PubMed 34652784Dubucs X, Balen F, Charpentier S, Lauque D, De Souto Barreto P, Tavassoli N, Houze-Cerfon CH, Rolland Y. Factors associated with Emergency Medical Dispatcher request and residents' inappropriate transfers from Nursing Homes to Emergency Department. Eur Geriatr Med. 2022 Apr;13(2):351-357. doi: 10.1007/s41999-021-00574-5. Epub 2021 Oct 15.
- Derived from this study: PubMed 38641801Gombault-Datzenko E, Costa N, Mounie M, Tavassoli N, Mathieu C, Roussel H, Lagarrigue JM, Berard E, Rolland Y, Molinier L. Cost of care pathways before and after appropriate and inappropriate transfers to the emergency department among nursing home residents: results from the FINE study. BMC Geriatr. 2024 Apr 19;24(1):353. doi: 10.1186/s12877-024-04946-x.
- 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.
Yves ROLLAND, MD PhD principal investigator
University Hospital, Toulouse
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Frail Elderly, run by University Hospital, Toulouse at 16 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 4 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 23 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 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?
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?
Inappropriate transfer to ED of NH residents (time frame: Baseline (T1 = inclusion at ED): retro-prospectively by the group of experts). 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 NCT02677272, which also lists 5 linked publications.
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 23 Feb 2024.