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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02677272
Other study ID # RC31/15/7464
Secondary ID 2015-A00723-46
Status Completed
Phase
First received
Last updated
Start date January 1, 2016
Est. completion date July 31, 2018

Study information

Verified date February 2024
Source University Hospital, Toulouse
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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). 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.


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


Recruitment information / eligibility

Status Completed
Enrollment 1040
Est. completion date July 31, 2018
Est. primary completion date July 31, 2018
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - to live in a Nursing Home - to be directly transferred from the NH to ED - to have not previously been included in FINE study Exclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Appropriateness of NH resident's transfer to ED


Locations

Country Name City State
France CH d'Albi Albi
France CH d'Auch Auch
France CH de Cahors Cahors
France CHI Castres Mazamet Castres
France CH Ariège Couserans Foix
France CH de Gourdon Gourdon
France CH Lannemezan Lannemezan
France CH Lavaur Lavaur
France CH de Lourdes Lourdes
France CH Castelsarrasin Moissac Moissac
France CH Montauban Montauban
France CH Rodez Rodez
France CH Saint Gaudens Saint Gaudens
France CHI Val d'Ariège Saint Girons
France Toulouse University Hospital (CHU de Toulouse) Toulouse
France CH de Bigorre Vic en Bigorre

Sponsors (3)

Lead Sponsor Collaborator
University Hospital, Toulouse Agence Régionale de la Santé - Midi Pyrénées, Ministry of Health, France

Country where clinical trial is conducted

France, 

References & Publications (4)

Bouzid 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 — View Citation

Dubucs 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 Ge — View Citation

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. — View Citation

Rolland 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 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
Baseline (T1 = inclusion at ED): retro-prospectively by the group of experts
Secondary 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 6 months before to 6 months after the transfer
Secondary 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. Baseline (T1 = inclusion at ED)
Secondary 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) Change at different time points: T0, T2 (up to 12 days,if concerned) and T3 (7 days after return to NH)
Secondary 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) Change at different time points: T1 (baseline), T2 (up to 12 days,if concerned) and T3 (7 days after return to NH)
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