Compared Efficacy of Nurse-led and GP-led Geriatric Assessment in PrImary Care (CEPIA)
24. juli 2017 oppdatert av: Assistance Publique - Hôpitaux de Paris
Compared Efficacy of Nurse-led and GP-led Geriatric Assessment in PrImary Care: A Pragmatic Three-arm Cluster Randomized Controlled Trial
Older patients account for around 10% of the population, of which 57% have a long-term illness, and 33% were admitted in the past year.
Geriatric assessment (GA) is a multidimensional assessment of general health status that can help identifying deficiencies and followed by a personalized care plan.
Assessment and management of elderly patients is a daily concern for the general practitioner (GP) but conflicting results have been reported so far relating to the clinical impact of GA when applied in the primary care setting.
This study protocol aims to assess the effect on morbi-mortality of a complex intervention in patients aged ≥70 years with chronic conditions in primary care. It aims to demonstrate that a GA adapted to primary care, followed by a personalized care plan and combined with successful interprofessional collaboration can improve clinically relevant outcomes in elderly patients with chronic conditions such as one-year overall mortality, unplanned hospital admission, emergency visits, or institutionalization.
The CEPIA study will also help addressing the issue of whether an improved benefit could be achieved from a systematic nurse-led or a case-by-case GP-led GA.
Studieoversikt
Status
Ukjent
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Forventet)
750
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Emilie Ferrat, MCU-MG
- Telefonnummer: +33 (0)1 49 81 44 71
- E-post: emilie.ferrat@u-pec.fr
Studer Kontakt Backup
- Navn: Claude Attali, PU-MG
- Telefonnummer: +33 (0)1 49 81 37 21
- E-post: attcl@wanadoo.fr
Studiesteder
-
-
-
Creteil, Frankrike, 94010
- Rekruttering
- Faculté de Médecine, Université Paris Est Créteil (UPEC)
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
70 år og eldre (Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Patients aged≥70 years with a long-term illness scheme or hospital admission the past 3 months
- Visiting their preferred general practioner (GP) or another GP in the same practice
- patient oral non opposition
Exclusion Criteria:
- Patient who does not speak French
- Severe disease with a life expectancy <12 months
- Institutionalized patients
- Patient insured under the French national health insurance system
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Systematic nurse-led GA
Interactive educational seminar for GPs and nurses, and focused on geriatric assessment in primary care combined with Systematic nurse-led GA and dedicated hotline for GPs seeking geriatric advice
|
Nurse-led or GP-led Geriatric assessment combined with an educational seminar focused on GA and personalized care-plan as well as a dedicated hotline for general practitioners seeking a geriatric advice Interactive educational seminar Primary care
Andre navn:
|
|
Eksperimentell: GP-led GA on a case-by-case basis, as decided by the GP
Interactive educational seminar for GPs, and focused on Geriatric assessment in primary care combined with a GP-led GA on a case-by-case basis, as decided by the GP, and a dedicated hotline for GPs seeking geriatric advice
|
Nurse-led or GP-led Geriatric assessment combined with an educational seminar focused on GA and personalized care-plan as well as a dedicated hotline for general practitioners seeking a geriatric advice Interactive educational seminar Primary care
Andre navn:
|
|
Ingen inngripen: No intervention
No educational seminar Usual care
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Primary composite endpoint combined with: - Percentage of all-cause mortality - Percentage of Unplanned hospital admission - Percentage of Emergency visits. - Percentage of Institutionalization
Tidsramme: At 12 months
|
At 12 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Percentage of all-cause mortality
Tidsramme: At 12 months
|
At 12 months
|
|
|
Percentage of Unplanned hospital admission
Tidsramme: At 12 months
|
At 12 months
|
|
|
Percentage of Emergency visits
Tidsramme: At 12 months
|
At 12 months
|
|
|
Percentage of Institutionalization
Tidsramme: At 12 months
|
At 12 months
|
|
|
Quality of life (Duke profile score)
Tidsramme: At Day 0 and 12 months
|
At Day 0 and 12 months
|
|
|
Autonomy by KATZ ALD score
Tidsramme: At Day 0 and 12 months
|
At Day 0 and 12 months
|
|
|
Number of medication prescription (polypharmacy)
Tidsramme: Up to 12 months
|
Up to 12 months
|
|
|
Percentage of Geriatric assessment performed
Tidsramme: Up to 12 months
|
Up to 12 months
|
|
|
Percentage of personalized care plan performed
Tidsramme: Up to 12 months
|
Up to 12 months
|
|
|
Percentage of geriatric phone advices requested by GPs
Tidsramme: Up to 12 months
|
Up to 12 months
|
|
|
Percentage of health care actions planned
Tidsramme: Up to 12 months
|
Up to 12 months
|
|
|
Percentage of satisfied general practitioner with the intervention
Tidsramme: 27months after the beginning of the study
|
self-assessment
|
27months after the beginning of the study
|
|
Satisfaction of general practitioners and nurses after completion of intervention
Tidsramme: 12 months after the beginning of the study
|
interview of general practionners and nurses by independant investigator
|
12 months after the beginning of the study
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Hovedetterforsker: Emilie Ferrat, MCU-MG, Université Paris Est (UPEC), IMRB, A-TVB DHU, CEpiA EA 7376 (Clinical Epidemiology and Ageing Unit)
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- Bouman A, van Rossum E, Nelemans P, Kempen GI, Knipschild P. Effects of intensive home visiting programs for older people with poor health status: a systematic review. BMC Health Serv Res. 2008 Apr 3;8:74. doi: 10.1186/1472-6963-8-74.
- Kuo HK, Scandrett KG, Dave J, Mitchell SL. The influence of outpatient comprehensive geriatric assessment on survival: a meta-analysis. Arch Gerontol Geriatr. 2004 Nov-Dec;39(3):245-54. doi: 10.1016/j.archger.2004.03.009.
- Stuck AE, Siu AL, Wieland GD, Adams J, Rubenstein LZ. Comprehensive geriatric assessment: a meta-analysis of controlled trials. Lancet. 1993 Oct 23;342(8878):1032-6. doi: 10.1016/0140-6736(93)92884-v.
- Stuck AE, Egger M, Hammer A, Minder CE, Beck JC. Home visits to prevent nursing home admission and functional decline in elderly people: systematic review and meta-regression analysis. JAMA. 2002 Feb 27;287(8):1022-8. doi: 10.1001/jama.287.8.1022.
- Frese T, Deutsch T, Keyser M, Sandholzer H. In-home preventive comprehensive geriatric assessment (CGA) reduces mortality--a randomized controlled trial. Arch Gerontol Geriatr. 2012 Nov-Dec;55(3):639-44. doi: 10.1016/j.archger.2012.06.012. Epub 2012 Jul 11.
- Ellis G, Whitehead MA, O'Neill D, Langhorne P, Robinson D. Comprehensive geriatric assessment for older adults admitted to hospital. Cochrane Database Syst Rev. 2011 Jul 6;(7):CD006211. doi: 10.1002/14651858.CD006211.pub2.
- Li CM, Chen CY, Li CY, Wang WD, Wu SC. The effectiveness of a comprehensive geriatric assessment intervention program for frailty in community-dwelling older people: a randomized, controlled trial. Arch Gerontol Geriatr. 2010 Feb;50 Suppl 1:S39-42. doi: 10.1016/S0167-4943(10)70011-X.
- Ferrat E, Bastuji-Garin S, Paillaud E, Caillet P, Clerc P, Moscova L, Gouja A, Renard V, Attali C, Breton JL, Audureau E. Efficacy of nurse-led and general practitioner-led comprehensive geriatric assessment in primary care: protocol of a pragmatic three-arm cluster randomised controlled trial (CEpiA study). BMJ Open. 2018 Apr 12;8(4):e020597. doi: 10.1136/bmjopen-2017-020597.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
24. mai 2016
Primær fullføring (Forventet)
24. august 2018
Studiet fullført (Forventet)
24. august 2018
Datoer for studieregistrering
Først innsendt
22. januar 2016
Først innsendt som oppfylte QC-kriteriene
22. januar 2016
Først lagt ut (Anslag)
27. januar 2016
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
26. juli 2017
Siste oppdatering sendt inn som oppfylte QC-kriteriene
24. juli 2017
Sist bekreftet
1. juni 2017
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- K140707
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
Kliniske studier på health care organization
-
Monash UniversityThe Alfred; Western Highlands Provincial Health Authority; Queensland HealthUkjent
-
Federal University of Minas GeraisConselho Nacional de Desenvolvimento Científico e TecnológicoUkjentDepresjon | Muskelsykdommer | Hetetokter | Angst | Premenstruell spenningBrasil
-
Kovacs FoundationAvsluttetLumbal spinal stenoseSpania
-
St. Joseph's Healthcare HamiltonRekruttering
-
Florida State UniversityUniversity of North Carolina, Chapel Hill; University of GeorgiaPåmelding etter invitasjonRisikoreduksjon for kardiovaskulær sykdomForente stater
-
Chunrui LiNanjing IASO Biotechnology Co., LtdRekrutteringPlasmacelleleukemi | Residiverende/refraktært myelomatoseKina
-
IWK Health CentreHar ikke rekruttert ennå
-
Manan ShuklaFullførtAstma | Kronisk sykdomForente stater
-
Samuel Lunenfeld Research Institute, Mount Sinai...Har ikke rekruttert ennåVelvære, psykologiskCanada