- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT05243004
Phone Nurse Consultation Benefit on Compliance With PreOperative Instructions for Patients Undergoing Scheduled Surgery (CIT-PO)
Assessment of a Phone Nurse Consultation Benefit on Compliance With the PreOperative Instructions for Patients Undergoing Scheduled Surgery and Entering the Operation Day
A preoperative reception unit (PORU) has been created at Foch Hospital to receive patients needing surgery and entering the same day of the operation (D0) as part of the reduction in average lengths of stay. This new mode of care requires a specific organization which requires the patient to become the main actor in his preparation.To optimize and make this new care fluid, a phone nurse consultation has been set up to support patients. The objective of this consultation is to discuss with the patient the different stages of his journey. The nurse checks the patient's level of information and reformulates if necessary so that he can receive clear and appropriate information, verifies that the patient has correctly integrated all that is expected for his preoperative preparation. It thus makes it possible to anticipate the issues that could impact the patient care process.The relevance of this consultation has never been assessed. However, the nurses have always good feedback from patients who are often surprised, satisfied with this interview and attentive. On the other hand, nurses who receive patients on the day of their intervention in PORU observe better fluidity in the care of patients who have had a phone nurse consultation. The patient is better prepared, which allows simpler and faster care.
This randomized controlled study will allow investigators to validate the perception of nurse and to assess the relevance of this phone nurse consultation in the best preoperative preparation of patients, the management of preoperative anxiety and the fluidity of patient care.
Panoramica dello studio
Tipo di studio
Iscrizione (Anticipato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Corinne Urvoy
- Numero di telefono: 33 1 46 25 27 64
- Email: c.urvoy@hopital-foch.com
Luoghi di studio
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Ile De France
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Suresnes, Ile De France, Francia, 92150
- Reclutamento
- Foch Hospital
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Contatto:
- Corinne URVOY
- Numero di telefono: 0033146252764
- Email: c.urvoy@hopital-foch.com
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Patient aged 18 years or over,
- Willing to undergo a scheduled surgery at Foch Hospital and entering the hospital the same morning of his intervention in the Preoperative Reception Unit (PORU),
- Having a scheduled pre-anesthetic consultation visit,
- Having signed a consent form,
- Affiliated with a health insurance plan.
Exclusion Criteria:
- Patient who does not speak or understand French,
- Patient requiring an invasive radiology procedure,
- Patient deprived of liberty or under guardianship.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Altro
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: Phone Nurse Consultation
Patients will benefit, in addition to the usual care, including a reminder by the secretary of the PORU the day before the operation, a phone call from nurse no later than 72 hours before surgery to explain and remind them of the instructions for preoperative preparation and answer any questions they may have.
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A phone call will be made by the nurse 72 hours before the surgery. During this phone call, the nurse :
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Nessun intervento: Standard care
Patients in this group will follow the usual preparation schedule including a reminder by the secretary of the PORU the day before the operation.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Compliance with preoperative medical preparation instructions between the 2 groups (with and without preoperative nurse consultation).
Lasso di tempo: At the intervention day (just before surgery)
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The preoperative medical preparation will be assessed by a composite criterion including compliance with:
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At the intervention day (just before surgery)
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Compliance with preoperative administrative preparation instructions between the 2 groups (with and without preoperative telephone nurse consultation).
Lasso di tempo: At the intervention day (just before surgery)
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The preoperative administrative preparation will be assessed by the following 2 criteria:
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At the intervention day (just before surgery)
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Benefit of a preoperative nurse consultation on patient anxiety
Lasso di tempo: at inclusion and at the intervention day (just before surgery)
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Anxiety will be assessed using a numerical scale from 0 (no anxiety) to 10 (highest level of anxiety)
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at inclusion and at the intervention day (just before surgery)
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Patient's satisfaction regarding preoperative support
Lasso di tempo: At the intervention day (just before surgery)
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Satisfaction will be assessed using the patient support satisfaction assessment questionnaire (from "Not at all satisfied" to "Very satisfied")
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At the intervention day (just before surgery)
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Patient's satisfaction regarding the phone nurse consultation
Lasso di tempo: At the intervention day (just before surgery)
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Satisfaction will be assessed using the satisfaction assessment questionnaire for the phone nurse consultation (from "Useless" to "Essential"
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At the intervention day (just before surgery)
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Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Elisabeth Hullier-Ammar, Foch Hospital
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Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Anticipato)
Completamento dello studio (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- 2021_0069
Piano per i dati dei singoli partecipanti (IPD)
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