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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05243004
Other study ID # 2021_0069
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 26, 2022
Est. completion date May 2023

Study information

Verified date April 2022
Source Hopital Foch
Contact Corinne Urvoy
Phone 33 1 46 25 27 64
Email c.urvoy@hopital-foch.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 520
Est. completion date May 2023
Est. primary completion date May 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Phone Nurse consultation
A phone call will be made by the nurse 72 hours before the surgery. During this phone call, the nurse : underlines the preoperative preparation instructions (skin preparation, fasting period, specific medical instructions given by the anesthesiologist, administrative instructions) ensures that the reason for hospitalization is understood answers the patient's questions.

Locations

Country Name City State
France Foch Hospital Suresnes Ile De France

Sponsors (1)

Lead Sponsor Collaborator
Hopital Foch

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Compliance with preoperative medical preparation instructions between the 2 groups (with and without preoperative nurse consultation). The preoperative medical preparation will be assessed by a composite criterion including compliance with:
skin preparation (shower and depilation if applicable)
preoperative fasting
medical instructions (stopping or continuing drug treatments)
At the intervention day (just before surgery)
Secondary Compliance with preoperative administrative preparation instructions between the 2 groups (with and without preoperative telephone nurse consultation). The preoperative administrative preparation will be assessed by the following 2 criteria:
the time of arrival,
instructions for filling in administrative documents (care consent, person to be notified, trustworthy, etc.).
At the intervention day (just before surgery)
Secondary Benefit of a preoperative nurse consultation on patient anxiety Anxiety will be assessed using a numerical scale from 0 (no anxiety) to 10 (highest level of anxiety) at inclusion and at the intervention day (just before surgery)
Secondary Patient's satisfaction regarding preoperative support Satisfaction will be assessed using the patient support satisfaction assessment questionnaire (from "Not at all satisfied" to "Very satisfied") At the intervention day (just before surgery)
Secondary Patient's satisfaction regarding the phone nurse consultation Satisfaction will be assessed using the satisfaction assessment questionnaire for the phone nurse consultation (from "Useless" to "Essential" At the intervention day (just before surgery)
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