- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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.
Study Overview
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Corinne Urvoy
- Phone Number: 33 1 46 25 27 64
- Email: c.urvoy@hopital-foch.com
Study Locations
-
-
Ile De France
-
Suresnes, Ile De France, France, 92150
- Recruiting
- Foch Hospital
-
Contact:
- Corinne URVOY
- Phone Number: 0033146252764
- Email: c.urvoy@hopital-foch.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
|
A phone call will be made by the nurse 72 hours before the surgery. During this phone call, the nurse :
|
|
No Intervention: 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Compliance with preoperative medical preparation instructions between the 2 groups (with and without preoperative nurse consultation).
Time Frame: At the intervention day (just before surgery)
|
The preoperative medical preparation will be assessed by a composite criterion including compliance with:
|
At the intervention day (just before surgery)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Compliance with preoperative administrative preparation instructions between the 2 groups (with and without preoperative telephone nurse consultation).
Time Frame: At the intervention day (just before surgery)
|
The preoperative administrative preparation will be assessed by the following 2 criteria:
|
At the intervention day (just before surgery)
|
|
Benefit of a preoperative nurse consultation on patient anxiety
Time Frame: at inclusion and at the intervention day (just before surgery)
|
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)
|
|
Patient's satisfaction regarding preoperative support
Time Frame: At the intervention day (just before surgery)
|
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)
|
|
Patient's satisfaction regarding the phone nurse consultation
Time Frame: At the intervention day (just before surgery)
|
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)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Elisabeth Hullier-Ammar, Foch Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2021_0069
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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