Phone Nurse Consultation Benefit on Compliance With PreOperative Instructions for Patients Undergoing Scheduled Surgery (CIT-PO)

April 26, 2022 updated by: Hopital Foch

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

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

520

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Ile De France
      • Suresnes, Ile De France, France, 92150

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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 :

  • 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.
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:

  • skin preparation (shower and depilation if applicable)
  • preoperative fasting
  • medical instructions (stopping or continuing drug treatments)
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:

  • 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)
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

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Elisabeth Hullier-Ammar, Foch Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 26, 2022

Primary Completion (Anticipated)

May 1, 2023

Study Completion (Anticipated)

May 1, 2023

Study Registration Dates

First Submitted

February 3, 2022

First Submitted That Met QC Criteria

February 14, 2022

First Posted (Actual)

February 16, 2022

Study Record Updates

Last Update Posted (Actual)

May 2, 2022

Last Update Submitted That Met QC Criteria

April 26, 2022

Last Verified

April 1, 2022

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)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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