NCT05243004

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
520

participants targeted

Target at P75+ for not_applicable surgery

Timeline
Completed

Started Apr 2022

Shorter than P25 for not_applicable surgery

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 3, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 16, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

April 26, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2023

Completed
Last Updated

May 2, 2022

Status Verified

April 1, 2022

Enrollment Period

1 year

First QC Date

February 3, 2022

Last Update Submit

April 26, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Compliance with preoperative administrative preparation instructions between the 2 groups (with and without preoperative telephone nurse consultation).

    At the intervention day (just before surgery)

  • Benefit of a preoperative nurse consultation on patient anxiety

    at inclusion and at the intervention day (just before surgery)

  • Patient's satisfaction regarding preoperative support

    At the intervention day (just before surgery)

  • Patient's satisfaction regarding the phone nurse consultation

    At the intervention day (just before surgery)

Study Arms (2)

Phone Nurse Consultation

EXPERIMENTAL

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.

Other: Phone Nurse consultation

Standard care

NO INTERVENTION

Patients in this group will follow the usual preparation schedule including a reminder by the secretary of the PORU the day before the operation.

Interventions

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.

Phone Nurse Consultation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Patient who does not speak or understand French,
  • Patient requiring an invasive radiology procedure,
  • Patient deprived of liberty or under guardianship.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Foch Hospital

Suresnes, Île-de-France Region, 92150, France

RECRUITING

Study Officials

  • Elisabeth Hullier-Ammar

    Foch Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 3, 2022

First Posted

February 16, 2022

Study Start

April 26, 2022

Primary Completion

May 1, 2023

Study Completion

May 1, 2023

Last Updated

May 2, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations