SurgeryCIT-PONCT05243004
Phone Nurse Consultation Benefit on Compliance With PreOperative Instructions for Patients Undergoing Scheduled Surgery
A study testing Phone Nurse consultation in people with Surgery, run by Hopital Foch at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgery
- What is being tested?
- Phone Nurse consultation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 520 participants
- Where
- 1 siteFrance
- Study dates
- 26 Apr 2022to May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patient who does not speak or understand French,
- Patient requiring an invasive radiology procedure,
- Patient deprived of liberty or under guardianship.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Foch Hospital
Suresnes, Île-de-France Region, 92150
Corinne URVOY, 0033146252764, c.urvoy@hopital-foch.com
About this study
Official title: 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.
- Conditions
- Surgery
- Being tested
- Phone Nurse consultation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phone Nurse consultationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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).
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.).
Measured: At the intervention day (just before surgery)
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)
Measured: at inclusion and at the intervention day (just before surgery)
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")
Measured: At the intervention day (just before surgery)
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"
Measured: At the intervention day (just before surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2022
- Study start26 Apr 2022
- Primary completionMay 2023 (estimated)
- Study completionMay 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 520 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hopital Foch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elisabeth Hullier-Ammar, Principal investigator, Foch Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05243004
- Sponsor's protocol ID
- 2021_0069
- Acronym
- CIT-PO
- Status last verified
- Apr 2022
- First submitted
- 3 Feb 2022
- Last updated
- 2 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of a Phone Nurse Consultation Benefit on Compliance With the PreOperative Instructions for Patients Undergoing Scheduled Surgery and Entering the Operation Day
- ClinicalTrials.gov ID
- NCT05243004
- Acronym / sponsor ID
- CIT-PO / 2021_0069
- Conditions
- Surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 520 participants (estimated)
- Lead sponsor
- Hopital FochUniversity, hospital or other
- Study start
- 26 Apr 2022 (actual)
- Primary completion
- May 2023 (estimated)
- Study completion
- May 2023 (estimated)
- First posted
- 16 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phone Nurse Consultation | Experimental | Other: Phone Nurse consultationPatients 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- Patient who does not speak or understand French,
- Patient requiring an invasive radiology procedure,
- Patient deprived of liberty or under guardianship.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Phone Nurse consultationA 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. | Other | Phone Nurse Consultation |
Primary outcome
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)
4 secondary outcomes
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)
Benefit of a preoperative nurse consultation on patient anxiety
Time frame: 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)
Patient's satisfaction regarding the phone nurse consultation
Time frame: At the intervention day (just before surgery)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elisabeth Hullier-Ammar principal investigator
Foch Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phone Nurse consultation in people with Surgery, run by Hopital Foch at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Corinne Urvoy (33 1 46 25 27 64, c.urvoy@hopital-foch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2022.