Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04352881 |
| Other study ID # |
APHP191120 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
November 10, 2020 |
| Est. completion date |
April 24, 2021 |
Study information
| Verified date |
February 2021 |
| Source |
Assistance Publique - Hôpitaux de Paris |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
For 12 years, the odontology service of the Pitié-Salpêtrière hospital group (GHPS) has been
responsible for day and night dental emergency care. Several surveys have been conducted in
order to analyze the sociological characteristics of the patients and the typology of the
acts performed. These studies indicate that pain is the main reason for consultations, cited
by 60 to 80% of patients.
So far, very few studies have been done in the context of emergencies. Very recently, a study
was undertaken on the satisfaction of patients consulting the odontological emergencies of
the GHPS, during a thesis work.
This study, carried out in collaboration with the URC Pitié Salpêtrière, under analysis,
relates to the satisfaction of patients consulting the odontological emergencies of the GHPS
during the day and week, Monday to Friday, excluding night and week emergencies -end (WE).
Attendance at night and during WE is important because it is sociologically and medically
different from that of day and week. It is therefore important to complete this study by
focusing on patients consulting the emergency room at night and during the weekend.
This work therefore responds to a request from the Odontology Emergency Reception Service
(SAUO) of the Pitié-Salpêtrière Hospital Group. It will be carried out in the form of a
survey whose objective is to assess: on the one hand, the effectiveness of the care provided
in this emergency functional unit, and on the other hand the satisfaction of the patients
after their passage to the emergency room .
Description:
I. Research progress Two investigators will take turns in the service for the search
duration. They will be responsible for informing patients of the research upon their arrival
in the service and for the data collection and telephone follow-ups.
The course of the research will take place as follows:
Day of consultation (D0):
1. Patient information on the search when he arrives in the service; explanation of its
objectives, its modalities and constraints.
2. Verification of eligibility criteria.
3. Collection of the patient's non-opposition by the dentist during the consultation
4. Consultation according to the usual care. During this procedure, the practitioner
performs a medical history and, according to the patient's answers, completes the
"General Information Questionnaire".
He carries out the emergency care and explains the postoperative consequences.
5. Patient filling in the satisfaction questionnaire immediately after consultation.
Telephone follow-up:
6. Telephone follow-up by the interviewer and fill in the questionnaire - in case of
non-availability of the patient on day 1, the patient will be recalled on day 2 and the
extrapolated data on the slope of the curve between D1 and D2
7. Telephone follow-up by the interviewer on the day and filling in the questionnaire - if
the patient is not available on day 3, the patient will be recalled on day 4 and the
data extrapolated according to the slope of the curve between D1 and D4; if the patient
is not available at D4, he will be recalled to D5 and the extrapolated data between D1
and D5.
8. Telephone follow-up on the interviewer's day and fill in the questionnaire in case of
non-availability of the patient on day 7, the patient will be recalled to D8 and the
data extrapolated according to the slope of the curve between D3 and D8; if the patient
is still not available on D8, he will be recalled to D9 and the extrapolated data
between D3 and D9.
For the night sample : from 6:30 pm to 8 am Recall should be 24 hours after the care, but it
seems not ethical or efficient to recall patients the night following ; an extension of 12
hours will be instaurated, taking then the recalls to 36h (D1), 84h (D3), and 180h (D7) after
the care.
For the WE sample : from 8 am to 6:30 pm D1: 24 hours after the care D3: 72 hours after the
care D7 :168 hours after the care
II.1.STATISTICAL ASPECTS
II.1. Statistical justification for the sample size 58,921 patients were received in
emergency consultation day and night during the year 2017. We wish to constitute a sample of
1% of the population concerned.
For the night sample The investigators are interested here in patients received in night
emergencies, 26 050 patients in 2018. On average 72 patients are received daily in
emergencies of day, about 504 per week.
According to a previous study in the department (15), 50% of patients in care could not be
included in the study or were lost to follow-up.
This leads to a number of 252 analysable patients per week. The investigators will therefore
conduct our study over 9 nights, to include 325 patients, ie 1.25% of the population
consulting For the WE sample The investigators are interested here in patients received in
Saturday and Sunday emergencies, 10 657 patients in 2018. On average 204 patients are
received each week-end in emergencies of day.
According to a previous study in the department (15), 50% of patients in care could not be
included in the study or were lost to follow-up.
This leads to a number of 102 analysable patients per week-end. The investigators will
therefore conduct our study over 2 week-ends, to include 204 patients, ie 1.9% of the
population consulting
II.2. Description of statistical methods A descriptive analysis of the characteristics of the
sample will be performed (age, sex, reason for consultation, diagnosis, prior appointment
test, average score of anxiety and pain scores on D0, D1, D3, D7, compliance with
instructions and making follow-up appointments,), satisfaction rating, appreciation of the
quality of medical care, politeness of staff, waiting time, assessment of the quality of the
care setting, the information received, the treatment received, and the recommendation of the
service to third parties will be made.
An analysis of the evolution of pain and anxiety scores between D0, D1, D3 and D7 will be
performed.
Correlations between the type of treatment and the perceived pain as well as the type of
treatment and the perceived anxiety will be made.
II.3. Method of taking into account missing or invalid data Patients unreachable during the
telephone follow-up period will be contacted the next day; the pain and anxiety scores will
then be extrapolated from the previous data and the new data collected, by calculating the
nearest point on the curve connecting these two data. If they are new unreachable, the data
will be considered missing. Data from patients with missing data will be analyzed separately.
III. DATA MANAGEMENT III.1. Terms of data collection The research does not foresee the use of
data extracted from existing information systems or from previously completed studies.
No nominative data will be collected as part of this research. The data will be rendered
non-identifying. They must not in any case show in clear the names of the persons concerned
or their address.
As part of this research, topics will be identified as follows:
N or W (depending on the Night or Week-end sample) - Chronological order of the person (3
digits) - first letter of the first name - first letter of last name The answers to the
different questionnaires (completed by the patients and the interviewers) will be entered
into an EXCEL file. This file will be protected by a password.
The seizure will be carried out by the coordinating investigator or one of those
collaborators (dentist or student) declared in the center and trained in research at the end
of each session.
III.2. Data circuit The investigators will collect the data directly from the patient during
the consultation or during telephone interviews on paper forms (CRF).
This data will then be entered into an Excel database specifically created for the search.
The database will be kept on the computer of the odontology service at the Pitié-Salpêtrière
hospital and will be protected by a password known only to research stakeholders.
Data analysis will be done by the principal investigator and the research stakeholders
