Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04354272 |
| Other study ID # |
APHP200464 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
April 21, 2020 |
| Est. completion date |
May 18, 2020 |
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). An
additional study (URGDENT-NW) aiming at completing this study by focusing on patients
consulting the emergency room at night and during the weekend is also in progress.
The COVID19 Crisis changed the organization and the venue of patients at the emergency dental
service.
Therefore this project, based on the same protocol as URGENT and URGDENT-WE, aims at
evaluating the Odontology Emergency Reception Service (SAUO) during the COVID 19 epidemy. 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 instaured, taking then the recalls to 36h (D1), 84h (D3), and 180h (D7) after
the care.
For the Day 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 The investigators want to assess the
activity of the service over 4 weeks during the COVID crisis by taking two readings per week
during the day and one during the night. The 1st figures of the service (week of March 16 to
22) indicate an average attendance of 80 patients day and 50 per night.
So the investigators will have 8 x 80 = 640 patients during the day period and 4x 50 = 200
patients per night 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 420 analysable patients per week.
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"
