Emergency SurgicalNCT03580863
Referred vs Spontaneous Visits at Pediatric ER: an Outcome Study
An observational study of Emergency Surgical, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Since 80's, admissions in Emergency medical services increase regularly. Children represents 30% of the patients in Emergency medical Service. Only 20% of admissions are hospitalized and only 3 % need emergency care. Consequences are team's exhaustion, a reduction of healthcare quality, a slowdown in emergency care. Read more about this study
- Who is it for?
- Ages 1 day to 18 years
- Conditions the study is for
- Emergency Surgical
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2018to Jan 2019
- Phase
- Observational
- 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 1 day to 18 years
- All sexes
- Child, Adult
Study population: * Any child attending the pediatric medical and surgical emergency department of Strasbourg University Hospital, accompanied by at least one of his parents. * Age of the patient: from birth to 18 years. * Patient sent by mail from a liberal doctor (general practitioner, liberal pediatrician, PMI, SOS doctor ...) for the first group.
Who may be able to join
- Any child attending the pediatric medical and surgical emergency department of Strasbourg University Hospital, accompanied by at least one of his parents.
- Age of the patient: from birth to 18 years.
- Patient sent by mail from a liberal doctor (general practitioner, liberal pediatrician, PMI, SOS doctor ...) for the first group.
- Or emergency consultant spontaneously for the second group.
- Understanding and speaking French
- Having agreed to participate in the study if it is old, or whose parents have agreed to participate in the study.
Who cannot join
- Patient unaccompanied by one of his parents
- Refusal to participate in the study.
- Vital emergency or immediate care needed
- Patient arriving at the emergency department at first alone with paramedics or the SMUR, then joined by his parents secondarily
- Patients referred by a liberal doctor but without mail.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Service D'Urgences Medico Chirurgicales Pediatriques
Strasbourg, 67091
Dimitar TCHOMAKOV, MD, PhD, 33.3.88.12.57.87, Dimitar.TCHOMAKOV@chru-strasbourg.fr
Marie NOUET, MD, 33 6 25 54 04 39, marie.nouet@gmail.com
About this study
Official title: Coverage and Future of Children Referred by a Liberal Doctor's Letter to Pediatric Emergency in Strasbourg Teaching Hospital Compared With Children Who Are Coming by Themselves in 2017
Since 80's, admissions in Emergency medical services increase regularly. Children represents 30% of the patients in Emergency medical Service. Only 20% of admissions are hospitalized and only 3 % need emergency care. Consequences are team's exhaustion, a reduction of healthcare quality, a slowdown in emergency care.
Investigator decided to realize an epidemiologic prospective study in Emergency medical and surgical Pediatric Service in Strasbourg Teaching Hospital to compare coverage of children who are referred by a liberal doctor with children who are coming by themselves matched with age and complaint.
This study will analyze the relevance of complaints and decision-making factors for the liberal doctor to send children in Emergency Medical and Surgical Service. Investigator will talk about the importance of close collaboration between liberal doctor and hospital doctor, as well as patient's information about basic care service on nights and week-ends in order to decrease the number of emergency admission.
- Conditions
- Emergency Surgical
- Keywords
- Pediatric, emergency surgical and medical service, Liberal doctor, complaint
What is being measured
The primary outcome is the main question the study is designed to answer.
Retrospective study of hospitalization frequency
Measured: The period from January 1st, 2016 to December 31st, 2017 will be examined
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2018
- Study start1 Jan 2018
- Primary completionJan 2019 (estimated)
- Study completionJan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emergency SurgicalStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dimitar TCHOMAKOV, MD, Principal investigator, University Hospital, Strasbourg, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03580863
- Sponsor's protocol ID
- 7008
- Status last verified
- Jan 2018
- First submitted
- 14 Jun 2018
- Last updated
- 11 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coverage and Future of Children Referred by a Liberal Doctor's Letter to Pediatric Emergency in Strasbourg Teaching Hospital Compared With Children Who Are Coming by Themselves in 2017
- ClinicalTrials.gov ID
- NCT03580863
- Acronym / sponsor ID
- 7008
- Conditions
- Emergency Surgical
- Keywords
- Pediatric, emergency surgical and medical service, Liberal doctor, complaint
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- Jan 2019 (estimated)
- Study completion
- Jan 2019 (estimated)
- First posted
- 9 Jul 2018 (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.
Since 80's, admissions in Emergency medical services increase regularly. Children represents 30% of the patients in Emergency medical Service. Only 20% of admissions are hospitalized and only 3 % need emergency care. Consequences are team's exhaustion, a reduction of healthcare quality, a slowdown in emergency care.
Investigator decided to realize an epidemiologic prospective study in Emergency medical and surgical Pediatric Service in Strasbourg Teaching Hospital to compare coverage of children who are referred by a liberal doctor with children who are coming by themselves matched with age and complaint.
This study will analyze the relevance of complaints and decision-making factors for the liberal doctor to send children in Emergency Medical and Surgical Service. Investigator will talk about the importance of close collaboration between liberal doctor and hospital doctor, as well as patient's information about basic care service on nights and week-ends in order to decrease the number of emergency admission.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 1 day to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- * Any child attending the pediatric medical and surgical emergency department of Strasbourg University Hospital, accompanied by at least one of his parents. * Age of the patient: from birth to 18 years. * Patient sent by mail from a liberal doctor (general practitioner, liberal pediatrician, PMI, SOS doctor ...) for the first group.
Key inclusion criteria (6 listed)
- Any child attending the pediatric medical and surgical emergency department of Strasbourg University Hospital, accompanied by at least one of his parents.
- Age of the patient: from birth to 18 years.
- Patient sent by mail from a liberal doctor (general practitioner, liberal pediatrician, PMI, SOS doctor ...) for the first group.
- Or emergency consultant spontaneously for the second group.
- Understanding and speaking French
Key exclusion criteria (5 listed)
- Patient unaccompanied by one of his parents
- Refusal to participate in the study.
- Vital emergency or immediate care needed
- Patient arriving at the emergency department at first alone with paramedics or the SMUR, then joined by his parents secondarily
- Patients referred by a liberal doctor but without mail.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Retrospective study of hospitalization frequency
Time frame: The period from January 1st, 2016 to December 31st, 2017 will be examined
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2018.
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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.
Dimitar TCHOMAKOV, MD principal investigator
University Hospital, Strasbourg, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Emergency Surgical, run by University Hospital, Strasbourg, France 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 6 inclusion and 5 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 11 Jul 2018. 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 Dimitar TCHOMAKOV, MD (33.3.88.12.57.87, Dimitar.TCHOMAKOV@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retrospective study of hospitalization frequency (time frame: The period from January 1st, 2016 to December 31st, 2017 will be examined). 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 11 Jul 2018.