Fractures, BoneNCT03852095
Single Time Management Diseases in Pediatric Traumatology
An observational study of Fractures, Bone, run by Fondation Lenval at 1 site in France.
Trial summary
A recent internal study evaluating the relevance of the visit to traumatology consultation in our establishment highlight that 49.3% of consultations were not relevant passages. The project consists of individualizing 5 to 6 pathologies and to create care sheets and patient sheets to be given to the care teams and… Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Fractures, Bone
- What is being tested?
- minor trauma
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 2 Nov 2018to 28 Jun 2019
- How long will I take part?
- 2 Months
- 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 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Child from 1 to 18 years old suffering an isolated minor trauma presenting at the Lenval Foundation emergency services.
Who may be able to join
- 0-18 years
- Positive diagnosis of elbow haemarthrosis, radial salter 1 fracture, fibula fracture 1 fracture, radial butter ball fracture, simple ankle sprain, simple knee sprain, fracture of the middle third of the clavicle .........
- No other associated anomaly
Who cannot join
- Refusal of the family ..............................................
- No understanding of the instructions ...............................
- Unaffiliated patient social security ..................................
- No French speaking .............
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single Time Management for Seven Common Disease in Pediatric Traumatology. A Monocentric Prospective Study
A recent internal study evaluating the relevance of the visit to traumatology consultation in our establishment highlight that 49.3% of consultations were not relevant passages. The project consists of individualizing 5 to 6 pathologies and to create care sheets and patient sheets to be given to the care teams and patients when the pathology lends itself to it. The aim is to reduce the irrelevant passage rate during these consultations, which is the source of absence from iterative work for parents, collateral expenses (toll, parking), absence from school for the children, unjustified expenses and X-ray examination unnecessary most often.
Read the detailed description
The Pediatric Orthopedics and Traumatology department proposes a reform of the care in Traumatology of the children in order to improve and homogenize the care for a better relevance of these.
A recent internal study (June 2018) evaluating the relevance of the visit to traumatology consultation in our establishment to highlight that 49.3% of consultations were not relevant passages (Benign diseases of sprained ankle type, muscular contusion or simple bone removals). Indeed, these specialist consultations are currently filled by pathologies of simple treatment that do not require medical follow-up (neither clinical nor radiological follow-up).
The project consists of individualizing 5 to 6 pathologies found in consultation recurrently which the scientific literature has established that their follow-up is not justified, and to create care sheets and patient sheets to be given to the care teams and patients when the pathology lends itself to it. These cards will include all the management of the pathology of the definition itself, including the treatment and expected outcomes.
The aim is to reduce the irrelevant passage rate during these consultations, which is the source of absence from iterative work for parents, collateral expenses (toll, parking), absence from school for the children, unjustified expenses and X-ray examination unnecessary most often.
The expected benefit is parental and child satisfaction, a time saving for the practitioner that he can reinvest in consultations for patients who are in fact a specialist opinion and a relative budget saving for the establishment.
The method of study of the decline of irrelevant consultations will be made by a systematic review of each reason for consultation over a period of 3 months after implementation of the cards and study of the percentage of irrelevant consultation over the same period. The objective pursued is a drop in attendance of at least 25% of consultations deemed irrelevant in Traumatology, associated with a satisfaction rate of parents greater than 90%.
- Conditions
- Fractures, Bone
- Being tested
- minor trauma
- Keywords
- Pediatric, traumatology, hemarthrosis, ankle, knee,, buckle fracture, clavicle, sprains
- Medical subject headings
- Fractures, Bone, Hemarthrosis, Sprains and Strains
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
minor traumaOther
Also called medical recommendation sheet
following the management of the patient's fracture in the emergency department, the patients / parents are recalled 2 months (J60) after the visit to the emergency room, and are interviewed by following the pre-established interrogation form, which checks the good agreement of the patient. treatment performed with the given sheet and recommendations, and assesses the satisfaction.
| Study group | Role | What they receive |
|---|---|---|
| minor trauma | Child from 1 to 18 years old suffering an isolated minor trauma presenting at the hospital emergency services. Receives: Other: minor trauma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of the number of patients routinely summoned to post-emergency trauma consultation
decrease in the number of patients coming back for an unjustified consultation for these 4 pathologies by comparing the period from 6 months preceding the start of the protocol to a period of 6 months after starting the protocol.
Measured: at 6 months
Secondary outcomes (2)
measurement of patient satisfaction
Call by phone the patient to measure the satisfaction by a standard questionnaire. the scale is composed of 7 closed questions on the satisfaction of care in emergencies, the follow-up of the patient by a city doctor. the answers are yes or no.
Measured: at 60 days after inclusion
compliance of care
call by phone the patient to verify the good compliance of the care. The improvement of the care will be evaluated according to the number of patient treated for one of these pathologies having felt the need to consult another doctor / orthopedic surgeon that is envisaged by the protocol (in the days following emergency room consultation).
Measured: at 60 days after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2019
- Study start2 Nov 2018
- Primary completion14 Jun 2019
- Study completion28 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fractures, BoneStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
- Target duration
- 2 Months
Sponsor and investigators
- Lead sponsor
- Fondation Lenval
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- RAMPAL VIRGINIE, MD, Principal investigator, Fondation Lenval - Nice Children Hospital CHU-Lenval
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03852095
- Sponsor's protocol ID
- 18-HPNCL-06
- Status last verified
- Feb 2019
- First submitted
- 21 Feb 2019
- Last updated
- 19 Jul 2019
- 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 19 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Time Management for Seven Common Disease in Pediatric Traumatology. A Monocentric Prospective Study
- ClinicalTrials.gov ID
- NCT03852095
- Acronym / sponsor ID
- 18-HPNCL-06
- Conditions
- Fractures, Bone
- Keywords
- Pediatric, traumatology, hemarthrosis, ankle, knee,, buckle fracture, clavicle, sprains
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Fondation LenvalUniversity, hospital or other
- Study start
- 2 Nov 2018 (actual)
- Primary completion
- 14 Jun 2019 (actual)
- Study completion
- 28 Jun 2019 (actual)
- First posted
- 22 Feb 2019 (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 recent internal study evaluating the relevance of the visit to traumatology consultation in our establishment highlight that 49.3% of consultations were not relevant passages. The project consists of individualizing 5 to 6 pathologies and to create care sheets and patient sheets to be given to the care teams and patients when the pathology lends itself to it. The aim is to reduce the irrelevant passage rate during these consultations, which is the source of absence from iterative work for parents, collateral expenses (toll, parking), absence from school for the children, unjustified expenses and X-ray examination unnecessary most often.
Detailed description
The Pediatric Orthopedics and Traumatology department proposes a reform of the care in Traumatology of the children in order to improve and homogenize the care for a better relevance of these.
A recent internal study (June 2018) evaluating the relevance of the visit to traumatology consultation in our establishment to highlight that 49.3% of consultations were not relevant passages (Benign diseases of sprained ankle type, muscular contusion or simple bone removals). Indeed, these specialist consultations are currently filled by pathologies of simple treatment that do not require medical follow-up (neither clinical nor radiological follow-up).
The project consists of individualizing 5 to 6 pathologies found in consultation recurrently which the scientific literature has established that their follow-up is not justified, and to create care sheets and patient sheets to be given to the care teams and patients when the pathology lends itself to it. These cards will include all the management of the pathology of the definition itself, including the treatment and expected outcomes.
The aim is to reduce the irrelevant passage rate during these consultations, which is the source of absence from iterative work for parents, collateral expenses (toll, parking), absence from school for the children, unjustified expenses and X-ray examination unnecessary most often.
The expected benefit is parental and child satisfaction, a time saving for the practitioner that he can reinvest in consultations for patients who are in fact a specialist opinion and a relative budget saving for the establishment.
The method of study of the decline of irrelevant consultations will be made by a systematic review of each reason for consultation over a period of 3 months after implementation of the cards and study of the percentage of irrelevant consultation over the same period. The objective pursued is a drop in attendance of at least 25% of consultations deemed irrelevant in Traumatology, associated with a satisfaction rate of parents greater than 90%.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| minor trauma | – | Other: minor traumaChild from 1 to 18 years old suffering an isolated minor trauma presenting at the hospital emergency services. |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Child from 1 to 18 years old suffering an isolated minor trauma presenting at the Lenval Foundation emergency services.
Key inclusion criteria (3 listed)
- 0-18 years
- Positive diagnosis of elbow haemarthrosis, radial salter 1 fracture, fibula fracture 1 fracture, radial butter ball fracture, simple ankle sprain, simple knee sprain, fracture of the middle third of the clavicle .........
- No other associated anomaly
Key exclusion criteria (4 listed)
- Refusal of the family ..............................................
- No understanding of the instructions ...............................
- Unaffiliated patient social security ..................................
- No French speaking .............
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 |
|---|---|---|
| minor traumaAlso: medical recommendation sheetfollowing the management of the patient's fracture in the emergency department, the patients / parents are recalled 2 months (J60) after the visit to the emergency room, and are interviewed by following the pre-established interrogation form, which checks the good agreement of the patient. treatment performed with the given sheet and recommendations, and assesses the satisfaction. | Other | minor trauma |
Primary outcome
Change of the number of patients routinely summoned to post-emergency trauma consultation
Time frame: at 6 months
decrease in the number of patients coming back for an unjustified consultation for these 4 pathologies by comparing the period from 6 months preceding the start of the protocol to a period of 6 months after starting the protocol.
2 secondary outcomes
measurement of patient satisfaction
Time frame: at 60 days after inclusion
compliance of care
Time frame: at 60 days after inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2019.
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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.
RAMPAL VIRGINIE, MD principal investigator
Fondation Lenval - Nice Children Hospital CHU-Lenval
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 Fractures, Bone, run by Fondation Lenval 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 3 inclusion and 4 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: finished, as of the sponsor's last update on 19 Jul 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of the number of patients routinely summoned to post-emergency trauma consultation (time frame: at 6 months). 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 19 Jul 2019.