NCT03852095

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 2, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 21, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 22, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 14, 2019

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 28, 2019

Completed
Last Updated

July 19, 2019

Status Verified

February 1, 2019

Enrollment Period

7 months

First QC Date

February 21, 2019

Last Update Submit

July 18, 2019

Conditions

Keywords

Pediatric, traumatology, hemarthrosis, ankle, knee,buckle fracture, clavicle, sprains

Outcome Measures

Primary Outcomes (1)

  • 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.

    at 6 months

Secondary Outcomes (2)

  • measurement of patient satisfaction

    at 60 days after inclusion

  • compliance of care

    at 60 days after inclusion

Study Arms (1)

minor trauma

Child from 1 to 18 years old suffering an isolated minor trauma presenting at the hospital emergency services.

Other: minor trauma

Interventions

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.

Also known as: medical recommendation sheet
minor trauma

Eligibility Criteria

Age1 Year - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Child from 1 to 18 years old suffering an isolated minor trauma presenting at the Lenval Foundation emergency services.

You may qualify if:

  • 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

You may not qualify if:

  • Refusal of the family ..............................................
  • No understanding of the instructions ...............................
  • Unaffiliated patient social security ..................................
  • No French speaking .............

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondation Lenval Hopitaux Pediatriques de Nice Chu Lenval

Nice, France

Location

MeSH Terms

Conditions

Fractures, BoneHemarthrosisSprains and Strains

Condition Hierarchy (Ancestors)

Wounds and InjuriesJoint DiseasesMusculoskeletal DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • RAMPAL VIRGINIE, MD

    Fondation Lenval - Nice Children Hospital CHU-Lenval

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 21, 2019

First Posted

February 22, 2019

Study Start

November 2, 2018

Primary Completion

June 14, 2019

Study Completion

June 28, 2019

Last Updated

July 19, 2019

Record last verified: 2019-02

Locations