Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000427572
Ethics application status
Approved
Date submitted
3/10/2006
Date registered
3/10/2006
Date last updated
11/03/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Paediatric Trauma Care Case Management Study
Scientific title
A Randomised Control Trial to evaluate the effectiveness of using senior nurses as Case Managers in improving clinical information gathering and service quality for delivering Trauma Care to children who are hospitalised due to severe injuries
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Trauma and severe injuries defined as damages to the body due to a sudden force which is external to the recipient. These damages include sprains, bruises, fractures, dislocations, concussions, contusions, penetration, and cuts. Typical examples of trauma among children are severe injuries due to motor-vehicle crashes. 1399 0
Condition category
Condition code
Injuries and Accidents 1491 1491 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A case management approach using senior trauma nurses in providing trauma care services to children who have been moderately or severely injured and hospitalised. Roles of theTrauma Case Manager (TCM) include the following functions:
• Coordinates care with other health care providers.
• Conducts initial and ongoing assessment to ensure the efficient use of resources
• Develops and monitors the use of clinical care protocols
• Manages outcomes
• Protects the financial interests of the hospital
• Promotes continuity of care through discharge
• Enhances the patient and family’s perception of the institution
• Advocates for the patient to get the required care and services

The intervention will be applied once consent has been obtained from the parent/carer of the patient until the patient is discharged from the hospital.
Intervention code [1] 1386 0
Treatment: Other
Comparator / control treatment
Patients in the control group will receive standard medical treatment as per their injury situation. These patients will be under the care of a surgical registrar according to the existing clinical guidelines stipulated by the Children's Hospital at Westmead policy and procedures.
Control group
Placebo

Outcomes
Primary outcome [1] 2062 0
The effectiveness of the case management approach using a senior nurse as the case manager for services delivery with outcomes of improving clinical information gathering and service quality.
Timepoint [1] 2062 0
Measured via the audit of the medical records, standardised and mandatory clinical forms on the day when the patient is discharged from the hospital.
Secondary outcome [1] 3553 0
Secondary outcomes are the length of stay in hospital and clinician-patient-parent communication and thus patients’ satisfaction.
Timepoint [1] 3553 0
These will also be measured on the day when the patient is discharged from the hospital.

Eligibility
Key inclusion criteria
Eligible subjects for this study will include children and adolescents, who are admitted to the hospital more than 4 hours following traumatic injuries and who meet the criteria for activation of a trauma call. Patients who meet the criteria for activation of a trauma call are likely to have an Injury Severity Score (ISS) of 9 or above.
Minimum age
0 Years
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Trauma patients who are admitted but for unpredicted reasons will not complete their treatment and management at Children's Hospital at Westmead (CHW) will be excluded from the study. Trauma patients who are admitted to the hospital, but died soon after without having the opportunity for a complete management regime will also be excluded from the study. Patients who are presented to the hospital with a trauma call but are admitted less than 4 hours will also be excluded.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation involved contacting the holder of the allocation schedule who was at the central administration
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomistaion with stratification by sex
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/10/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
140
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1629 0
Hospital
Name [1] 1629 0
the Children's Hospital at Westmead
Country [1] 1629 0
Australia
Primary sponsor type
Individual
Name
Lawrence T. Lam
Address
Country
Secondary sponsor category [1] 1429 0
Individual
Name [1] 1429 0
Frank Ross
Address [1] 1429 0
Country [1] 1429 0
Secondary sponsor category [2] 1430 0
Individual
Name [2] 1430 0
Fiona Fahy
Address [2] 1430 0
Country [2] 1430 0
Secondary sponsor category [3] 1431 0
Individual
Name [3] 1431 0
SVS Soundappan
Address [3] 1431 0
Country [3] 1431 0
Secondary sponsor category [4] 1432 0
Individual
Name [4] 1432 0
Daniel T Cass
Address [4] 1432 0
Country [4] 1432 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3075 0
The Children's Hospital at Westmead Human Ethics Committee
Ethics committee address [1] 3075 0
Ethics committee country [1] 3075 0
Australia
Date submitted for ethics approval [1] 3075 0
Approval date [1] 3075 0
Ethics approval number [1] 3075 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27613 0
Address 27613 0
Country 27613 0
Phone 27613 0
Fax 27613 0
Email 27613 0
Contact person for public queries
Name 10575 0
Lawrence T. Lam
Address 10575 0
The Children's Hospital at Westmead
Locked Bag 4001
Westmead NSW 2145
Country 10575 0
Australia
Phone 10575 0
+61 2 98453055
Fax 10575 0
Email 10575 0
[email protected]
Contact person for scientific queries
Name 1503 0
Lawrence T. Lam
Address 1503 0
The Children's Hospital at Westmead
Locked Bag 4001
Westmead NSW 2145
Country 1503 0
Australia
Phone 1503 0
+61 2 98453055
Fax 1503 0
Email 1503 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Plain language summaryNo The study was completed with about 120 patients re... [More Details]

Documents added automatically
No additional documents have been identified.