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Trial registered on ANZCTR


Registration number
ACTRN12613000722796
Ethics application status
Approved
Date submitted
28/06/2013
Date registered
1/07/2013
Date last updated
21/01/2019
Date data sharing statement initially provided
21/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Prospective evaluation of tertiary survey for identification of missed musculoskeletal injuries in trauma patients.
Scientific title
The tertiary physiotherapy survey in identification of missed musculoskeletal injuries in trauma patients.
Secondary ID [1] 282757 0
nil
Universal Trial Number (UTN)
Trial acronym
PREVENT study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Trauma 289497 0
Condition category
Condition code
Injuries and Accidents 289822 289822 0 0
Other injuries and accidents
Musculoskeletal 289823 289823 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 289824 289824 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Trauma survey include a rapid primary survey to immediately identify and manage life-threatening injuries followed by a head to toe secondary survey supplemented with diagnostic testing is the standard of care in trauma management. Tertiary survey had been introduced to identify injuries missed during the primary and secondary surveys performed in the resuscitation room, and includes a repeated head-to-toe examination and review of all laboratory and radiology studies, usually completed within 24 hours of admission.
Once trauma call is activated, cardiothoracic surgery and emergency physiotherapists’ pagers are alerted
Senior cardiothoracic and senior emergency physiotherapists (Coordinators) screen patients and provide tertiary survey forms to allocated physiotherapists (assessors) in respective wards.
(For trauma admissions occurring overnight during the week and over the weekend, a senior physiotherapist will coordinate and screen any eligible trauma patients)
Within 24 hours, the assessors will inform the coordinators when ready to assess the patient.
Blinding:
If trauma team has already completed the tertiary survey, one of the coordinators will cover trauma team’s tertiary survey with an opaque paper before assessor conducts tertiary survey on the patient. The patient will also be encouraged by the coordinator prior to the assessor’s tertiary survey, not to disclose what trauma team may have informed the patient after their tertiary survey.

Similarly, if the trauma team has not completed tertiary survey, the coordinator will inform the patient not to disclose assessor’s tertiary findings to the trauma team.

Once the assessors complete the tertiary survey assessment form, the forms will return to the coordinators
Coordinators then will document when the treating team has completed the tertiary survey form/photocopy treating team trauma survey

Physiotherapists and medical/trauma team who are conducting the tertiary survey will be blinded from each other’s tertiary survey as described above. However, pre tertiary survey information (results of initial work up, physical examination and radiologic studies that have been performed as part of primary/secondary surveys) will be available to both physiotherapists who are completing the tertiary survey and the medical/trauma team. This would be considered the norm for any patients having a tertiary survey.

Currently, when a treating physiotherapist identifies a missed injury, the physiotherapist would inform the treating team of such finding. Therefore, when an assessor prior to the trauma team has identified a missed injury, the coordinator will inform the trauma team of the findings.

For the purpose of this study, missed injury is defined as any injuries missed after primary and secondary surveys conducted within 24 hours of admission. This is the definitive assessment
Intervention code [1] 287423 0
Diagnosis / Prognosis
Intervention code [2] 287435 0
Early detection / Screening
Comparator / control treatment
Tertiary survey completed by trauma team/admitting team within 24 hours of patient admission to the hospital
Control group
Active

Outcomes
Primary outcome [1] 289889 0
The number of missed musculoskeletal injuries identified by physiotherapist and admitting trauma team
Timepoint [1] 289889 0
12 months
Primary outcome [2] 291029 0
Comparison of new or missed and types of musculoskeletal injuries identified by physiotherapist to admitting trauma team
Timepoint [2] 291029 0
12 months
Secondary outcome [1] 303492 0
Number of tertiary survey completed by physiotherapists earlier than the treating team
Timepoint [1] 303492 0
12 months

Eligibility
Key inclusion criteria
Age more than 18 years, English speaking backgroun, any trauma patients which trauma call was activated upon arrival in ED
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No one is excluded

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
To determine the sample size needed, a retrospective audit of trauma admissions in July 2013 was carried out (unpublished data). 104 patients were assessed and 10 injuries were identified as missed, corresponding to a prevalence of missed injuries of 10%, or a sensitivity of the Trauma team review to identify injuries of 90%. In order to demonstrate that the physiotherapist review would identify injuries with a clinically acceptable sensitivity of 95%, corresponding to a 5% increase in sensitivity, at a confidence interval of 0.1, a sample size of around 150 patients is needed
Analysis:
The outcomes are compared using 2x2 table. This will have P group and T group as the diagnostic test, and the presence or absence of a missed injury as the pathology. A Chi-square test can be used to determine the sensitivity and specificity for assessments by Physiotherapists and Trauma team and whether there are any differences.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
6/01/2014
Actual
21/01/2014
Date of last participant enrolment
Anticipated
6/01/2015
Actual
21/01/2015
Date of last data collection
Anticipated
Actual
21/01/2015
Sample size
Target
466
Accrual to date
Final
466
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 1183 0
Liverpool Hospital - Liverpool
Recruitment postcode(s) [1] 7032 0
2170 - Liverpool
Recruitment postcode(s) [2] 7039 0
2570 - Camden
Recruitment postcode(s) [3] 7040 0
2200 - Bankstown
Recruitment postcode(s) [4] 7041 0
2176 - Prairiewood
Recruitment postcode(s) [5] 7042 0
2560 - Campbelltown
Recruitment postcode(s) [6] 7075 0
2163 - Villawood
Recruitment postcode(s) [7] 7076 0
2190 - Greenacre
Recruitment postcode(s) [8] 7077 0
2197 - Bass Hill
Recruitment postcode(s) [9] 7078 0
2198 - Georges Hall
Recruitment postcode(s) [10] 7079 0
2199 - Yagoona
Recruitment postcode(s) [11] 7080 0
2200 - Condell Park
Recruitment postcode(s) [12] 7081 0
2211 - Padstow
Recruitment postcode(s) [13] 7082 0
2212 - Revesby
Recruitment postcode(s) [14] 7083 0
2213 - Panania
Recruitment postcode(s) [15] 7084 0
2214 - Milperra
Recruitment postcode(s) [16] 7085 0
2163 - Lansdowne
Recruitment postcode(s) [17] 7086 0
2164 - Smithfield
Recruitment postcode(s) [18] 7087 0
2165 - Fairfield Heights
Recruitment postcode(s) [19] 7088 0
2166 - Cabramatta
Recruitment postcode(s) [20] 7089 0
2168 - Ashcroft
Recruitment postcode(s) [21] 7090 0
2171 - Cecil Hills
Recruitment postcode(s) [22] 7091 0
2172 - Pleasure Point
Recruitment postcode(s) [23] 7092 0
2173 - Holsworthy
Recruitment postcode(s) [24] 7093 0
2174 - Edmondson Park
Recruitment postcode(s) [25] 7094 0
2175 - Horsley Park
Recruitment postcode(s) [26] 7095 0
2176 - Bossley Park
Recruitment postcode(s) [27] 7096 0
2177 - Bonnyrigg
Recruitment postcode(s) [28] 7097 0
2178 - Kemps Creek
Recruitment postcode(s) [29] 7098 0
2179 - Austral
Recruitment postcode(s) [30] 7099 0
2555 - Badgerys Creek
Recruitment postcode(s) [31] 7100 0
2556 - Bringelly
Recruitment postcode(s) [32] 7101 0
2557 - Gledswood Hills
Recruitment postcode(s) [33] 7102 0
2565 - Denham Court
Recruitment postcode(s) [34] 7103 0
2745 - Glenmore Park
Recruitment postcode(s) [35] 7104 0
2167 - Glenfield
Recruitment postcode(s) [36] 7105 0
2174 - Ingleburn Milpo
Recruitment postcode(s) [37] 7106 0
2179 - Austral
Recruitment postcode(s) [38] 7107 0
2557 - Catherine Field
Recruitment postcode(s) [39] 7108 0
2558 - Eagle Vale
Recruitment postcode(s) [40] 7109 0
2559 - Blairmount
Recruitment postcode(s) [41] 7110 0
2560 - Appin
Recruitment postcode(s) [42] 7111 0
2563 - Menangle Park
Recruitment postcode(s) [43] 7112 0
2564 - Macquarie Fields
Recruitment postcode(s) [44] 7113 0
2565 - Ingleburn
Recruitment postcode(s) [45] 7114 0
2566 - Minto
Recruitment postcode(s) [46] 7115 0
2567 - Narellan
Recruitment postcode(s) [47] 7116 0
2568 - Menangle
Recruitment postcode(s) [48] 7117 0
2569 - Douglas Park
Recruitment postcode(s) [49] 7118 0
2570 - Camden South
Recruitment postcode(s) [50] 7119 0
2571 - Buxton
Recruitment postcode(s) [51] 7120 0
2572 - Thirlmere
Recruitment postcode(s) [52] 7121 0
2573 - Tahmoor
Recruitment postcode(s) [53] 7122 0
2574 - Pheasants Nest
Recruitment postcode(s) [54] 7123 0
2745 - Glenmore Park
Recruitment postcode(s) [55] 7124 0
2752 - Silverdale
Recruitment postcode(s) [56] 7125 0
2787 - Oberon

Funding & Sponsors
Funding source category [1] 287526 0
Hospital
Name [1] 287526 0
Liverpool Hospital
Country [1] 287526 0
Australia
Primary sponsor type
Hospital
Name
Liverpool Hospital
Address
Elizabeth St, Liverpool, NSW 2170
Country
Australia
Secondary sponsor category [1] 286276 0
None
Name [1] 286276 0
Address [1] 286276 0
Country [1] 286276 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289507 0
South Western Sydney Local Health District
Ethics committee address [1] 289507 0
Ethics committee country [1] 289507 0
Australia
Date submitted for ethics approval [1] 289507 0
01/10/2013
Approval date [1] 289507 0
27/11/2013
Ethics approval number [1] 289507 0
13/037

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

Contacts
Principal investigator
Name 41122 0
Ms Serena Hong
Address 41122 0
Physiotherapy Department
Liverpool Hospital
Level 1 Health Services Building
Cnr Campbell and Goulburn Streets,
Liverpool, NSW, 2170
Country 41122 0
Australia
Phone 41122 0
+61 2 9828 4703
Fax 41122 0
Email 41122 0
[email protected]
Contact person for public queries
Name 41123 0
Serena Hong
Address 41123 0
Physiotherapy Department
Liverpool Hospital
Level 1 Health Services Building
Cnr Campbell and Goulburn Streets,
Liverpool, NSW, 2170
Country 41123 0
Australia
Phone 41123 0
+61 2 98284703
Fax 41123 0
Email 41123 0
[email protected]
Contact person for scientific queries
Name 41124 0
Serena Hong
Address 41124 0
Physiotherapy Department
Liverpool Hospital
Level 1 Health Services Building
Cnr Campbell and Goulburn Streets,
Liverpool, NSW, 2170
Country 41124 0
Australia
Phone 41124 0
+61 2 9828 4703
Fax 41124 0
Email 41124 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Sharing de identified individual participant data is not approved by the ethics


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.