Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613001218785
Ethics application status
Not yet submitted
Date submitted
5/11/2013
Date registered
5/11/2013
Date last updated
5/11/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of a formalised trauma tertiary survey procedure on missed injury rates in multi-trauma patients, protocol for a cluster-randomised controlled trial.
Scientific title
In patients admitted to hospital with multi-trauma, does a formalised tertiary survey procedure compared with routine care reduce missed injuries?
Secondary ID [1] 283511 0
None
Universal Trial Number (UTN)
U1111-1149-9161
Trial acronym
MITTS (Missed Injury reduction by Trauma Tertiary Survey)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Missed injury after multi-trauma 290429 0
Condition category
Condition code
Injuries and Accidents 290820 290820 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will consist of:
1) The implementation of a formalised Trauma Tertiary Survey (TTS) form. This form prompts documentation for relevant features of history (such as mechanism of injury) and physical examination of relevant body regions. Furthermore the form prompts for review and documentation of relevant pathology and imaging results. The final part of the form includes a (new) injury list.
2) All medical and nursing staff on trauma admitting wards will attend two education sessions on the rationale and use of the TTS form, provided by a chief or associate researcher in small-group work-shop format.
The duration of education will be 2 separate sessions of approximately 45 min each
3) Key stake holder engagement (Hospital executives, Directors of trauma admitting units; Emergency Department, General Surgery, Orthopaedic Surgery, Neurosurgery, Intensive Care Unit) with a clear directive to all levels of medical and nursing staff for compliance with training and education sessions and mandatory TTS form completion as part of routine care within 24 hours of admission.

The intervention (Form, Education, Executive directive) will be conducted over several wards, and is expected to take up to 4 weeks for each hospital.

Participating hospitals (clusters) will be 1:1 randomised to either immediate (Group 1) or delayed (Group 2) introduction of TTS, using computer generated random number function. Group 1 will implement formalised TTS in the first 12 months, with continuation of formalised TTS in the second 12 months. Group 2 hospitals will continue routine trauma care in the first 12 months followed by implementation of formalised TTS in the second 12 months.

After cluster (hospital) randomisation occurs - the hospital coordinator will be informed of the allocation. If the hospital is allocated to the TTS - the 4 week introduction/education will start, where the hospitals (clusters) randomised to the routine care, start data collection. After 12 months of data collection - the hospitals providing routine care change to the introduce TTS. The 4 week TTS /introduction and education will occur and afterwards another 12 month data collection periods will occur


Time Schedule of enrolment
The intervention will be introduced over a 1-month period via formalised TTS and education on trauma admitting wards via key stakeholder engagement. In the Group 1 hospitals this will occur at the start of the trial. For the Group 2 hospitals, this introduction period will occur after the 12-month data collection period for routine care (Group 1: TTS implementation --> TTS maintenance, Group 2: standard care --> TTS implementation). Overall recruitment is expected to take approximately 24-25 months, with another 12 months for complete follow up.

Optimising patient enrolment and outcomes:
The study will require initial education on TTS performance on introduction and ongoing education while maintaining this intervention. Although the clinical workload for participating hospitals will not increase, there will be additional education and research resources required. Ongoing education for all staff working on trauma admitting wards (rationale and logistics of TTS performance) is essential. Telephone follow-up compliance despite consent is often sub-optimal, hence the research assistants will be trained to prime and prepare participants for this, as to not include patient who are unwilling or unable to be followed up. We will ask for alternative phone numbers and ask for consent to contact GPs at 1, 6 and 12 months.



Intervention code [1] 288216 0
Other interventions
Comparator / control treatment
Standard (existing) care will be at the discretion of the trauma admitting teams of the control hospitals. Standard care is defined as performing a clinical examination based on clinical judgment and without standardised forms. A TTS during standard care it is defined as a documented tertiary survey as part of a clinical examination within 24 hours of admission. A review of only the previously known injuries only is NOT a tertiary survey.
Control group
Active

Outcomes
Primary outcome [1] 290816 0
The primary outcome is missed injury rate post hospital discharge (Type III missed injury) at 1, 6 and 12 months

During 1, 6 and 12 months follow up interviews patients will be asked about injuries that were detected after discharge. These self-reported injuries will be checked against relevant medical records and imaging reports and defined by the expert panel as missed injury (definitely, likely, unlikely, unknown) or a complication of care or injury. An injury will only be classified as definite or likely (Type III) ‘missed injury’ if there is no evidence (in medical record or radiology report) of the self-reported injury during the hospital stay. The panel will determine the clinical significance of these injuries based on change in management and expected effect on (duration) of morbidity.
Timepoint [1] 290816 0
1, 6 and 12 months
Secondary outcome [1] 305358 0
Maintenance of intervention effect (comparing two 12 month periods in Group 1)

Comparing the primary outcome (Type III injuries as defined above) routine care vs TTS introduction (before and after comparison for Hospitals in Group 1)
Timepoint [1] 305358 0
1,6 and 12 months
Secondary outcome [2] 305371 0
In-hospital missed injury rate (Type I and II combined)

Type I: Injury missed at initial assessment (primary and secondary survey and emergency intervention), but detected within 24 hours, before or through formal TTS

Type II: Injury missed by TTS, detected in hospital after 24 hours

These injuries will be collected by daily review of the medical records by a trained research assistant. They will be checked against relevant medical records and imaging reports and defined by the expert panel as missed injury (definitely, likely, unlikely, unknown) or a complication of care or injury. The panel will determine the clinical significance of these injuries based on change in management and expected effect on (duration) of morbidity.
Timepoint [2] 305371 0
Hospital discharge
Secondary outcome [3] 305372 0
Proportion of TTS performed

A TTS in the intervention phases is defined as completion of the formal TTS form within 24 hours of admission, where during standard care it is defined as a documented tertiary survey as part of a clinical examination within 24 hours of admission. A review of only the previously known injuries only is NOT a tertiary survey.
Timepoint [3] 305372 0
24 hours after admission
Secondary outcome [4] 305373 0
Hospital bed days (including ICU bed days)

As per hospital information system
Timepoint [4] 305373 0
Hospital discharge
Secondary outcome [5] 305374 0
(Number and proportion of) Clinically significant missed injuries

as determined by expert panel - as per secondary outcome [2]
Timepoint [5] 305374 0
Hospital discharge (Type I and II)
1, 6, 12 months (Type III)
Secondary outcome [6] 305375 0
Interventions required for delayed diagnosis (Type I and II) or missed injuries (Type III)

- As per medical records (including the operating theater database)
Timepoint [6] 305375 0
Hospital discharge (Type I and II)
1, 6, 12 months (Type III)
Secondary outcome [7] 305376 0
Requirement for advanced Diagnostic imaging (CT, MRI, USS)

- As per radiology database
Timepoint [7] 305376 0
Hospital discharge (Type I and II)
1, 6, 12 months (Type III)
Secondary outcome [8] 305377 0
Predefined complications of care and injury (post-operative infection (wound infection, cathether related urinary tract infection, pneumonia, sepsis), and venous thrombo-embolism (Deep Vein Thrombosis, Pulmonary embolism)

As per medical record
Timepoint [8] 305377 0
Hospital discharge (Type I and II)
1, 6, 12 months (Type III)
Secondary outcome [9] 305378 0
Readmissions to hospital

- All readmissions related to original trauma
Timepoint [9] 305378 0
1, 6, 12 months
Secondary outcome [10] 305379 0
Days off work

Self reported - via telephone interview
Timepoint [10] 305379 0
1, 6, 12 months
Secondary outcome [11] 305380 0
Quality of life

Euroqol questionnaire (EQ-5D-5L)
Timepoint [11] 305380 0
1, 6 and 12 months
Secondary outcome [12] 305381 0
mortality (and cause of death)

As per Death registry
Timepoint [12] 305381 0
12 months

Eligibility
Key inclusion criteria
- Admitted for at least 24 hours to hospital

AND any of:

- Injuries in two or more body regions
- High impact mechanism (high speed motor vehicle collision, pedestrian versus car, fall from >1.5 meter)
- Chest or abdominal injuries
- Fractured neck of femur under the age of 65 years.
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
refusal of consent

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)
This is a cluster randomised trial.

Patients will not be individually randomised and will receive management that is standard practice or standard practice with a formalised TTS.

Participating hospitals (clusters) will be 1:1 randomised to either immediate (Group 1) or delayed (Group 2) introduction of TTS, using computer generated random number function.

As such there is no allocation concealment - although there will be limited disclosure to individual patients and a statistician not involved with randomisation and the data collection will be involved with analysis.

All patients of individual hospitals will receive the same treatment arm.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participating hospitals (clusters) will be 1:1 randomised to either immediate (Group 1) or delayed (Group 2) introduction of TTS, using computer generated random number function. A statistician not involved with the data collection will conduct the randomisation. Results of the randomisation will be communicated to the operations manager of the study, who will inform the participating hospitals of the allocation.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
cluster randomised controlled trial (immediate vs delayed introduction of TTS)
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
The primary analysis will be by intention-to-treat (ITT). Per-protocol analyses will also be performed, based on all patients completing 1, 6 and 12 months follow-up. We anticipate a decrease in post discharge (Type III) injuries from 14% to 9%.

De-identified data will be analysed using SPSS v20.0 software (SPPS Inc, Chicago, IL, USA). For continuous variables we will use an independent t-test and chi-square test will be used to compare differences in proportions. All results will be presented with 95% confidence intervals.

Health economic analyses will include a within trial incremental cost-effectiveness evaluation of formal TTS versus standard care. The outcome measure, incremental cost-effectiveness ratio, directly compares the difference in costs between the formal TTS and standard care with the difference in health related quality of life. Health related quality of life will be measured in quality adjusted life years (QALYs) derived from changes in EQ-5D-5L measured at multiple time points. A cost-effective threshold of $50,000 per QALY will be used to determine whether the intervention was cost-effective. A 95% confidence interval around the incremental cost-effectiveness ratio will be estimated using bias-adjusted bootstrapping. In addition, sensitivity analyses and sub-group analyses will be conducted to identify the parameters and patient characteristics that affect the likelihood of the intervention being cost-effective.
A p-value of 0.05 or less will be deemed statistically significant.

The sample size for a cluster-randomized trial requires adjustment of the number of patients that a corresponding individually randomized trial would have needed. This is due to variation between the clusters, and results in a correction using the intra-cluster correlation coefficient (ICC). Using an alpha of 0.05 and a power of 0.80, a sample size of 638 patients per group, with 1-year follow-up completed, would be required if individually randomised. Our previous study achieved a telephone follow up rate of 40% at 6 months. Extrapolating a similar conservative follow-up rate at 12 months, a total of 3,190 patients will be required (1,595 for each cohort) to answer the primary hypothesis. To separately answer a before-and-after comparison in Group 2 hospitals a similar sample is required. This results in a sample of 6,380 patients, with complete 1-year follow-up in at least 2,552. Since approximately 0.4% of all ED presentations consist of multi-trauma patients, approximately 1,600,000 ED presentations will be required. For an approximate 24-month recruitment period, this equates to 16 hospitals that have an average annual census of 50,000 presentations.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2014
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
2552
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,WA,VIC
Recruitment hospital [1] 1650 0
Gold Coast Hospital - Southport

Funding & Sponsors
Funding source category [1] 288213 0
Other
Name [1] 288213 0
A funding request to the Queensland Emergency Medicine Research Foundation (QEMRF) is in progress.
Country [1] 288213 0
Australia
Primary sponsor type
Hospital
Name
Gold Coast University Hospital
Address
c/o Department of Emergency Medicine
1 Hospital Boulevard
Southport, QLD, 4215
Country
Australia
Secondary sponsor category [1] 286937 0
University
Name [1] 286937 0
Bond University
Address [1] 286937 0
14 University Drive
Robina , QLD, 4226
Country [1] 286937 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 290123 0
Gold Coast Health Service District
Ethics committee address [1] 290123 0
Ethics committee country [1] 290123 0
Australia
Date submitted for ethics approval [1] 290123 0
15/01/2014
Approval date [1] 290123 0
Ethics approval number [1] 290123 0

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

Contacts
Principal investigator
Name 44070 0
A/Prof Gerben Keijzers
Address 44070 0
c/o Emergency Department, Gold Coast University Hospital, 1 Hospital Boulevard, Southport, 4215 QLD
Country 44070 0
Australia
Phone 44070 0
+61 7 5687 5274
Fax 44070 0
Email 44070 0
[email protected]
Contact person for public queries
Name 44071 0
Gerben Keijzers
Address 44071 0
c/o Emergency Department, Gold Coast University Hospital, 1 Hospital Boulevard, Southport, 4215 QLD
Country 44071 0
Australia
Phone 44071 0
+61 7 5687 5274
Fax 44071 0
Email 44071 0
[email protected]
Contact person for scientific queries
Name 44072 0
Gerben Keijzers
Address 44072 0
c/o Emergency Department, Gold Coast University Hospital, 1 Hospital Boulevard, Southport, 4215 QLD
Country 44072 0
Australia
Phone 44072 0
+61 7 5687 5274
Fax 44072 0
Email 44072 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
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseWhat is the effect of a formalised trauma tertiary survey procedure on missed injury rates in multi-trauma patients? Study protocol for a randomised controlled trial.2015https://dx.doi.org/10.1186/s13063-015-0733-y
N.B. These documents automatically identified may not have been verified by the study sponsor.