Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001053213
Ethics application status
Approved
Date submitted
11/03/2018
Date registered
25/06/2018
Date last updated
25/06/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Preliminary Trial of the Introduction of Computerised Decision Support to Assist Resuscitation of the Severely Injured in a Level 1 Trauma Centre in India
Scientific title
A Preliminary Trial to Determine the Effectiveness of Trauma Resuscitation Computerised Decision Support for the Severely Injured in a Level 1 Trauma Centre in India
Secondary ID [1] 294304 0
Nil
Universal Trial Number (UTN)
Trial acronym
TRR AIIMS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Injuries 307009 0
Condition category
Condition code
Emergency medicine 306104 306104 0 0
Resuscitation
Injuries and Accidents 306989 306989 0 0
Other injuries and accidents
Public Health 306990 306990 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Brief name: A computerised decision support tool for trauma management
The Trauma Reception and Resuscitation system, developed at The Alfred Hospital Melbourne (www.trrproject.org accessed 13 August 2017) displays patient information, captures real-time data as well as providing decision support as 'action prompts' for life saving interventions.. The system requires trained staff to input any confirmed/unconfirmed diagnoses, treatments and respond to advisory prompts to perform life saving interventions. The control group data was entered using an on-line, purpose-built tool REDCap™ secure web application (https://www.project-redcap.org/ accessed 13 August 2017). The data mirrored information being extracted by the TRR system, including date and time, anonymised patient details, vital signs, diagnoses and treatments administered. The TRR system recorded data automatically whereas, the nursing staff was required to access and record data on REDCaps at the time of event or retrospectively. TRR system trained senior nursing staff in the trauma centre provided the intervention. Senior trauma nurses will start the TRR system and administer it between 8am and 5pm when severely ill patients arrive at the Trauma Centre and are assigned into Bay 2. They will also be in charge of recording data into the online system for the control group.
An overseer of the project was allocated at the site to monitor and promote adherence of the intervention during staff meetings.
In brief, the TRR LCD display screen includes patient details (age, sex, allergies, weight, mechanisms of injury), vital signs, confirmed/unconfirmed diagnoses and treatments. Based on medical algorithms using vital signs and nurse inputs, it provides the trauma team with 'action prompts' or alerts to assist in decision making processes. These advisory prompts can be accepted or declined by staff, allowing clinical judgement to be made by the trauma team. It requires a dedicated trauma team member to interact with the system during resuscitation procedures. As an exception, vital signs are transferred wirelessly from a Philips MX800 monitor (Amsterdam, Netherlands).
The REDCaps data include questions/short answer format, multiple choice, yes/no as well as 'other' for comments. Vital signs are to be noted by hand by looking at the Philips MX800 monitor during resuscitation.
TRR system use at the Alfred Hospital resulted in improved protocol compliance and reduced errors and morbidity. Traumatic shock management errors were reduced by 26%. These results provided a rationale for implementation and system operation at the trial site.
Intervention code [1] 300603 0
Treatment: Devices
Comparator / control treatment
The control group are all patients treated in bay 1, with no TRR intervention.
Control group
Active

Outcomes
Primary outcome [1] 305135 0
The difference in the documentation of life saving interventions performed during the first 30 minutes of resuscitation between the TRR intervention group (bay 2) [TRR data derived from the TRR system analytics] versus the controls (bay 1) [control data derived from the medical record] will be initially entered into an excel spreadsheet and then analysed using Stata 15.1 statistical software.
Timepoint [1] 305135 0
The first 30 minutes after patient arrival, when the vital signs monitor and TRR system starts operating.
Primary outcome [2] 306300 0
The secondary outcome is to determine the time at which Life Saving Interventions are delivered as assessed by TRR system and audit of medical records..
Timepoint [2] 306300 0
The first 30 minutes after patient arrival, when the vital signs monitor and TRR system starts operating.
Secondary outcome [1] 348109 0
The frequency of Life Saving Interventions (Haemorrhage Control; Airway Interventions; Pleural Decompression; Assisted Ventilation; Intravenous Access; Fluid, Blood Products and Drug Administration) will be captured and time-stamped by the TRR© system and then compared against the hand-written Medical Record of the Control group.
Timepoint [1] 348109 0
The first 30 minutes after patient arrival, when the vital signs monitor and TRR system starts operating.
Secondary outcome [2] 348293 0
The accuracy of life saving interventions performed during the first 30 minutes of resuscitation
Timepoint [2] 348293 0
The first 30 minutes after patient arrival, when the vital signs monitor and TRR system starts operating.

Eligibility
Key inclusion criteria
Patients admitted directly from accident scene into Resuscitation Bay 2 of the JPN Apex Trauma Center.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Inter-hospital transfers, patients younger than 18 and patients declared deceased on arrival.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
No concealment
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
Other
Other design features
Patients are allocated to 1 of 6 resuscitation bays in the JPN Apex Trauma Center, with Bays 1 and 2 receiving the greatest load. For this trial, the TRR© system was installed into Bay 2 of the 6-bay resuscitation area. Control group (without TRR© intervention) consisted of patients allocated into Bay 1. All patient data were collected during the same time span of study
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Normally distributed continuous variables will be presented using mean (standard deviation), while ordinal or skewed data will be presented using median (inter-quartile range). Error bars for graphical data represent 95% confidence intervals. Student’s t-test will be used to calculate statistical significance between two means, the Wilcoxon Rank Sum test for two medians, the chi-squared test for two proportions, and Fisher’s exact test when the count in a two-by-two table cell is less than 5. A p-value of < 0.05 will be considered statistically significant. All analyses will be performed using Stata version 13.1 (Statacorp, College Station, Texas, USA).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
4/04/2017
Date of last participant enrolment
Anticipated
Actual
7/07/2017
Date of last data collection
Anticipated
Actual
14/08/2017
Sample size
Target
100
Accrual to date
Final
123
Recruitment outside Australia
Country [1] 9674 0
India
State/province [1] 9674 0
New Delhi

Funding & Sponsors
Funding source category [1] 298949 0
Government body
Name [1] 298949 0
The Australian Department of Industry, Innovation, and Science
Country [1] 298949 0
Australia
Funding source category [2] 298950 0
Government body
Name [2] 298950 0
Government of India Department of Science and Technology
Country [2] 298950 0
India
Primary sponsor type
University
Name
Monash University
Address
Wellington Road, Clayton Victoria 3800
Country
Australia
Secondary sponsor category [1] 298163 0
Government body
Name [1] 298163 0
All India Institute of Medical Science
Address [1] 298163 0
Ansari Nagar, New Delhi Delhi 110029
Country [1] 298163 0
India

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299886 0
Institute Ethics Committee All India Institute of Medical Sciences
Ethics committee address [1] 299886 0
Ethics committee country [1] 299886 0
India
Date submitted for ethics approval [1] 299886 0
Approval date [1] 299886 0
01/07/2016
Ethics approval number [1] 299886 0
IEC/NP-327/2013 RP-24/2013 OP-3/01.07.2016
Ethics committee name [2] 299887 0
Monash University Humans Research Ethics Committee
Ethics committee address [2] 299887 0
Ethics committee country [2] 299887 0
Australia
Date submitted for ethics approval [2] 299887 0
Approval date [2] 299887 0
01/07/2016
Ethics approval number [2] 299887 0
CF16/1814-2016000929

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

Contacts
Principal investigator
Name 81870 0
Prof Mark Fitzgerald
Address 81870 0
National Trauma Research Institute
Level 4/89 Commercial Road
Melbourne VIC 3004.
Country 81870 0
Australia
Phone 81870 0
+61390762000
Fax 81870 0
Email 81870 0
[email protected]
Contact person for public queries
Name 81871 0
Yesul Kim
Address 81871 0
National Trauma Research Institute
Level 4/89 Commercial Road
Melbourne VIC 3004.
Country 81871 0
Australia
Phone 81871 0
+61390762000
Fax 81871 0
Email 81871 0
[email protected]
Contact person for scientific queries
Name 81872 0
Yesul Kim
Address 81872 0
National Trauma Research Institute
Level 4/89 Commercial Road
Melbourne VIC 3004.
Country 81872 0
Australia
Phone 81872 0
+61390762000
Fax 81872 0
Email 81872 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
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