Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000578303
Ethics application status
Approved
Date submitted
7/08/2008
Date registered
14/11/2008
Date last updated
4/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Accident Care Evaluation Study examines the effect of an educational program and a clinic that provides specialist medical assessment and referral for patients who have had soft tissue and whiplash injury following motor vehicle accidents, with the aim of improving recovery time and reducing costs for patients.
Scientific title
Accident Care Evaluation Study: the effect of an educational program and a clinic that provides specialist medical assessment and referral early to improve health outcomes and reduce costs in patients who have mild to moderate soft tissue injuries including whiplash associated disorders, following motor vehicle accidents compared with a control group with similar injuries who receive standard care available in the Australian Capital Territory.
Universal Trial Number (UTN)
Trial acronym
ACE Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Soft tissue injuries 3484 0
Condition category
Condition code
Injuries and Accidents 3640 3640 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1. Specialist assessment involves patients attending a clinic created exclusively for the Accident Care Evaluation Study, and includes the services of a physician with specialist musculoskeletal training and nurse educator.
Clinic participants are assessed and treatment plans are developed to assist the patient’s primary health care professionals and ancillary healthcare providers manage their care. Assessment and treatment is based on evidenced based guidelines for the management of acute musculoskeletal pain. The examining physician obtains a medical history that includes past medical history, regular medications, occupation, home domestic situation, injury history, treatment to date, investigations to date, current symptoms, results of functional assessment tools and the patient's current expectations in relation to their injury. A physical examination, structured on evidence-based-practice, is performed in relation to the specific injuries involved. A detailed explanation of the nature and likely natural history of their condition is provided to the participant.

2.Treatment Planning.
Following assessment the patient is given a detailed explanation of the nature and likely natural history of their condition. In most cases this involves an explanation of the 'pain-dysfunction cycle' using the aid of a PowerPoint presentation. The patient receives an outline of the recommended treatment program including a range of rehabilitation exercises with specific written instructions reinforcing their rehabilitation program. The exercise instruction sheets have step-by-step instructions and digital photographs to assist with patient recall and exercise techniques. The patient is also given written advice about any specific concerns related to protective posturing and the use of medication.
Further investigative and therapeutic referral and review is offered, while the nurse educator contacts the patient at 2 weeks and then again at 3 months. Physician review is available up to the 4 month period after which patients are referred back to their primary health providers.
Where indicated, the physician will coordinate referral to appropriate health care providers for medical imaging, psychological counseling or physiotherapy. Prompt and comprehensive written communication is sent to all involved health care providers, including the patient’s general practitioner, after each patient contact. The participants are followed up at 6 and 12 months by questionnaire.
3. Education
Educational resources have been developed to promote and increase awareness of the ACE study and its objectives during the course of the interventional research period. Aimed at 2 distinct groups, health care providers and patients who are involved in motor car accidents the resources are in many formats and include the following: hard copy material for patients includes posters, brochures, exercise and treatment sheets, a power point presentation and a 24 page booklet “The fast road to recovery”, while for health professionals there is the booklet “Information and Resources for Health Care Professionals”, brochures, posters and for both groups, an Accident Care Evaluation website.
In addition, education sessions are organised for health professionals ranging from emergency department nurses and doctors, general practitioners and their nurse practitioners and allied health such as physiotherapists and chiropractors. The Accident Care Evaluation Clinic physician generally conducted the sessions while the ACE Nurse Educator spoke to the nurse practitioners and supported the other sessions with the educational material. The general practitioners session were run over two separate six week periods, rotating 3 discreet lectures, while sessions ran three times over a twelve month period to catch rotating medical staff from both participating hospitals.

Media releases were published in local professional publications, and letters were sent to health care providers informing them of ACE and the education information sessions
Intervention code [1] 3208 0
Rehabilitation
Comparator / control treatment
Standard care is the care that was currently available to patients in the community who incur injury following a motor vehicle accident in the Australian Capital Territory. This care can be provided by local hospital emergency departments, general practitioners, specialist doctors or allied health and is not influenced or provided by the Accident Care Evaluation Group
This study is a sequential cohort study where the control group was recruited before the intervention period began and occurred over a 10 month period. Participants recieved standard care for 12 months
Control group
Active

Outcomes
Primary outcome [1] 4538 0
Health outcome measures for recovery for both the control and intervention groups include the The Functional Rating Index (FRI)
Timepoint [1] 4538 0
6 and 12 months
Secondary outcome [1] 7683 0
Measures of participant psychological well being use the Hospital Anxiety and Depression Scale (HADS).
Timepoint [1] 7683 0
6 and 12 months
Secondary outcome [2] 7684 0
Predictors for recovery will be determined by examining patient demographics, compensable status, and claim history
Timepoint [2] 7684 0
12 months
Secondary outcome [3] 8499 0
The Short Form-36 ( SF-36) uses specific utilities to measure the effectiveness of an intervention
Timepoint [3] 8499 0
6 and 12 Months

Eligibility
Key inclusion criteria
Participants are those who suffer mild to moderate soft tissue injuries and/or uncomplicated long bone fractures as a result of motor vehicle crashes in the Australian Capital Territory (ACT) and present to an emergency department in the Australian Capital Territory(ACT), or are referred to the study by a General Practitioner, and have not stayed in hospital for more than 3 days
Minimum age
18 Years
Maximum age
69 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Those who have not incurred soft tissue injury as a result of a motor vehicle accident in the Australian Capital Territory (ACT) or do not live in the Australian Capital Territory (ACT) or those who did not wait to see a doctor in the emergency departments in the Australian Capital Territory (ACT) or those with a documented psychiatric history or those who are pregnant or those who have sustained injuries that keep them in hospital more than 3 days

Study design
Purpose of the study
Prevention
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
Other
Other design features
Sequential controlled cohort study
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
29/09/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
193
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3702 0
Charities/Societies/Foundations
Name [1] 3702 0
National Roads and Motorists Association (NRMA)-Australian Capital Territory Public Road Safety Trust
Country [1] 3702 0
Australia
Primary sponsor type
University
Name
Australian National University (ANU)
Address
Australian National University (ANU)
Canberra.
Australian Capital Territory 0200
Country
Australia
Secondary sponsor category [1] 3320 0
None
Name [1] 3320 0
Address [1] 3320 0
Country [1] 3320 0
Other collaborator category [1] 362 0
University
Name [1] 362 0
Professor Ian Cameron University of Sydney
Address [1] 362 0
University of Sydney
NSW. 2006
Country [1] 362 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5753 0
Australian Capital Territory Health-Human Research Ethics Committee (ACT-HREC)
Ethics committee address [1] 5753 0
Ethics committee country [1] 5753 0
Australia
Date submitted for ethics approval [1] 5753 0
01/10/2005
Approval date [1] 5753 0
23/05/2006
Ethics approval number [1] 5753 0
ETH 10/05.757
Ethics committee name [2] 5754 0
Human Research Ethics Committee Calvary Hospital Canberra
Ethics committee address [2] 5754 0
Ethics committee country [2] 5754 0
Australia
Date submitted for ethics approval [2] 5754 0
01/12/2005
Approval date [2] 5754 0
14/11/2006
Ethics approval number [2] 5754 0
120-2005
Ethics committee name [3] 5755 0
Australian National University Human Research Ethics Committee (ANU HREC)
Ethics committee address [3] 5755 0
Ethics committee country [3] 5755 0
Australia
Date submitted for ethics approval [3] 5755 0
01/12/2005
Approval date [3] 5755 0
11/05/2006
Ethics approval number [3] 5755 0
2006/46
Ethics committee name [4] 5756 0
University of Sydney Human Research Ethics Committee
Ethics committee address [4] 5756 0
Ethics committee country [4] 5756 0
Australia
Date submitted for ethics approval [4] 5756 0
01/08/2006
Approval date [4] 5756 0
07/09/2006
Ethics approval number [4] 5756 0
9382

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

Contacts
Principal investigator
Name 28792 0
Address 28792 0
Country 28792 0
Phone 28792 0
Fax 28792 0
Email 28792 0
Contact person for public queries
Name 11949 0
Susannah Littleton
Address 11949 0
PO Box 117
Deakin West
ACT 2600
Country 11949 0
Australia
Phone 11949 0
0411014881
Fax 11949 0
0262325956
Email 11949 0
[email protected]
Contact person for scientific queries
Name 2877 0
Associate Professor Paul N Smith
Address 2877 0
Level 3
Clinical Services Building
173 Strickland Cres
Deakin. ACT
2600
Country 2877 0
Australia
Phone 2877 0
1300790788
Fax 2877 0
0262828866
Email 2877 0
[email protected]

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What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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