Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615001367538
Ethics application status
Approved
Date submitted
11/12/2015
Date registered
16/12/2015
Date last updated
12/12/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
A clinical pathway of care to improve recovery after whiplash
Scientific title
In patients with whiplash injury, does a guideline-based clinical pathway of care improve health outcomes compared to usual care?
Secondary ID [1] 288056 0
National Health and Medical Research Council (APP1075736)
Universal Trial Number (UTN)
U1111-1177-1902
Trial acronym
Whiplash ImPaCT (Whiplash Implementation Pathway of Care Trial)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
whiplash (whiplash associated disorder) 296920 0
neck pain 296921 0
Condition category
Condition code
Musculoskeletal 297162 297162 0 0
Other muscular and skeletal disorders
Injuries and Accidents 297163 297163 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants randomised to receive the intervention will receive care according to the clinical care pathway and based on their projected risk. The risk stratification is assessed by completing the clinical prediction rule completed online (online tool).

Low risk:
Participants stratified into low risk will receive a more minimal intervention comprising up to 3 sessions with their primary health care provider, providing guideline based advice (remain active and return to normal activities) and a neck specific exercise program based on guidelines. The decision to provide 1-3 sessions is at the discretion of the primary health care provider, and may depend on factors such as symptoms, presenting impairments and logistics. Primary health care providers typically provide these sessions individually, for 20-40 minutes duration on average. All sessions should be completed within 12 weeks after injury. Supporting information regarding the advice and exercises will also be provided as part of the online tool.

Medium/ high risk:
Participants stratified into medium or high risk will be referred to a specialist provider who has been trained specifically for this study. The clinical pathway of care recommends that this referral occur between 3 and 6 weeks after injury. The initial specialist assessment is anticipated to take 1 hour. As per recommendations in the pathway, the specialist provider will complete a more detailed assessment of physical and psychological factors including sensory disturbances, motor and muscle function, post-traumatic stress symptoms, pain catastrophisation, anxiety and beliefs about the injury and subsequent recovery.
The specialist provider (SP) will then undertake one of three actions:
1. Continue current care: monitored by specialist.
This first pathway of care will be chosen when the results of the assessment indicate below threshold scores on psychological questionnaires and central sensitisation, and if the specialist provider identifies the patient’s original primary health care provider has appropriate expertise to provide the recommended care, A treatment plan will be developed in conjunction with the patient and the patient’s primary health care provider. The SP will provide specific advice about the optimal approach to future treatment, with the recommendation to modify the approach if necessary. The SP, in consultation with the patient and the primary health care provider, will also identify the primary treatment goal and advise about anticipate outcomes for the remaining episode of care. Advice will also be provided about the duration of future treatment and the anticipated number of treatments required (eg 20-30 minute sessions provided by the primary carer as frequently as mutually agreed between the SP and the primary health care provider). A critical component of this plan is separation or discharge planning with a view to ensuring the patient is confident and competent with self-directed, active management within an appropriate timeframe not exceeding six months from the time of injury. The SP will review the patient at regular intervals. The frequency of the review sessions will be agreed collaboratively after discussion between the specialist and the primary health care provider. Up to 3 review sessions (of up to 1 hours duration) are anticipated to be provided and should be completed by 12 weeks after injury. The purpose of review sessions are to monitor the patient’s progress and to adjust the treatment plan as necessary.
2. Specialist provides care: physical and CBT approach
The second pathway of care will be chosen when based on the more detailed assessment, results indicate moderate to severe symptoms and mild to moderate symptoms on psychological questionnaires. The SP will provide care that addresses the physical and psychological characteristics identified in the more detailed assessment. The package of care will be exercise based physical therapy with psychologically informed therapy following a cognitive behavioral therapy approach. To date these interventions have the highest level of evidence in clinical guidelines for whiplash, with several RCT’s underpinning these recommendations. Examples of therapy that may be provided in these sessions would be exercise therapy to rehabilitate impairments in cervical motor control, sensorimotor control and functional rehabilitation; psychologically informed therapy to address unhelpful beliefs identified such as pain catastrophisaton, fear avoidance, poor self efficacy and passive coping strategies. The provider will also work with the patient to negotiate treatment goals and anticipated outcomes for the episode of care. The SP will determine the number of sessions (up to 6 sessions of approximately 1 hour each) and the duration of this episode of care as well formulating a discharge plan. The aim of this intervention is to ensure that the patient is confident and competent with self-directed, active management within an appropriate timeframe not exceeding six months from the time of injury.
(3) Specialist refers for alternate care.
In the third pathway, based on the more detailed assessment, where results indicate moderate to severe symptoms, the specialist provider will refer for interdisciplinary management as directed by the clinical guideline and pathway. For example, at present, clinical guidelines recommend referral to a psychologist if the Impact of Events Scale (IES) is above 46, indicating moderate to severe post-traumatic stress symptoms. In addition if pain is high and not resolving or there are clear signs of central sensitization, the specialist provider may refer for pain management in accordance with the acute pain management guidelines (which has recently incorporated in the updated MAA (2014) whiplash guidelines. The specialist will facilitate this referral in liaison with the primary health care provider. Once referred, sessions provided will be at the discretion of the practitioner who receives the referral.

Whilst this intervention primarily is directed at providing appropriate care within 3 months of injury, the overall aim is to ensure that the patient is competent in self-directed active management not exceeding 6 months from the time of injury.
As per the secondary aims of this study, adherence to the pathway including the number and nature of sessions provided in each pathway will be collected by way of patient log book completed every 2 weeks and clinical survey completed at 12 months.

An online tool, developed specifically for this study, will be provided to support implementation of the pathway. The online tool comprises patient and practitioner resources (e.g. questionnaires/relevant assessment tools, exercise videos, case vignettes for specialist providers) that will facilitate progress through the pathway. The various steps will be automated and will provide practitioners with: the risk classification of patients; suggested management strategies; and schedule for review of outcomes. This tool will be available to patients, primary health care providers, and specialist providers in the intervention group for the duration of the trial (12 months)
Intervention code [1] 293375 0
Rehabilitation
Intervention code [2] 293376 0
Early detection / Screening
Intervention code [3] 293377 0
Prevention
Comparator / control treatment
Participants randomised to control will receive usual care regardless of their risk category. Usual care will be provided by their primary health care provider who will not be informed of the risk category. Decisions regarding the number of treatment sessions, content of management (assessment and treatment), and referral to other professionals will depend on clinical judgment. No attempt to change usual care of participants will be made.
Control group
Active

Outcomes
Primary outcome [1] 296774 0
Rating of change (Global Rating of Change)
The specific question is : "With respect to your whiplash injury, compared to when you first entered the study, how would you describe yourself these days?" (circle the most appropriate). The scale ranges from -5 (vastly worse), through 0 (unchanged) to +5 (completely recovered).

Timepoint [1] 296774 0
Baseline, 3,6 and 12 months after randomization
Primary outcome [2] 296849 0
Neck Related Disability (Neck Disability Index)
Timepoint [2] 296849 0
Baseline, .3,6 and 12 months after randomization
Secondary outcome [1] 319301 0
Confidence in performing activities while in pain (Pain Self Efficacy Questionnaire)
Timepoint [1] 319301 0
Baseline, 3,6 and 12 months after randomization
Secondary outcome [2] 319508 0
Health and disability (WHODASII- World Health Organization disability assessment schedule II short form)
Timepoint [2] 319508 0
Baseline, 3,6 and 12 months after randomization
Secondary outcome [3] 319509 0
Pain intensity over the last 24 hours and over the last week (Numerical Rating Scale 0-10)
Timepoint [3] 319509 0
Baseline, 3,6 and 12 months after randomization
Secondary outcome [4] 319510 0
Post-traumatic stress symptom levels (Post-traumatic Stress Diagnostic Scale)
Timepoint [4] 319510 0
Baseline, 3,6 and 12 months after randomization
Secondary outcome [5] 319511 0
Catastrophic thinking related to pain (Pain Catatrophising Scale)
Timepoint [5] 319511 0
Baseline, 3,6 and 12 months after randomization
Secondary outcome [6] 319512 0
Health Status (SF-12)
Timepoint [6] 319512 0
Baseline, 3,6 and 12 months after randomization
Secondary outcome [7] 319513 0
Patient-generated measure of function (Patient-Specific Functional Scale)
Timepoint [7] 319513 0
Baseline, 3,6 and 12 months after randomization
Secondary outcome [8] 319514 0
Direct and indirect costs (costs per QALY saved)

The primary cost-effectiveness outcome will be cost per QALY saved. This will be calculated using utility weights generated using participants’ SF-12 responses, translated to SF-6D utilities using the Brazier et al. (2002) (Brazier, Roberts et al. 2002) algorithm or, if completed by the time this trial commences, the Australian algorithm that is currently being developed by Viney and colleagues (Viney 2012).
Secondary cost outcomes will be direct costs and indirect costs. Direct costs (e.g. general practitioner, physiotherapy, chiropractor and pharmaceutical service) will be calculated using rebates taken from the Medicare Benefits Schedule, worker’s compensation schemes and the Pharmaceutical Benefits Scheme. Direct health-care cost (e.g. consumer co-payments) and non-health care costs, which are not captured by these insurer payments, will be identified using patient cost diaries. Patients will be asked to complete cost diaries in order to capture the direct costs; for example, other professional care, transportation costs, medication costs and time spent by family members or volunteers providing care.

The indirect costs associated with their injury include the patient’s lost economic productivity due to poor health. A shadow wage rate will be used to identify the opportunity cost of time spent away from work due to their injury. These costs will be calculated using income and employment data collected via a baseline questionnaire.
Timepoint [8] 319514 0
Baseline, 3,6 and 12 months after randomization
Secondary outcome [9] 319515 0
Practitioner adherence to the pathway of care (Questionnaire).
Professional practice outcomes will be captured by questionnaires completed by the primary carers, specialist providers and the patient at 3 months. This questionnaire has been adapted from professional practice questionnaires used in previous whiplash research (Rebbeck, Maher et al. 2006, Rebbeck, Refshauge et al. 2006, Rebbeck, Macedo et al. 2013, Rebbeck, Macedo et al. 2013)
Timepoint [9] 319515 0
3 months after commencement of treatment

Eligibility
Key inclusion criteria
Participants consist of people with whiplash and their clinicians (both primary health care providers and specialist providers).

People with whiplash are eligible for inclusion if they:
1. have sustained a grade I-III whiplash associated disorder (WAD);
2. are within 6 weeks of injury;
3. aged 18-65 years; and
4. are proficient in written and spoken English.

Clinicians
Primary health care providers are registered general practitioners, physiotherapists, chiropractors, or osteopaths nominated by the patients who consent to participant in this study. Specialist providers will be recruited by chief investigators prior to the study commencement. For the purposes of clarity in this study, a specialist provider is a health care provider with expertise in the management of complex whiplash.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria are:
1. known or suspected serious spinal pathology (e.g. metastatic disease of the spine);
2. confirmed fracture or dislocation at time of injury (WAD IV); and
3. lack of fluency in spoken and written English insufficient for informed consent and questionnaire completion.

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)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random permuted blocks, stratified for the risk sub-group and treatment site.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Data Analysis
The primary and secondary health outcomes will be analysed independently, using cross-sectional analyses, at 12 weeks, 6, and 12 months post-intervention using generalised linear models methods, with an appropriate link function, to test for an intervention effect adjusted for the baseline values. Effect sizes will be calculated for all measures with an effect size of 0.2 considered small, 0.5 medium and 0.8 large. Alpha will be set at 0.05. If there is a statistically significant treatment effect, we will also calculate number needed to treat (NNT) to achieve recovery of function and 95% confidence intervals.

Professional practice outcomes will be analysed using both descriptive statistics and qualitative content analysis. Median scores will be calculated for ordinal data and frequency distribution will be reported. Codes or keywords will be identified from literature prior to analysis of the responses from the open-ended questions. Occurrences of the identified codes or keywords will be documented through frequency counts.

Effect modifiers: The group variable (‘low risk’ or ‘medium/high risk’) will be tested for its association with treatment effect by adding a predictor x treatment group interaction term to the regression equation.

Power Analysis
With the outcome being change in Neck Disability Index (NDI) pre-post, based on detecting a medium effect size (10% change on the NDI is considered clinically worthwhile, SD:18) in a 2 X 2 interaction with a power of .80 and alpha of .05, the required minimum is 196 participants. Given that we expect 50% high vs low risk, this equates to 50 participants in each cell (High-Low risk, Usual Care-Intervention). Taking into account a 15% drop-out rate, we will recruit 236 participants. This sample size will be sufficient for the Global Rating of Change (GRC) outcome where the effect size is anticipated to be larger at 0.75 (clinically worthwhile change is 15%, SD: 20).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/03/2016
Actual
21/06/2016
Date of last participant enrolment
Anticipated
30/03/2018
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
236
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 4931 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 4932 0
Canterbury Hospital - Campsie
Recruitment hospital [3] 4933 0
Concord Repatriation Hospital - Concord
Recruitment hospital [4] 4935 0
Gold Coast Hospital - Southport
Recruitment hospital [5] 4936 0
The Prince Charles Hospital - Chermside
Recruitment hospital [6] 4937 0
Ipswich Hospital - Ipswich
Recruitment hospital [7] 7107 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 12439 0
2050 - Camperdown
Recruitment postcode(s) [2] 12440 0
2194 - Campsie
Recruitment postcode(s) [3] 12441 0
2139 - Concord Repatriation Hospital
Recruitment postcode(s) [4] 12442 0
4215 - Southport
Recruitment postcode(s) [5] 12443 0
4032 - Chermside
Recruitment postcode(s) [6] 12444 0
4305 - Ipswich
Recruitment postcode(s) [7] 14865 0
4102 - Woolloongabba

Funding & Sponsors
Funding source category [1] 292492 0
Government body
Name [1] 292492 0
National Health and Medical Research Council (NHMRC)
Country [1] 292492 0
Australia
Funding source category [2] 292493 0
Government body
Name [2] 292493 0
State Insurance Regulatroy Authority (SIRA) of NSW
Country [2] 292493 0
Australia
Funding source category [3] 292494 0
Government body
Name [3] 292494 0
Motor Accidents Insurance Commission of Queensland
Country [3] 292494 0
Australia
Primary sponsor type
University
Name
Griffith University
Address
Professor Michele Sterling
Griffith University
Menzies Health Institute Queensland, Gold Coast campus,
Parklands Drive
Southport
QLD 4222, Australia
Country
Australia
Secondary sponsor category [1] 291204 0
University
Name [1] 291204 0
University of Sydney
Address [1] 291204 0
Dr Trudy Rebbeck
Faculty of Health Sciences
Discipline of Physiotherapy
University of Sydney Cumberland Campus
75 East Street, Lidcombe, NSW 2141, Australia
Country [1] 291204 0
Australia
Other collaborator category [1] 278719 0
University
Name [1] 278719 0
University of Queensland
Address [1] 278719 0
Professor Justin Kenardy
Centre for National Research on Disability and Rehabilitation Medicine (CONROD)
The University of Queensland
Level 7 UQ Oral Health Centre
Herston QLD 4029 Australia
Country [1] 278719 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293960 0
Griffith University
Ethics committee address [1] 293960 0
Ethics committee country [1] 293960 0
Australia
Date submitted for ethics approval [1] 293960 0
Approval date [1] 293960 0
01/07/2014
Ethics approval number [1] 293960 0
AHS/10/14/HREC
Ethics committee name [2] 294040 0
University of Sydney, Human Research Ethics Committee
Ethics committee address [2] 294040 0
Ethics committee country [2] 294040 0
Australia
Date submitted for ethics approval [2] 294040 0
Approval date [2] 294040 0
24/10/2014
Ethics approval number [2] 294040 0
2014/778
Ethics committee name [3] 294041 0
NSW Sydney Local Health District
Ethics committee address [3] 294041 0
Ethics committee country [3] 294041 0
Australia
Date submitted for ethics approval [3] 294041 0
Approval date [3] 294041 0
06/07/2015
Ethics approval number [3] 294041 0
HREC/15/RPAH/73

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

Contacts
Principal investigator
Name 61942 0
Prof Michele Sterling
Address 61942 0
Centre for National Research on Disability and Rehabilitation Medicine (CONROD)
Menzies Health Institute Qld
Griffith University, Gold Coast Campus
Parklands Dve
Southport
QLD 4222
Country 61942 0
Australia
Phone 61942 0
+61 7 5678 0368
Fax 61942 0
Email 61942 0
[email protected]
Contact person for public queries
Name 61943 0
Trudy Rebbeck
Address 61943 0
Faculty of Health Sciences
Discipline of Physiotherapy
University of Sydney, Cumberland Campus
75 East St Lidcombe
NSW 2141
Country 61943 0
Australia
Phone 61943 0
+61 2 9299 0700
Fax 61943 0
Email 61943 0
[email protected]
Contact person for scientific queries
Name 61944 0
Michele Sterling
Address 61944 0
Centre for National Research on Disability and Rehabilitation Medicine (CONROD)
Menzies Health Institute Qld
Griffith University, Gold Coast Campus
Parklands Dve
Southport
QLD 4222

Griffith University


Country 61944 0
Australia
Phone 61944 0
+61 7 5678 0368
Fax 61944 0
Email 61944 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
EmbaseImplementation of a guideline-based clinical pathway of care to improve health outcomes following whiplash injury (Whiplash ImPaCT): protocol of a randomised, controlled trial.2016https://dx.doi.org/10.1016/j.jphys.2016.02.006
N.B. These documents automatically identified may not have been verified by the study sponsor.