RecruitingACTRN12615001367538

A clinical pathway of care to improve recovery after whiplash

In patients with whiplash injury, does a guideline-based clinical pathway of care improve health outcomes compared to usual care?


Sponsor

Griffith University

Enrollment

236 participants

Start Date

Jun 21, 2016

Study Type

Interventional

Conditions

Summary

Over the last several years we have been working hard to understand recovery from whiplash injuries to help develop more effective treatments. We now believe that recovery may be facilitated if we change how care is delivered soon after their whiplash injury. We now need to test this process. In this randomised trial, people with whiplash will be allocated to two different processes of care. In the first process, people with receive the treatment normally provided to individuals with a whiplash injury. In the second process, people will receive care based on a questionnaire that assesses their risk of recovery. Care will range from 1-3 sessions with their usual health care provider, to referral to a health care provider with specialist expertise in whiplash injury. This specialist provider will then undertake a more detailed assessment of physical and psychological measures. The specialist provider may either 1) continue providing people with treatment , 2) refer them back to their own health care provider with advice on their or 3) refer them to another practitioner for additional treatment. The outcomes will be assessed at the initial assessment and three follow-up assessments at: 3, 6 and 12 months after the first assessment. Health outcomes assessed will questionnaires relating to how neck pain affects daily activities and in what way neck pain affects people personally. This study will uncover the best process to help people with whiplash recover.


Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 65 Yearss

Plain Language Summary

Simplified for easier understanding

This study is testing a new way of managing care for people with whiplash injuries from car accidents. Instead of giving everyone the same treatment, this approach uses a questionnaire to assess each person's recovery risk and then matches the level of care to that risk — from a few sessions with a regular health provider to specialist assessment and treatment. Researchers will track outcomes at 3, 6, and 12 months to see which approach works best. You may be eligible if: - You are between 18 and 65 years old - You sustained a whiplash injury within the past 6 weeks - Your whiplash is classified as Grade I–III (no bone fracture or dislocation) - You can read and speak English You may NOT be eligible if: - You have a known or suspected serious spinal condition (such as cancer in the spine) - You had a confirmed fracture or dislocation at the time of your injury (Grade IV) - You cannot communicate in English Talk to your doctor about whether this trial might be right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

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 c

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)


Locations(7)

Royal Prince Alfred Hospital - Camperdown

NSW,QLD, Australia

Canterbury Hospital - Campsie

NSW,QLD, Australia

Concord Repatriation Hospital - Concord

NSW,QLD, Australia

Gold Coast Hospital - Southport

NSW,QLD, Australia

The Prince Charles Hospital - Chermside

NSW,QLD, Australia

Ipswich Hospital - Ipswich

NSW,QLD, Australia

Princess Alexandra Hospital - Woolloongabba

NSW,QLD, Australia

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ACTRN12615001367538