Abstract
BackgroundEvidence generated from reliable research is not frequently implemented into clinical practice. Evidence-based clinical practice guidelines are a potential vehicle to achieve this. A recent systematic review of implementation strategies of guideline dissemination concluded that there was a lack of evidence regarding effective strategies to promote the uptake of guidelines. Recommendations from this review, and other studies, have suggested the use of interventions that are theoretically based because these may be more effective than those that are not. An evidence-based clinical practice guideline for the management of acute low back pain was recently developed in Australia. This provides an opportunity to develop and test a theory-based implementation intervention for a condition which is common, has a high burden, and for which there is an evidence-practice gap in the primary care setting.AimThis study aims to test the effectiveness of a theory-based intervention for implementing a clinical practice guideline for acute low back pain in general practice in Victoria, Australia. Specifically, our primary objectives are to establish if the intervention is effective in reducing the percentage of patients who are referred for a plain x-ray, and improving mean level of disability for patients three months post-consultation.Methods/DesignThis study protocol describes the details of a cluster randomised controlled trial. Ninety-two general practices (clusters), which include at least one consenting general practitioner, will be randomised to an intervention or control arm using restricted randomisation. Patients aged 18 years or older who visit a participating practitioner for acute non-specific low back pain of less than three months duration will be eligible for inclusion. An average of twenty-five patients per general practice will be recruited, providing a total of 2,300 patient participants. General practitioners in the control arm will receive access to the guideline using the existing dissemination strategy. Practitioners in the intervention arm will be invited to participate in facilitated face-to-face workshops that have been underpinned by behavioural theory. Investigators (not involved in the delivery of the intervention), patients, outcome assessors and the study statistician will be blinded to group allocation.Trial registrationAustralian New Zealand Clinical Trials Registry ACTRN012606000098538 (date registered 14/03/2006).
Highlights
Evidence generated from reliable research is not frequently implemented into clinical practice
The most up-to-date evaluation of specific implementation strategies is a systematic review of guideline dissemination and implementation strategies that summarises the findings of 235 studies, 39 percent of which are in primary care [2]
The majority of the included studies report some improvement in care with the use of an implementation strategy
Summary
Research in many areas of health care has consistently demonstrated variability between the recommendations of evidence-based clinical practice guidelines (CPGs) and actual clinical practice [1]. The trials had varying success in changing certain behaviours of the included practitioners and provide some information about effective methods of reducing x-ray referral These studies do not provide comprehensive information about successful change of other behaviours, and none utilised a behavioural theory-based intervention strategy, measured patient outcomes, or conducted a cost-effectiveness analysis. The recently released Australian National Health and Medical Research Council (NHMRC)-endorsed evidencebased CPG for acute LBP management provides an opportunity to assess the effects of a targeted behavioural theory-based implementation strategy for use in general medical practice. This trial will assess the effectiveness of the implementation strategy both at the GP and patient levels, and assess the cost-effectiveness of the strategy. A companion paper in Implementation Science details the methods for the economic evaluation [28]
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