Study protocol

IMPLEmenting a clinical practice guideline for acute low back pain evidence-based manageMENT in general practice (IMPLEMENT): Cluster randomised controlled trial study protocol

Joanne E McKenzie¹ , Simon D French¹ , Denise A O'Connor¹ , Jeremy M Grimshaw^2,3 , Duncan Mortimer^4,5 , Susan Michie⁶ , Jill Francis⁷ , Neil Spike⁸ , Peter Schattner⁸ , Peter M Kent^8,9,10 , Rachelle Buchbinder^9,10 and Sally E Green¹

¹Monash Institute of Health Services Research, Monash University, Melbourne, Australia

²Clinical Epidemiology Program, Ottawa Health Research Institute, Ottawa, Canada

³Department of Medicine, University of Ottawa, Ottawa, Canada

⁴Centre for Health Economics, Faculty of Business & Economics, Monash University, Melbourne, Australia

⁵Health Economics, Division of Health Sciences, University of South Australia, Adelaide, Australia

⁶Department of Psychology, University College London, UK

⁷Health Services Research Unit, University of Aberdeen, Scotland, UK

⁸School of Primary Health Care, Monash University, Australia

⁹Monash Department of Clinical Epidemiology, Cabrini Hospital, Australia

¹⁰Department of Epidemiology and Preventive Medicine, Monash University, Australia

author email corresponding author email

Implementation Science 2008, 3:11doi:10.1186/1748-5908-3-11

Published:	22 February 2008

Abstract

Background

Evidence 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.

Aim

This 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/Design

This 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 registration

Australian New Zealand Clinical Trials Registry ACTRN012606000098538 (date registered 14/03/2006).