Study protocol of a cluster randomised controlled trial
BACKGROUND: Evidence-based clinical practice guidelines may improve treatment quality, but the uptake of guideline recommendations is often incomplete and slow. Recently new low back pain guidelines are being launched in Denmark. The guidelines are considered to reduce personal and public costs. The aim of this study is to evaluate whether a complex, multifaceted implementation strategy of the low back pain guidelines will reduce secondary care referral and improve patient outcomes compared to the usual simple implementation strategy. METHODS/DESIGN: In a two-armed cluster randomised trial, 100 general practices (clusters) and 2,700 patients aged 18 to 65 years from the North Denmark region will be included. Practices are randomly allocated 1:1 to a simple or a complex implementation strategy. Intervention practices will receive a complex implementation strategy, including guideline facilitator visits, stratification tools, and quality reports on low back pain treatment. Primary outcome is referral to secondary care. Secondary outcomes are pain, physical function, health-related quality of life, patient satisfaction with care and treatment outcome, employment status, and sick leave. Primary and secondary outcomes pertain to the patient level. Assessments of outcomes are blinded and follow the intention-to-treat principle. Additionally, a process assessment will evaluate the degree to which the intervention elements will be delivered as planned, as well as measure changes in beliefs and behaviours among general practitioners and patients. DISCUSSION: This study provides knowledge concerning the process and effect of an intervention to implement low back pain guidelines in general practice, and will provide insight on essential elements to include in future implementation strategies in general practice. TRIAL REGISTRATION: Registered as NCT01699256 on ClinicalTrials.gov.
Implementation Science, 2013, Vol 8, Issue 124, p. 1-10
Adolescent; Adult; Aged; Cluster Analysis; Cost Control; Denmark; Female; General Practice; Guideline Adherence; Humans; Low Back Pain; Male; Middle Aged; Outcome Assessment (Health Care); Practice Guidelines as Topic; Program Development; Referral and Consultation; Surveys and Questionnaires; Young Adult; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't