Abstract
BackgroundEvidence-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/designIn 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.DiscussionThis 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 registrationRegistered as NCT01699256 on ClinicalTrials.gov.
Highlights
Evidence-based clinical practice guidelines may improve treatment quality, but the uptake of guideline recommendations is often incomplete and slow
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
The new guidelines are expected to improve overall treatment and they describe the roles of different healthcare providers and define when a general practitioner (GP) should refer a patient to a secondary care spine centre
Summary
Evidence-based clinical practice guidelines may improve treatment quality, but the uptake of guideline recommendations is often incomplete and slow. 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. LBP generates personal, social, and public costs, and in 2005, Danish costs for treatment, sick leaves, The new guidelines are expected to improve overall treatment and they describe the roles of different healthcare providers and define when a GP should refer a patient to a secondary care spine centre. Primary care treatment is considered sufficient for most LBP patients, and secondary referral is usually only recommended if the patient does not improve within eight weeks of primary care treatment. More patients are expected to improve by following the guidelines, and referral to secondary care can be reduced
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