Study protocol of an economic evaluation of an extended implementation strategy for the treatment of low back pain in general practice: a cluster randomised controlled trial

Implementation Science

Karin Dam Petersen¹  Martin Bach Jensen³  Kjeld Møller Pedersen²  Allan Riis³  Cathrine Elgaard Jensen¹ 

[1] Danish Center for Healthcare Improvements, Faculty of Social Sciences and Faculty of Health Sciences, Aalborg University, Aalborg, Denmark;Centre of Health Economics Research, Faculty of Business and Social Sciences, University of Southern Denmark, Odense, Denmark;Department of Clinical Medicine, Aalborg University, Aalborg, Denmark

关键词: Low back pain;    Randomised clinical trial;    Compliance;    Guideline adherence;    Cost-utility;    Cost-effectiveness;    Economic evaluation;    Implementation strategies;    Study protocol;   

Others  :  1139537
DOI  :  10.1186/s13012-014-0140-x

 received in 2014-09-03, accepted in 2014-09-19,  发布年份 2014

【 摘 要 】

Background

In Denmark, guidelines on low back pain management are currently being implemented; in association with this, a clinical trial is conducted. A health economic evaluation is carried out alongside the clinical trial to assess the cost-effectiveness of an extended implementation strategy to increase the general practitioners¿ adherence to the guidelines. In addition to usual dissemination, the extended implementation strategy is composed of visits from a guideline facilitator, stratification tools, and feedback on guideline adherence. The aim of this paper is to provide the considerations on the design of the health economic evaluation.

Methods/design

The economic evaluation is carried out alongside a cluster randomised controlled trial consisting of 60 general practices in the North Denmark Region. An expected 1,200 patients between the age of 18 and 65 years with a low back pain diagnosis will be enrolled. The economic evaluation comprises both a cost-effectiveness analyses and a cost-utility analysis. Effectiveness measures include referral to secondary care, health-related quality of life measured by EQ-5D-5L, and disability measured by the Roland Morris disability questionnaire. Cost measures include all relevant additional costs of the extended implementation strategy compared to usual implementation. The economic evaluation will be performed from both a societal perspective and a health sector perspective with a 12-month time horizon.

Discussion

It is expected that the extended implementation strategy will reduce the number of patients referred to secondary care. It is hypothesised that the additional upfront cost of extended implementation will be counterbalanced by improvements in clinical practice and patient-related outcomes, thereby rendering the extended implementation strategy cost-effective.

Trial registration

ClinicalTrials.gov: NCT01699256 webcite

【 授权许可】

   
2014 Elgaard Jensen et al.; licensee BioMed Central Ltd.

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