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Study protocol for a cluster randomized controlled trial to evaluate a referral strategy for axial spondyloarthritis in young primary care patients with chronic low back pain; an impact study.
BMC Musculoskelet Disord. 2016 07 12; 17:278.BM

Abstract

BACKGROUND

Axial spondyloarthritis (axSpA) is a disabling inflammatory joint disease with chronic low back pain (CLBP) as leading symptom. Recognizing axSpA in the large amount of CLBP patients is difficult for general practioners (GP). This evaluation aims to assess the effect of a referral strategy for axSpA in young primary care patients with CLBP by comparing the use of the strategy with usual care. The effect is measured at three different levels; by patient reported outcomes (the clinical effect), process and costs evaluation.

METHODS/DESIGN

This study design is a cluster randomized controlled trial with GP as clusters. GPs throughout the Netherlands are invited to participate and randomized to either the intervention or the control group. Patients from participating GPs are invited to participate if they have ever been registered with low back pain, without radiation (ICPC L03) and aged 18-45 years. To be included in the study, patients need to have current low back pain and chronic low back pain (>12 weeks). In the intervention arm a referral strategy for axSpA will be applied in CLBP patients, in the control arm care as usual will be provided for CLBP patients. The referral strategy consists of four easy to use variables. All are questions about the back pain complaints of the patients. Data is prospectively collected in an online database at baseline (T0), 4 months (T1), 12 months (T2) and 24 months (T3). After time point T1 (4 months) patients from the control group will also receive the intervention i.e. the application of a referral strategy for axSpA. The effect of the referral strategy is measured at three different levels, by patient outcomes (e.g. pain scores, quality of life), process measures (e.g. number of axSpA diagnoses by rheumatologists) and by costs (work productivity and health care resources use). Our primary outcome is the Roland Morris Disability Questionnaire after 4 months, secondary outcomes are pain and quality of life. Costs will be assessed before and after the use of the referral strategy, to estimate if the use of the strategy will lead to a reduction in health care costs and improvement in work participation.

DISCUSSION

It is anticipated that using the axSpA referral strategy for primary care CLBP patients will increase the quality of life of CLBP patients, will result in more (correct) diagnoses of axSpA by the rheumatologists, and will be cost-effective. Ultimately, the results of this study may contribute to the startup of a national implementation of the axSpA referral strategy to identify timely CLBP patients with axSpA.

TRIAL REGISTRATION

NCT01944163 , date of registration; September 6, 2013 (Clinicaltrials.gov).

Authors+Show Affiliations

Erasmus MC, Department of Rheumatology, Wytemaweg 80, 3015, CN, Rotterdam, The Netherlands. l.vanhoeven@erasmusmc.nl. Maasstad Hospital, Department of Rheumatology, Maasstadweg 21, 3079, DZ, Rotterdam, The Netherlands. l.vanhoeven@erasmusmc.nl.Erasmus MC, Department of Public Health, Wytemaweg 80, 3015, CN, Rotterdam, The Netherlands.Erasmus MC, Department of General Practice, Wytemaweg 80, 3015, CN, Rotterdam, The Netherlands.Erasmus MC, Department of Rheumatology, Wytemaweg 80, 3015, CN, Rotterdam, The Netherlands.Erasmus MC, Department of Rheumatology, Wytemaweg 80, 3015, CN, Rotterdam, The Netherlands. Maasstad Hospital, Department of Rheumatology, Maasstadweg 21, 3079, DZ, Rotterdam, The Netherlands.

Pub Type(s)

Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

27405752

Citation

van Hoeven, Lonneke, et al. "Study Protocol for a Cluster Randomized Controlled Trial to Evaluate a Referral Strategy for Axial Spondyloarthritis in Young Primary Care Patients With Chronic Low Back Pain; an Impact Study." BMC Musculoskeletal Disorders, vol. 17, 2016, p. 278.
van Hoeven L, Vergouwe Y, Koes BW, et al. Study protocol for a cluster randomized controlled trial to evaluate a referral strategy for axial spondyloarthritis in young primary care patients with chronic low back pain; an impact study. BMC Musculoskelet Disord. 2016;17:278.
van Hoeven, L., Vergouwe, Y., Koes, B. W., Hazes, J. M., & Weel, A. E. (2016). Study protocol for a cluster randomized controlled trial to evaluate a referral strategy for axial spondyloarthritis in young primary care patients with chronic low back pain; an impact study. BMC Musculoskeletal Disorders, 17, 278. https://doi.org/10.1186/s12891-016-1132-6
van Hoeven L, et al. Study Protocol for a Cluster Randomized Controlled Trial to Evaluate a Referral Strategy for Axial Spondyloarthritis in Young Primary Care Patients With Chronic Low Back Pain; an Impact Study. BMC Musculoskelet Disord. 2016 07 12;17:278. PubMed PMID: 27405752.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Study protocol for a cluster randomized controlled trial to evaluate a referral strategy for axial spondyloarthritis in young primary care patients with chronic low back pain; an impact study. AU - van Hoeven,Lonneke, AU - Vergouwe,Yvonne, AU - Koes,Bart W, AU - Hazes,Johanna M W, AU - Weel,Angelique E A M, Y1 - 2016/07/12/ PY - 2015/10/13/received PY - 2016/06/23/accepted PY - 2016/7/14/entrez PY - 2016/7/14/pubmed PY - 2017/12/5/medline KW - Axial Spondyloarthritis KW - Chronic Low Back Pain KW - Cluster Randomized Trial KW - Cost-effectiveness KW - Primary Care KW - Referral SP - 278 EP - 278 JF - BMC musculoskeletal disorders JO - BMC Musculoskelet Disord VL - 17 N2 - BACKGROUND: Axial spondyloarthritis (axSpA) is a disabling inflammatory joint disease with chronic low back pain (CLBP) as leading symptom. Recognizing axSpA in the large amount of CLBP patients is difficult for general practioners (GP). This evaluation aims to assess the effect of a referral strategy for axSpA in young primary care patients with CLBP by comparing the use of the strategy with usual care. The effect is measured at three different levels; by patient reported outcomes (the clinical effect), process and costs evaluation. METHODS/DESIGN: This study design is a cluster randomized controlled trial with GP as clusters. GPs throughout the Netherlands are invited to participate and randomized to either the intervention or the control group. Patients from participating GPs are invited to participate if they have ever been registered with low back pain, without radiation (ICPC L03) and aged 18-45 years. To be included in the study, patients need to have current low back pain and chronic low back pain (>12 weeks). In the intervention arm a referral strategy for axSpA will be applied in CLBP patients, in the control arm care as usual will be provided for CLBP patients. The referral strategy consists of four easy to use variables. All are questions about the back pain complaints of the patients. Data is prospectively collected in an online database at baseline (T0), 4 months (T1), 12 months (T2) and 24 months (T3). After time point T1 (4 months) patients from the control group will also receive the intervention i.e. the application of a referral strategy for axSpA. The effect of the referral strategy is measured at three different levels, by patient outcomes (e.g. pain scores, quality of life), process measures (e.g. number of axSpA diagnoses by rheumatologists) and by costs (work productivity and health care resources use). Our primary outcome is the Roland Morris Disability Questionnaire after 4 months, secondary outcomes are pain and quality of life. Costs will be assessed before and after the use of the referral strategy, to estimate if the use of the strategy will lead to a reduction in health care costs and improvement in work participation. DISCUSSION: It is anticipated that using the axSpA referral strategy for primary care CLBP patients will increase the quality of life of CLBP patients, will result in more (correct) diagnoses of axSpA by the rheumatologists, and will be cost-effective. Ultimately, the results of this study may contribute to the startup of a national implementation of the axSpA referral strategy to identify timely CLBP patients with axSpA. TRIAL REGISTRATION: NCT01944163 , date of registration; September 6, 2013 (Clinicaltrials.gov). SN - 1471-2474 UR - https://www.unboundmedicine.com/medline/citation/27405752/Study_protocol_for_a_cluster_randomized_controlled_trial_to_evaluate_a_referral_strategy_for_axial_spondyloarthritis_in_young_primary_care_patients_with_chronic_low_back_pain L2 - https://bmcmusculoskeletdisord.biomedcentral.com/articles/10.1186/s12891-016-1132-6 DB - PRIME DP - Unbound Medicine ER -