Effect of Low Back Pain Risk-Stratification Strategy on Patient Outcomes and Care Processes: the MATCH Randomized Trial in Primary Care

Journal of General Internal Medicine - Tập 33 - Trang 1324-1336 - 2018
Dan Cherkin1, Benjamin Balderson1, Rob Wellman1, Clarissa Hsu1,2, Karen J. Sherman1, Sarah C. Evers1, Rene Hawkes1, Andrea Cook1, Martin D. Levine3, Diane Piekara1, Pam Rock1, Katherine Talbert Estlin4, Georgie Brewer5, Mark Jensen5, Anne-Marie LaPorte5, John Yeoman5, Gail Sowden6, Jonathan C. Hill6, Nadine E. Foster6
1Kaiser Permanente Washington Health Research Institute, Seattle, USA
2Center for Community Health and Evaluation, Seattle, USA
3Iora Health, Lynwood, USA
4Fortuna, USA
5Seattle, USA
6Arthritis Research UK, Primary Care Centre, Research Institute for Primary Care and Health Sciences, Keele University, Keele, UK

Tóm tắt

The STarT Back strategy for categorizing and treating patients with low back pain (LBP) improved patients’ function while reducing costs in England. This trial evaluated the effect of implementing an adaptation of this approach in a US setting. The Matching Appropriate Treatments to Consumer Healthcare needs (MATCH) trial was a pragmatic cluster randomized trial with a pre-intervention baseline period. Six primary care clinics were pair randomized, three to training in the STarT Back strategy and three to serve as controls. Adults receiving primary care for non-specific LBP were invited to provide data 2 weeks after their primary care visit and follow-up data 2 and 6 months (primary endpoint) later. The STarT Back risk-stratification strategy matches treatments for LBP to physical and psychosocial obstacles to recovery using patient-reported data (the STarT Back Tool) to categorize patients’ risk of persistent disabling pain. Primary care clinicians in the intervention clinics attended six didactic sessions to improve their understanding LBP management and received in-person training in the use of the tool that had been incorporated into the electronic health record (EHR). Physical therapists received 5 days of intensive training. Control clinics received no training. Primary outcomes were back-related physical function and pain severity. Intervention effects were estimated by comparing mean changes in patient outcomes after 2 and 6 months between intervention and control clinics. Differences in change scores by trial arm and time period were estimated using linear mixed effect models. Secondary outcomes included healthcare utilization. Although clinicians used the tool for about half of their patients, they did not change the treatments they recommended. The intervention had no significant effect on patient outcomes or healthcare use. A resource-intensive intervention to support stratified care for LBP in a US healthcare setting had no effect on patient outcomes or healthcare use. National Clinical Trial Number NCT02286141.

Tài liệu tham khảo

Martin BI, Deyo RA, Mirza SK, Turner JA, Comstock BA, Hollingworth W, Sullivan SD. Expenditures and health status among adults with back and neck problems. JAMA 2008;299:656–64. Von Korff M, Kolodny A, Deyo RA, Chou R. Long-term opioid therapy reconsidered. Ann Intern Med 2011;155:325–8. Von Korff M, Franklin G. Responding to America's iatrogenic epidemic of prescription opioid addiction and overdose. Wolters Kluwer Health, Inc.; Philadelphia 2016. Moore JE. Chronic low back pain and psychosocial issues. Phys Med Rehabil Clin N Am 2010;21(4):801–15. Boothby JL, Thorn BE, Stroud MW, Jensen MP. Coping with pain. In: Gatchel RJ, Turk DC, editors. Psychosocial factors in pain: critical perspectives. New York: Guilford Press; 1999: 343–59. Jensen MP, Karoly P. Control beliefs, coping efforts, and adjustment to chronic pain. J Consult Clin Psychol 1991;59:431–8. Hill JC, Dunn KM, Lewis M, Mullis R, Main CJ, Foster NE, Hay EM. A primary care back pain screening tool: identifying patient subgroups for initial treatment. Arthritis Rheum 2008;59:632–41. Hill JC, Whitehurst DG, Lewis M, et al. Comparison of stratified primary care management for low back pain with current best practice (STarT Back): a randomised controlled trial. Lancet 2011;378:1560–71. Foster NE, Mullis R, Hill JC, et al. Effect of stratified care for low back pain in family practice (IMPaCT Back): a prospective population-based sequential comparison. Ann Fam Med 2014;12:102–11. Whitehurst DG, Bryan S, Lewis M, Hay EM, Mullis R, Foster NE. Implementing stratified primary care management for low back pain: cost-utility analysis alongside a prospective, population-based, sequential comparison study. Spine 2015;40(4):405–414.. Hay EM, Dunn KM, Hill JC, et al. A randomised clinical trial of subgrouping and targeted treatment for low back pain compared with best current care. The STarT Back Trial Study Protocol BMC Musculoskelet Disord 2008;9:58. Hill JC, Vohora K, Dunn KM, Main CJ, Hay EM. Comparing the STarT back screening tool's subgroup allocation of individual patients with that of independent clinical experts. Clin J Pain 2010;26:783–7. Sowden G, Hill J, Konstantinou K, et al. Subgrouping for targeted treatment in primary care for low back pain: the treatment system and clinical training programmes used in the IMPaCT Back study (ISRCTN 55174281). Fam Pract 2012; 29(1):50–62. Main CJ, Sowden G, Hill JC, Watson PJ, Hay EM. Integrating physical and psychological approaches to treatment in low back pain: the development and content of the STarT Back trial’s ‘high-risk’ intervention (StarT Back; ISRCTN 37113406) Physiotherapy 2012; 98; 2: 110–117. Murphy SE, Blake C, Power CK, Fullen BM. Comparison of a stratified group intervention (STarT Back) with usual group care in patients with low back pain: a non-randomised controlled trial. Spine (Phila Pa 1976). 2016; 41(8):645-52. Karlen E, McCathie B. Implementation of a quality improvement process aimed to deliver higher-value physical therapy for patients with low back pain: case report. Phys Ther 2015;95(12):1712–21. Karstens S, Krug K, Hill JC, Stock C, Steinhaeuser J, Szecsenyi J, et al. Validation of the German version of the STarT-Back Tool (STarT-G): a cohort study with patients from primary care practices. BMC Musculoskelet Disord 2015;16:346. Karstens S, Joos S, Hill JC, Krug K, Szecsenyi J, Steinhauser J. General practitioners views of implementing a stratified treatment approach for low back pain in Germany: a qualitative study. PLoS One 2015;10(8):e0136119. Matsudaira K, Oka H, Kikuchi N, Haga Y, Sawada T, Tanaka S. Psychometric properties of the Japanese version of the STarT back tool in patients with low back pain. PLoS One 2016;11(3):e0152019. Cherkin D, Balderson B, Brewer G et al. Evaluation of a risk-stratification strategy to improve primary care for back pain: the MATCH cluster randomized trial protocol. BMC Musculoskelet Disord 2016;17:361. Hemming K, Haines TP, Chilton AJ, et al. The stepped wedge cluster randomized trial: rationale, design, analysis, and reporting. BMJ 2015;351:h391. Bombardier C, Hayden J, Beaton DE. Minimal clinically important difference. Low back pain: outcome measures. J Rheumatol 2001;28(2):431–8. Chiarotto A, Deyo RA, Terwee CB, et al. Core outcome domains for clinical trials in non-specific low back pain. Eur Spine J 2015;24(6):1127–42. Laird NM, Ware JH. Random-effects models for longitudinal data. Biometrics 1982;38:963–74. Pinheiro JC, Bates D.M. Approximations to the log-likelihood function in the nonlinear mixed-effects model. J Comput Graph Stat; 1995;4:12–35. Suri P, Delaney K, Rundell SD, Cherkin DC. Predictive validity of the STarT back tool for risk of persistent disabling back pain in a U.S primary care setting. Arch Phys Med Rehabil. 2018;S0003-9993(18)30204–1. https://doi.org/10.1016/j.apmr.2018.02.016 Riis A, Jensen CE, Bro F, Maindal HT, Petersen KD, Bendtsen MD, Jensen MB. A multifaceted implementation strategy versus passive implementation of low back pain guidelines in general practice: a cluster randomised controlled trial. Implement Sci 2016;11(1):143. Shanafelt TD, Dyrbye LN, West CP. Addressing physician burnout: the way forward. JAMA. 2017; 317(9): 901–902.