Evaluation of a risk-stratification strategy to improve primary care for low back pain: the MATCH cluster randomized trial protocol.
Evaluation of a risk-stratification strategy to improve primary care for low back pain: the MATCH cluster randomized trial protocol.
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DOI：
10.1186/s12891-016-1219-0
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发表时间：
2016-08-24
影响因子：
2.3
通讯作者：
Yeoman J
中科院分区：
文献类型：
--
作者：
Cherkin D;Balderson B;Brewer G;Cook A;Estlin KT;Evers SC;Foster NE;Hill JC;Hawkes R;Hsu C;Jensen M;LaPorte AM;Levine MD;Piekara D;Rock P;Sherman K;Sowden G;Wellman R;Yeoman J
尽管治疗背痛的方法有很多，并且用于解决该问题的医疗资源也不断增加，但背痛相关残疾的患病率和影响并没有改善。现在人们认识到，心理社会因素以及身体因素是背痛不良后果的重要预测因素。 STarT Back 风险分层方法是一种很有前景的新方法，可将治疗与康复过程中的身体和心理社会障碍相匹配，改善患者的身体功能，同时降低英国 (UK) 的护理成本。该试验评估了该策略在美国医疗保健环境中的实施情况。华盛顿州综合医疗保健系统中的六家大型初级保健诊所被随机分组，其中三家接受针对背痛的强化质量改善干预，另外三家作为长期趋势的对照。干预措施包括为医生提供 6 次一小时的培训课程、为物理治疗师提供 5 天的培训、对临床医生进行个性化和团体辅导，以及将 STarT Back 工具集成到电子健康记录中。该预后工具使用 9 个问题对持续性致残性疼痛的低、中或高风险患者进行分类，并针对适合每个亚组的循证治疗方案提出建议。年满 18 岁、因非特异性腰痛接受初级保健的患者被邀请在初级保健就诊后 1-3 周提供数据，并在 2 个月和 6 个月后提供随访数据（主要终点）。主要结果是背部相关的身体功能和疼痛严重程度。采用意向治疗方法，通过比较实施前和实施后 2 个月和 6 个月随访的平均变化来估计干预对患者结果的影响。纳入控制诊所可以根据长期趋势进行调整。将使用具有随机效应的线性混合模型来估计干预组和时间段的变化分数差异。次要结果包括医疗保健利用和遵守临床指南。该试验将提供第一个随机试验证据，证明在美国医疗保健服务系统中实施风险分层和匹配的腰痛治疗方案的临床有效性。 NCT02286141。注册日期：2014 年 11 月 5 日。本文的在线版本 (doi:10.1186/s12891-016-1219-0) 包含补充材料，可供授权用户使用。
Despite numerous options for treating back pain and the increasing healthcare resources devoted to this problem, the prevalence and impact of back pain-related disability has not improved. It is now recognized that psychosocial factors, as well as physical factors, are important predictors of poor outcomes for back pain. A promising new approach that matches treatments to the physical and psychosocial obstacles to recovery, the STarT Back risk stratification approach, improved patients’ physical function while reducing costs of care in the United Kingdom (UK). This trial evaluates implementation of this strategy in a United States (US) healthcare setting. Six large primary care clinics in an integrated healthcare system in Washington State were block-randomized, three to receive an intensive quality improvement intervention for back pain and three to serve as controls for secular trends. The intervention included 6 one-hour training sessions for physicians, 5 days of training for physical therapists, individualized and group coaching of clinicians, and integration of the STarT Back tool into the electronic health record. This prognostic tool uses 9 questions to categorize patients at low, medium or high risk of persistent disabling pain with recommendations about evidence-based treatment options appropriate for each subgroup. Patients at least 18 years of age, receiving primary care for non-specific low back pain, were invited to provide data 1–3 weeks after their primary care visit and follow-up data 2 months and 6 months (primary endpoint) later. The primary outcomes are back-related physical function and pain severity. Using an intention to treat approach, intervention effects on patient outcomes will be estimated by comparing mean changes at the 2 and 6 month follow-up between the pre- and post-implementation periods. The inclusion of control clinics permits adjustment for secular trends. Differences in change scores by intervention group and time period will be estimated using linear mixed models with random effects. Secondary outcomes include healthcare utilization and adherence to clinical guidelines. This trial will provide the first randomized trial evidence of the clinical effectiveness of implementing risk stratification with matched treatment options for low back pain in a United States health care delivery system. NCT02286141. Registered November 5, 2014. The online version of this article (doi:10.1186/s12891-016-1219-0) contains supplementary material, which is available to authorized users.