Ehde Dawn M, Alschuler Kevin N, Sullivan Mark D, Molton Ivan P, Ciol Marcia A, Bombardier Charles H, Curran Mary C, Gertz Kevin J, Wundes Annette, Fann Jesse R
Department of Rehabilitation Medicine, School of Medicine, University of Washington, 325 9th Ave, Box 359612, Seattle, WA 98104, USA.
Department of Rehabilitation Medicine, School of Medicine, University of Washington, 325 9th Ave, Box 359612, Seattle, WA 98104, USA; Department of Neurology, School of Medicine, University of Washington, UW Multiple Sclerosis Center, 1536 N 115th St, McMurray Building Suite 130, Seattle, WA 98133, USA.
Contemp Clin Trials. 2018 Jan;64:219-229. doi: 10.1016/j.cct.2017.10.001. Epub 2017 Oct 5.
Evidence-based pharmacological and behavioral interventions are often underutilized or inaccessible to persons with multiple sclerosis (MS) who have chronic pain and/or depression. Collaborative care is an evidence-based patient-centered, integrated, system-level approach to improving the quality and outcomes of depression care. We describe the development of and randomized controlled trial testing a novel intervention, MS Care, which uses a collaborative care model to improve the care of depression and chronic pain in a MS specialty care setting.
We describe a 16-week randomized controlled trial comparing the MS Care collaborative care intervention to usual care in an outpatient MS specialty center. Eligible participants with chronic pain of at least moderate intensity (≥3/10) and/or major depressive disorder are randomly assigned to MS Care or usual care. MS Care utilizes a care manager to implement and coordinate guideline-based medical and behavioral treatments with the patient, clinic providers, and pain/depression treatment experts. We will compare outcomes at post-treatment and 6-month follow up.
We hypothesize that participants randomly assigned to MS Care will demonstrate significantly greater control of both pain and depression at post-treatment (primary endpoint) relative to those assigned to usual care. Secondary analyses will examine quality of care, patient satisfaction, adherence to MS care, and quality of life. Study findings will aid patients, clinicians, healthcare system leaders, and policy makers in making decisions about effective care for pain and depression in MS healthcare systems. (PCORI- IH-1304-6379; clinicaltrials.gov: NCT02137044). This trial is registered at ClinicalTrials.gov, protocol NCT02137044.
基于证据的药物和行为干预措施,对于患有慢性疼痛和/或抑郁症的多发性硬化症(MS)患者而言,常常未得到充分利用或难以获得。协作式照护是一种以证据为基础、以患者为中心、综合的系统层面方法,旨在改善抑郁症照护的质量和结果。我们描述了一种新型干预措施“MS照护”的开发及随机对照试验,该干预措施采用协作式照护模式,以改善MS专科护理环境中抑郁症和慢性疼痛的照护。
我们描述了一项为期16周的随机对照试验,在一个门诊MS专科中心将“MS照护”协作式照护干预措施与常规护理进行比较。符合条件的慢性疼痛强度至少为中度(≥3/10)和/或患有重度抑郁症的参与者被随机分配到“MS照护”组或常规护理组。“MS照护”利用一名照护经理与患者、诊所医护人员以及疼痛/抑郁症治疗专家一起实施和协调基于指南的医学和行为治疗。我们将比较治疗后及6个月随访时的结果。
我们假设,相对于分配到常规护理组的参与者,随机分配到“MS照护”组的参与者在治疗后(主要终点)对疼痛和抑郁症的控制将显著更好。二级分析将检查照护质量、患者满意度、对MS护理的依从性以及生活质量。研究结果将有助于患者、临床医生、医疗保健系统领导者和政策制定者就MS医疗系统中疼痛和抑郁症的有效照护做出决策。(PCORI - IH - 1304 - 6379;clinicaltrials.gov:NCT02137044)。该试验已在ClinicalTrials.gov注册,试验方案编号为NCT02137044。