Ip-Buting Ada, Kelly Jenny, Santana Maria J, Penz Erika D, Flemons W Ward, Tsai Willis H, Fraser Kristin L, Hanly Patrick J, Pendharkar Sachin R
W21C Research and Innovation Centre, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.
Department of Community Health Sciences, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.
BMJ Open. 2017 Mar 29;7(3):e014012. doi: 10.1136/bmjopen-2016-014012.
Despite the high prevalence of sleep-disordered breathing (SDB) and the significant health consequences associated with untreated disease, access to diagnosis and treatment remains a challenge. Even patients with severe SDB (severe obstructive sleep apnoea or hypoventilation), who are at particularly high risk of adverse health effects, are subject to long delays. Previous research has demonstrated that, within a sleep clinic, management by alternative care providers (ACPs) is effective for patients with milder forms of SDB. The purpose of this study is to compare an ACP-led clinic (ACP Clinic) for patients with severe SDB to physician-led care, from the perspective of clinical outcomes, health system efficiency and cost.
The study is a randomised, controlled, non-inferiority study in which patients who are referred with severe SDB are randomised to management by a sleep physician or by an ACP. ACPs will be supervised by sleep physicians for safety. The primary outcome is positive airway pressure (PAP) adherence after 3 months of therapy. Secondary outcomes include: long-term PAP adherence; clinical response to therapy; health-related quality of life; patient satisfaction; healthcare usage; wait times from referral to treatment initiation and cost-effectiveness. The economic analysis will be performed using the perspective of a publicly funded healthcare system.
Ethics approval was obtained from the Conjoint Health Research Ethics Board (ID: REB13-1280) at the University of Calgary. Results from this study will be disseminated through presentations at scientific conferences and publication in peer-reviewed journals.
NCT02191085; Pre-results.
尽管睡眠呼吸障碍（SDB）的患病率很高，且未经治疗的疾病会带来严重的健康后果，但获得诊断和治疗仍然是一项挑战。即使是患有严重SDB（严重阻塞性睡眠呼吸暂停或通气不足）的患者，他们面临不良健康影响的风险特别高，也会经历长时间的延误。先前的研究表明，在睡眠诊所内，由替代护理提供者（ACP）进行管理对症状较轻的SDB患者有效。本研究的目的是从临床结果、卫生系统效率和成本的角度，比较针对严重SDB患者的由ACP主导的诊所（ACP诊所）与由医生主导的护理。
该研究是一项随机对照非劣效性研究，将被转诊的严重SDB患者随机分配接受睡眠医生或ACP的管理。为确保安全，ACP将由睡眠医生进行监督。主要结局是治疗3个月后的气道正压（PAP）依从性。次要结局包括：长期PAP依从性；治疗的临床反应；健康相关生活质量；患者满意度；医疗保健使用情况；从转诊到开始治疗的等待时间以及成本效益。经济分析将从公共资助的医疗保健系统的角度进行。
已获得卡尔加里大学联合健康研究伦理委员会（编号：REB13 - 1280）的伦理批准。本研究的结果将通过在科学会议上的报告以及在同行评审期刊上发表来进行传播。
NCT02191085；预结果。
