Liang Jenifer, Abramson Michael J, Zwar Nicholas, Russell Grant, Holland Anne E, Bonevski Billie, Mahal Ajay, Hecke Benjamin van, Phillips Kirsten, Eustace Paula, Paul Eldho, Petrie Kate, Wilson Sally, George Johnson
Centre for Medicine Use and Safety, Monash University, Parkville, Victoria, Australia.
School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.
BMJ Open. 2017 Sep 18;7(9):e016985. doi: 10.1136/bmjopen-2017-016985.
Up to half of all smokers develop clinically significant chronic obstructive pulmonary disease (COPD). Gaps exist in the implementation and uptake of evidence-based guidelines for managing COPD in primary care. We describe the methodology of a cluster randomised controlled trial (cRCT) evaluating the efficacy and cost-effectiveness of an interdisciplinary model of care aimed at reducing the burden of smoking and COPD in Australian primary care settings.
A cRCT is being undertaken to evaluate an interdisciplinary model of care (RADICALS - Review of Airway Dysfunction and Interdisciplinary Community-based care of Adult Long-term Smokers). General practice clinics across Melbourne, Australia, are identified and randomised to the intervention group (RADICALS) or usual care. Patients who are current or ex-smokers, of at least 10 pack years, including those with an existing diagnosis of COPD, are being recruited to identify 280 participants with a spirometry-confirmed diagnosis of COPD. Handheld lung function devices are being used to facilitate case-finding. RADICALS includes individualised smoking cessation support, home-based pulmonary rehabilitation and home medicines review. Patients at control group sites receive usual care and Quitline referral, as appropriate. Follow-ups occur at 6 and 12 months from baseline to assess changes in quality of life, abstinence rates, health resource utilisation, symptom severity and lung function. The primary outcome is change in St George's Respiratory Questionnaire score of patients with COPD at 6 months from baseline.
This project has been approved by the Monash University Human Research Ethics Committee and La Trobe University Human Ethics Committee (CF14/1018 - 2014000433). Results of the study will be disseminated in peer-reviewed journals and research conferences. If the intervention is successful, the RADICALS programme could potentially be integrated into general practices across Australia and sustained over time.
ACTRN12614001155684; Pre-results.
高达半数的吸烟者会患上具有临床意义的慢性阻塞性肺疾病（COPD）。在初级保健中实施和采用基于证据的COPD管理指南方面存在差距。我们描述了一项整群随机对照试验（cRCT）的方法，该试验评估了一种跨学科护理模式在减轻澳大利亚初级保健环境中吸烟和COPD负担方面的疗效和成本效益。
正在进行一项cRCT，以评估一种跨学科护理模式（RADICALS——成人长期吸烟者气道功能障碍及基于社区的跨学科护理评估）。确定澳大利亚墨尔本的全科诊所，并将其随机分为干预组（RADICALS）或常规护理组。招募目前或曾经吸烟、吸烟史至少10包年的患者，包括那些已确诊患有COPD的患者，以确定280名经肺功能测定确诊为COPD的参与者。正在使用手持式肺功能设备来促进病例发现。RADICALS包括个性化戒烟支持、家庭肺康复和家庭药物审查。对照组地点的患者接受常规护理，并在适当时转介到戒烟热线。从基线开始在6个月和12个月时进行随访，以评估生活质量、戒烟率、卫生资源利用、症状严重程度和肺功能的变化。主要结局是从基线开始6个月时COPD患者圣乔治呼吸问卷评分的变化。
本项目已获得莫纳什大学人类研究伦理委员会和拉筹伯大学人类伦理委员会的批准（CF14/1018 - 2014000433）。研究结果将在同行评审期刊和研究会议上发表。如果干预成功，RADICALS项目可能会被整合到澳大利亚各地的全科医疗中，并长期持续下去。
ACTRN12614001155684；预结果。
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