Improving the management of multimorbidity in general practice: protocol of a cluster randomised controlled trial (The 3D Study).
Improving the management of multimorbidity in general practice: protocol of a cluster randomised controlled trial (The 3D Study).
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DOI：
10.1136/bmjopen-2016-011261
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发表时间：
2016-04-25
期刊：
影响因子：
2.9
通讯作者：
Salisbury C
中科院分区：
文献类型：
--
作者：
Man MS;Chaplin K;Mann C;Bower P;Brookes S;Fitzpatrick B;Guthrie B;Shaw A;Hollinghurst S;Mercer S;Rafi I;Thorn J;Salisbury C
越来越多的人生活在多重恐惧症中。如何最好地管理这些患者的证据基础很薄弱。目前的临床指南通常侧重于单一的条件，这可能无法反映多Morphine患者的需求。3D研究的目的是开发、实施和评估一种干预措施，以改善全科医生对多发性骨髓瘤患者的管理。这是一项实用的双组随机对照试验。布里斯托、大曼彻斯特和格拉斯哥周围的32家全科诊所将随机接受“三维干预”或常规护理。3D是一项复杂的干预措施，包括影响实践组织的组成部分，患者审查的进行，与二级护理的整合以及促进实践组织变革的措施。变化包括改善护理的连续性，以患者为中心的审查取代对每种疾病的审查，重点是患者的生活质量、心理健康和多种药物。我们的目标是招募1383名患有3种或3种以上慢性疾病的患者。这在5%显著性水平下提供了90%的把握度，以检测主要结局（使用EQ-5D-5L评估的15个月时健康相关生活质量）中0.27 SD的效应量。 次要结局指标评估以患者为中心、疾病负担和治疗负担。主要分析将是针对基线、分层/最小化、聚类和重要协变量进行调整的多水平回归模型。嵌套过程评价将评估执行情况、有效机制以及干预措施与当地情况的互动。成本后果和成本效益的经济分析将以质量调整寿命年为基础。本研究已获得西南（弗伦谢）国家卫生服务（NHS）研究伦理委员会的批准（14/SW/0011）。调查结果将通过最终报告、同行评审出版物和指南传播给医疗保健专业人员、专员和政策制定者。ISRCTN 06180958;预结果。
An increasing number of people are living with multimorbidity. The evidence base for how best to manage these patients is weak. Current clinical guidelines generally focus on single conditions, which may not reflect the needs of patients with multimorbidity. The aim of the 3D study is to develop, implement and evaluate an intervention to improve the management of patients with multimorbidity in general practice. This is a pragmatic two-arm cluster randomised controlled trial. 32 general practices around Bristol, Greater Manchester and Glasgow will be randomised to receive either the ‘3D intervention’ or usual care. 3D is a complex intervention including components affecting practice organisation, the conduct of patient reviews, integration with secondary care and measures to promote change in practice organisation. Changes include improving continuity of care and replacing reviews of each disease with patient-centred reviews with a focus on patients' quality of life, mental health and polypharmacy. We aim to recruit 1383 patients who have 3 or more chronic conditions. This provides 90% power at 5% significance level to detect an effect size of 0.27 SDs in the primary outcome, which is health-related quality of life at 15 months using the EQ-5D-5L. Secondary outcome measures assess patient centredness, illness burden and treatment burden. The primary analysis will be a multilevel regression model adjusted for baseline, stratification/minimisation, clustering and important co-variables. Nested process evaluation will assess implementation, mechanisms of effectiveness and interaction of the intervention with local context. Economic analysis of cost-consequences and cost-effectiveness will be based on quality-adjusted life years. This study has approval from South-West (Frenchay) National Health Service (NHS) Research Ethics Committee (14/SW/0011). Findings will be disseminated via final report, peer-reviewed publications and guidance to healthcare professionals, commissioners and policymakers. ISRCTN06180958; Pre-results.