Effect of a Primary Care Management Intervention on Mental Health-Related Quality of Life Among Survivors of Sepsis: A Randomized Clinical Trial.
Effect of a Primary Care Management Intervention on Mental Health-Related Quality of Life Among Survivors of Sepsis: A Randomized Clinical Trial.
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DOI：
10.1001/jama.2016.7207
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发表时间：
2016-06-28
影响因子：
120.7
通讯作者：
Gensichen, Jochen
中科院分区：
文献类型：
--
作者：
Schmidt, Konrad;Worrack, Susanne;Von Korff, Michael;Davydow, Dimitry;Brunkhorst, Frank;Ehlert, Ulrike;Pausch, Christine;Mehlhorn, Juliane;Schneider, Nico;Scherag, Andre;Freytag, Antje;Reinhart, Konrad;Wensing, Michel;Gensichen, Jochen
脓毒症幸存者面临长期的后遗症，这些后遗症会降低与健康相关的生活质量（HRQoL），并导致对初级保健机构的护理需求增加，如药物、物理治疗或精神卫生保健。为了检验以初级保健为基础的干预是否能改善精神HRQoL， 2011年2月至2014年12月进行了一项随机临床试验。291例≥18岁的脓毒症（包括脓毒性休克）存活患者来自德国9个重症监护病房（ICU）。参与者被随机分为常规治疗组（n=143）和12个月干预组（n=148）。通常的护理由他们的初级保健医生（PCP）提供，包括定期接触，转介给专家和药物处方和/或其他治疗。干预还包括PCP和患者培训，由训练有素的护士提供病例管理，由咨询医生为PCP提供临床决策支持。主要观察指标为ICU出院后和ICU后6个月的精神HRQoL变化，采用简短健康调查36 （SF-36；范围0-100；评分越高表示损害越低，最小临床重要差异5分）的精神成分摘要（MCS）。291例患者的平均年龄为61.6岁（SD 14.4）， 66.2% （n=192）为男性，84.4% （n=244）在ICU住院期间需要机械通气（中位12天，范围0-134）。在icu后6个月和12个月，75.3% （n=219，干预112例，对照组107例）和69.4% （n=202，干预107例，对照组95例）完成随访。6个月时总死亡率为13.7%（40例死亡，21例干预，19例对照组），12个月时总死亡率为18.2%（53例死亡，27例干预，26例对照组）。在干预组患者中，104例（70.3%）患者接受了高水平的完整性干预。MCS评分变化(干预组基线，平均=49.1,6个月=52.9，变化=3.79分（95%CI 1.05; 6.54）与对照组基线，平均=49.3,6个月=51.0，变化=1.64分（95%CI -1.22; 4.51），平均治疗效果=2.15 (95%CI -1.79; 6.09)，差异无统计学意义；p=0.28)，两组间PCP治疗亦无差异。在败血症幸存者中，与常规治疗相比，以初级保健为重点的团队干预并没有改善精神HRQoL或影响PCP治疗。ISRCTN注册;http://www.isrctn.com/ISRCTN61744782
Sepsis survivors face long-term sequelae which diminish health-related quality of life (HRQoL) and result in increased care needs in the primary care setting as medication, physiotherapy or mental health care. To examine if a primary care-based intervention improves mental HRQoL A randomized clinical trial was conducted between February 2011 and December 2014. 291 patients ≥18 years who survived sepsis (including septic shock) were recruited from nine intensive care units (ICU) across Germany. Participants were randomized to usual care (n=143) or to a 12-month intervention (n=148). Usual care was provided by their primary care physician (PCP) and included periodic contacts, referrals to specialists and prescription of medication and/or other treatment. The intervention additionally included PCP and patient training, case management provided by trained nurses and clinical decision support for PCPs by consulting physicians. The primary outcome was change in mental HRQoL between ICU discharge and six months post-ICU using the Mental Component Summary (MCS) of the Short-Form Health Survey 36 (SF-36; range 0-100; higher ratings indicating lower impairment, minimal clinically important difference five score points). The mean age of the 291 patients was 61.6 years (SD 14.4), 66.2% (n=192) were male, and 84.4% (n=244) required mechanical ventilation during their ICU stay (median 12 days, range 0-134). At six and 12 months post-ICU, 75.3% (n=219, 112 intervention, 107 control) and 69.4% (n=202, 107 intervention, 95 control) completed follow-up, respectively. Overall mortality was 13.7% at six months (40 deaths, 21 intervention, 19 control) and 18.2% at 12 months (53 deaths, 27 intervention, 26 control). Among intervention group patients, 104 (70.3%) received the intervention at high levels of integrity. There was neither a significant difference in change of MCS scores (intervention group baseline, mean=49.1, six months=52.9, change=3.79 score points (95%CI 1.05; 6.54) vs. control group baseline, mean =49.3, six months=51.0, change=1.64 score points (95%CI -1.22; 4.51) mean treatment effect=2.15 (95%CI -1.79; 6.09); p=0.28), nor in PCP care delivered between both groups. Among sepsis survivors, a primary-care-focused team-based intervention did not improve mental HRQoL or impact PCP care compared with usual care. ISRCTN registry; http://www.isrctn.com/ISRCTN61744782
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