Barley Elizabeth A, Walters Paul, Haddad Mark, Phillips Rachel, Achilla Evanthia, McCrone Paul, Van Marwijk Harm, Mann Anthony, Tylee Andre
Florence Nightingale School of Nursing and Midwifery, James Clerk Maxwell Building, King's College London, London, United Kingdom.
Dorset HealthCare University NHS Foundation Trust, Weymouth and Portland Community Mental Health Team, Mental Health Centre, Weymouth, Dorset, United Kingdom.
PLoS One. 2014 Jun 5;9(6):e98704. doi: 10.1371/journal.pone.0098704. eCollection 2014.
Depression is common in people with coronary heart disease (CHD) and associated with worse outcome. This study explored the acceptability and feasibility of procedures for a trial and for an intervention, including its potential costs, to inform a definitive randomized controlled trial (RCT) of a nurse-led personalised care intervention for primary care CHD patients with current chest pain and probable depression.
Multi-centre, outcome assessor-blinded, randomized parallel group study. CHD patients reporting chest pain and scoring 8 or more on the HADS were randomized to personalized care (PC) or treatment as usual (TAU) for 6 months and followed for 1 year. Primary outcome was acceptability and feasibility of procedures; secondary outcomes included mood, chest pain, functional status, well being and psychological process variables.
1001 people from 17 General Practice CHD registers in South London consented to be contacted; out of 126 who were potentially eligible, 81 (35% female, mean age = 65 SD11 years) were randomized. PC participants (n = 41) identified wide ranging problems to work on with nurse-case managers. Good acceptability and feasibility was indicated by low attrition (9%), high engagement and minimal nurse time used (mean/SD = 78/19 mins assessment, 125/91 mins telephone follow up). Both groups improved on all outcomes. The largest between group difference was in the proportion no longer reporting chest pain (PC 37% vs TAU 18%; mixed effects model OR 2.21 95% CI 0.69, 7.03). Some evidence was seen that self efficacy (mean scale increase of 2.5 vs 0.9) and illness perceptions (mean scale increase of 7.8 vs 2.5) had improved in PC vs TAU participants at 1 year. PC appeared to be more cost effective up to a QALY threshold of approximately £3,000.
Trial and intervention procedures appeared to be feasible and acceptable. PC allowed patients to work on unaddressed problems and appears cheaper than TAU.
Controlled-Trials.com ISRCTN21615909.
抑郁症在冠心病(CHD)患者中很常见,且与更差的预后相关。本研究探讨了一项试验及一种干预措施(包括其潜在成本)的可接受性和可行性,以为一项针对患有当前胸痛且可能患有抑郁症的基层医疗冠心病患者的由护士主导的个性化护理干预的确定性随机对照试验(RCT)提供信息。
多中心、结果评估者设盲、随机平行组研究。报告胸痛且在医院焦虑抑郁量表(HADS)上得分8分或更高的冠心病患者被随机分为接受个性化护理(PC)或常规治疗(TAU),为期6个月,并随访1年。主要结局是程序的可接受性和可行性;次要结局包括情绪、胸痛、功能状态、幸福感和心理过程变量。
来自伦敦南部17个全科冠心病登记处的1001人同意被联系;在126名可能符合条件的人中,81人(35%为女性,平均年龄 = 65±11岁)被随机分组。PC组参与者(n = 41)指出了与护士个案管理员合作要解决的广泛问题。低损耗率(9%)、高参与度和最少的护士工作时间使用(平均/标准差 = 78/19分钟评估,125/91分钟电话随访)表明了良好的可接受性和可行性。两组在所有结局方面均有改善。组间最大差异在于不再报告胸痛的比例(PC组为37%,TAU组为18%;混合效应模型优势比2.21,95%置信区间0.69,7.03)。有一些证据表明,在1年时,PC组参与者的自我效能感(平均量表增加2.5,而TAU组为0.9)和疾病认知(平均量表增加7.8,而TAU组为2.5)有所改善。在大约3000英镑的质量调整生命年(QALY)阈值之前,PC似乎更具成本效益。
试验和干预程序似乎是可行且可接受的。PC使患者能够解决未解决的问题,且似乎比TAU更便宜。
Controlled-Trials.com ISRCTN21615909