Richards Suzanne H, Dickens Chris, Anderson Rob, Richards David A, Taylor Rod S, Ukoumunne Obioha C, Turner Katrina M, Gandhi Manish, Kuyken Willem, Gibson Andrew, Davey Antoinette, Warren Fiona, Winder Rachel, Campbell John
University of Exeter Medical School, Exeter, St Luke's Campus, Exeter, EX1 2LU, UK.
University of Leeds Institute of Health Sciences, University of Leeds, Level 10 Worsley Building, Leeds, LS2 9JN, UK.
Trials. 2018 Apr 2;19(1):211. doi: 10.1186/s13063-018-2576-9.
Around 17% of people attending UK cardiac rehabilitation programmes have depression. Optimising psychological wellbeing is a rehabilitation goal, but provision of psychological care is limited. We developed and piloted an Enhanced Psychological Care (EPC) intervention embedded within cardiac rehabilitation, aiming to test key areas of uncertainty to inform the design of a definitive randomised controlled trial (RCT) and economic evaluation.
An external pilot randomised controlled trial (RCT) randomised eight cardiac rehabilitation teams (clusters) to either usual care of cardiac rehabilitation provision (UC), or EPC in addition to UC. EPC comprised mental health care coordination and patient-led behavioural activation with nurse support. Adults eligible for cardiac rehabilitation following an acute coronary syndrome and identified with new-onset depressive symptoms during an initial nurse assessment were eligible. Measures were performed at baseline and 5- and 8-month follow-ups and compared between EPC and UC. Team and participant recruitment and retention rates, and participant outcomes (clinical events, depression, anxiety, health-related quality of life, patient experiences, and resource use) were assessed.
Eight out of twenty teams were recruited and randomised. Of 614 patients screened, 55 were eligible and 29 took part (5%, 95% CI 3 to 7% of those screened), with 15 patient participants cluster randomised to EPC and 14 to UC. Nurse records revealed that 8/15 participants received the maximum number of EPC sessions offered; and 4/15 received no sessions. Seven out of fifteen EPC participants were referred to another NHS psychological service compared to none in UC. We followed up 27/29 participants at 5 months and 17/21 at 8 months. The mean difference (EPC minus UC) in depressive symptoms (Beck Depression Inventory) at follow-up (adjusting for baseline score) was 1.7 (95% CI - 3.8 to 7.3; N = 26) at 5 months and 4.4 (95% CI - 1.4 to 10.2; N = 17) at 8 months.
While valued by patients and nurses, organisational and workload constraints are significant barriers to EPC implementation. There remains a need to develop and test new models of psychological care within cardiac rehabilitation. Our study offers important data to inform the design of future trials of similar interventions.
ISRCTN34701576 . Registered on 29 May 2014. Funding details: UK NIHR HTA Programme (project 12/189/09).
在参加英国心脏康复计划的人群中，约17%患有抑郁症。优化心理健康是康复目标之一，但心理护理的提供有限。我们开发并试点了一种嵌入心脏康复的强化心理护理（EPC）干预措施，旨在测试关键的不确定领域，为确定性随机对照试验（RCT）的设计和经济评估提供依据。
一项外部试点随机对照试验将八个心脏康复团队（群组）随机分为接受心脏康复常规护理（UC），或在UC基础上接受EPC。EPC包括心理健康护理协调和在护士支持下由患者主导的行为激活。符合急性冠状动脉综合征后心脏康复条件且在初次护士评估中被确定有新发抑郁症状的成年人符合入选标准。在基线、5个月和8个月随访时进行测量，并在EPC和UC之间进行比较。评估团队和参与者的招募与留存率，以及参与者的结局（临床事件、抑郁、焦虑、健康相关生活质量、患者体验和资源使用）。
二十个团队中有八个被招募并随机分组。在筛查的614名患者中，55名符合条件，29名参与（占筛查者的5%，95%CI为3%至7%），15名患者参与者被群组随机分配到EPC组，14名分配到UC组。护士记录显示,15名参与者中有8名接受了提供的最多EPC疗程；15名中有4名未接受任何疗程。15名EPC参与者中有7名被转介到另一家国民保健服务（NHS）心理服务机构，而UC组无人被转介。我们在5个月时对29名参与者中的27名进行了随访，在8个月时对21名中的17名进行了随访。随访时（根据基线评分调整后）抑郁症状（贝克抑郁量表）的平均差异（EPC减去UC）在5个月时为1.7（95%CI -3.8至7.3；N = 26），在8个月时为4.4（95%CI -1.4至10.2；N = 17）。
虽然受到患者和护士的重视，但组织和工作量限制是EPC实施的重大障碍。仍有必要在心脏康复中开发和测试新的心理护理模式。我们的研究提供了重要数据，为未来类似干预试验的设计提供参考。
ISRCTN34701576。于2014年5月29日注册。资金详情：英国国家卫生研究院卫生技术评估计划（项目12/189/09）。
