Leeds Institute of Health Sciences, Faculty of Medicine, University of Leeds, Leeds, UK.
Faculty of Health Sciences, University of Southampton, Southampton, UK.
Health Technol Assess. 2017 Dec;21(76):1-292. doi: 10.3310/hta21760.
BACKGROUND: Pain affects most people approaching the end of life and can be severe for some. Opioid analgesia is effective, but evidence is needed about how best to support patients in managing these medicines. OBJECTIVES: To develop a self-management support toolkit (SMST) and delivery strategy and to test the feasibility of evaluating this intervention in a future definitive trial. DESIGN: Phase I - evidence synthesis and qualitative interviews with patients and carers. Phase II - qualitative semistructured focus groups and interviews with patients, carers and specialist palliative care health professionals. Phase III - multicentre mixed-methods single-arm pre-post observational feasibility study. PARTICIPANTS: Phase I - six patients and carers. Phase II - 15 patients, four carers and 19 professionals. Phase III - 19 patients recruited to intervention that experienced pain, living at home and were treated with strong opioid analgesia. Process evaluation interviews with 13 patients, seven carers and 11 study nurses. INTERVENTION: Self-Management of Analgesia and Related Treatments at the end of life (SMART) intervention comprising a SMST and a four-step educational delivery approach by clinical nurse specialists in palliative care over 6 weeks. MAIN OUTCOME MEASURES: Recruitment rate, treatment fidelity, treatment acceptability, patient-reported outcomes (such as scores on the Brief Pain Inventory, Self-Efficacy for Managing Chronic Disease Scale, Edmonton Symptom Assessment Scale, EuroQol-5 Dimensions, Satisfaction with Information about Medicines Scale, and feasibility of collecting data on health-care resource use for economic evaluation). RESULTS: Phase I - key themes on supported self-management were identified from evidence synthesis and qualitative interviews. Phase II - the SMST was developed and refined. The delivery approach was nested within a nurse-patient consultation. Phase III - intervention was delivered to 17 (89%) patients, follow-up data at 6 weeks were available on 15 patients. Overall, the intervention was viewed as acceptable and valued. Descriptive analysis of patient-reported outcomes suggested that interference from pain and self-efficacy were likely to be candidates for primary outcomes in a future trial. No adverse events related to the intervention were reported. The health economic analysis suggested that SMART could be cost-effective. We identified key limitations and considerations for a future trial: improve recruitment through widening eligibility criteria, refine the SMST resources content, enhance fidelity of intervention delivery, secure research nurse support at recruiting sites, refine trial procedures (including withdrawal process and data collection frequency), and consider a cluster randomised design with nurse as cluster unit. LIMITATIONS: (1) The recruitment rate was lower than anticipated. (2) The content of the intervention was focused on strong opioids only. (3) The fidelity of intervention delivery was limited by the need for ongoing training and support. (4) Recruitment sites where clinical research nurse support was not secured had lower recruitment rates. (5) The process for recording withdrawal was not sufficiently detailed. (6) The number of follow-up visits was considered burdensome for some participants. (7) The feasibility trial did not have a control arm or assess randomisation processes. CONCLUSIONS: A future randomised controlled trial is feasible and acceptable. STUDY AND TRIAL REGISTRATION: This study is registered as PROSPERO CRD42014013572; Current Controlled Trials ISRCTN35327119; and National Institute for Health Research (NIHR) Portfolio registration 162114. FUNDING: The NIHR Health Technology Assessment programme.
背景:疼痛影响着接近生命终点的大多数人,一些人会感到剧痛。阿片类镇痛药有效,但需要有证据表明如何最好地支持患者管理这些药物。 目的:制定自我管理支持工具包(SMST)和交付策略,并测试在未来的确定性试验中评估这种干预措施的可行性。 设计:第一阶段——对患者和护理人员进行证据综合和定性访谈。第二阶段——对患者、护理人员和专科姑息治疗卫生专业人员进行定性半结构式焦点小组和访谈。第三阶段——多中心混合方法单臂前后观察可行性研究。 参与者:第一阶段——六名患者和护理人员。第二阶段——15 名患者、四名护理人员和 19 名专业人员。第三阶段——19 名接受过疼痛治疗、在家中居住且接受强阿片类镇痛药治疗的疼痛患者入组。对 13 名患者、7 名护理人员和 11 名研究护士进行了过程评估访谈。 干预措施:自我管理的镇痛和相关临终治疗(SMART)干预措施,包括 SMST 和由姑息治疗临床护士专家在 6 周内进行的四步教育交付方法。 主要观察指标:招募率、治疗一致性、治疗可接受性、患者报告的结果(如简要疼痛量表、慢性疾病自我管理效能量表、埃德蒙顿症状评估量表、EuroQol-5 维度、对药物信息的满意度量表和收集卫生保健资源使用数据进行经济评估的可行性)。 结果:第一阶段——从证据综合和定性访谈中确定了支持自我管理的关键主题。第二阶段——开发和完善了 SMST。交付方法嵌套在护士-患者咨询中。第三阶段——对 17 名(89%)患者进行了干预,15 名患者可获得 6 周的随访数据。总体而言,该干预措施被认为是可以接受和有价值的。对患者报告结果的描述性分析表明,疼痛和自我效能的干扰可能是未来试验的主要结果。没有报告与干预相关的不良事件。卫生经济学分析表明,SMART 可能具有成本效益。我们确定了未来试验的关键限制和考虑因素:通过扩大资格标准提高招募率,完善 SMST 资源内容,增强干预措施的一致性,在招募地点获得研究护士的支持,完善试验程序(包括退出程序和数据收集频率),并考虑以护士为单位的聚类随机设计。 局限性:(1)招募率低于预期。(2)干预内容仅侧重于强阿片类药物。(3)由于需要持续培训和支持,干预措施的一致性受到限制。(4)未获得临床研究护士支持的招募地点的招募率较低。(5)退出记录过程不够详细。(6)一些参与者认为随访次数过多。(7)可行性试验没有对照组,也没有评估随机化过程。 结论:未来的随机对照试验是可行和可接受的。 研究和试验注册:本研究在 PROSPERO(CRD42014013572)、当前对照试验(ISRCTN35327119)和英国国家卫生与保健优化研究所(NIHR)组合注册(162114)中注册。 资金来源:英国国家卫生与保健优化研究所(NIHR)健康技术评估计划。
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