School of Health Sciences, Bangor University, Bangor, UK.
North Wales Organisation for Randomised Trials in Health, Bangor University, Bangor, UK.
Health Technol Assess. 2020 May;24(25):1-150. doi: 10.3310/hta24250.
Most people who are dying want to be cared for at home, but only half of them achieve this. The likelihood of a home death often depends on the availability of able and willing lay carers. When people who are dying are unable to take oral medication, injectable medication is used. When top-up medication is required, a health-care professional travels to the dying person's home, which may delay symptom relief. The administration of subcutaneous medication by lay carers, although not widespread UK practice, has proven to be key in achieving better symptom control for those dying at home in other countries.
To determine if carer administration of as-needed subcutaneous medication for common breakthrough symptoms in people dying at home is feasible and acceptable in the UK, and if it would be feasible to test this intervention in a future definitive randomised controlled trial.
We conducted a two-arm, parallel-group, individually randomised, open pilot trial of the intervention versus usual care, with a 1 : 1 allocation ratio, using convergent mixed methods.
Home-based care without 24/7 paid care provision, in three UK sites.
Participants were dyads of adult patients and carers: patients in the last weeks of their life who wished to die at home and lay carers who were willing to be trained to give subcutaneous medication. Strict risk assessment criteria needed to be met before approach, including known history of substance abuse or carer ability to be trained to competency.
Intervention-group carers received training by local nurses using a manualised training package.
Quantitative data were collected at baseline and 6-8 weeks post bereavement and via carer diaries. Interviews with carers and health-care professionals explored attitudes to, experiences of and preferences for giving subcutaneous medication and experience of trial processes. The main outcomes of interest were feasibility, acceptability, recruitment rates, attrition and selection of the most appropriate outcome measures.
In total, 40 out of 101 eligible dyads were recruited (39.6%), which met the feasibility criterion of recruiting > 30% of eligible dyads. The expected recruitment target (≈50 dyads) was not reached, as fewer than expected participants were identified. Although the overall retention rate was 55% (22/40), this was substantially unbalanced [30% (6/20) usual care and 80% (16/20) intervention]. The feasibility criterion of > 40% retention was, therefore, considered not met. A total of 12 carers (intervention, = 10; usual care, = 2) and 20 health-care professionals were interviewed. The intervention was considered acceptable, feasible and safe in the small study population. The context of the feasibility study was not ideal, as district nurses were seriously overstretched and unfamiliar with research methods. A disparity in readiness to consider the intervention was demonstrated between carers and health-care professionals. Findings showed that there were methodological and ethics issues pertaining to researching last days of life care.
The success of a future definitive trial is uncertain because of equivocal results in the progression criteria, particularly poor recruitment overall and a low retention rate in the usual-care group. Future work regarding the intervention should include understanding the context of UK areas where this has been adopted, ascertaining wider public views and exploring health-care professional views on burden and risk in the NHS context. There should be consideration of the need for national policy and of the most appropriate quantitative outcome measures to use. This will help to ascertain if there are unanswered questions to be studied in a trial.
Current Controlled Trials ISRCTN11211024.
This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in ; Vol. 24, No. 25. See the NIHR Journals Library website for further project information.
大多数临终者希望在家中接受照顾，但只有一半的人能够实现这一愿望。在家中去世的可能性通常取决于是否有能力且愿意提供帮助的非专业护理人员。当临终者无法口服药物时，会使用注射药物。当需要补充药物时，医护人员需要前往临终者的家中，这可能会延迟症状缓解。虽然在英国，非专业护理人员皮下给药的做法并不常见，但在其他国家，这种做法已被证明是实现更好的居家临终症状控制的关键。
确定在英国，由非专业护理人员按需皮下给药治疗居家临终者常见突破性症状是否可行和可接受，如果在未来的确定性随机对照试验中对此干预措施进行测试是否可行。
我们进行了一项两臂、平行组、个体随机、开放试点试验，比较了干预组与常规护理组，分配比例为 1:1，使用收敛混合方法。
在家中接受护理，但没有 24/7 的付费护理服务，在英国三个地点进行。
参与者为成年患者和护理人员的二人组：生命最后几周希望在家中去世的患者和愿意接受培训以给予皮下药物的非专业护理人员。在接近患者之前，需要满足严格的风险评估标准，包括已知的药物滥用史或护理人员是否有能力接受培训以达到胜任能力。
干预组的护理人员接受当地护士使用手册化培训包的培训。
基线和丧亲后 6-8 周收集定量数据，并通过护理人员日记进行收集。对护理人员和医护专业人员进行访谈，以探讨他们对给予皮下药物的态度、经验和偏好，以及对试验过程的体验。主要关注的结果是可行性、可接受性、招募率、失访率和选择最合适的结局测量指标。
共有 101 对符合条件的二人组中，有 40 对（39.6%）被招募，达到了招募超过 30%符合条件的二人组的可行性标准。由于预期的参与者人数较少，因此未达到预期的招募目标（≈50 对）。尽管总体保留率为 55%（22/40），但这是极不平衡的[常规护理组为 30%（6/20），干预组为 80%（16/20）]。因此，保留率超过 40%的可行性标准未被满足。共有 12 名护理人员（干预组，n=10；常规护理组，n=2）和 20 名医护专业人员接受了访谈。在小样本研究人群中，该干预措施被认为是可接受、可行且安全的。可行性研究的背景并不理想，因为地区护士严重超负荷，且不熟悉研究方法。护理人员和医护专业人员之间表现出对干预措施的准备程度存在差异。研究结果表明，在研究临终关怀护理的最后几天时，存在与方法和伦理相关的问题。
由于进展标准存在不确定性，特别是总体招募情况不佳，常规护理组的保留率较低，未来确定性试验的成功与否不确定。未来关于该干预措施的研究应包括了解英国已经采用该措施的地区的情况，了解更广泛的公众意见，并探索医护专业人员在 NHS 背景下对负担和风险的看法。需要考虑国家政策的必要性，以及使用最合适的定量结局测量指标。这将有助于确定是否有需要在试验中研究的未解决问题。
当前对照试验 ISRCTN11211024。
该项目由英国国家卫生研究院（NIHR）卫生技术评估计划资助，将在；第 24 卷，第 25 期。有关该项目的更多信息，请访问 NIHR 期刊库网站。
