Poolman Marlise, Wright Stella, Hendry Annie, Goulden Nia, Holmes Emily, Byrne Anthony, Perkins Paul, Hoare Zoe, Nelson Annmarie, Hiscock Julia, Hughes Dyfrig A, O'Connor Julie, Foster Betty, Reymond Liz, Lewis Penney, Wee Bee, Roberts Rossella, Parkinson Anne, Roberts Sian, Wilkinson Clare
North Wales Centre for Primary Care Research, Bangor University, Wrexham, UK
Specialist Palliative Care, Betsi Cadwaladr University Health Board, Wrexham, UK.
BMJ Open. 2025 Jun 12;15(6):e084476. doi: 10.1136/bmjopen-2024-084476.
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 the approach, including a 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 healthcare 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.
The secondary outcome measure was time to symptom relief, calculated using data items from the carer diary, after the patient had died.
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, n=10; usual care, n=2) and 20 healthcare professionals were interviewed. The intervention was considered acceptable, feasible and safe in the small study population. The intervention group had a considerably shorter time to medication administration than the usual-care group (median time to administer medication in intervention=5 min, usual-care=105 min). Intervention group carers felt confident in administering medication. Healthcare professional support was sought by intervention group carers in 24 out of 147 (16.3%) medication administration entries. The context of the feasibility study was not ideal, as district nurses were overstretched, unfamiliar with research methods and possibly not in equipoise. A disparity in readiness to consider the intervention was demonstrated between carers, who were uniformly enthusiastic, and healthcare professionals who were not. Findings confirmed methodological and ethics issues pertaining to researching the 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 healthcare professional views on burden and risk in the NHS context. There should be consideration of the need for national policy and the most appropriate quantitative outcome measures to use. This will help to ascertain if there are unanswered questions to be studied in a trial.
ISRCTN11211024.
确定在英国，由护理人员为在家中临终的患者按需皮下注射药物以缓解常见的突发症状是否可行且可接受，以及在未来进行确定性随机对照试验中对该干预措施进行测试是否可行。
我们进行了一项双臂、平行组、个体随机、开放的试点试验，将该干预措施与常规护理进行比较，分配比例为1:1，采用聚合混合方法。
英国三个地区，提供非24小时付费护理的居家护理服务。
参与者为成年患者及其护理人员组成的二元组：处于生命最后几周且希望在家中离世的患者，以及愿意接受皮下注射药物培训的非专业护理人员。在采用该方法之前，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能够接受培训并达到胜任水平。
干预组的护理人员接受当地护士使用标准化培训包进行的培训。
在基线时以及丧亲后6 - 8周收集定量数据，并通过护理人员日记收集。对护理人员和医疗保健专业人员进行访谈，以探讨对皮下注射药物的态度、经验和偏好，以及试验过程的体验。主要关注的结局是可行性、可接受性、招募率、损耗率以及选择最合适的结局指标。
次要结局指标是患者死亡后，根据护理人员日记中的数据项计算的症状缓解时间。
在101个符合条件的二元组中，共招募了40个（39.6%），达到了招募超过30%符合条件二元组的可行性标准。由于确定的参与者少于预期，未达到预期的招募目标（约50个二元组）。尽管总体保留率为55%（22/40）, 但严重不均衡（常规护理组为30%（6/20），干预组为80%（16/20））。因此，认为未达到保留率>40%的可行性标准。共对12名护理人员（干预组10名，常规护理组2名）和20名医疗保健专业人员进行了访谈。在这个小研究群体中，该干预措施被认为是可接受、可行且安全的。干预组的给药时间比常规护理组短得多（干预组给药的中位时间为5分钟，常规护理组为105分钟）。干预组的护理人员对给药感到有信心。在147次给药记录中，干预组护理人员有24次（16.3%）寻求医疗保健专业人员的支持。可行性研究的背景并不理想，因为地区护士工作负担过重，不熟悉研究方法，可能也未处于均衡状态。护理人员对该干预措施普遍热情高涨，而医疗保健专业人员则不然，两者在考虑该干预措施的意愿上存在差异。研究结果证实了在研究临终护理方面存在的方法学和伦理问题。
由于进展标准的结果不明确，特别是总体招募情况不佳以及常规护理组的保留率较低，未来确定性试验的成功尚不确定。关于该干预措施的未来工作应包括了解在英国采用该措施的地区背景，确定更广泛的公众观点，并探讨医疗保健专业人员在英国国家医疗服务体系背景下对负担和风险的看法。应考虑国家政策的必要性以及使用最合适的定量结局指标。这将有助于确定在试验中是否存在未解决的问题有待研究。
ISRCTN11211024
