de Nooijer Kim, Van Den Noortgate Nele, Pype Peter, Pivodic Lara, Van den Block Lieve
End-of-life Care Research Group, Vrije Universiteit Brussel (VUB) & Ghent University, Brussels, Belgium
End-of-life Care Research Group, Vrije Universiteit Brussel (VUB) & Ghent University, Brussels, Belgium.
BMJ Open. 2025 Feb 3;15(2):e077495. doi: 10.1136/bmjopen-2023-077495.
The primary study aims were to evaluate the implementation, mechanisms and context of a timely short-term specialised palliative care intervention for older people with frailty (Frailty+ intervention) as well as to assess the feasibility of a randomised controlled trial to evaluate Frailty+. Our secondary aim was to describe any preliminary effects of Frailty+.
Pilot randomised controlled trial with process evaluation.
SETTING/PARTICIPANTS: We aimed to recruit 50 adults (≥70 years) with Clinical Frailty Scale score 5-7, and complex care needs and their main family carer, if available, from two Belgian hospitals on discharge.
Patients were randomised to the Frailty+ intervention alongside standard care or standard care alone.
Implementation and trial feasibility were assessed through interviews, focus groups and quantitative data. The primary outcome to be used in a potential full-scale trial if the study is feasible and implementable was mean change in five palliative care symptoms over 8 weeks.
We enrolled 37 patients (19 intervention, 18 control) and 26 family carers (15 intervention, 11 control). Patients and family carers valued the home visits from palliative care nurses, and nurses saw value in Frailty+. But most patients received only one visit over 8 weeks, and nurses did not organise foreseen multidisciplinary meetings, referring to absence of urgent needs. Many aspects of the trial methods were feasible, but recruitment was challenging. The baseline mean score on the five palliative care symptoms was 6.0 and 5.6 in intervention and control group, respectively; and 4.5 and 4.1 at 8 weeks (adjusted ratio 1.0, ie, no effects on symptoms).
While Frailty+ was generally welcomed by older people with frailty, families and palliative care nurses, our process evaluation uncovered multiple barriers, mostly rooted in the current organisation of specialised palliative care that is tailored to advanced stages of illness. Ensuring timely access requires efforts beyond timely referral alone, and implies profound organisational and cultural change.
ISRCTN39282347.
主要研究目的是评估针对体弱老年人的及时短期专科姑息治疗干预措施(体弱+干预措施)的实施情况、作用机制和背景,以及评估一项评估体弱+干预措施的随机对照试验的可行性。次要目的是描述体弱+干预措施的任何初步效果。
采用过程评估的试点随机对照试验。
设置/参与者:我们的目标是从比利时两家医院出院的50名成年人(≥70岁)中招募临床衰弱量表评分为5 - 7分、有复杂护理需求的患者,如有主要家庭照顾者也将其纳入。
患者被随机分配接受体弱+干预措施并辅以标准护理,或仅接受标准护理。
通过访谈、焦点小组和定量数据评估实施情况和试验可行性。如果该研究可行且可实施,在潜在的大规模试验中使用的主要结局指标是8周内五个姑息治疗症状的平均变化。
我们招募了37名患者(19名干预组,18名对照组)和26名家庭照顾者(15名干预组,11名对照组)。患者和家庭照顾者重视姑息治疗护士的家访,护士也认为体弱+干预措施有价值。但大多数患者在8周内仅接受了一次家访,护士没有组织预期的多学科会议,称没有迫切需求。试验方法的许多方面是可行的,但招募工作具有挑战性。干预组和对照组五个姑息治疗症状的基线平均得分分别为6.0和5.6;8周时分别为4.5和4.1(调整比值为1.0,即对症状无影响)。
虽然体弱+干预措施总体上受到体弱老年人、家庭和姑息治疗护士的欢迎,但我们的过程评估发现了多个障碍,这些障碍大多源于当前针对疾病晚期阶段的专科姑息治疗组织方式。确保及时获得服务需要的努力不仅仅是及时转诊,还意味着深刻的组织和文化变革。
ISRCTN39282347。