Carer administration of as-needed subcutaneous medication for breakthrough symptoms in people dying at home: the CARiAD feasibility RCT.

BACKGROUND: 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. OBJECTIVES: 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. DESIGN: 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. SETTING: Home-based care without 24/7 paid care provision, in three UK sites. PARTICIPANTS: 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: Intervention-group carers received training by local nurses using a manualised training package. MAIN OUTCOME MEASURES: 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. RESULTS: 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 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. CONCLUSION: 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. TRIAL REGISTRATION: Current Controlled Trials ISRCTN11211024. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 24, No. 25. See the NIHR Journals Library website for further project information.

Most people in the UK would prefer to die at home, but only half of them achieve this. This usually depends on having able and willing lay carers (family or friends) to help look after them. Once swallowing is not possible, medicine is given continually under the skin (syringe driver). If common problems such as pain, vomiting or agitation break through, health-care professionals attend to give extra doses. The wait for a health-care professional to arrive can be distressing. In the UK, it is legal (but not routine) for lay carers to give needle-free subcutaneous injections themselves. We reworked an Australian carer education package for UK use. The best way to find out if this would work well is to do a randomised controlled trial. This is a test in which, at random, half of the people taking part receive 'usual care' and the other half receive the 'new care' or intervention. A pilot randomised controlled trial (a 'test' trial to see if a larger one is worth doing) was carried out to determine if lay carer injections were possible in the UK. We approached 90 dyads (a dying person and a key carer) and, of these, 40 were willing to take part and 22 completed the follow-up visit, so we could analyse their data. Of these 22 dyads, 16 were in the intervention group (lay carer injects) and six were in the control group (usual care). All carers were asked to keep a diary. Carers and health-care professionals were interviewed (qualitative study) and carer preferences were assessed. This new practice was safe, acceptable and welcomed. Carer confidence increased rapidly, symptom control was quicker and the interviews backed up these findings. Recruitment was low owing to overstretched health-care professionals. Only certain families were picked. Dyads in the usual-care group often wished they were in the intervention group. Carers found it difficult to complete some of the questionnaires that were used to measure the effect of the intervention. Therefore, uncertainty remains as to whether or not a full trial should proceed. Because the practice is already legal, some areas in the UK are already undertaking it. We plan to study what makes this practice possible or less possible to achieve.

CARer-ADministration of as-needed subcutaneous medication for breakthrough symptoms in homebased dying patients (CARiAD): study protocol for a UK-based open randomised pilot trial.

BACKGROUND: While the majority of seriously ill people wish to die at home, only half achieve this. The likelihood of someone dying at home often depends on the availability of able and willing lay carers to support them. Dying people are usually unable to take oral medication. When top-up symptom relief medication is required, a clinician travels to the home to administer injectable medication, with attendant delays. The administration of subcutaneous injections by lay carers, though not widespread practice in the UK, has proven key in achieving home deaths in other countries. Our aim is to determine if carer-administration of as-needed subcutaneous medication for four frequent breakthrough symptoms (pain, nausea, restlessness and noisy breathing) in home-based dying patients is feasible and acceptable in the UK. METHODS: This paper describes a randomised pilot trial across three UK sites, with an embedded qualitative study. Dyads of adult patients/carers are eligible, where patients are in the last weeks of life and wish to die at home, and lay carers who are willing to be trained to give subcutaneous medication. Dyads who do not meet strict risk assessment criteria (including known history of substance abuse or carer ability to be trained to competency) will not be approached. Carers in the intervention arm will receive a manualised training package delivered by their local nursing team. Dyads in the control arm will receive usual care. The main outcomes of interest are feasibility, acceptability, recruitment rates, attrition and selection of the most appropriate outcome measures. Interviews with carers and healthcare professionals will explore attitudes to, experiences of and preferences for giving subcutaneous medication and experience of trial processes. The study has obtained full ethical approval. DISCUSSION: This study will rehearse the procedures and logistics which will be undertaken in a future definitive randomised controlled trial and will inform the design of such a study. Findings will illuminate methodological and ethical issues pertaining to researching last days of life care. The study is funded by the National Institute for Health Research (Health Technology Assessment [HTA] project 15/10/37). TRIAL REGISTRATION: ISRCTN, ISRCTN 11211024 . Registered on 27 September 2016.

Laycarers can confidently prepare and administer subcutaneous injections for palliative care patients at home: A randomized controlled trial.

BACKGROUND: Palliative care patients consistently nominate home as their preferred care environment. This is challenging without support from laycarers, especially if patients require subcutaneously administered symptom relief. Laycarers typically lack confidence with this task and request professional guidance. AIM: To explore differences in laycarers' confidence in administering subcutaneous injections depending upon whether a laycarer, registered nurse or pharmacist prepared injections for subsequent administration by laycarers. DESIGN: Prospective randomized controlled trial with three intervention arms: laycarer prepares, labels and stores injections; registered nurse prepares injections; and pharmacist prepares injections for later administration by laycarer. SETTING/PARTICIPANTS: In all, 93 laycarers, from 24 urban and rural community services, completed the study. RESULTS: The primary outcome of interest was laycarer confidence with injection administration; analysis of variance revealed no significant differences between the three intervention arms; mean values ranged from 5.9 to 6.1 out of 7 ( F(2, 90) = 0.50, p = 0.61). Comparison of confidence after laycarer preparation versus other (nurse or pharmacist) was not statistically significant ( t = 0.7, df = 90, p = 0.49). Averaged over intervention arms, confidence levels increase significantly with injecting experience, from 5.3 to 6.1 ( F(1, 75) = 47.6, p < 0.001). CONCLUSION: Upskilled laycarers can confidently administer subcutaneous injections for loved ones, regardless of who prepares injections. This finding can improve patient outcomes and potentially decrease unwanted admissions to inpatient facilities.

An educational package that supports laycarers to safely manage breakthrough subcutaneous injections for home-based palliative care patients: development and evaluation of a service quality improvement.

BACKGROUND: Palliative care services strive to support people to live and die well in their chosen environment, with optimal symptom control and a pattern of care supportive of laycarers. The likelihood of patients remaining at home often depends upon laycarers, who may be required to manage subcutaneous medications. AIM AND DESIGN: This study reports the development, trial and evaluation of a package that teaches laycarers to manage subcutaneous medications used for symptom control in home-based patients. The package was developed by palliative care stakeholders and comprises an educational session, delivered by nurses, and a range of demonstrative, audiovisual and written resources. SETTINGS/PARTICIPANTS: The package was trialled across 24 sites and was evaluated by 76 laycarers (pre- and post-use) and 53 nurses (at study completion). RESULTS: Outcomes of primary interest were perceived global usefulness of the package and rated relevance of components. Laycarers and nurses rated the usefulness and relevance of the package highly - all means were above 5 on a 7-point scale. Also, laycarers were invited to comment on the package, and three focus groups for 26 nurses explored post hoc issues following package implementation. CONCLUSIONS: In terms of the palliative patient's illness trajectory, consensus was that the time for package introduction depended upon each particular clinical situation and laycarer. Nursing opinion was divided concerning whether it is safe and appropriate for laycarers to manage subcutaneous injections. Nevertheless, this study demonstrates that the package supports laycarers to manage subcutaneous medications. This has important implications for families, services and health-care systems.

OLFACTORY-BULB SIZE AND NOCTURNALITY IN BIRDS.

Recent evidence shows that, despite earlier beliefs, many birds have a functional sense of smell. There is also considerable variation in olfactory-bulb size among bird species, yet the evolutionary significance of this variation has remained elusive. We argue that birds living under low-light conditions, where vision is less efficient, should have evolved or maintained an increased olfactory ability and, hence, larger olfactory bulbs. Using a family-level comparative analysis to control at least partially for taxonomic artifacts, we show that none of a series of ecological variables (diet, nest type, development, nest dispersion, and migratory behavior) accounts for variation in olfactory-bulb size once the effects of body size and brain size (measured by cerebral-hemisphere length) have been controlled. Activity timing, however, accounts for significant variation even after the removal of these other variables. We discovered 13 independent cases in which nocturnal or crepuscular lineages have evolved a diurnal habit, or vice versa, and compared relative olfactory-bulb sizes between each branch pair. In all but one case, nocturnal or crepuscular birds have larger olfactory bulbs than their diurnal counterparts. We therefore demonstrate a widespread relationship between ecology and the evolutionary development of a part of the brain.