ActiveMental HealthPregnancy, Children & Inherited Conditions
INvestigating the use of intranasal DIamorphine and midazolam in the manaGement Of pain and anxiety, and freeing nursing resources, in palliative care (The INDIGO study)
A nasal spray could let family carers give powerful pain and anxiety drugs to dying patients at home, replacing injections that currently require a nurse visit. This matters because many terminally ill people want to die at home, but in their final weeks they often develop severe pain or agitation and can no longer swallow tablets. The standard solution—injections of diamorphine and midazolam under the skin—requires a trained community nurse, who typically takes at least 90 minutes to arrive. Carers can be trained to give injections, but many are unwilling to do so. The result is that patients wait too long for relief. If this research succeeds, carers would instead spray the medications up the patient’s nose—a faster, simpler method that avoids needles. The project will first co-design training materials with patients, carers, and clinicians, then test whether the approach works in a small feasibility study. If the intervention proves deliverable and acceptable, the next step would be a full trial to measure whether it actually reduces suffering and frees up nursing time. The goal is a practical change in how end-of-life care is delivered at home.
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- Research Question Is it possible to develop and test an intervention to rapidly alleviate pain and anxiety in patients receiving palliative care in their last few weeks of life, that can be delivered by carers? - Background A large proportion of palliative care patients want to die at home and a significant number achieve this. At the end of life, patients often experience symptoms including pain and agitation/distress and are often unable to take oral medications. Patients at home are supported by relatives/carers, district or community nursing teams, GPs and community palliative care teams. Patients are usually prescribed anticipatory, or just in case, subcutaneous medications for breakthrough symptoms. The challenge with these medications is administration of them. Either this is from community nursing teams, or carers/relatives who are trained. However, carer administered medication is not universally available and often carers do not want to give injections. If community nurses are needed then the wait time can be at least 90mins. We feel this is too long for patients to wait to have breakthrough medication for symptom control at the end of life. - Aims and Objectives 1. To co-design training materials in conjunction with patients, carers and healthcare professionals as to the intranasal route of medication delivery for patients at home at the end of life 2. Run a non randomised feasibility study of the intervention and data collection tools and to use findings to design an RCT - Methods We will conduct this trial in two work packages: In work package 1, we will adopt an evidence-, theory-, and person-based approach (a co-production approach) to develop a behavioural intervention to train: 1) Carers to administer intranasal diamorphine and midazolam at home; 2) Palliative care professionals to deliver the training to carers and people at end-of-life. Work package 2 will consist of a single arm feasibility study, to address two questions 1) Can the treatment package developed in work package 1 be delivered to patients at end of life, and their carers, and does it need to be modified in the light of input from carers, and patients where possible?. 2) Can probable trial procedures and data collection be undertaken in this group, with high fidelity and minimal distress?. - Timelines for Delivery We will aim to deliver the two work packages over 33 months with package 1 being delivered over 18 months and package 2 over 15 months. - Anticipated impact and dissemination If feasibility of the intervention and trial is shown, the next stage on the path to impact will be an effectiveness trial.
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