Chapter 2Developing the intervention

Publication Details

Manualised education package

Introduction

From discussion with our Australian co-investigators, we developed a good understanding of the Caring Safely at Home resources, which consist of carer and HCP resources. When the CARiAD study commenced, carer resources that were part of the Caring@Home study comprised:

  • Illustrated step-by-step guides that provided a simple structured approach to the preparation and administration of SC injections –
    • opening and drawing up from an ampoule
    • 10-step plan – blunt needle technique
    • 10-step plan – no-needle technique
    • injection via cannula – blunt needle technique
    • injection via cannula – no-needle technique.
  • A practice demonstration kit, including a cannula and other equipment that are required for the preparation and delivery of SC injections.
  • Colour-coded medication labels for labelling prepared syringes.
  • A fridge magnet that was colour coded to help the clinician or caregiver match the relevant medication with the patient’s symptoms.
  • A daily diary to document aspects of medication administration.
  • A series of videos, ‘Palliative subcutaneous medication administration: a guide for carers’, that demonstrated aspects of SC medication preparation and administration.
  • A booklet, ‘Subcutaneous medication and palliative care: a guide for caregivers’, that covered topics including frequently asked questions, the importance of symptom control, management of common palliative symptoms, commonly used SC medications and injecting processes.

The HCP resources comprised:

  • the Caring Safely at Home Standardised Education Framework
  • detailed instruction guidelines for the Caring Safely at Home resources and education framework
  • a competency checklist that provides the clinician with a mechanism to ensure that the caregiver is competent to safely inject SC medications
  • a clinician lanyard that provides a useful overview of the educational framework and the colour-coding scheme utilised for the medications.

The Queensland materials continue to be freely available on the project website (www.caringathomeproject.com.au/; accessed 5 January 2020) and are updated frequently (most recent update 12 June 2019). The materials are now available for use in all Australian jurisdictions.

In this chapter, we describe the development of the manualised training package that was used in the CARiAD trial. It does not cover all of the supporting trial documents, for example the participant information sheets (PISs), screening log or daily DN checklist.

Methods

We developed the manualised training package materials in three distinct stages:

  1. clarifying focus and scope
  2. developing the content
  3. deciding the design, colour scheme and layout.

The final materials would be used in the trial and feedback would be obtained on their utility, acceptability and feasibility via qualitative interviews and informal feedback processes.

A more detailed description of each of the three stages is as follows:

  1. Clarifying focus and scope.
    After detailed review of the suite of Australian materials (including any updates during the time the CARiAD trial materials were developed), and after accounting for practice differences between Australia and the UK, the materials were adapted for a UK trial setting. All references to the Australian practice of drawing as-needed medication up in advance, labelling with colour-coded labels and storing in the fridge (with supporting aide memoires such as fridge magnets and lanyards) were removed. All references to the Queensland-wide framework Guidelines for the Handling of Medication in Community-Based Palliative Care Services in Queensland (March 2015) were removed. Wording was scrutinised and, if needed, aligned with the UK practice of carer administration being tested in the trial. Details in the Australian framework pertinent to the CARiAD trial were included in the trial protocol.
    Permission was granted by our Australian co-applicants for us to use the graphics in their materials as appropriate.
    The Quality of Life in Life-Threatening Illness--Family Carer Version (QOLLTI-F) questionnaire was added to the diary, to be completed every 48 hours following the first administration of SC as-needed medication (see Appendix 2).41
  2. Developing the content.
    This stage required detailed, word-for-word consideration of the Australian materials and adjustments as appropriate. In the first instance this was carried out by the core CARiAD team, who also cross-checked the content against other available documents (specifically the Lincolnshire policy and supporting documentation and the risk assessment tools for self-medicating).35,42 This was reviewed by the co-applicants who are clinicians. As a final check prior to discussion at the expert consensus workshops, it was considered by our public contributor co-applicants. Overall, minimal adaptation was needed, including of terminology and drug names. Detail included in the Australian Standard Education Framework was incorporated into the training that HCPs received on the trial.
  3. Deciding the final design, colour scheme and layout.
    The final design stage was an iterative process between the core team and the design company, with invaluable input from the public contributor co-applicants, especially on colour scheme choice (distinctive enough but not intrusive, i.e. not using too strong colours and using different colours for different trial booklets to support ease of recognition for carers and HCPs) and cover graphics.

Results

The final set of documents included in the CARiAD trial manualised training pack for carers comprised:

  • ‘Subcutaneous medication for breakthrough symptoms in the last days of life: a guide for carers’ (see Report Supplementary Material 1).
    This was adapted from the booklet ‘Subcutaneous medication and palliative care: a guide for caregivers’ and covered similar topic areas. In addition, it included information on how to know which medication to give, how long to wait for medication to work, how often to give medication, which symptoms medication can be given for in the trial, how many doses could be given, what to do if too much medication is given and what to do if the carer is not available to give medications. A section was also included broaching the concept of the ‘last injection’. After careful discussion with our public contributor co-applicants, the following paragraph was added –

    There may come a time when you are giving the injections when the person you are caring for is very ill and will soon die. This might mean that the time when they die is near to when you have last given them medication. It is very important for you to know that these two things are not related and the medication has not ended their life. The nurse training you to give injections will discuss any worries or concerns you may have about this.

Rather than leaving it to individual clinicians to find their own way of explaining this, the text was intended to provide a script on which the HCP’s explanation to the carer could be based.

  • A carer diary (intervention or usual care), which was A5 size (see Report Supplementary Material 1). This was divided into the following sections –
    • introduction, explaining provenance and focus
    • contact details of the teams involved in the dying person’s care and space to record medical appointments
    • instructions for use of the diary when recording symptom management
    • information on the prescribed as-needed medication (intervention group diary only)
    • record of symptoms and subsequent management (one page per entry, 15 entries per booklet)
    • QOLLTI-F questionnaire (three copies per diary, additional diaries provided by DN teams as required).

Changes to the carer diary included assigning a full A5 page to each administration entry (rather than five administration entries per page, as in the Australian carer diary) and amending the medication information table to align with commonly used medication in the UK. The context of a RCT necessitated the need for carer diaries with different content for the two trial groups; therefore, two versions of the diary were produced.

  • Step-by-step guides with images illustrating the required actions (see Report Supplementary Material 1) –
    • step-by-step guide to opening and drawing-up medications from an ampoule
    • 10-step plan for preparing and giving as-needed SC injections using a blunt needle technique
    • 10-step plan for preparing and giving as-needed SC injections using a no-needle technique.

An injection training pack was also included so that the carer could practise giving needle-less injections (i.e. via a cannula). We listed the suggested content to be assembled by the HCP from their stocks (see Report Supplementary Material 1). Given that ampoule openers are not in widespread use, these were provided to the HCPs for inclusion in the training packs.

In relation to carer resources, we were advised that the video resources were not often used and that carers preferred the printed resources; therefore, video resources were not developed.

More extensive changes were required to the HCP resources, as it was outside the scope of the trial to generate a standardised education framework for a UK context. The framework was therefore removed from the HCP resources along with the detailed instruction guidelines, as HCPs delivering the intervention would be comprehensively trained by the core CARiAD trial team. Additional resources were developed to support HCPs and ensure the safety of patients and carers (see Report Supplementary Material 2) and comprised:

  • risk assessment (RA) tool
  • information for prescribers (intervention group only)
  • daily checklist for DNs – this document was an aide memoire of all the trial-related tasks to be carried out at DN visits
  • adverse event (AE) record – to be kept in the patient’s notes and returned to the trial team at the end of the study. It defined AEs, serious adverse events (SAEs) and related events, included a table to record AEs and provided a prompt of the circumstances in which a separate SAE form should be recorded.

The competency checklist was amended to include the following questions about the nominated carer:

  • Is aware of the symptoms of pain, restlessness/anxiety, nausea/vomiting and noisy breathing and which medications to use for each of these symptoms?
  • Can reconstitute drugs if required?
  • Understands the importance of completing all associated study paperwork?
  • Is aware of how many as-needed doses can be administered of each drug in 24 hours?
  • Understands the importance of contacting the health-care team immediately if an error is made with medications or unusual symptoms develop?

The date, signature and name of the HCP were also included in the competency checklist. In addition, two columns were added so that ongoing checks of competency could be recorded if needed.

The intervention under scrutiny in the CARiAD trial was carer administration of as-needed SC medication and, for this reason, the training to enable carers in this practice was key. The printed documents described supported carer training and, therefore, there was ongoing review of these materials throughout the trial, resulting in minor changes.

Expert consensus work

Introduction

The aim of the expert consensus workshops was to refine trial processes, guide the adaptation of the existing Australian training materials for use in a UK context and inform the development of other supporting documents. The chosen format was based on the successful model used in the Early Lung Cancer Identification and Diagnosis (ELCID) trial.43

Methods

Two workshops were planned with invited UK experts: one in North Wales and one in the southern part of the UK (either south Wales or Gloucestershire). The invited experts from the three recruitment sites were to include public contributors, primary care clinicians [general practitioners (GPs) and DNs], specialist palliative care (SPC) clinicians, research nurses (RNs), pharmacists and representatives of other support services [including hospice at home and Marie Curie (London, UK)]. Workshops were facilitated by two members of the core CARiAD trial team, one of whom made notes throughout the workshop. Workshop attendees were given background to the trial, including detail on how the question for the research was developed and the existing Australian training package that was to be adapted for the CARiAD trial. The facilitators then led discussions on the following areas:

  • identifying and approaching participants
  • consent processes
  • prescription, supply and storage of drugs
  • delivery of the intervention
  • monitoring and accountability
  • follow-up measures
  • post-bereavement interviews
  • ethics concerns
  • resource pack.

Attendees were given the opportunity to freely discuss, ask for clarification on or raise any queries or concerns about these areas. In addition, the core CARiAD team raised specific questions that required input.

Workshops were audio-recorded and a summary of discussions and resultant actions from each workshop was produced.

Results

Following the first workshop in North Wales, the decision was taken to have two separate workshops in the southern part of the UK (i.e. for both south Wales and Gloucestershire recruitment sites), as it became apparent that the specific details of the local ways of working would be vital in understanding how to deliver the trial intervention. Discussions at each workshop built on and refined those from previous workshops, interpreting them in a local context. There were 10–12 attendees at each of the three workshops, with at least one representative of each of the invited groups present at each meeting. A co-chief investigator for the study (MP) facilitated two of the workshops, supported by the trial manager (JR). The third workshop was facilitated by the principal investigator (PI) for the site (AB) and the qualitative lead for the study (AN).

Identifying and approaching participants

All sites agreed that specific DN teams who were deemed to be stable and had the capacity to take on research should be chosen to take part and be responsible for identifying eligible patient/carer dyads. This decision was to be made with the input of the local DN matrons or equivalent. HCPs who were linked with these teams were to be made aware of the study and that the named DN team was involved. They had to have knowledge of the RA tool (see Report Supplementary Material 2) and would be asked to flag potential patients to the DN team. No concerns were raised about difficulties in identifying dyads suitable for the CARiAD trial by the DN teams, and discussion focused on the practicalities of how, when and where patients and their carers should be approached.

There was considerable discussion around the content of the RA tool. It was noted that there was no need for the RA tool to exclude patients who were known to have human immunodeficiency virus (HIV) or hepatitis as, first, universal precautions should be taken and, second, there was no risk of needle-stick injury as needles would not come into contact with the patient’s blood owing to the no-needle administration technique. It was also suggested that RA using the RA tool should be ongoing to account for changes in circumstances. Other factors discussed included how to include GPs in the RA process, what to do if there was more than one carer, whether or not a question about social support for the carer was appropriate, the inclusion of a free-text box for additional issues and the need for a question about a suitable environment for drug storage.

Consent processes

The benefit of research staff being responsible for the consent process was discussed, as they have experience in explaining trial-specific procedures, such as equipoise and randomisation, to ensure that consent was fully informed and that dyads were clear that agreeing to take part did not guarantee that they would be able to administer as-needed SC medications.

Attendees were asked to consider the balance between the benefits of a RN obtaining informed consent and the potential burden caused by introducing a new colleague (i.e. the RN) to a dyad during such a sensitive time. Public contributors suggested that an acceptable course of action was that, first, the DNs introduced the concept of the study and gave the information sheets and, second, if the dyad was interested in participating, the DN could attend a joint visit with the RN to introduce the RN to the dyad. During subsequent discussion in Gloucestershire, it was suggested that a joint visit might not be necessary and that it would be appropriate for the DNs to ask the dyad if they would be happy for a RN to visit independently.

Prescription, supply and storage of drugs

The legal responsibilities of the prescribers was discussed. If all usual prescribing procedures are followed correctly, training to competency of carers evidenced by the DNs and the delegation of administration duties clearly demonstrated, the legal responsibilities for all HCPs involved remain the same as in usual care. However, as the anticipatory medications prescribed for patients in the intervention group may be administered by a carer rather than a HCP, it was felt that all GPs (the usual prescribers) in the area covered by the DN teams involved in identifying potential participants for CARiAD would need to agree in principle to their patients being approached. Potential other prescribers who should be informed of the study were also identified across the three sites; these included advanced nurse practitioners, DNs, pharmacists and SPC nurses.

The CARiAD team raised the issue of reconstitution of drugs for discussion, as diamorphine is a commonly used drug and needs reconstitution (morphine does not need reconstitution). The workshop attendees confirmed that morphine is used as first-line SC opioid and the use of diamorphine would be limited to a small percentage of cases in which exceptions apply. In North Wales, this was supported by a recent change in the local health board’s official prescribing policy. Therefore, it was felt that these small number of patients should be dealt with on a case-by-case basis, with the DNs liaising with the prescriber to negotiate the use of morphine as an alternative and being able to train carers to reconstitute diamorphine when needed.

It was also noted that because all drugs would be in glass ampoules, blunt filter needles should be used for drawing up medications and it was agreed that a reusable ampoule opener should be provided in the injection training kit, alongside the step-by-step guide to opening an ampoule, to minimise the risk of injury.

Delivery of the intervention

No major concerns were raised about the delivery of the intervention; however, there were certain factors that attendees felt that the research team needed to take into consideration. These mainly centred around support for the carer, including ensuring that they are able to access as-needed support 24/7, and being mindful of carer burden.

Practical issues raised included the need for a second SC butterfly administration site and that carers would need to know how to check when the administration site is compromised. It was also noted that the use of a second SC butterfly site may not be routine in all areas, so this should be emphasised to the DN teams. Similarly, as the research team are relying on DNs to undertake daily visits to these patients, this should be checked with individual teams as this may not always be the case.

Monitoring and accountability

Practicalities around how carer administration of medications would be recorded in patient notes were discussed. It was suggested that information could be transferred to the medication administration chart by the DNs and marked as ‘carer administered’ during the daily checks. Some members felt that a copy of the RA and competency checklist should also be included in the patient notes.

Limits of how many doses of carer-administered as-needed medication that could be given in 24 hours for the same indication were discussed. The agreement was three doses to balance pragmatism and safety considerations. If a further dose of medication for the same indication was needed within 24 hours, this could not be carer administered and a review by a HCP should be sought. The frequency of carer administration of commonly used medication was discussed and agreed that they should, in general, not be given more frequently than every 4 hours. The attendees noted that failure to respond fully to medication may sometimes indicate a different reason for the symptom (e.g. pain could be caused by a new urinary retention, for which a catheter, and not increasing doses of pain relief, is needed) and that clinical review should be sought if symptoms are not settling or are persisting or increasing. This concern was carefully weighed against the need to give timely symptom relief, which is often achieved by increased doses of pain relief medication. Attendees, drawing on experiences of public contributor carers and current usual care in the community setting, agreed that a carer could be given specific permission by the prescriber to give one further dose of morphine or midazolam 1 hour after the previous administration, if required.

For safety reasons, it was felt that prescribers and OOH services should be made aware that dose steps/options should not be prescribed for patients in the intervention group and that dose changes could not be suggested to the carer over the telephone. If the as-needed dose of medication was adjusted, this had to be communicated to the clinical team and the carer. It was suggested that space should be provided in the medication table at the front of intervention carer diaries for updating dose information. A SPC pharmacist at the North Wales workshop suggested including a dose–volume column to aid carers in giving the correct dose of medication.

The patchwork of OOH services available was discussed in some detail, showing the challenges involved in ensuring that there was awareness of the CARiAD study across the board. The group advised that the CARiAD team can flag inclusion on the study to the OOH services themselves, using current mechanisms.

Follow-up measures and post-bereavement interviews

The proposed plans for conducting the post-bereavement follow-up and qualitative interview with the carer were deemed to be an acceptable balance between not overburdening the carer and being soon enough that they would still have accurate recall. Feedback from attendees suggested that earlier time points may also be acceptable. The workshops emphasised the importance of signposting to bereavement services at this visit when appropriate. It was generally felt that the best way to do this would be to signpost via the GP.

It was agreed that, ideally, the follow-up visit should be conducted by the same person who completed the baseline visit, but that if this was not possible it would be acceptable for a different person to do this. As the intention was for the baseline visit to be conducted by the RN, this would require the RN to remain blinded to the randomisation allocation. RNs attending the workshop expressed a strong preference for being unblinded, as it is usually part of the RN role to deliver the randomisation allocation news to a participant and it was felt that their knowledge of allocation would be beneficial to the management of the study processes.

Ethics concerns

No concerns were raised that posed a significant risk to the commencement of the study. For all points raised, the attendees were asked to consider if this was something that was specific to the CARiAD intervention or something that would also be relevant to usual practice in the UK.

The main concern was the potential for carer burden, which was raised in all workshops. This included concerns about randomisation and the potential for distress when families were not randomised to the intervention group. Strategies for minimising this risk were discussed, which focused mainly on establishing an open dialogue between participants and RNs/DNs to allow an explanation of equipoise and the randomisation process. The importance of the initial approach and explanation of the study was discussed, and the reliance on the experience of RNs to do this effectively to ensure that patients and carers understood all of the trial processes as well as difficult events such as the ‘last injection’.

There was a general view that the risk of overdose was no different from the usual risk involved when carers administer oral opioids at home. Similarly, with regard to patients who may attempt to coerce a carer into giving an increased dose, the risk was deemed to be comparable with that in usual practice, as drugs are already present in the home.

There were questions about what would happen if the carer gave the wrong drug, but attendees were reassured by the CARiAD team who reported that there were no recorded incidents of this in the Australian study and that if this were to happen it should be noted by DNs during drug stock checks, which attendees reported were part of usual practice.

There was much discussion at the south Wales workshop about professional accountability and the responsibilities and legal position if things went wrong. The group was informed of research insurance and the sponsor’s role.

There was uncertainty about whether or not there was any issue in taking part in the trial for carers who were also HCPs, and if the relevant medical or nursing councils held a view on their eligibility to take part. It was generally felt that, although HCPs who found themselves in a caring role should not be excluded, it would be beneficial to obtain a supporting statement from the relevant councils if possible.

Discussion

The consensus workshops provided rich, site-specific information from a range of expert stakeholders to inform the trial processes and the development of carer training materials. Attendees were positive and supportive about the trial and its aims, and the majority of concerns that were expressed were addressed by the trial team or other attendees by sharing their experiences.

Suggestions made in the workshops were considered by the core CARiAD team and were incorporated into training materials and other trial documents accordingly. It was apparent that clear guidelines for prescribing for intervention patients would be required and that an information sheet for prescribers should be compiled to enable prescribers to adhere to these. This summarised the issues raised in the workshop and suggested dose regimens for as-needed medications. As reconstitution was not likely to be common, it was felt that no step-by-step guide for this would be needed. Specific changes that were required to the RA tool were removing reference to the risk of transmissible disease, adding a check that there was a suitable place to store medications and amending it to allow it to be used as an ongoing document. Carer burden concerns were addressed as much as possible in the carer handbook and through signposting to OOH services as well as by ensuring that during training carers were aware that there was no obligation to administer as-needed medications, even when trained.

The importance of GP support for the study, particularly regarding the prescribing requests for intervention patients, required all general practices in the areas covered by the chosen DN teams to indicate that they had no objections to patients being approached to take part. Although some DN teams planned to involve the GP in the initial RA, this was unlikely to happen in every case, and for this reason the general practices were targeted by the core CARiAD team prior to opening trial recruitment.

The issue of whether or not the RNs could be unblinded was not resolved, and further discussion of this with the core CARiAD team and trial steering committee was required.

After DN teams were identified at each site, they were trained by the trial manager in how to recruit participants and how to train carers in the intervention group. They were provided with all of the materials and information, and the purpose of the documents was clearly explained, particularly the RA tool and the competency checklists. When usual-care processes already existed and there had been no strong views in the consensus workshops about the need for any changes to these, and as long as there was no impact on safety, DN teams were encouraged to continue with these processes. For this reason, no trial paperwork was provided for drug stock checks because these checks were already being carried out as part of current practice. When DN teams felt that it was appropriate and feasible for the carer, the carer was trained to complete the Medication Administration Record along with the carer diaries.

The General Medical Council (GMC) and Nursing and Midwifery Council (NMC) were contacted to establish their stance on recruiting carers to the CARiAD study who were also HCPs. Although they were unable to offer complete clarity, they did not object to HCPs being included in the study. As all carer participants were to be trained as lay carers, regardless of their background, they were not excluded from taking part.