Screening data were collected by a researcher or CRNs on all the patients on the study nurse’s caseload. Data were collected on sex, age, referral status (existing patient or new referral) and eligibility.
Baseline data collection
The researcher or CRN completed the baseline case report form (CRF), which captured data on participants’ medical history (e.g. type of advanced disease, date of diagnosis), reason for referral to palliative care, palliative treatments received (within the past month) and current medications for pain, nausea and constipation. The baseline CRF also asked participants whether or not, in a future study, they would take
part if they were randomised to receive either the intervention or standard care as usual (yes/no response). This question was included to inform the acceptability of randomisation processes in a future definitive trial. Participants were also asked to complete an outcome measure pack comprising five validated self-reported outcome measures on pain, self-efficacy, common symptoms, quality of life and satisfaction with medicines information. These outcome measures are described inParticipant self-reported outcome measures. Follow-up schedule
Participants were followed up for 6 weeks from the date of baseline assessment. Six-week follow-up was chosen because the risk of short survival in this population meant that demonstrating early and sustained improvements in self-management within a few weeks would be particularly important in this context. During the 6-week follow-up period, participants were contacted by a researcher at three time points post baseline:
1. week 2 (day 14) 2. week 4 (day 28) 3. week 6 (day 42).
The exact timing of follow-up visits was flexible to fit around participants’medical and other appointments, although efforts were made to keep follow-up visits within±2 days of the scheduled appointment date. Follow-up visits were usually conducted face to face between the participant, their carer and a researcher. Participants were offered a telephone follow-up if this was more convenient.
At each follow-up visit the researcher completed a follow-up CRF and asked the participant to complete the outcome measure pack (as described above). The follow-up CRF captured data on any of the following activities since the last follow-up (or baseline) visit:
1. which factsheets had been given to the participant
2. whether or not any self-management goals had been set (or reviewed)
3. whether or not the participant and/or carer had watched either of the video podcasts. Participant and carer interview
As part of the final follow-up visit (week 6) participants (and carers, when appropriate) were asked to take part in an audio-recorded face-to-face semistructured interview together with a study researcher. Participants and carers were interviewed together. The topic guide for these interviews focused on two broad areas. First, participants and their carers were asked what they thought about taking part in the trial and how they were managing their medicines. These questions were intended to explore participants’ and carers’acceptability of trial procedures, what they thought of the intervention itself and how it had been delivered to them by their CNS. These questions were designed to understand the extent to which participants and their carers were aware of the formalised educational process, the acceptability of the SMST resources (i.e. what they liked and did not like about it), their continued use of the intervention and whether or not their participation had any effect on their confidence with managing medicines. Interview guides are reproduced inAppendix 22.
Study nurse interview
In addition to participant and carer interviews, all study nurses were invited to take part in an audio-recorded semistructured interview after follow-up had closed for all participants at their site. These interviews covered a range of topics designed to capture their experiences of participating in the research process (including the training workshop), as well as their views on the acceptability of the intervention and whether or not they felt that they could integrate it into their clinical practice. The topic guides for the study nurse interviews are reproduced inAppendix 22.
Final data collection
At each site, when the last participant had completed 6 weeks of follow-up (or had withdrawn from the trial) a final data collection CRF was completed to capture the following data on all patients at that site:
l date of death or date last known to be alive
l place of death and preferred place of death (if known)
l health-care resource use over the 6-week follow-up period (these data are reported inChapter 4as they relate to the health economic evaluation of the overall intervention)
l current medication prescribed for pain, nausea and constipation. Adverse events
The intervention was evaluated within a patient population with advanced disease and who are
approaching the end of life. Thus, it was expected that episodes of acute illness or infection, new medical problems and deterioration of existing medical problems would occur and could result in prolonged hospitalisation, hospital readmission, significant or permanent disability or incapacity, or death. In recognition of this, events fulfilling the definition of an adverse event or serious adverse event were not reported in this study unless the event resulted from administration of any research procedure.
Non-study nurse data collection: assessing contamination
To inform the design of a future definitive trial, it was considered appropriate to evaluate whether or not within individual sites the practice of non-study nurses was influenced as a consequence of working in a team where their colleagues were using the SMART intervention. To assess contamination, an online survey was sent to all non-study nurses working in the community palliative care teams at the four recruitment sites. The survey captured data on:
l demographics (age, sex, grade/band)
l duration of palliative care experience
l whether or not they were an independent prescriber
l whether or not they were aware of the SMART study and what it was about
l whether they had discussed the SMART study with colleagues who were using the intervention
l if they were aware of the study or had discussed it with a colleague, whether or not this had influenced their own practice supporting medicines management with their patients.
A copy of the online survey questions to non-study CNSs is reproduced inAppendix 23. Participant self-reported outcome measures
Pain was measured using the short-form Brief Pain Inventory (BPI).71Using a 0–10 numerical rating scale (anchored 0,‘no pain’, and 10,‘pain as bad as you can imagine’), the BPI allows respondents to rate their worst, least and average pain intensity during the past 24 hours, as well as present pain. The responses to the four pain intensity items are reported separately. Using a 0–10 numerical rating scale (anchored 0, ‘does not interfere’, and 10,‘completely interferes’), respondents are also asked to rate the extent to which pain interferes with general activity, mood, walking ability, normal work, relations with other people, sleep and enjoyment of life.
Self-efficacy was measured using the SES (adapted for palliative care).69This scale contains six items that assess an individual’s confidence with managing symptoms of illness and was adapted for a palliative care context. Each item is measured on a 1–10 numerical rating scale, anchored 1,‘not confident at all’, and 10,‘totally confident’.
Symptom burden was measured using the Edmonton Symptom Assessment Scale (ESAS).72The ESAS is a 10-item tool designed to assess common symptoms in palliative care patients. Each item is measured using a 0–10 numerical rating scale anchored 0,‘no (symptom)’, and 10,‘worst (symptom)’. The ESAS was
originally developed in cancer patients but has been extensively used at end of life. The final item, ‘other problems’, was modified to represent drowsiness.
Health-related quality of life was measured using the EuroQol-5 Dimensions, five-level version (EQ-5D-5L),73 which is a standardised, generic measure of health-related quality of life. It provides a single index value for describing and valuing health status calculated from a simple descriptive profile consisting of the following five dimensions: usual activities, self-care, mobility, pain/discomfort and anxiety/depression. The EQ-5D-5L index is reported not in this chapter, but inChapter 4, as it relates to the health economic evaluation of the overall SMART intervention. The EQ-5D-5L also provides an overall measure of health- related quality of life by asking respondents to rate their present health state from 0,‘worst health you can imagine’, to 100,‘best health you can imagine’, which is reported in this chapter.
Satisfaction with medicines information was measured using the Satisfaction with Information about
Medicines Scale (SIMS),74which consists of 17 items about the types of information required to facilitate safe self-management. For each item, respondents are asked to rate the amount of information they have received using the following response scale: too much, about right, too little, none received or none needed.