The primary aim of this prospective randomised controlled feasibility study was to make recommendations to inform the design of a future RCT to investigate the effect of spiritual support on specified outcomes in patients with end stage heart failure. 47 patients with end stage heart failure (NHYA IV) were randomised to control (standard care, n=25) or intervention (standard care plus spiritual support, n=22) groups. Spiritual support consisted of a 1 hour discussion facilitated by trained volunteers using the ‘Spiritual Enquiry Tool’ at 2 monthly intervals over 6 months (i.e. 4 times in total). Participants completed measures of spiritual wellbeing (WHO-SRPB Field Test Instrument), depression/anxiety (HAD), and health related quality of life (EQ-5D-3L) at 0, 2, 4, and 6 months. Purpose designed questionnaires captured NHS resource use and potential confounding factors (change in circumstances, life events, symptoms, medication) at 2, 4 and 6 months, in addition to demographic information at baseline and intervention patients’ satisfaction with the spiritual support service at month 6. Secondary aims were to investigate the effect and cost effectiveness of spiritual support on the above mentioned outcomes if the sample size was sufficient, or to explore trends worthy of further investigation if the sample size was insufficient. Primary findings 133 eligible patients were invited to take part and 104 accepted an information pack, giving an uptake of 35%, The resulting sample size was small (n=47), with 38 complete data sets [18 controls and 20 intervention] As a result of poor uptake, attrition and missing data (for example associated with fatigue, co-morbidity and death) the ability to detect significant changes in study outcomes with the intervention in this feasibility study was compromised; a finding consistent with the National Institute of Health Research (Evans et al.; 2013). Recruitment and data collection took longer than expected because of patient and staff related factors; 18 months to recruit 47 patients and 2 years to collect the data rather than the estimated 9 months to recruit 65 patients and 15 months to collect the data. Considerable effort and time was needed by the research team to recruit patients and to keep them in the study, and by the volunteers to deliver the intervention. Of the 8 trained volunteers, 2 dropped out because of ill health and lack of transport. Inclusion of an administrator and a dedicated research nurse is recommended. The measures were, on the whole, suitable for this patient group, but another QOL measure, such as the Kansas City KCCQ-12, may be additionally useful to capture other aspects of life important to patients, such as ‘enjoyment of life’ which are not included in the EQ-5D-3L. The WHO-SRPB Field Test Instrument was quite long and complex so some patients needed help filling it in. It would be worth testing a shorter simpler measure of spiritual wellbeing in another study. With the WHO-SRPB Field Test Instrument, domain spirituality scores ranged from 4.0 to 18.8 (average 12/13), with the biggest change in any individual of 7 points. Differences in scores between intervention and control groups ranged from 0.3 to 1.4. Spiritual wellbeing was negatively correlated with anxiety (Rho ranging from -.306 to -.385, p<0.1) and depression (Rho ranging from -.342 to -.648, p<0.05); a finding which supports the existing literature, suggesting that spiritual wellbeing mitigates against anxiety and depression. Spiritual wellbeing may be associated with better QOL, but this was not supported by the limited data from this study. Secondary findings No significant effects were identified for the intervention (spiritual support) on spiritual wellbeing, QOL, anxiety or depression. The following trends require further investigation: • Spiritual support may have a positive effect on QOL and anxiety; both were improved in the intervention group at 0-2 months (QOL increased +4 and anxiety -1.2) and were worse in control group at 0-2 months (QOL -8, anxiety +0.8). Alternatively there may be a group allocation effect so we would recommend that study measures are completed prior to start of the intervention. The intervention group’s QOL declined less than the control group’s overall. • Withdrawal of spiritual support from the intervention group (at the end of the study) may have a negative effect. Depression scores increased in intervention patients (+0.9) and decreased in control patients (-0.6) at the end of the study (months 4-6). We would recommend that measures continue to be completed after the intervention has stopped. • Spiritual support may lower NHS resource use; a lower resource cost of £204 per intervention patient was noted over the study period. • Spiritual support may be cost effective if rolled out to more patients as part of routine care, rather than being offered on a cost per head basis within a trial. All service delivery and programme costs were £875 per patient, over 68% of these costs were attributed to training., If the intervention were offered to twice the number of patients over a longer period of time, the data suggests that the provision of spiritual support may meet the NICE ‘willingness to pay’ threshold of £20-30,000 per QALY gained. • Spiritual support was valued by those receiving it. Nurses were initially uncomfortable with/lacked confidence in having end of life conversations with patients, indicating the need for training.
|University of South Wales
|Nevill Hall Thrombosis and General Research Fund
|Number of pages
|Published - Aug 2017