This is the only randomised controlled trial of a specialist hospital advisory PCT. It has failed to show a significant difference between the ‘full-PCT’ and ‘telephone-PCT’ in respect of the primary outcome measures, and particularly symptoms and HRQoL. However, we have completed meticulously a randomised controlled trial that provides robust, detailed and comprehensive information about the clinical course and care of patients dying of cancer and other chronic diseases in an acute hospital setting. We are able to conclude from our data that in both treatment groups the management of patients entered into the study (as reflected in the primary outcome measures) was of a high standard, that their symptoms were significantly improved, that patients and carers were highly satisfied with the care they received and the information they were given, and that communication and liaison between the hospital and primary care teams was good and generally of a high order. These are important findings, irrespective of the comparison of interventions.
In both groups there were highly significant improvements in bothersome symptoms and HRQoL which were apparent within 1 week and sustained for the duration of the 4 week observation period. The usual course in such patients is one of deterioration in physical symptoms (Coyle et al, 1990
; Ventafridda et al, 1990
, Peruselli et al, 1999
). There was a consistent direction to the comparisons of the main outcome measures and satisfaction scores in favour of ‘full-PCT’, though the differences between the groups were not significant. However, there was a highly significant difference in the number of patients who switched intervention groups, in favour of the ‘full-PCT’. It seems clear from these data that patients in both groups were being well managed. This poses the question as to whether either or both interventions contributed to this good management.
Early studies completed before the development of hospice and specialist palliative care showed that physical and psychological symptoms were common and often inadequately treated (Hinton, 1963
). Specialist services for dying patients began in the 1960s and 1970s, but the quality of care in hospitals and the community inevitably varied in different localities. In one survey published in 1984 of a random sample of 262 deaths, ‘a high proportion’ had ineffectively controlled pain, cough, dyspnoea or insomnia (Wilkes, 1984
A large survey of family members of people who died from cancer in the UK in 1990 indicated that pain and other symptoms in these patients were common and caused considerable distress (Addington-Hall and Mccarthy, 1995
). Sixty-one per cent of patients experienced pain in their last week of life and other symptoms (dyspnoea, vomiting and constipation) were common and were often not well controlled. The same study highlighted deficiencies in giving information to and communication with patients and their families. More recently, the SUPPORT study in five teaching hospitals in the United States surveyed more than 4000 patients hospitalised with life-threatening diagnoses. The data highlighted major problems of unrelieved pain and failures of communication (The Support Principal Investigators, 1995
). For example, for 50% of the conscious patients who died in hospital, family members reported moderate or severe pain at least half of the time. The findings in these studies have been reflected in emotive and sometimes harrowing case reports (Anonymous, 1989
; Fenton, 1992
) which have drawn attention to widespread failures in management of patients dying in acute hospitals. In contrast, the positive changes we have demonstrated in the primary outcome measures in this study suggest that patients received a high standard of care in both groups.
The lack of a significant difference between the two interventions may be a false negative in that there is a difference but we have failed to show it. There are some pointers in our findings which indicate that this may be the case. The factors which may have contributed include the selection of an unrepresentative sample of patients; contamination of the control group; and insufficient numbers of patients. In the planning of this study we had anticipated all of these potential difficulties of conducting an RCT which have been highlighted by others (Kane et al, 1985
; Mcwhinney et al, 1994
; Aranda, 2000
) and had taken steps to overcome them (the unequal randomisation ratio, broad entry criteria, and maintenance of a high level of awareness of the study amongst all hospital staff over a 2-year period). In spite of this only 38% of potential patient recruits were randomised. Our data indicate that the non-randomised patients were less well and had a shorter survival time. Clinical activity data show that they received more intensive input from the PCT than either study group. It seems that we have excluded from the study a group of patients who may be most needy in terms of specialist palliative care and who may have been more likely to show differences between the interventions. One of the major challenges in palliative care research is to develop measures to capture outcome data from such patients in a way that is practical and ethical.
The best design for this RCT would have been a comparison of ‘full-PCT’ with no input from the PCT at all. This was rejected on ethical grounds on the basis that randomisation would take place after referral to the PCT. Instead we decided to provide a minimal telephone service intervention as the ‘control’, but we probably allowed this telephone intervention to develop too far into a structured package of care in its own right.
Another factor which is likely to have influenced the care of patients in the control group was the educational activity of the PCT within the hospital which continued as normal throughout the study. Regular seminars were held for oncology house staff (who often then moved into the main hospital) and study days were organised for nursing staff throughout the hospital. In addition the day-to-day activity of the PCT within the hospital would have had a significant educational influence.
The aim of the study was ambitious: to demonstrate a difference in outcomes (if one exists) between two levels of advice and support from a multidisciplinary PCT providing a package of care in addition to the usual care given in a university teaching hospital. In the light of our ‘negative’ result questions will be asked about our trial design and in particular whether a randomised controlled trial was the best option. We believe a RCT was the right design to use. By imposing the rigour necessary to undertake such a study, we have collected high quality and comprehensive data. It is not the research paradigm which has failed, rather it is the inadequacy of the measures in capturing outcome data from patients who are very ill and frail.
In conclusion, we were not able to differentiate clearly in an acute hospital setting between two models of service delivery of specialist palliative care, partly because both were associated with highly significant improvements in the primary outcome measures. Our study shows a high level of care for patients dying in this setting in this particular group of hospitals. We believe that this reflects the fact that there have been major improvements in the last two to three decades in the way that dying patients are looked after. These have not been implemented universally but the activity of a specialist PCT in a general hospital is likely to raise standards of care for such patients. We agree with Wilkes (1993
) that ‘we can look back and see that the hospice movement has irreversibly improved the standards of care for the dying’. Our data also demonstrate that this quality of care can be effectively provided to patients in acute hospital beds.