This study is the first randomised controlled trial of a nurse led follow-up programme over the year after discharge from intensive care. It achieved its target sample size, and the intervention was reliably delivered. The outcome measures included both general and specific measures of health related quality of life and mental health and were appropriate to the research questions asked. The intervention was not effective in improving health related quality of life in the year after discharge from intensive care with regard to the outcome measures. The intervention also did not show effectiveness in any of the a priori subgroups, which included severity of illness, chronic comorbidity, intensive care experience, and length of stay in intensive care.
We believe that this study has high internal validity. The study recruited from three centres, one of which had an existing follow-up service and two that did not. The expert centre taught the other centres in the delivery of the intervention. The patients recruited to the trial are broadly representative of UK intensive care admissions.1
However, those included in our study were likely to have been more severely ill than patients admitted to intensive care in other countries as our patients represented level 3 dependency care or the requirement for support of multiorgan failure.24
This may affect the external validity and generalisability of the result. Study baseline quality of life scores were measured in hospital after discharge from the intensive care unit and mean scores for the mental and physical components of the SF-36 questionnaire were consistent with previous literature.2 33 34
Baseline HADS scores showed a moderately high overall level of anxiety and depression, as found in previous studies in this population.
The intervention was delivered with high reliability in all centres and mirrored UK practice at the time of development. Markers of this include that more than 90% of patients had the main elements of the intervention delivered. Despite encouragement to do so, only a minority of patients brought a relative with them to the clinic. With the key role of relatives in delivering care, we were surprised this number was not higher. Also, about a third of the patients required specialist medical referrals and a further third psychological referral. These data reflect the high, and presumably often unmet, need for specialist care in this patient group. Intensive care doctors were involved in the care of up to half of the patients at the clinics, mainly at the request of the nurses rather than of the patients, and were involved in all specialist referrals. The vast majority of patients were offered a visit to the intensive care unit, and three quarters took up this offer independently of the clinic appointment. From these data it is clear that the intervention was coordinated at the clinics but was delivered across the entire first year after discharge from the intensive care unit. Losses to the study over the first year were due to deaths (11.2%), withdrawal, and loss to follow-up (21.7%). Such mortality figures are in keeping with previous reports from similar patient cohorts.2 34
A 20% withdrawal or loss to follow-up is also broadly in keeping with other studies in this patient cohort.2 34
However, we performed sensitivity analysis to analyse the effects of such losses to follow-up, which showed that the results were not affected by such losses.
The scores for the physical and mental components of the SF-36 rose from baseline values at six and 12 months’ follow-up in both groups but remained below population norms at all times, in line with previous findings.2 18 33 34
Psychological distress scores tended to improve over the year but still represented a significant degree of psychological morbidity in both groups. As above, nearly a third of these patients required psychological referral, and ready access to such care is simply not available currently in the UK. Clearly, despite the results of this study, more needs to be done to identify patients with significant morbidity and suitable assessment and treatment options put in place.
As part of a sensitivity analysis, we analysed the primary outcomes according to treatment received and per protocol. These analyses show a slight increase in the intervention effect, but it remained non-significant. This may suggest that greater penetration of the intervention contributes to an improved outcome but will not on its own bring about important improvements. Subgroup analyses also did not yield any notable differences between intervention and control groups.
A key part of the economic evaluation was to explore under what circumstances the conclusions would alter. This was undertaken using sensitivity analysis but the results remained robust to different underlying assumptions. Furthermore, given that there was no evidence of differences in QALYs, follow-up programmes could only be cost effective if they had the same or lower cost than standard care. This seems implausible over a 12 month follow-up period given the data we have. However, for the average difference in cost of £2316, follow-up programmes would need to provide 0.12 QALYs above standard care over a 12 month period to have an incremental cost per QALY of £20
000. This value is well above the upper limit of the 95% credible interval obtained in the base case or any of the sensitivity analyses.
There may be a variety of reasons why an improvement in health related quality of life was not observed in this study. Firstly, our complex intervention package may truly be ineffective. The intervention was developed from the experiences of an existing intensive care follow-up programme with many years experience, with additional regard to current UK practice in this field and with detailed knowledge of the morbidity that occurs in the year after discharge from intensive care.2 7 9
However, although well informed, these follow-up programmes are not strongly evidence based. A further reason may be that our intervention did not account for important aspects of a patient’s illness such as delirium and cognitive dysfunction and the complexity of the role of patients’ relatives in their recovery (these aspects have emerged in the literature as important factors in patient recovery since our trial intervention was designed).35 36 37
It may be that medical review is always appropriate for such complex patients and that a multiprofessional approach is required for this group at all times.
Our intervention differed from standard UK practice in that we included all intensive care patients with level 3 dependency irrespective of their length of stay in intensive care. Many centres invite only those patients with longer lengths of stay to their programmes, believing that these patients may gain greater benefit. However, our subgroup analysis did not show a significant treatment effect in patients with longer lengths of stay. Further, patients with short stays are known to have significant physical and psychological morbidity after admission to intensive care.
The timing of the intervention may have contributed to the non-significant findings (the first follow-up clinic was held at three months after discharge), and different results might have been seen if there had been more emphasis on early interventions occurring in hospital or in the immediate period after hospital. Our physical rehabilitation package did, however, start in hospital but may have been inadequate for the needs of these patients. A previous study has suggested that a physical rehabilitation programme does improve physical outcome when delivered in hospital after discharge from intensive care through to three months after discharge.38
The knowledge of physical rehabilitation requirements after critical illness has advanced since we designed the intervention, with more attention being paid to starting rehabilitation while the patient is still in the intensive care unit.39
Elements of our intervention might also have strayed inadvertently into the practice for our control patients (that is, contamination across groups might have occurred). However, the data indicate that there were higher referral rates to specialist services in the intervention group than the control group (data not shown), suggesting that the management of patients in the intervention group was indeed different from that in the control group. This gives some reassurance that contamination was minimal. The intervention effect was also consistent across the centres, suggesting there was not differential drift of the components of the intervention group into the control group across centres, which might have been expected if contamination had occurred in individual sites.
Finally, the conduct of the study may have inadvertently impaired the delivery of the intervention. Although it is often stated that the conduct of a research project can improve the studied outcome through the Hawthorne effect, it may be that this was not the case in this study. After the study, the nurses who delivered the intervention indicated that the completion of detailed questionnaires at the clinic appointments (most of which were part of the clinical assessment at that time as well as of the outcomes assessment at the main outcome points) did sometimes feel intrusive, potentially making the clinic reviews feel more like a research follow-up session rather than a review and treatment session. This may have reduced the effectiveness of the intervention.
Strengths and limitations of study
Strengths of this study include it being the first multicentre randomised controlled trial of nurse led follow-up of patients over the year after their discharge from intensive care. We achieved the target sample size, and the intervention was delivered with high validity. The outcomes used were robust and well validated in a variety of clinical areas. We believe the study was delivered with high internal reliability. The external validity and generalisability may be reduced by the high severity of illness of patients treated in UK intensive care practice. Limitations include a comparatively small sample size to detect important changes in less common outcomes, including some physical and psychological outcomes. Patient selection may also have been too inclusive for this study. We selected all patients who had required intensive care, but the intervention may have been of greater benefit to more severely ill patients or those who required longer stay in intensive care.
Further studies should attempt to identify effective ways to select patients most likely to benefit from follow-up after intensive care. They also need to elucidate more clearly the role of delirium and cognitive dysfunction on recovery and indeed on patients’ ability to complete clinical and outcome questionnaires. A greater understanding of the complexity of the role of patients’ relatives in their recovery and rehabilitation after critical illness is also required. Finally, the role of early physical rehabilitation based in the intensive care unit itself needs to be further explored.36
Our study showed no evidence that a nurse led follow-up programme was effective or cost effective in improving patients’ health related quality of life in the first year after their discharge from intensive care. Hospitals using intensive care follow-up programmes with a similar model of care should review their practice in light of our results.
What is already known on this topic
- Critically ill patients who require intensive care have severe and prolonged physical and psychological morbidity, and excess mortality, in the years after discharge from intensive care
- Intensive care follow-up programmes have been developed in an attempt to improve the quality of life of these patients, but evidence for the effectiveness of such programmes is lacking
What this study adds
- This pragmatic study showed that nurse led follow-up clinics were neither effective nor cost effective in improving patients’ quality of life in the year after their discharge from intensive care
- Use of such follow-up programmes should be reviewed in light of these results