The PRaCTICaL study of nurse led, intensive care follow-up programmes for improving long term outcomes from critical illness: a pragmatic randomised controlled trialBMJ 2009; 339 doi: https://doi.org/10.1136/bmj.b3723 (Published 16 October 2009) Cite this as: BMJ 2009;339:b3723
- B H Cuthbertson, chief of critical care medicine and professor of anaesthesia1,
- J Rattray, senior lecturer2,
- M K Campbell, director and professor3,
- M Gager, intensive care follow-up nurse4,
- S Roughton, intensive care follow-up nurse35,
- A Smith, intensive care follow-up nurse2,
- A Hull, consultant pyschiatrist6,
- S Breeman, trial manager3,
- J Norrie, professor of biomedical statistics7,
- D Jenkinson, statistician3,
- R Hernández, health psychologist38,
- M Johnston, professor of health psychology9,
- E Wilson, consultant in anaesthesia and intensive care 10,
- C Waldmann, consultant in anaesthesia and intensive care4
- on behalf of the PRaCTICaL study group
- 1Department of Critical Care Medicine, Sunnybrook Health Sciences Centre, Toronto
- 2School of Nursing and Midwifery, University of Dundee, Dundee
- 3Health Services Research Unit, University of Aberdeen, Aberdeen AB32
- 4Intensive Care Unit, Royal Berkshire and Battle Hospital, Reading
- 5Intensive Care Unit, Aberdeen Royal Infirmary, Aberdeen
- 6Department of Mental Health, Murray Royal Hospital, Perth
- 7Robertson Centre for Biostatistics, University of Glasgow, Glasgow
- 8Health Economics Research Unit, University of Aberdeen
- 9Health Psychology Unit, University of Aberdeen
- 10Department of Anaesthesia and Intensive Care Medicine, Ninewells Hospital and Medical School, Dundee
- Correspondence to: B H Cuthbertson
- Accepted 26 June 2009
Objectives To test the hypothesis that nurse led follow-up programmes are effective and cost effective in improving quality of life after discharge from intensive care.
Design A pragmatic, non-blinded, multicentre, randomised controlled trial.
Setting Three UK hospitals (two teaching hospitals and one district general hospital).
Participants 286 patients aged ≥18 years were recruited after discharge from intensive care between September 2006 and October 2007.
Intervention Nurse led intensive care follow-up programmes versus standard care.
Main outcome measure(s) Health related quality of life (measured with the SF-36 questionnaire) at 12 months after randomisation. A cost effectiveness analysis was also performed.
Results 286 patients were recruited and 192 completed one year follow-up. At 12 months, there was no evidence of a difference in the SF-36 physical component score (mean 42.0 (SD 10.6) v 40.8 (SD 11.9), effect size 1.1 (95% CI −1.9 to 4.2), P=0.46) or the SF-36 mental component score (effect size 0.4 (−3.0 to 3.7), P=0.83). There were no statistically significant differences in secondary outcomes or subgroup analyses. Follow-up programmes were significantly more costly than standard care and are unlikely to be considered cost effective.
Conclusions A nurse led intensive care follow-up programme showed no evidence of being effective or cost effective in improving patients’ quality of life in the year after discharge from intensive care. Further work should focus on the roles of early physical rehabilitation, delirium, cognitive dysfunction, and relatives in recovery from critical illness. Intensive care units should review their follow-up programmes in light of these results.
Trial registration ISRCTN 24294750
Members of the PRaCTICaL study group were A McDonald, G McPherson, CR Ramsay, L Vale, C Pflanz-Sinclair, University of Aberdeen; JAW Wildsmith, Ninewells Hospital and Medical School, Dundee; S Rose, Berkshire Healthcare Foundation NHS Trust, Bracknell; and B Williams, Intensive Care Society, London. Chairman of the trial steering committee was Timothy Walsh, Royal Infirmary of Edinburgh, Edinburgh.
Contributors: BHC, JR, MKC, MG, SR, AH, JN, RH, MJ, EW, and CW participated in the study design, data collection, data analysis, and in writing the final paper; had access to all data; and approved the final version of the paper. AS, SB, and DJ participated in the data collection, data analysis and in writing the final paper; had access to all data; and approved the final version of the paper. BHC is guarantor for the study.
Funding: The study is supported by a research grant from the Chief Scientist Office of the Scottish Government Health Directorates. The Health Services Research Unit is also funded by the Chief Scientist Office of the Scottish Government Health Directorates. The researchers are completely independent of the funders, and the views expressed are those of the authors alone. The study sponsor was the University of Aberdeen, which had no role in the study design; collection, analysis, and interpretation of data; writing of the article; or the decision to submit it for publication. The researchers are completely independent of the sponsors in their research activities.
Competing interests: None declared.
Ethical approval: The project gained full ethical approval.
Data sharing: No additional data available.
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