The PRaCTICaL study of nurse led, intensive care follow-up programmes for improving long term outcomes from critical illness: a pragmatic randomised controlled trial

Abstract

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 >or=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.

Fig 1 Consort flow diagram of patient recruitment and retention for the study. “Not responded” relates to patients who did not complete a questionnaire at six months but did so at 12 months (primary outcome point).

Fig 2 A priori subgroup analyses of SF-36 scores (physical and mental components) adjusted for minimisation covariates.