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

Department of Critical Care Medicine, Sunnybrook Health Sciences Centre, Toronto.
BMJ (online) (Impact Factor: 16.38). 10/2009; 339(oct16 1):b3723. DOI: 10.1136/bmj.b3723
Source: PubMed

ABSTRACT 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.
A pragmatic, non-blinded, multicentre, randomised controlled trial.
Three UK hospitals (two teaching hospitals and one district general hospital).
286 patients aged >or=18 years were recruited after discharge from intensive care between September 2006 and October 2007.
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.
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.
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.
ISRCTN 24294750.

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Available from: John Norrie, Jul 28, 2015
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    • "These clinics were usually nurse-led with or without multi-professional input and with the broad aims of screening survivors for complications and providing or referring them to specialist services as necessary (Griffiths et al. 2006, Modrykamien 2012, Egerod et al. 2013). However, this model has not demonstrated tangible benefits (Cuthbertson et al. 2009) despite being well received by survivors and their families (Engstrom et al. 2008, Peterssen et al. 2011). The standardised provision of rehabilitation initiatives which address psychological and physical domains with the intention of improving longterm outcomes for survivors are still required (Rubenfeld 2007, Jackson et al. 2012). "
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    ABSTRACT: Aims and objectivesTo critically appraise the available literature and summarise the evidence related to the use, prevalence, purpose and potential therapeutic benefits of intensive care unit diaries following survivors' discharge from hospital and identify areas for future exploration.Background Intensive care unit survivorship is increasing as are associated physical and psychological complications. These complications can impact on the quality of life of survivors and their families. Rehabilitation services for survivors have been sporadically implemented and lack an evidence base. Patient diaries in intensive care have been implemented in Scandinavia and Europe with the intention of filling memory gaps, enable survivors to set realistic recovery goals and cement their experiences in reality.DesignA review of original research articles.Methods The review used key terms and Boolean operators across a 34-year time frame in: CIHAHL, Medline, Scopus, Proquest, Informit and Google Scholar for research reports pertaining to the area of enquiry. Twenty-two original research articles met the inclusion criteria for this review.ResultsThe review concluded that diaries are prevalent in Scandinavia and parts of Europe but not elsewhere. The implementation and ongoing use of diaries is disparate and international guidelines to clarify this have been proposed. Evidence which demonstrates the potential of diaries in the reduction of the psychological complications following intensive care has recently emerged. Results from this review will inform future research in this area.Conclusions Further investigation is warranted to explore the potential benefits of diaries for survivors and improve the evidence base which is currently insufficient to inform practice. The exploration of prospective diarising in the recovery period for survivors is also justified.Relevance to clinical practiceIntensive care diaries are a cost effective intervention which may yield significant benefits to survivors.
    Journal of Clinical Nursing 12/2014; 24(9-10). DOI:10.1111/jocn.12736 · 1.23 Impact Factor
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    • "The intervention was delivered primarily in the ICU. Cuthbertson et al. 2009 (PRaCTICaL) [21] Discharge Home: Nurse-led follow-up clinic at 3 and 9 months post-hospital discharge, in combination with a manual based, self-directed, physical rehabilitation programme introduced in hospital. At 12 months, there were no statistically significant differences in HRQoL or any secondary measures between groups. "
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    ABSTRACT: Increasing numbers of patients are surviving critical illness, but survival may be associated with a constellation of physical and psychological sequelae that can cause ongoing disability and reduced health-related quality of life. Limited evidence currently exists to guide the optimum structure, timing, and content of rehabilitation programmes. There is a need to both develop and evaluate interventions to support and expedite recovery during the post-ICU discharge period. This paper describes the construct development for a complex rehabilitation intervention intended to promote physical recovery following critical illness. The intervention is currently being evaluated in a randomised trial (ISRCTN09412438; funder Chief Scientists Office, Scotland). The intervention was developed using the Medical Research Council (MRC) framework for developing complex healthcare interventions. We ensured representation from a wide variety of stakeholders including content experts from multiple specialties, methodologists, and patient representation. The intervention construct was initially based on literature review, local observational and audit work, qualitative studies with ICU survivors, and brainstorming activities. Iterative refinement was aided by the publication of a National Institute for Health and Care Excellence guideline (No. 83), publicly available patient stories (Healthtalkonline), a stakeholder event in collaboration with the James Lind Alliance, and local piloting. Modelling and further work involved a feasibility trial and development of a novel generic rehabilitation assistant (GRA) role. Several rounds of external peer review during successive funding applications also contributed to development. The final construct for the complex intervention involved a dedicated GRA trained to pre-defined competencies across multiple rehabilitation domains (physiotherapy, dietetics, occupational therapy, and speech/language therapy), with specific training in post-critical illness issues. The intervention was from ICU discharge to 3 months post-discharge, including inpatient and post-hospital discharge elements. Clear strategies to provide information to patients/families were included. A detailed taxonomy was developed to define and describe the processes undertaken, and capture them during the trial. The detailed process measure description, together with a range of patient, health service, and economic outcomes were successfully mapped on to the modified CONSORT recommendations for reporting non-pharmacologic trial interventions. The MRC complex intervention framework was an effective guide to developing a novel post-ICU rehabilitation intervention. Combining a clearly defined new healthcare role with a detailed taxonomy of process and activity enabled the intervention to be clearly described for the purpose of trial delivery and reporting. These data will be useful when interpreting the results of the randomised trial, will increase internal and external trial validity, and help others implement the intervention if the intervention proves clinically and cost effective.
    Trials 01/2014; 15(1):38. DOI:10.1186/1745-6215-15-38 · 2.12 Impact Factor
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    • "SF-36 does not include questions on sleep, cognitive functioning, sexual functioning, nutrition and communication, which might all be affected in our patient population. Other studies have suggested that SF- 36 is not sufficiently sensitive to determine the effect of issues such as delirium on HRQoL (Cuthbertson et al. 2009, Torgersen et al. 2011). Further studies are needed to address these issues and find a more appropriate tool for HRQoL after intensive care. "
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    ABSTRACT: AIMS AND OBJECTIVES: To investigate the effects of delirium in the intensive care unit on health-related quality of life, healthcare dependency and memory after discharge and to explore the association between health-related quality of life and memories, patient diaries and intensive care unit follow-up. BACKGROUND: Up to 83% of intensive care unit patients experience delirium. In addition to increased risk of mortality, morbidity and cognitive impairment, the experience itself is unpleasant. A number of studies have focused on memories associated with delirium, but the association between delirium, memories and health-related quality needs further investigation. DESIGN: We used an observational multicentre design with telephone interviews. METHODS: Adult intensive care unit patients (n = 360) were consecutively recruited and interviewed using the intensive care unit-Memory Tool one week after intensive care unit. Interviews were repeated after two and six months and supplemented with Short Form-36 and the Barthel Index. RESULTS: Delirium was detected in 60% of the patients in our study, and delirious patients had significantly fewer factual memories and more memories of delusion than nondelirious patients up to six months postintensive care unit discharge. Delirium, memories and intensive care unit diaries with follow-up did not affect health-related quality of life and healthcare dependency. Memories of delusions might have an impact on patients assessed as nondelirious. CONCLUSIONS: More than half of the patients in intensive care unit experience delirium, which is associated with fewer factual memories and more memories of delusions. Short Form-36 might not be sensitive to delirium-related outcomes. Future research should include the development of better assessment tools to determine the long-term consequences of intensive care unit delirium. RELEVANCE TO CLINICAL PRACTICE: We recommend regular assessment to prevent, detect and treat delirium. We also recommend an intensive care unit follow-up programme providing an opportunity for postintensive care unit patients, particularly previously delirious patients, to discuss their memories and experiences with intensive care unit professionals.
    Journal of Clinical Nursing 05/2013; DOI:10.1111/jocn.12250 · 1.23 Impact Factor
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