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

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          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 ≥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

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          Most cited references22

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          Memory, delusions, and the development of acute posttraumatic stress disorder-related symptoms after intensive care.

          To examine prospectively the relationship between memories of intensive care (ICU) and levels of anxiety after ICU discharge, the stability of these memories with time, and their relationship to the development of acute posttraumatic stress disorder (PTSD)-related symptoms. Case series cohort assessed by interview at 2 and 8 wks after ICU discharge. District general hospital (serving a population of 350,000) general intensive care unit. Memories of ICU and anxiety levels were studied in 45 patients after ICU discharge. Thirty patients were examined again at 8 wks to assess memory stability and development of acute PTSD-related symptoms. Standardized interviews and questionnaires were used to assess memory for ICU, anxiety, and depression 2 wks after ICU discharge. In addition, PTSD-related symptoms and panic were assessed 8 wks after ICU discharge. A total of 33 of 45 patients had delusional memories from ICU at 2 wks; nine of the patients with delusional memories had no factual memories, and these patients had higher anxiety levels 2 wks after ICU discharge (p < .0001). Thirty patients had paired assessments at 2 and 8 wks. Those patients who had no factual recall of ICU but had delusional memories at 2 wks scored highly for PTSD-related symptoms and panic attacks at 8 wks (p = .023 and .014, respectively). The only predictors of possible acute PTSD-related symptoms at the 8-wk assessment were trait anxiety (p = .006) and having delusional memories without recall of factual events in the ICU at 2 wks (p < .0001). Only delusional memories were retained over time, whereas the recall of factual events in the ICU declined. We propose that the development of acute PTSD-related symptoms may be related more to recall of delusions alone. This study suggests that even relatively unpleasant memories for real events during critical illness may give some protection from anxiety and the later development of PTSD-related symptoms when memories of delusions are prominent.
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            Rehabilitation after critical illness: a randomized, controlled trial.

            To evaluate the effectiveness of a rehabilitation program following critical illness to aid physical and psychological recovery. Randomized controlled trial, blind at follow-up with final assessment at 6 months. Two district general hospitals and one teaching hospital. Patients were 126 consecutively admitted intensive care patients meeting the inclusion criteria. Control patients received ward visits, three telephone calls at home, and clinic appointments at 8 wks and 6 months. Intervention patients received the same plus a 6-wk self-help rehabilitation manual. We measured levels of depression and anxiety (Hospital Anxiety and Depression Scale), phobic symptoms (Fear Index), posttraumatic stress disorder (PTSD)-related symptoms (Impact of Events Scale), and scores on the Short-Form Health Survey physical dimension 8 wks and 6 months after intensive care unit (ICU) treatment. Memory for ICU was assessed at 2 wks post-ICU discharge using the ICU Memory Tool.The intervention group improved, compared with the control patients, on the Short-Form Health Survey physical function scores at 8 wks and 6 months (p =.006), and there was a trend to a lower rate of depression at 8 wks (12% vs. 25%). However, there were no differences in levels of anxiety and PTSD-related symptoms between the groups. The presence of delusional memories was correlated significantly with both anxiety and Impact of Events Scale scores. A self-help rehabilitation manual is effective in aiding physical recovery and reducing depression. However, in those patients recalling delusional memories from the ICU, further psychological care may be needed to reduce the incidence of anxiety and PTSD-related symptoms.
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              Health-related quality of life and posttraumatic stress disorder in survivors of the acute respiratory distress syndrome.

              Despite considerable progress in intensive care management of the acute respiratory distress syndrome (ARDS), little is known about health-related quality of life in long-term survivors. In addition, intensive care treatment can be extremely stressful, and many survivors of ARDS report adverse experiences such as respiratory distress, anxiety, or pain during intensive care unit (ICU) treatment. This study was performed to assess health-related quality of life in survivors of ARDS and to test the hypothesis that adverse experiences during ICU treatment result in posttraumatic stress disorder (PTSD) and negative effects on health-related quality of life. Retrospective, cohort, case-controlled analyses. A 12-bed multidisciplinary ICU of a tertiary care university hospital, capable of providing extracorporeal life support for adults with severe ARDS. We studied 80 patients who were admitted to our hospital from 1985 to 1995 and who survived an episode of ARDS. ARDS was defined according to the criteria of the American-European Consensus Conference on ARDS. Health-related quality of life was measured using the Health Status Questionnaire of the self-administered Medical Outcomes Study Short Form Survey that consists of 36 questions (SF-36) and the German version of the Post Traumatic Stress Syndrome 10-Questions Inventory (PTSS-10), a self-report scale for the diagnosis of posttraumatic stress disorder based on the Diagnostic and Statistical Manual (Third Edition) criteria (American Psychiatric Association). The number of adverse experiences (anxiety, respiratory distress, pain, and nightmares) during intensive care was evaluated by means of a structured questionnaire. For each patient with ARDS, three age- and gender-comparable controls were randomly selected from databases providing normal values for the SF-36 and PTSS-10 scores in populations at risk for posttraumatic stress disorder. Survivors of ARDS showed statistically significant impairments in all eight health dimensions of the SF-36 when compared with normal controls (median reduction 21.3%, p < .006) with maximal impairments in physical function (median reduction 28.9%, p = .000) and a 38% higher frequency of chronic pain (p = .0001). Three of 34 patients reporting none, or one, adverse experience had evidence of posttraumatic stress disorder vs. 19 of 46 patients remembering multiple traumatic episodes (p = .007). Patients reporting multiple adverse experiences described the lowest health-related quality of life, with maximal impairments in psychosocial functioning (p < .005) and only small limitations in physical function. Long-term survivors of ARDS describe a good overall health-related quality of life. Major impairments in mental health domains of health-related quality of life are associated with the development of posttraumatic stress disorder and are a possible result of traumatic experiences during ICU therapy.
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                Author and article information

                Contributors
                Role: chief of critical care medicine and professor of anaesthesia
                Role: senior lecturer
                Role: director and professor
                Role: intensive care follow-up nurse
                Role: intensive care follow-up nurse
                Role: intensive care follow-up nurse
                Role: consultant pyschiatrist
                Role: trial manager
                Role: professor of biomedical statistics
                Role: statistician
                Role: health psychologist
                Role: professor of health psychology
                Role: consultant in anaesthesia and intensive care
                Role: consultant in anaesthesia and intensive care
                Journal
                BMJ
                bmj
                BMJ : British Medical Journal
                BMJ Publishing Group Ltd.
                0959-8138
                1468-5833
                2009
                2009
                16 October 2009
                : 339
                : b3723
                Affiliations
                [1 ]Department of Critical Care Medicine, Sunnybrook Health Sciences Centre, Toronto
                [2 ]School of Nursing and Midwifery, University of Dundee, Dundee
                [3 ]Health Services Research Unit, University of Aberdeen, Aberdeen AB32
                [4 ]Intensive Care Unit, Royal Berkshire and Battle Hospital, Reading
                [5 ]Intensive Care Unit, Aberdeen Royal Infirmary, Aberdeen
                [6 ]Department of Mental Health, Murray Royal Hospital, Perth
                [7 ]Robertson Centre for Biostatistics, University of Glasgow, Glasgow
                [8 ]Health Economics Research Unit, University of Aberdeen
                [9 ]Health Psychology Unit, University of Aberdeen
                [10 ]Department of Anaesthesia and Intensive Care Medicine, Ninewells Hospital and Medical School, Dundee
                Author notes
                Correspondence to: B H Cuthbertson brian.cuthbertson@ 123456sunnybrook.ca
                Article
                cutb660365
                10.1136/bmj.b3723
                2763078
                19837741
                c51389e6-0990-49ba-a325-62d33a241b6c

                This is an open-access article distributed under the terms of the Creative Commons Attribution Non-commercial License, which permits use, distribution, and reproduction in any medium, provided the original work is properly cited, the use is non commercial and is otherwise in compliance with the license. See: http://creativecommons.org/licenses/by-nc/2.0/ and http://creativecommons.org/licenses/by-nc/2.0/legalcode.

                History
                : 26 June 2009
                Categories
                Research
                Health Policy
                Clinical Trials (Epidemiology)
                Delirium
                Memory Disorders (Psychiatry)
                Physiotherapy
                Adult Intensive Care
                Sports and Exercise Medicine
                Health Economics
                Health Service Research
                Sociology

                Medicine
                Medicine

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