Alastair M. Hull

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

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

Increased Hospital-Based Physical Rehabilitation and Information Provision After Intensive Care Unit Discharge: The RECOVER Randomized Clinical Trial

IMPORTANCE Critical illness results in disability and reduced health-related quality of life (HRQOL), but the optimum timing and components of rehabilitation are uncertain. OBJECTIVE To evaluate the effect of increasing physical and nutritional rehabilitation plus information delivered during the post-intensive care unit (ICU) acute hospital stay by dedicated rehabilitation assistants on subsequent mobility, HRQOL, and prevalent disabilities. DESIGN, SETTING, AND PARTICIPANTS A parallel group, randomized clinical trial with blinded outcome assessment at 2 hospitals in Edinburgh, Scotland, of 240 patients discharged from the ICU between December 1, 2010, and January 31, 2013, who required at least 48 hours of mechanical ventilation. Analysis for the primary outcome and other 3-month outcomes was performed between June and August 2013; for the 6- and 12-month outcomes and the health economic evaluation, between March and April 2014. INTERVENTIONS During the post-ICU hospital stay, both groups received physiotherapy and dietetic, occupational, and speech/language therapy, but patients in the intervention group received rehabilitation that typically increased the frequency of mobility and exercise therapies 2- to 3-fold, increased dietetic assessment and treatment, used individualized goal setting, and provided greater illness-specific information. Intervention group therapy was coordinated and delivered by a dedicated rehabilitation practitioner. MAIN OUTCOMES AND MEASURES The Rivermead Mobility Index (RMI) (range 0-15) at 3 months; higher scores indicate greater mobility. Secondary outcomes included HRQOL, psychological outcomes, self-reported symptoms, patient experience, and cost-effectiveness during a 12-month follow-up (completed in February 2014). RESULTS Median RMI at randomization was 3 (interquartile range [IQR], 1-6) and at 3 months was 13 (IQR, 10-14) for the intervention and usual care groups (mean difference, -0.2 [95% CI, -1.3 to 0.9; P = .71]). The HRQOL scores were unchanged by the intervention (mean difference in the Physical Component Summary score, -0.1 [95% CI, -3.3 to 3.1; P = .96]; and in the Mental Component Summary score, 0.2 [95% CI, -3.4 to 3.8; P = .91]). No differences were found for self-reported symptoms of fatigue, pain, appetite, joint stiffness, or breathlessness. Levels of anxiety, depression, and posttraumatic stress were similar, as were hand grip strength and the timed Up & Go test. No differences were found at the 6- or 12-month follow-up for any outcome measures. However, patients in the intervention group reported greater satisfaction with physiotherapy, nutritional support, coordination of care, and information provision. CONCLUSIONS AND RELEVANCE Post-ICU hospital-based rehabilitation, including increased physical and nutritional therapy plus information provision, did not improve physical recovery or HRQOL, but improved patient satisfaction with many aspects of recovery. TRIAL REGISTRATION isrctn.com Identifier: ISRCTN09412438.

A Pragmatic Randomised, Controlled Trial of Intensive Care follow up programmes in improving Longer-term outcomes from critical illness. The PRACTICAL study

BackgroundA number of intensive care (ICU) patients experience significant problems with physical, psychological, and social functioning for some time after discharge from ICU. These problems have implications not just for patients, but impose a continuing financial burden for the National Health Service. To support recovery, a number of hospitals across the UK have developed Intensive Care follow-up clinics. However, there is a lack of evidence base to support these, and this study aims to test the hypothesis that intensive care follow up programmes are effective and cost-effective at improving physical and psychological quality of life in the year after intensive care discharge.Methods/DesignThis is a multi-centre, pragmatic, randomised controlled trial. Patients (n = 270) will be recruited prior to hospital discharge from three intensive care units in the UK, and randomised to one of two groups. The control group will receive standard in-hospital follow-up and the intervention group will participate in an ICU follow-up programme with clinic appointments 2–3 and 9 months after ICU discharge.The primary outcome measure is Health-related Quality of Life (HRQoL) 12 months after ICU discharge as measured by the Short Form-36. Secondary measures include: HRQoL at six months; Quality-adjusted life years using EQ-5D; posttraumatic psychopathology as measured by Davidson Trauma Scale; and anxiety and depression using the Hospital Anxiety and Depression Scale at both six and twelve months after ICU discharge. Contacts with health services in the twelve months after ICU discharge will be measured as part of the economic analysis.DiscussionThe provision of intensive care follow-up clinics within the UK has developed in an ad hoc manner, is inconsistent in both the number of hospitals offering such a service or in the type of service offered. This study provides the opportunity to evaluate such services both in terms of patient benefit and cost-effectiveness. The results of this study therefore will inform clinical practice and policy with regard to the appropriate development of such services aimed at improving outcomes after intensive care.Trial RegistrationISRCTN24294750.

The use of diaries in psychological recovery from intensive care

Intensive care patients frequently experience memory loss, nightmares, and delusional memories and some may develop symptoms of anxiety, depression, and post-traumatic stress. The use of diaries is emerging as a putative tool to ‘fill the memory gaps’ and promote psychological recovery. In this review, we critically analyze the available literature regarding the use and impact of diaries for intensive care patients specifically to examine the impact of diaries on intensive care patients’ recovery. Diversity of practice in regard to the structure, content, and process elements of diaries for intensive care patients exists and emphasizes the lack of an underpinning psychological conceptualization. The use of diaries as an intervention to aid psychological recovery in intensive care patients has been examined in 11 studies, including two randomized controlled trials. Inconsistencies exist in sample characteristics, study outcomes, study methods, and the diary intervention itself, limiting the amount of comparison that is possible between studies. Measurement of the impact of the diary intervention on patient outcomes has been limited in both scope and time frame. Furthermore, an underpinning conceptualization or rationale for diaries as an intervention has not been articulated or tested. Given these significant limitations, although findings tend to be positive, implementation as routine clinical practice should not occur until a body of evidence is developed to inform methodological considerations and confirm proposed benefits.

Intensive care diaries to promote recovery for patients and families after critical illness: A Cochrane Systematic Review

OBJECTIVES To assess the effect of an intensive care unit (ICU) diary versus no ICU diary on patients, and their caregivers or families, during the patients recovery from admission to an ICU. DESIGN Systematic review of randomized controlled trials (RCTs) and clinical controlled trials. DATA SOURCES CENTRAL, MEDLINE, CINAHL, EMBASE, PsycINFO, PILOT; Web of Science Conference Proceedings, clinical trial registries and reference lists of identified trials. REVIEW METHODS Studies evaluated the effectiveness of patient diaries, when compared to no ICU diary, for patients or family members to promote recovery after admission to ICU were included. Outcome measures for describing recovery from ICU included the risk of post-traumatic stress disorder (PTSD), anxiety, depression and post-traumatic stress symptomatology, health-related quality of life and costs. We used standard methodological approaches as expected by The Cochrane Collaboration. Two review authors independently reviewed titles for inclusion, extracted data and undertook risk of bias according to pre-specified criteria. RESULTS We identified three eligible studies; two describing ICU patients (N=358), and one describing relatives of ICU patients (N=30). No study adequately reported on risk of PTSD as described using a clinical interview, family or caregiver anxiety or depression, health-related quality of life or costs. Within a single study there was no clear evidence of a difference in risk for developing anxiety (RR 0.29, 95% CI 0.07-1.19) or depression (RR 0.38, 95% CI 0.12-1.19) in participants who received ICU diaries, in comparison to those that did not receive a patient diary. Within a single study there was no evidence of difference in median post-traumatic stress symptomatology scores (diaries 24, SD 11.6; no diary 24, SD 11.6) and delusional ICU memory recall (RR 1.04, 95% CI 0.84-1.28) between the patients recovering from ICU admission who received patient diaries, and those who did not. One study reported reduced post-traumatic stress symptomatology in family members of patients recovering from admission to ICU who received patient diaries (median 19; range 14-28), in comparison to no diary (median 28; range 14-38). CONCLUSIONS Currently there is minimal evidence from RCTs of the benefits or harms of patient diaries for patients and their caregivers or family members. A small study has described their potential to reduce post-traumatic stress symptomatology in family members. However, there is currently inadequate evidence to support their effectiveness in improving psychological recovery after critical illness for patients and their family members.

A randomised controlled trial evaluating a rehabilitation complex intervention for patients following intensive care discharge: the RECOVER study

Introduction Patients who survive an intensive care unit admission frequently suffer physical and psychological morbidity for many months after discharge. Current rehabilitation pathways are often fragmented and little is known about the optimum method of promoting recovery. Many patients suffer reduced quality of life. Methods and analysis The authors plan a multicentre randomised parallel group complex intervention trial with concealment of group allocation from outcome assessors. Patients who required more than 48 h of mechanical ventilation and are deemed fit for intensive care unit discharge will be eligible. Patients with primary neurological diagnoses will be excluded. Participants will be randomised into one of the two groups: the intervention group will receive standard ward-based care delivered by the NHS service with additional treatment by a specifically trained generic rehabilitation assistant during ward stay and via telephone contact after hospital discharge and the control group will receive standard ward-based care delivered by the current NHS service. The intervention group will also receive additional information about their critical illness and access to a critical care physician. The total duration of the intervention will be from randomisation to 3 months postrandomisation. The total duration of follow-up will be 12 months from randomisation for both groups. The primary outcome will be the Rivermead Mobility Index at 3 months. Secondary outcomes will include measures of physical and psychological morbidity and function, quality of life and survival over a 12-month period. A health economic evaluation will also be undertaken. Groups will be compared in relation to primary and secondary outcomes; quantitative analyses will be supplemented by focus groups with patients, carers and healthcare workers. Ethics and dissemination Consent will be obtained from patients and relatives according to patient capacity. Data will be analysed according to a predefined analysis plan. Trial registration The trial is registered as ISRCTN09412438 and funded by the Chief Scientist Office, Scotland.

Neglect of the complex: why psychotherapy for post-traumatic clinical presentations is often ineffective

Evidence of efficacy in studies of post-traumatic conditions is largely derived from studies in which variables are kept to a minimum. Extrapolation of treatments from uncomplicated disorders to complex conditions may therefore be called evidence-based without being evidenced. Complex conditions with polysymptomatic presentations and extensive comorbidity are being denied proper evaluation, and patients most severely traumatised from the early stages of their development are not provided with rigorously evaluated psychotherapies because they are more difficult to study in the manner approved by research protocols. Such evidence as there is suggests that the simple extension of treatments for uncomplicated disorders is seriously inadequate. This has significant implications for health services responsible for the provision of the most efficacious treatments to those whose disorders arise from severe trauma, often very early in their life.

Recognition of the neurobiological insults imposed by complex trauma and the implications for psychotherapeutic interventions

Considerable research has been conducted on particular approaches to the psychotherapy of post-traumatic stress disorder (PTSD). However, the evidence indicates that modalities tested in randomised controlled trials (RCTs) are far from 100% applicable and effective and the RCT model itself is inadequate for evaluating treatments of conditions with complex presentations and frequently multiple comorbidities. Evidence at levels 2 and 3 cannot be ignored. Expert-led interventions consistent with the emerging understanding of affective neuroscience are needed and not the unthinking application of a dominant therapeutic paradigm with evidence for PTSD but not complex PTSD. The over-optimistic claims for the effectiveness of cognitive–behavioural therapy (CBT) and misrepresentation of other approaches do not best serve a group of patients greatly in need of help; excluding individuals with such disorders as untreatable or treatment-resistant when viable alternatives exist is not acceptable.

The creation of patient diaries as a therapeutic intervention – for whom?

There is now widespread evidence of the potential adverse psychological impact of critical illness (Parker et al., 2015; Nikayin et al., 2016; Rabiee et al., 2016). While many patients will show great resilience, others may develop post-traumatic stress disorder (PTSD) that endures for several years (Bryant et al., 2015) or anxiety or depressive symptoms, often comorbidly (Parker et al., 2015; Nikayin et al., 2016; Rabiee et al., 2016). One intervention that is thought to reduce these negative psychological outcomes is the use of patient diaries. These tend to be completed by nurses and, on many occasions, relatives. Their putative use is to fill any ‘memory gaps’ and provide a ‘sense of coherence’ for patients after critical care (Engstrom et al., 2009). However, for the relative, a diary may function more as a ‘journal’ that includes information not just about the patient and the patient’s experience but also the relatives’ feelings, hopes and emotions. There are a number of important issues to be considered in relation to the use of diaries (Aitken et al., 2013), five of which will be discussed in this editorial: the wish to help, early interventions, journals for relatives, whether journals for relatives are separate to diaries for patients and reframing interventions to include the relatives.

A family intervention to reduce delirium in hospitalised ICU patients: A feasibility randomised controlled trial

BACKGROUND Family members could play an important role in preventing and reducing the development of delirium in Intensive Care Units (ICU) patients. This study sought to assess the feasibility of design and recruitment, and acceptability for family members and nurses of a family delivered intervention to reduce delirium in ICU patients. METHOD A single centre randomised controlled trial in an Australian medical/surgical ICU was conducted. Sixty-one family members were randomised (29 in intervention and 32 in non-intervention group). Following instructions, the intervention comprised the family members providing orientation or memory clues (family photographs, orientation to surroundings) to their relative each day. In addition, family members conducted sensory checks (vision and hearing with glasses and hearing aids); and therapeutic or cognitive stimulation (discussing family life, reminiscing) daily. Eleven ICU nurses were interviewed to gain insight into the feasibility and acceptability of implementing the intervention from their perspective. RESULTS Recruitment rate was 28% of eligible patients (recruited n=90, attrition n=1). Following instruction by the research nurse the family member delivered the intervention which was assessed to be feasible and acceptable by family members and nurses. Protocol adherence could be improved with alternative data collection methods. Nurses considered the activities acceptable. CONCLUSION The study was able to recruit, randomise and retain family member participants. Further strategies are required to assess intervention fidelity and improve data collection.