Lisa Salisbury

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.

The development and feasibility of a ward-based physiotherapy and nutritional rehabilitation package for people experiencing critical illness:

Objective: To investigate ward-based rehabilitation after critical illness and undertake a pilot study exploring the feasibility of delivering enhanced physiotherapy and nutritional rehabilitation. Design: Service evaluation (part A) and pilot feasibility randomized controlled trial (part B). Setting: Hospital inpatient wards following discharge from intensive care. Participants: Part A involved 24 people with an intensive care stay of four days or more. Part B involved 16 participants randomized into a control (n = 8) or intervention (n = 8) group. Interventions: Part A defined the current ‘standard’ physiotherapy and nutritional interventions. In part B the control group received this ‘standard’ service while the intervention group received this ‘standard’ service plus enhanced rehabilitation. Main measures: Part A collected process outcomes of current interventions and outcomes that included calorie and protein intake and the Rivermead Mobility Index. In part B process outcomes determined differences between groups. Outcomes included those undertaken in part A plus an incremental shuttle test, handgrip dynamometry and visual analogue scales. Results: Part A found low levels of ward-based physiotherapy (walking and transfer practice once per week) and dietetic input (0.8 visits per week). Part B found an increased frequency of both physiotherapy (P = 0.002) and dietetic (P = 0.001) visits in the intervention group. Physical and nutritional outcomes were suitable for use after critical illness, but no statistically significant differences were found between groups. Power calculations indicated 100 participants per group would be required for a definitive study. Conclusions: This feasibility pilot work has informed the design of a larger study to evaluate enhanced rehabilitation following critical illness.

Rehabilitation after critical illness: could a ward‐based generic rehabilitation assistant promote recovery?

AIM The aim of this paper is to explore issues surrounding the implementation of a generic rehabilitation assistant (GRA) to provide ward-based rehabilitation after critical illness. BACKGROUND Following critical illness a range of both physical and psychological problems can occur that include muscle wasting and weakness, fatigue, reduced appetite, post-traumatic stress, anxiety and depression. Limited research exists evaluating the provision of rehabilitation to this patient group. This paper explores one possible service delivery model providing ward-based rehabilitation after critical illness. The model explored is a GRA working in conjunction with ward-based staff. RESULTS We describe how a GRA worked effectively with ward-based teams to provide additional rehabilitation in the period after discharge from intensive care. Benefits included greater continuity of care that was flexible to the individual needs of patients. Some aspects of the role were challenging for the GRA and highlighted the need for good communication skills. A need for comprehensive training of the GRA was demonstrated. CONCLUSIONS Our experience demonstrates that it is feasible to deliver ward-based rehabilitation after critical illness using the GRA service delivery model. RELEVANCE TO CLINICAL PRACTICE This model of service delivery offers the potential to improve outcomes for patients after a critical illness. Further research evaluating this model of care is required before implementation into clinical practice.

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.

Physical rehabilitation interventions for adult patients during critical illness: an overview of systematic reviews

Background Physical rehabilitation interventions aim to ameliorate the effects of critical illness-associated muscle dysfunction in survivors. We conducted an overview of systematic reviews (SR) evaluating the effect of these interventions across the continuum of recovery. Methods Six electronic databases (Cochrane Library, CENTRAL, DARE, Medline, Embase, and Cinahl) were searched. Two review authors independently screened articles for eligibility and conducted data extraction and quality appraisal. Reporting quality was assessed and the Grading of Recommendations Assessment, Development and Evaluation approach applied to summarise overall quality of evidence. Results Five eligible SR were included in this overview, of which three included meta-analyses. Reporting quality of the reviews was judged as medium to high. Two reviews reported moderate-to-high quality evidence of the beneficial effects of physical therapy commencing during intensive care unit (ICU) admission in improving critical illness polyneuropathy/myopathy, quality of life, mortality and healthcare utilisation. These interventions included early mobilisation, cycle ergometry and electrical muscle stimulation. Two reviews reported very low to low quality evidence of the beneficial effects of electrical muscle stimulation delivered in the ICU for improving muscle strength, muscle structure and critical illness polyneuropathy/myopathy. One review reported that due to a lack of good quality randomised controlled trials and inconsistency in measuring outcomes, there was insufficient evidence to support beneficial effects from physical rehabilitation delivered post-ICU discharge. Conclusions Patients derive short-term benefits from physical rehabilitation delivered during ICU admission. Further robust trials of electrical muscle stimulation in the ICU and rehabilitation delivered following ICU discharge are needed to determine the long-term impact on patient care. This overview provides recommendations for design of future interventional trials and SR. Trial registration number CRD42015001068.

A Feasibility Study to Investigate the Clinical Application of Functional Electrical Stimulation (FES), for Dropped Foot, During the Sub-Acute Phase of Stroke - A Randomized Controlled Trial

Purpose Functional electrical stimulation (FES), for dropped foot, has been shown to have positive benefits in chronic stroke. It has been suggested that similar benefits may be seen earlier after stroke. The aim of this feasibility study was to evaluate the trial methodology of undertaking a randomized controlled trial (RCT) of FES in sub-acute stroke. Method: This was a randomized feasibility study with non-blinded outcomes at 6 and 12 weeks. Sixteen sub-acute stroke in-patients with dropped foot were randomized into two groups (control, n =  7; intervention, n  =  9). Both groups received routine gait re-education and an orthotic device, the control group used an ankle foot orthosis and the intervention group used FES. Outcome measures included gait velocity and cadence, Functional Ambulation Classification, Visual Analogue Scale of perception of walking, and the Stroke Impact Scale. Results: Eligibility criteria developed for inclusion of participants in the trial were appropriate. Set-up of FES during sub-acute stroke was feasible but more challenging than with chronic patients. Outcome measures were suitable and have informed the choice of measures for future work. Conclusions: It is feasible to undertake a trial evaluating FES during the sub-acute phase of recovery after stroke. A larger RCT is required.

“Functional electrical stimulation (FES) impacted on important aspects of my life”—A qualitative exploration of chronic stroke patients' and carers' perceptions of FES in the management of dropped foot

Our purpose was to explore the impact of functional electrical stimulation (FES), as applied in the management of dropped foot, on patients with chronic stroke and their carers. A qualitative phenomenological study was undertaken. Participants were recruited from the Lothian FES clinic. Data were collected by using semistructured face-to-face interviews and analysed by using the framework of interpretative phenomenological analysis (IPA). Thirteen patients and nine carers consented to participate in the study. The overarching theme that emerged from the data was that “FES impacted on important aspects of my life.” Four subthemes were identified: 1) “Walking with FES is much better”; 2) “FES helped regain control of life”; 3) “Feeling good comes with using FES”; and 4) “FES is not perfect but it is of value.” This study provides insights into the perceptions of patients and carers of the impact of FES. These results have implications for clinicians delivering an FES service for the management of dropped foot after stroke.

Systemic inflammation after critical illness: relationship with physical recovery and exploration of potential mechanisms

Background Physical recovery following critical illness is slow, often incomplete and is resistant to rehabilitation interventions. We aimed to explore the contribution of persisting inflammation to recovery, and investigated the potential role of human cytomegalovirus (HCMV) infection in its pathogenesis. Methods In an a priori nested inflammatory biomarker study in a post-intensive care unit (ICU) rehabilitation trial (RECOVER; ISRCTN09412438), surviving adult ICU patients ventilated >48 h were enrolled at ICU discharge and blood sampled at ICU discharge (n=184) and 3 month follow-up (N=123). C-reactive protein (CRP), human neutrophil elastase (HNE), interleukin (IL)-1β, IL-6, IL-8, transforming growth factor β1 (TGFβ1) and secretory leucocyte protease inhibitor (SLPI) were measured. HCMV IgG status was determined (previous exposure), and DNA PCR measured among seropositive patients (lytic infection). Physical outcome measures including the Rivermead Mobility Index (RMI) were measured at 3 months. Results Many patients had persisting inflammation at 3 months (CRP >3 mg/L in 59%; >10 mg/L in 28%), with proinflammatory phenotype (elevated HNE, IL-6, IL-8, SLPI; low TGFβ1). Poorer mobility (RMI) was associated with higher CRP (β=0.13; p<0.01) and HNE (β=0.32; p=0.03), even after adjustment for severity of acute illness and pre-existing co-morbidity (CRP β=0.14; p<0.01; HNE β=0.30; p=0.04). Patients seropositive for HCMV at ICU discharge (63%) had a more proinflammatory phenotype at 3 months than seronegative patients, despite undetectable HMCV by PCR testing. Conclusions Inflammation is prevalent after critical illness and is associated with poor physical recovery during the first 3 months post-ICU discharge. Previous HCMV exposure is associated with a proinflammatory phenotype despite the absence of detectable systemic viraemia. Trial registration number ISRCTN09412438, post results.

Exercise rehabilitation following intensive care unit discharge for recovery from critical illness: executive summary of a Cochrane Collaboration systematic review

Skeletal muscle wasting and weakness are major complications of critical illness and underlie the profound physical and functional impairments experienced by survivors after discharge from the intensive care unit (ICU). Exercise‐based rehabilitation has been shown to be beneficial when delivered during ICU admission. This review aimed to determine the effectiveness of exercise rehabilitation initiated after ICU discharge on primary outcomes of functional exercise capacity and health‐related quality of life. We sought randomized controlled trials, quasi‐randomized controlled trials, and controlled clinical trials comparing an exercise intervention commenced after ICU discharge vs. any other intervention or a control or ‘usual care’ programme in adult survivors of critical illness. Cochrane Central Register of Controlled Trials, Medical Literature Analysis and Retrieval System Online (MEDLINE), Excerpta Medica Database, and Cumulative Index to Nursing and Allied Health Literature databases were searched up to February 2015. Dual, independent screening of results, data extraction, and quality appraisal were performed. We included six trials involving 483 patients. Overall quality of evidence for both outcomes was very low. All studies evaluated functional exercise capacity, with three reporting positive effects in favour of the intervention. Only two studies evaluated health‐related quality of life and neither reported differences between intervention and control groups. Meta‐analyses of data were precluded due to variation in study design, types of interventions, and selection and reporting of outcome measurements. We were unable to determine an overall effect on functional exercise capacity or health‐related quality of life of interventions initiated after ICU discharge for survivors of critical illness. Findings from ongoing studies are awaited. Future studies need to address methodological aspects of study design and conduct to enhance rigour, quality, and synthesis.

PReventing early unplanned hOspital readmission aFter critical ILlnEss (PROFILE): protocol and analysis framework for a mixed methods study.

Introduction Survivors of critical illness experience multidimensional disabilities that reduce quality of life, and 25–30% require unplanned hospital readmission within 3 months following index hospitalisation. We aim to understand factors associated with unplanned readmission; develop a risk model to identify intensive care unit (ICU) survivors at highest readmission risk; understand the modifiable and non-modifiable readmission drivers; and develop a risk assessment tool for identifying patients and areas for early intervention. Methods and analysis We will use mixed methods with concurrent data collection. Quantitative data will comprise linked healthcare records for adult Scottish residents requiring ICU admission (1 January 2000–31 December 2013) who survived to hospital discharge. The outcome will be unplanned emergency readmission within 90 days of index hospital discharge. Exposures will include pre-ICU demographic data, comorbidities and health status, and critical illness variables representing illness severity. Regression analyses will be used to identify factors associated with increased readmission risk, and to develop and validate a risk prediction model. Qualitative data will comprise recorded/transcribed interviews with up to 60 patients and carers recently experiencing unplanned readmissions in three health board regions. A deductive and inductive thematic analysis will be used to identify factors contributing to readmissions and how they may interact. Through iterative triangulation of quantitative and qualitative data, we will develop a construct/taxonomy that captures reasons and drivers for unplanned readmission. We will validate and further refine this in focus groups with patients/carers who experienced readmissions in six Scottish health board regions, and in consultation with an independent expert group. A tool will be developed to screen for ICU survivors at risk of readmission and inform anticipatory interventions. Ethics and dissemination Data linkage has approval but does not require ethical approval. The qualitative study has ethical approval. Dissemination with key healthcare stakeholders and policymakers is planned. Trial registration number UKCRN18023.