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Protocol for a mixed-methods exploratory investigation of care following intensive care discharge: the REFLECT study
IntroductionA substantial number of patients discharged from intensive care units (ICUs) subsequently die without leaving hospital. It is unclear how many of these deaths are preventable. Ward-based management following discharge from ICU is an area that patients and healthcare staff are concerned about. The primary aim of REFLECT (Recovery Following Intensive Care Treatment) is to develop an intervention plan to reduce in-hospital mortality rates in patients who have been discharged from ICU.Methods and analysisREFLECT is a multicentre mixed-methods exploratory study examining ward care delivery to adult patients discharged from ICU. The study will be made up of four substudies. Medical notes of patients who were discharged from ICU and subsequently died will be examined using a retrospective case records review (RCRR) technique. Patients and their relatives will be interviewed about their post-ICU care, including relatives of patients who died in hospital following ICU discharge. Staff involved in the care of patients post-ICU discharge will be interviewed about the care of this patient group. The medical records of patients who survived their post-ICU stay will also be reviewed using the RCRR technique. The analyses of the substudies will be both descriptive and use a modified grounded theory approach to identify emerging themes. The evidence generated in these four substudies will form the basis of the intervention development, which will take place through stakeholder and clinical expert meetings.Ethics and disseminationEthical approval has been obtained through the Wales Research and Ethics Committee 4 (17/WA/0107). We aim to disseminate the findings through international conferences, international peer-reviewed journals and social media.Trial registration numberISRCTN14658054.
A Chest Patch for Continuous Vital Sign Monitoring: Clinical Validation Study During Movement and Controlled Hypoxia (Preprint)
BACKGROUND The standard of care in general wards includes periodic manual measurements, with the data entered into track-and-trigger charts, either on paper or electronically. Wearable devices may support health care staff, improve patient safety, and promote early deterioration detection in the interval between periodic measurements. However, regulatory standards for ambulatory cardiac monitors estimating heart rate (HR) and respiratory rate (RR) do not specify performance criteria during patient movement or clinical conditions in which the patient’s oxygen saturation varies. Therefore, further validation is required before clinical implementation and deployment of any wearable system that provides continuous vital sign measurements. OBJECTIVE The objective of this study is to determine the agreement between a chest-worn patch (VitalPatch) and a gold standard reference device for HR and RR measurements during movement and gradual desaturation (modeling a hypoxic episode) in a controlled environment. METHODS After the VitalPatch and gold standard devices (Philips MX450) were applied, participants performed different movements in seven consecutive stages: at rest, sit-to-stand, tapping, rubbing, drinking, turning pages, and using a tablet. Hypoxia was then induced, and the participants’ oxygen saturation gradually reduced to 80% in a controlled environment. The primary outcome measure was accuracy, defined as the mean absolute error (MAE) of the VitalPatch estimates when compared with HR and RR gold standards (3-lead electrocardiography and capnography, respectively). We defined these as clinically acceptable if the rates were within 5 beats per minute for HR and 3 respirations per minute (rpm) for RR. RESULTS Complete data sets were acquired for 29 participants. In the movement phase, the HR estimates were within prespecified limits for all movements. For RR, estimates were also within the acceptable range, with the exception of the sit-to-stand and turning page movements, showing an MAE of 3.05 (95% CI 2.48-3.58) rpm and 3.45 (95% CI 2.71-4.11) rpm, respectively. For the hypoxia phase, both HR and RR estimates were within limits, with an overall MAE of 0.72 (95% CI 0.66-0.78) beats per minute and 1.89 (95% CI 1.75-2.03) rpm, respectively. There were no significant differences in the accuracy of HR and RR estimations between normoxia (≥90%), mild (89.9%-85%), and severe hypoxia (<85%). CONCLUSIONS The VitalPatch was highly accurate throughout both the movement and hypoxia phases of the study, except for RR estimation during the two types of movements. This study demonstrated that VitalPatch can be safely tested in clinical environments to support earlier detection of cardiorespiratory deterioration. CLINICALTRIAL ISRCTN Registry ISRCTN61535692; https://www.isrctn.com/ISRCTN61535692
Protocol for a prospective, controlled, cross-sectional, diagnostic accuracy study to evaluate the specificity and sensitivity of ambulatory monitoring systems in the prompt detection of hypoxia and during movement
IntroductionAutomated continuous ambulatory monitoring may provide an alternative to intermittent manual vital signs monitoring. This has the potential to improve frequency of measurements, timely escalation of care and patient safety. However, a major barrier to the implementation of these wearable devices in the ward environment is their uncertain reliability, efficiency and data fidelity. The purpose of this study is to test performance of selected devices in a simulated clinical setting including during movement and low levels of peripheral oxygen saturation.Methods and analysisThis is a single centre, prospective, controlled, cross-sectional, diagnostic accuracy study to determine the specificity and sensitivity of currently available ambulatory vital signs monitoring equipment in the detection of hypoxia and the effect of movement on data acquisition. We will recruit up to 45 healthy volunteers who will attend a single study visit; starting with a movement phase and followed by the hypoxia exposure phase where we will gradually decrease saturation levels down to 80%. We will simultaneously test one chest patch, one wrist worn only and three wrist worn with finger probe devices against ‘clinical standard ‘and ‘gold standard’ references. We will measure peripheral oxygen saturations, pulse rate, heart rate and respiratory rate continuously and arterial blood gases intermittently throughout the study.Ethics and disseminationThis study has received ethical approval by the East of Scotland Research Ethics Service REC 2 (19/ES/0008). The results will be broadly distributed through conference presentations and peer-reviewed publications.Trial registration numberISRCTN61535692registered on 10/06/2019.
The Use of Wearable Pulse Oximeters in the Prompt Detection of Hypoxemia and During Movement: Diagnostic Accuracy Study
Background Commercially available wearable (ambulatory) pulse oximeters have been recommended as a method for managing patients at risk of physiological deterioration, such as active patients with COVID-19 disease receiving care in hospital isolation rooms; however, their reliability in usual hospital settings is not known. Objective We report the performance of wearable pulse oximeters in a simulated clinical setting when challenged by motion and low levels of arterial blood oxygen saturation (SaO2). Methods The performance of 1 wrist-worn (Wavelet) and 3 finger-worn (CheckMe O2+, AP-20, and WristOx2 3150) wearable, wireless transmission–mode pulse oximeters was evaluated. For this, 7 motion tasks were performed: at rest, sit-to-stand, tapping, rubbing, drinking, turning pages, and using a tablet. Hypoxia exposure followed, in which inspired gases were adjusted to achieve decreasing SaO2 levels at 100%, 95%, 90%, 87%, 85%, 83%, and 80%. Peripheral oxygen saturation (SpO2) estimates were compared with simultaneous SaO2 samples to calculate the root-mean-square error (RMSE). The area under the receiver operating characteristic curve was used to analyze the detection of hypoxemia (ie, SaO2<90%). Results SpO2 estimates matching 215 SaO2 samples in both study phases, from 33 participants, were analyzed. Tapping, rubbing, turning pages, and using a tablet degraded SpO2 estimation (RMSE>4% for at least 1 device). All finger-worn pulse oximeters detected hypoxemia, with an overall sensitivity of ≥0.87 and specificity of ≥0.80, comparable to that of the Philips MX450 pulse oximeter. Conclusions The SpO2 accuracy of wearable finger-worn pulse oximeters was within that required by the International Organization for Standardization guidelines. Performance was degraded by motion, but all pulse oximeters could detect hypoxemia. Our findings support the use of wearable, wireless transmission–mode pulse oximeters to detect the onset of clinical deterioration in hospital settings. Trial Registration ISRCTN Registry 61535692; http://www.isrctn.com/ISRCTN61535692 International Registered Report Identifier (IRRID) RR2-10.1136/bmjopen-2019-034404
The Use of Wearable Pulse Oximeters in the Prompt Detection of Hypoxemia and During Movement: Diagnostic Accuracy Study (Preprint)
BACKGROUND Commercially available wearable (ambulatory) pulse oximeters have been recommended as a method for managing patients at risk of physiological deterioration, such as active patients with COVID-19 disease receiving care in hospital isolation rooms; however, their reliability in usual hospital settings is not known. OBJECTIVE We report the performance of wearable pulse oximeters in a simulated clinical setting when challenged by motion and low levels of arterial blood oxygen saturation (SaO<sub>2</sub>). METHODS The performance of 1 wrist-worn (Wavelet) and 3 finger-worn (CheckMe O2+, AP-20, and WristOx2 3150) wearable, wireless transmission–mode pulse oximeters was evaluated. For this, 7 motion tasks were performed: at rest, sit-to-stand, tapping, rubbing, drinking, turning pages, and using a tablet. Hypoxia exposure followed, in which inspired gases were adjusted to achieve decreasing SaO<sub>2</sub> levels at 100%, 95%, 90%, 87%, 85%, 83%, and 80%. Peripheral oxygen saturation (SpO<sub>2</sub>) estimates were compared with simultaneous SaO<sub>2</sub> samples to calculate the root-mean-square error (RMSE). The area under the receiver operating characteristic curve was used to analyze the detection of hypoxemia (ie, SaO<sub>2</sub><90%). RESULTS SpO<sub>2</sub> estimates matching 215 SaO<sub>2</sub> samples in both study phases, from 33 participants, were analyzed. Tapping, rubbing, turning pages, and using a tablet degraded SpO<sub>2</sub> estimation (RMSE>4% for at least 1 device). All finger-worn pulse oximeters detected hypoxemia, with an overall sensitivity of ≥0.87 and specificity of ≥0.80, comparable to that of the Philips MX450 pulse oximeter. CONCLUSIONS The SpO<sub>2</sub> accuracy of wearable finger-worn pulse oximeters was within that required by the International Organization for Standardization guidelines. Performance was degraded by motion, but all pulse oximeters could detect hypoxemia. Our findings support the use of wearable, wireless transmission–mode pulse oximeters to detect the onset of clinical deterioration in hospital settings. CLINICALTRIAL ISRCTN Registry 61535692; http://www.isrctn.com/ISRCTN61535692 INTERNATIONAL REGISTERED REPORT RR2-10.1136/bmjopen-2019-034404
Mobilisation in the EveNing to TreAt deLirium (MENTAL): protocol for a mixed-methods feasibility randomised controlled trial
IntroductionDelirium is common in critically ill patients and is associated with longer hospital stays, increased mortality and higher healthcare costs. A number of risk factors have been identified for the development of delirium in intensive care, two of which are sleep disturbance and immobilisation. Non-pharmacological interventions for the management of intensive care unit (ICU) delirium have been advocated, including sleep protocols and early mobilisation. However, there is a little published evidence evaluating the feasibility and acceptability of evening mobilisation.Methods and analysisMobilisation in the EveNing to TreAt deLirium (MENTAL) is a two-centre, mixed-methods feasibility randomised controlled trial (RCT). Sixty patients will be recruited from ICUs at two acute NHS trusts and randomised on a 1:1 basis to receive additional evening mobilisation, delivered between 19:00 and 21:00, or standard care. The underpinning hypothesis is that the physical exertion associated with evening mobilisation will promote better sleep, subsequently having the potential to reduce delirium incidence. The primary objective is to assess the feasibility and acceptability of a future, multicentre RCT. The primary outcome measures, which will determine feasibility, are recruitment and retention rates, and intervention fidelity. Acceptability of the intervention will be evaluated through semi-structured interviews of participants and staff. Secondary outcome measures include collecting baseline, clinical and outcome data to inform the power calculations of a future definitive trial.Ethics and disseminationEthical approval has been obtained through the Wales Research and Ethics Committee 6 (22/WA/0106). Participants are required to provide written informed consent. We aim to disseminate the findings through international conferences, international peer-reviewed journals and social media.Trial registration numberNCT05401461.
Multidisciplinary team perception of games‐based therapy in critical care: A service evaluation
AbstractBackgroundAs survivorship following critical illness improves, there is greater focus on maximizing recovery. As well as physical effects, critical illness often results in cognitive impairments such as delirium, anxiety, or disorientation. In other populations, such as delirium, non‐pharmacological approaches to manage these conditions are preferred, including re‐orientation and ensuring personal care needs are met. Cognitive rehabilitation is also well documented for patients with neuropsychological deficits. Treatments include memory aids, compensation strategies, and functional execution. In other hospital populations, games and activities have been utilized to optimize patient engagement, stimulation, and aid recovery, but it is considered an emerging therapy in intensive care.AimsThis service evaluation aimed to gather multidisciplinary team members' perceptions of the use of games based therapy (GBT) in critical care, including patient engagement and acceptability in clinical practice.Study designA UK‐based single‐centre qualitative service evaluation. Purposive sampling was used to identify interviewees within an adult intensive care who had experience of using a recently implemented GBT intervention. Qualitative data were collected through semi‐structured interviews, which were recorded and transcribed verbatim. Data were analysed using thematic analysis.ResultsEight staff members across the multidisciplinary team were interviewed. One overarching theme of humanizing health care was identified, with three sub‐themes of enhancing recovery, non‐physical components of care, and bespoke tailoring. In addition, further recommendations for development of the service were summarized.ConclusionGBT was well received by staff in clinical practice. It was described as a supportive adjunct to traditional care and rehabilitation, enhancing staff‐patient relationships. While it was recognized it may not suit all patients, GBT has the potential to enhance cognitive and physical recovery.
Investigating the impact of physical activity interventions on delirium outcomes in intensive care unit patients: A systematic review and meta-analysis
Background To investigate the impact of physical activity interventions, including early mobilisation, on delirium outcomes in critically ill patients. Methods Electronic database literature searches were conducted, and studies were selected based on pre-specified eligibility criteria. Cochrane Risk of Bias-2 and Risk Of Bias In Non-randomised Studies-of Interventions quality assessment tools were utilised. Grading of Recommendations, Assessment, Development and Evaluations was used to assess levels of evidence for delirium outcomes. The study was prospectively registered on PROSPERO (CRD42020210872). Results Twelve studies were included; ten randomised controlled trials one observational case-matched study and one before-after quality improvement study. Only five of the included randomised controlled trial studies were judged to be at low risk of bias, with all others, including both non-randomised controlled trials deemed to be at high or moderate risk. The pooled relative risk for incidence was 0.85 (0.62–1.17) which was not statistically significant in favour of physical activity interventions. Narrative synthesis for effect on duration of delirium found favour towards physical activity interventions reducing delirium duration with median differences ranging from 0 to 2 days in three comparative studies. Studies comparing varying intervention intensities showed positive outcomes in favour of greater intensity. Overall levels of evidence were low quality. Conclusions Currently there is insufficient evidence to recommend physical activity as a stand-alone intervention to reduce delirium in Intensive Care Units. Physical activity intervention intensity may impact on delirium outcomes, but a lack of high-quality studies limits the current evidence base.
Problems in care and avoidability of death after discharge from intensive care: a multi-centre retrospective case record review study
Abstract Background Over 138,000 patients are discharged to hospital wards from intensive care units (ICUs) in England, Wales and Northern Ireland annually. More than 8000 die before leaving hospital. In hospital-wide populations, 6.7–18% of deaths have some degree of avoidability. For patients discharged from ICU, neither the proportion of avoidable deaths nor the reasons underlying avoidability have been determined. We undertook a retrospective case record review within the REFLECT study, examining how post-ICU ward care might be improved. Methods A multi-centre retrospective case record review of 300 consecutive post-ICU in-hospital deaths, between January 2015 and March 2018, in 3 English hospitals. Trained multi-professional researchers assessed the degree to which each death was avoidable and determined care problems using the established Structured Judgement Review method. Results Agreement between reviewers was good (weighted Kappa 0.77, 95% CI 0.64–0.88). Discharge from an ICU for end-of-life care occurred in 50/300 patients. Of the remaining 250 patients, death was probably avoidable in 20 (8%, 95% CI 5.0–12.1) and had some degree of avoidability in 65 (26%, 95% CI 20.7–31.9). Common problems included out-of-hours discharge from ICU (168/250, 67.2%), suboptimal rehabilitation (167/241, 69.3%), absent nutritional planning (76/185, 41.1%) and incomplete sepsis management (50/150, 33.3%). Conclusions The proportion of deaths in hospital with some degree of avoidability is higher in patients discharged from an ICU than reported in hospital-wide populations. Extrapolating our findings suggests around 550 probably avoidable deaths occur annually in hospital following ICU discharge in England, Wales and Northern Ireland. This avoidability occurs in an elderly frail population with complex needs that current strategies struggle to meet. Problems in post-ICU care are rectifiable but multi-disciplinary. Trial Registration: ISRCTN14658054.
Physiotherapy and Optimised Enteral Nutrition In the post-acute phase of critical illness (PHOENIX): protocol for a mixed methods feasibility randomised controlled trial
IntroductionEach year in the UK, 140 000 patients are discharged from intensive care units (ICUs) to general hospital wards, almost all with complex rehabilitation needs. 84% of patients still require nutritional support and 98% are not physically independent. Despite this, many are discharged from ICU without a nutrition plan, and failure to recognise malnutrition is common. Consequently, malnutrition persists in the ward environment, leading to poor outcomes and acting as a barrier to successful physical rehabilitation. This transition from intensive care to the ward represents a key stage in the recovery journey, and a window for optimising physical independence prior to hospital discharge, decreasing the need for support in the community. However, uncertainty as to how best to provide ongoing rehabilitation which combines adequate nutrition and exercise on the general ward has driven widespread variation in practice.We have previously shown the benefits of delivering a structured rehabilitation strategy in the ICU. However, the ward environment poses different challenges to the development of an integrated rehabilitation pathway. There is a need to evaluate the clinical and cost-effectiveness of structured rehabilitation strategies when delivered outside the ICU.Methods and analysisPhysiotherapy and Optimised Enteral Nutrition In the post-acute phase of critical illness is a bi-centre, mixed methods feasibility randomised controlled trial (RCT). 60 patients will be recruited from ICUs at two acute National Health Service Trusts and randomised on a 1:1 basis to receive either individualised physiotherapy and optimised nutrition post discharge from ICU (intervention) or standard care. The primary objective is to assess the acceptability of the intervention and feasibility of a future, multicentre RCT. The primary outcome measures, which will determine feasibility, are recruitment and retention rates, and intervention fidelity. Acceptability of the intervention will be evaluated through semistructured interviews of participants and staff. Secondary outcome measures include collecting baseline, clinical and outcome data to inform the power calculations of a future definitive trial.Ethics and disseminationEthical approval has been obtained through the Wales Research and Ethics Committee 2 (24/WA/0050). We aim to disseminate the findings through international conferences, international peer-reviewed journals and social media.Trial registration numberNCT06159868. Prospectively registered on 28 November 2023.
Digital health interventions in adult intensive care and recovery after critical illness to promote survivorship care
Digital health refers to the field of using and developing technology to improve health outcomes. Digital health and digital health interventions (DHIs) within the area of intensive care and critical illness survivorship are rapidly evolving. Digital health interventions refer to technologies in clinical interventional format. A DHI could support clinicians with increasing clinical demands to have improved oversight of their patients’ recovery trajectory or potential for deterioration, improve efficiency of healthcare delivery, and/or predict patient outcomes. In this narrative review, DHIs are explored across the continuum from in the ICU (recognising and managing clinical deterioration, identifying individuals at risk of poor recovery outcomes, tailoring care of the ICU patient and supporting the emotional needs of their family) through to integration in the primary care setting (adjuncts to ICU follow-up clinics and tracking, coaching and remote monitoring). Some of the DHIs discussed in this narrative review (to name a few) include interventions delivered via: Telehealth, artificial intelligence, wearable devices, virtual reality, and mobile phone applications (apps). Additionally, exploration of DHIs used successfully in other health fields are discussed to highlight potential opportunities for adaptation to the ICU context. Finally, the review provides an overview of considerations needed in the development of new DHIs. Development should consider the intended user, barriers to technology engagement and design. In the implementation of a new DHI, the World Health Organization (WHO) Global Strategy on Digital Health and appropriate evaluation should be considered prior to scaling up. Optimal implementation of DHIs could help address the key challenges of the ICU field.
The impact of musculoskeletal ill health on quality of life and function after critical care: a multicentre prospective cohort study
SummaryPhysical disability is a common component of post‐intensive care syndrome, but the importance of musculoskeletal health in this population is currently unknown. We aimed to determine the musculoskeletal health state of intensive care unit survivors and assess its relationship with health‐related quality of life; employment; and psychological and physical function. We conducted a multicentre prospective cohort study of adults admitted to intensive care for > 48 h without musculoskeletal trauma or neurological insult. Patients were followed up 6 months after admission where musculoskeletal health state was measured using the validated Musculoskeletal Health Questionnaire score. Of the 254 participants, 150 (59%) had a musculoskeletal problem and only 60 (24%) had received physiotherapy after discharge. Functional Comorbidity Index, Clinical Frailty Scale, duration of intensive care unit stay and prone positioning were all independently associated with worse musculoskeletal health. Musculoskeletal health state moderately correlated with quality of life, rs = 0.499 (95%CI 0.392–0.589); anxiety, rs = ‐0.433 (95%CI ‐0.538 to ‐0.315); and depression, rs = ‐0.537 (95%CI ‐0.631 to ‐0.434) (all p < 0.001). Patients with a musculoskeletal problem were less physically active than those without a problem (median (IQR [range]) number of 30 min physical activity sessions per week 1 (0–3.25 [0–7]) vs. 4 (1–7 [0–7]), p < 0.001, respectively). This study found that musculoskeletal health problems were common after intensive care unit stay. However, we observed that < 25% of patients received physical rehabilitation after discharge home. Our work has identified potential high‐risk groups to target in future interventional studies.