Building a Covid-19 secure intensive care unit: A human-centred design approach.

Background: The Covid-19 pandemic has highlighted weaknesses in the National Health Service critical care provision including both capacity and infrastructure. Traditionally, healthcare workspaces have failed to fully incorporate Human-Centred Design principles resulting in environments that negatively affect the efficacy of task completion, patient safety and staff wellbeing. In the summer of 2020, we received funds for the urgent construction of a Covid-19 secure critical care facility. The aim of this project was to design a pandemic resilient facility centred around both staff and patient requirements and safety, within the available footprint. Methods: We developed a simulation exercise, underpinned by Human-Centred Design principles, to evaluate intensive care designs through Build Mapping, Tasks Analysis and Qualitative data. Build Mapping involved taping out sections of the design and mocking up with equipment. Task Analysis and qualitative data were collected following task completion. Results: 56 participants completed the build simulation exercise generating 141 design suggestions (69 task related, 56 patient and relative related, 16 staff related). Suggestions translated to 18 multilevel design improvements; five significant structural changes (Macro level) including wall moves and lift size change. Minor improvements were made at a Meso and Micro design level. Critical care design drivers identified included functional drivers (visibility, Covid-19 secure environment, workflow, and task efficiency) and behavioural drivers (learning and development, light, humanising intensive care and design consistency). Conclusion: Success of clinical tasks, infection control, patient safety and staff/patient wellbeing are highly dependent on clinical environments. Primarily, we have improved clinical design by focusing on user requirements. Secondly, we developed a replicable approach to exploring healthcare build plans revealing significant design changes, that may have only been identified once built.

Ambulatory blood pressure monitoring using telemedicine: proof-of-concept cohort and failure modes and effects analyses.

Background: The COVID-19 pandemic has accelerated adoption of remote consulting in healthcare. Despite opportunities posed by telemedicine, most hypertension services in Europe have suspended ambulatory blood pressure monitoring (ABPM). Methods: We examined the process and performance of remotely delivered ABPM using two methodologies: firstly, a Failure Modes and Effects Analysis (FMEA) and secondly, a quantitative analysis comparing ABPM data from a subgroup of 65 participants of the Screening for Hypertension in the INpatient Environment (SHINE) diagnostic accuracy study. The FMEA was performed over seven sessions from February to March 2021, with a multidisciplinary team comprising a patient representative, a research coordinator with technical expertise and four research clinicians. Results: The FMEA identified a single high-risk step in the remote ABPM process. This was cleaning of monitoring equipment in the context of the COVID-19 pandemic, unrelated to the remote setting. A total of 14 participants were scheduled for face-to-face ABPM appointments, before the UK March 2020 COVID-19 lockdown; 62 were scheduled for remote ABPM appointments since emergence of the COVID-19 pandemic between November 2020 and August 2021. A total of 65 (88%) participants completed ABPMs; all obtained sufficient successful measurements for interpretation. For the 10 participants who completed face-to-face ABPM, there were 402 attempted ABPM measurements and 361 (89%) were successful. For the 55 participants who completed remote ABPM, there were 2516 attempted measurements and 2214 (88%) were successful. There was no significant difference in the mean per-participant error rate between face-to-face (0.100, SD 0.009) and remote (0.143, SD 0.132) cohorts (95% CI for the difference -0.125 to 0.045 and two-tailed P-value 0.353). Conclusions: We have demonstrated that ABPM can be safely and appropriately provided in the community remotely and without face-to-face contact, using video technology for remote fitting appointments, alongside courier services for delivery of equipment to participants.

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.

Non-contact physiological monitoring of post-operative patients in the intensive care unit.

Prolonged non-contact camera-based monitoring in critically ill patients presents unique challenges, but may facilitate safe recovery. A study was designed to evaluate the feasibility of introducing a non-contact video camera monitoring system into an acute clinical setting. We assessed the accuracy and robustness of the video camera-derived estimates of the vital signs against the electronically-recorded reference values in both day and night environments. We demonstrated non-contact monitoring of heart rate and respiratory rate for extended periods of time in 15 post-operative patients. Across day and night, heart rate was estimated for up to 53.2% (103.0 h) of the total valid camera data with a mean absolute error (MAE) of 2.5 beats/min in comparison to two reference sensors. We obtained respiratory rate estimates for 63.1% (119.8 h) of the total valid camera data with a MAE of 2.4 breaths/min against the reference value computed from the chest impedance pneumogram. Non-contact estimates detected relevant changes in the vital-sign values between routine clinical observations. Pivotal respiratory events in a post-operative patient could be identified from the analysis of video-derived respiratory information. Continuous vital-sign monitoring supported by non-contact video camera estimates could be used to track early signs of physiological deterioration during post-operative care.

Experiences of current vital signs monitoring practices and views of wearable monitoring: A qualitative study in patients and nurses.

AIMS: To understand current experiences of vital signs monitoring of patients and clinical staff on a surgical ward, and views on the introduction of wearable ambulatory monitoring into the general ward environment. DESIGN: Qualitative study. METHODS: Semi-structured interviews using topic guides were conducted with 15 patients and 15 nurses on a surgical ward between July 2018 and August 2019. The concept of ambulatory wearable devices for clinical monitoring was introduced at the end of the interview. RESULTS: Three interconnected themes were identified. Vital sign data as evidence for escalation, examined nurses' use of data to support escalation of care and the implications for patients perceived to be deteriorating who have not reached the threshold for escalation. The second theme, Trustworthiness of vital sign data, described nurses' practice of using manual measurements to recheck or confirm automated vital signs readings when concerned. The final theme, finding a balance between continuous and intermittent monitoring, both patients and nurses agreed that although continuous monitoring may improve safety and reassurance, these needed to be balanced with multiple limitations. Factors to be considered included noise pollution, comfort, and impact on patient mobility and independence. Introduction of the concept of ambulatory wearable devices was viewed positively by both groups as offering solutions to some of the issues identified with traditional monitoring. However, most agreed that this would not be suitable for all patients and should not replace direct nurse/patient contact. CONCLUSION: Both patients and staff identified the benefits of continuous monitoring to improve patient safety but, due to limitations, use should be carefully considered and patient-centred. IMPACT: Feedback from nurses and patients suggests there is scope for ambulatory monitoring systems to be integrated into the hospital environment; however, both groups emphasized these should not add more noise to the ward nor replace direct nursing contact.

A Chest Patch for Continuous Vital Sign Monitoring: Clinical Validation Study During Movement and Controlled Hypoxia.

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. TRIAL REGISTRATION: ISRCTN Registry ISRCTN61535692; https://www.isrctn.com/ISRCTN61535692.

Human factors in escalating acute ward care: a qualitative evidence synthesis.

BACKGROUND: Identifying how human factors affect clinical staff recognition and managment of the deteriorating ward patient may inform process improvements. We systematically reviewed the literature to identify (1) how human factors affect ward care escalation (2) gaps in the current literature and (3) critique literature methodologies. METHODS: We undertook a Qualitative Evidence Synthesis of care escalation studies. We searched MEDLINE, EMBASE and CINHAL from inception to September 2019. We used the Critical Appraisal Skills Programme and the Grading of Recommendations Assessment-Development and Evaluation and Confidence in Evidence from Reviews of Qualitative Research tool to assess study quality. RESULTS: Our search identified 24 studies meeting the inclusion criteria. Confidence in findings was moderate (20 studies) to high (4 studies). In 16 studies, the ability to recognise changes in the patient's condition (soft signals), including skin colour/temperature, respiratory pattern, blood loss, personality change, patient complaint and fatigue, improved the ability to escalate patients. Soft signals were detected through patient assessment (looking/listening/feeling) and not Early Warning Scores (eight studies). In contrast, 13 studies found a high workload and low staffing levels reduced staff's ability to detect patient deterioration and escalate care. In eight studies quantifiable deterioration evidence (Early Warning Scores) facilitated escalation communication, particularly when referrer/referee were unfamiliar. Conversely, escalating concerning non-triggering patients was challenging but achieved by some clinical staff (three studies). Team decision making facilitated the clinical escalation (six studies). CONCLUSIONS: Early Warning Scores have clinical benefits but can sometimes impede escalation in patients not meeting the threshold. Staff use other factors (soft signals) not captured in Early Warning Scores to escalate care. The literature supports strategies that improve the escalation process such as good patient assessment skills. PROSPERO REGISTRATION NUMBER: CRD42018104745.

Non-contact vital sign monitoring of patients in an intensive care unit: A human factors analysis of staff expectations.

BACKGROUND: Infra-red and thermal imaging enable wireless systems to monitor patients' vital signs and absence of wires may improve patient experiences. No studies have explored staff perceptions of the concept of this specific type of technology in the adult population. Understanding existing working systems before introducing technology could improve adoption. METHODS: We conducted semi-structured interviews with Intensive Care Unit (ICU) staff exploring perceptions of wireless patient monitoring. We used the Systems Engineering Initiative for Patient Safety (SEIPS) model to guide thematic analysis. RESULTS: We identified usability themes relating to staff perceptions of current patient monitoring experiences, staff perceptions of patient/relative expectations of ICU care, troubleshooting, hierarchy of monitoring, and consensus of trust. CONCLUSION: The concept of wireless monitoring has perceived benefits for patients and staff. The Systems Engineering Initiative for Patient Safety model guided a systems-based exploratory evaluation. Results highlight the social and environmental factors which may influence usability, adoption, or abandonment of wireless technology in the ICU.

Wearability Testing of Ambulatory Vital Sign Monitoring Devices: Prospective Observational Cohort Study.

BACKGROUND: Timely recognition of patient deterioration remains challenging. Ambulatory monitoring systems (AMSs) may provide support to current monitoring practices; however, they need to be thoroughly tested before implementation in the clinical environment for early detection of deterioration. OBJECTIVE: The objective of this study was to assess the wearability of a selection of commercially available AMSs to inform a future prospective study of ambulatory vital sign monitors in an acute hospital ward. METHODS: Five pulse oximeters (4 with finger probes and 1 wrist-worn only, collecting pulse rates and oxygen saturation) and 2 chest patches (collecting heart rates and respiratory rates) were selected to be part of this study: The 2 chest-worn patches were VitalPatch (VitalConnect) and Peerbridge Cor (Peerbridge); the 4 wrist-worn devices with finger probe were Nonin WristOx2 3150 (Nonin), Checkme O2+ (Viatom Technology), PC-68B, and AP-20 (both from Creative Medical); and the 1 solely wrist-worn device was Wavelet (Wavelet Health). Adult participants wore each device for up to 72 hours while performing usual "activities of daily living" and were asked to score the perceived exertion and perception of pain or discomfort by using the Borg CR-10 scale; thoughts and feelings caused by the AMS using the Comfort Rating Scale (CRS); and to provide general free text feedback. Median and IQRs were reported and nonparametric tests were used to assess differences between the devices' CRS scores. RESULTS: Quantitative scores and feedback were collected in 70 completed questionnaires from 20 healthy volunteers, with each device tested approximately 10 times. The Wavelet seemed to be the most wearable device (P<.001) with an overall median (IQR) CRS score of 1.00 (0.88). There were no statistically significant differences in wearability between the chest patches in the CRS total score; however, the VitalPatch was superior in the Attachment section (P=.04) with a median (IQR) score of 3.00 (1.00). General pain and discomfort scores and total percentage of time worn are also reflective of this. CONCLUSIONS: Our results suggest that adult participants prefer to wear wrist-worn pulse oximeters without a probe compressing the fingertip and they prefer to wear a smaller chest patch. A compromise between wearability, reliability, and accuracy should be made for successful and practical integration of AMSs within the hospital environment.

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.

INTRODUCTION: Automated 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 ANALYSIS: This 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 DISSEMINATION: This 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 NUMBER: ISRCTN61535692 registered on 10/06/2019.

A qualitative exploration of escalation of care in the acute ward setting.

BACKGROUND: "Failure to Rescue" includes failing to prevent avoidable patient deterioration and death. Despite its use, delays in care escalation still affect patient outcomes. AIMS AND OBJECTIVE: The aim of this qualitative service evaluation was to map the barriers and facilitators to the escalation of care in the acute ward setting and identify those that are modifiable. DESIGN: A total of 55 hours of qualitative observations were completed to capture care escalation events. These were conducted at two hospital sites in one National Health Service trust. METHODS: Observations were iterative, with research team meetings being used to discuss the data and future methods. Field notes were analysed thematically by two researchers, extracting data on barriers and facilitators to escalation of care. RESULTS: Clinical nursing staff challenged the sensitivity and specificity of Early Warning Scores, describing tool failings in certain clinical scenarios. Staff did not escalate based on the alerting Early Warning Scores alone but used other clinical factors, such as bleeding, which are not necessarily captured in the scoring systems. Staff frequently did not re-escalate low-level scores. Patient and non-patient factors identified as posing barriers to escalation were complex care needs, patient outlier status, and involvement of multiple care teams. Factors negatively affecting the chain of communication during escalation were team tension, staffing levels, and inadequate handover. CONCLUSION: This service evaluation identified barriers and facilitators to the escalation of care in the acute ward setting. Unlike other studies, we found that re-escalation or tracking of deterioration was problematic. Patients identified as being at a higher risk of escalation failure included complex patients, outliers, and patients with multiple care teams. RELEVANCE TO CLINICAL PRACTICE: This service evaluation demonstrates continuing health care communication barriers. Patient groups (complex patients and outliers) risk process failures during escalation. This can be applied in clinical practice by staff anticipating problems in these patients, documenting clear escalation pathways.

How human factors affect escalation of care: a protocol for a qualitative evidence synthesis of studies.

INTRODUCTION: Failure to rescue is defined as mortality after complications during hospital care. Incidence ranges 10.9%-13.3% and several national reports such as National Confidential Enquiry into Patient Outcomes and Death and National Institute of Clinical Excellence CG 50 highlight failure to rescue as a significant problem for safe patient care.To avoid failure to rescue events, there must be successful escalation of care. Studies indicate that human factors such as situational awareness, team working, communication and a culture promoting safety contribute to avoidance of failure to rescue events. Understanding human factors is essential to developing work systems that mitigate barriers and facilitate prompt escalation of care. This qualitative evidence synthesis will identify and synthesise what is known about the human factors that affect escalation of care. METHODS AND ANALYSIS: We will search MEDLINE (Ovid), EMBASE (Ovid) and CINAHL, between database inception and 2018, for studies describing human factors affecting failure to rescue and/or care escalation. A search strategy was developed by two researchers and a medical librarian. Only studies exploring in-hospital (ward) populations using qualitative data collection methods will be included. Screening will be conducted by two researchers. We are likely to undertake a thematic synthesis, using the Thomas and Harden framework. Selected studies will be assessed for quality, rigour and limitations. Two researchers will extract and thematically synthesise codes using a piloted data extraction tool to develop analytical themes. ETHICS AND DISSEMINATION: The qualitative evidence synthesis will use available published literature and no ethical approval is required. This synthesis will be limited by the quality of studies, rigour and reproducibility of study findings. Results will be published in a peer-reviewed journal, publicised at conferences and on social media. PROSPERO REGISTRATION NUMBER: CRD42018104745.

A service evaluation comparing CVVH an CVVHD in minimising circuit failure.

BACKGROUND: A significant problem during continuous renal replacement therapy is premature circuit failure, affecting efficacy and molecular clearance. Techniques to improve circuit failure are anticoagulation, access site and modality. A modality change was introduced, moving from continuous veno-venous haemofiltration to continuous veno-venous haemodiafiltration as a result of existing issues with failing circuit times and failure rates. AIM: The aim of this service evaluation was to ascertain if the use of continuous veno-venous haemodiafiltration compared to continuous veno-venous haemofiltration had affected failed circuit survival times and rates. METHODS: A service evaluation was chosen because the focus was to ascertain what effect a practice change had had on a particular service. The service evaluation was registered with the local trust's audit department and gained university ethical approval. It was anticipated that the data generated would be used to inform, question and improve practices. Patients who received renal replacement therapy (RRT) from May 2012 to January 2013 were retrospectively identified. Patients received continuous veno-venous haemofiltration for the duration of their treatment before September 2012 and continuous veno-venous haemodiafiltration after. A total of 78 patients were identified as receiving RRT; 41 of these patients had failed circuits. RESULTS: A total of 182 failed circuits were analysed. The median duration of failed circuits during continuous veno-venous haemofiltration was shorter (2·75 h, standard deviation (SD) = 13·82) when compared to continuous veno-venous haemodiafiltration (11 h, SD = 15·26, p < 0·001, 95% confidence interval (CI) 2·5-10). Circuit failure rate in continuous veno-venous haemofiltration was 56% compared to 43% in continuous veno-venous haemodiafiltration. After performing a Cox regression analysis, continuous veno-venous haemofiltration appeared to have a 1·87 times (CI 1·18-2·82, p > 0·007) more likely chance of failure. CONCLUSION: The use of continuous veno-venous haemodiafiltration has had an overall positive effect on the haemofiltration service by reducing the number of failed circuits and increasing circuit survival times, which may have improved the efficacy of the service. Continuous veno-venous haemodiafiltration may be a more appropriate modality of choice in non-septic patients requiring prolonged continuous RRT episodes.