Inconsistent relationship between depth of sedation and intensive care outcome: systematic review and meta-analysis.

PURPOSE: To determine the effect of depth of sedation on intensive care mortality, duration of mechanical ventilation, and other clinically important outcomes. METHODS: We searched MEDLINE, Embase, Cochrane Register of Controlled Trials, Cumulative Index to Nursing and Allied Health Literature, PsycINFO from 2000 to 2020. Randomised controlled trials (RCTs) and cohort studies that examined the effect of sedation depth were included. Two reviewers independently screened, selected articles, extracted data and appraised quality. Data on study design, population, setting, patient characteristics, study interventions, depth of sedation and relevant outcomes were extracted. Quality was assessed using Critical Appraisal Skills Programme tools. RESULTS: We included data from 26 studies (n=7865 patients): 8 RCTs and 18 cohort studies. Heterogeneity of studies was substantial. There was no significant effect of lighter sedation on intensive care mortality. Lighter sedation did not affect duration of mechanical ventilation in RCTs (mean difference (MD): -1.44 days (95% CI -3.79 to 0.91)) but did in cohort studies (MD: -1.52 days (95% CI -2.71 to -0.34)). No statistically significant benefit of lighter sedation was identified in RCTs. In cohort studies, lighter sedation improved time to extubation, intensive care and hospital length of stay and ventilator-associated pneumonia. We found no significant effects for hospital mortality, delirium or adverse events. CONCLUSION: Evidence of benefit from lighter sedation is limited, with inconsistency between observational and randomised studies. Positive effects were mainly limited to low quality evidence from observational studies, which could be attributable to bias and confounding factors.

Family INvolvement in inTensive care: A qualitative exploration of critically ill patients, their families and critical care nurses (INpuT study).

AIMS AND OBJECTIVES: To understand the different factors that impact on the involvement of adult family members in the care of critically ill patients from the perspective of patients, families and nurses, with the aim to inform the enactment of a patient- and family-centred care intervention to support the patient-family-nurse partnership in care involvement. BACKGROUND: Existing evidence lacks theoretical underpinning and clarity to support enactment of patient- and family-centred care and involvement of families in the care of the critically ill patient. DESIGN: Qualitative exploratory design using thematic analysis. METHODS: This study was conducted at two adult intensive care units in two tertiary university hospitals in the central belt of Scotland. Between 2013-2014, we conducted semi-structured interviews with critically ill survivors (n = 19) and adult family members (n = 21), and five focus groups with nurses (n = 15) across both settings. Data were digitally recorded, transcribed verbatim, and uploaded in NVivo 10. Data were analysed thematically using a constructivist epistemology. Ethical approval was obtained prior to data collection. Data are reported according to the Consolidated Criteria for Reporting Qualitative Research checklist. RESULTS: Family's situational awareness; the perceived self in care partnership; rapport and trust; and personal and family attributes were the main factors that affected family involvement in care. Two key themes were identified as principles to enact patient- and family-centred care in adult intensive care units: "Need for 'Doing family'" and "Negotiations in care involvement." CONCLUSIONS: Negotiating involvement in care requires consideration of patients' and family members' values of doing family and the development of a constructive patient-family-nurses' partnership. RELEVANCE TO CLINICAL PRACTICE: Future policy and research should consider patients' and family's needs to demonstrate family bonds within a negotiated process in care participation, when developing tools and frameworks to promote patient- and family-centred care in adult intensive care units.

Development of Process Control Methodology for Tracking the Quality and Safety of Pain, Agitation, and Sedation Management in Critical Care Units.

OBJECTIVE: To develop sedation, pain, and agitation quality measures using process control methodology and evaluate their properties in clinical practice. DESIGN: A Sedation Quality Assessment Tool was developed and validated to capture data for 12-hour periods of nursing care. Domains included pain/discomfort and sedation-agitation behaviors; sedative, analgesic, and neuromuscular blocking drug administration; ventilation status; and conditions potentially justifying deep sedation. Predefined sedation-related adverse events were recorded daily. Using an iterative process, algorithms were developed to describe the proportion of care periods with poor limb relaxation, poor ventilator synchronization, unnecessary deep sedation, agitation, and an overall optimum sedation metric. Proportion charts described processes over time (2 monthly intervals) for each ICU. The numbers of patients treated between sedation-related adverse events were described with G charts. Automated algorithms generated charts for 12 months of sequential data. Mean values for each process were calculated, and variation within and between ICUs explored qualitatively. SETTING: Eight Scottish ICUs over a 12-month period. PATIENTS: Mechanically ventilated patients. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: The Sedation Quality Assessment Tool agitation-sedation domains correlated with the Richmond Sedation Agitation Scale score (Spearman ρ = 0.75) and were reliable in clinician-clinician (weighted kappa; κ = 0.66) and clinician-researcher (κ = 0.82) comparisons. The limb movement domain had fair correlation with Behavioral Pain Scale (ρ = 0.24) and was reliable in clinician-clinician (κ = 0.58) and clinician-researcher (κ = 0.45) comparisons. Ventilator synchronization correlated with Behavioral Pain Scale (ρ = 0.54), and reliability in clinician-clinician (κ = 0.29) and clinician-researcher (κ = 0.42) comparisons was fair-moderate. Eight hundred twenty-five patients were enrolled (range, 59-235 across ICUs), providing 12,385 care periods for evaluation (range 655-3,481 across ICUs). The mean proportion of care periods with each quality metric varied between ICUs: excessive sedation 12-38%; agitation 4-17%; poor relaxation 13-21%; poor ventilator synchronization 8-17%; and overall optimum sedation 45-70%. Mean adverse event intervals ranged from 1.5 to 10.3 patients treated. The quality measures appeared relatively stable during the observation period. CONCLUSIONS: Process control methodology can be used to simultaneously monitor multiple aspects of pain-sedation-agitation management within ICUs. Variation within and between ICUs could be used as triggers to explore practice variation, improve quality, and monitor this over time.

Understanding nurses' decision-making when managing weaning from mechanical ventilation: a study of novice and experienced critical care nurses in Scotland and Greece.

AIM AND OBJECTIVES: To examine how nurses collect and use cues from respiratory assessment to inform their decisions as they wean patients from ventilatory support. BACKGROUND: Prompt and accurate identification of the patient's ability to sustain reduction of ventilatory support has the potential to increase the likelihood of successful weaning. Nurses' information processing during the weaning from mechanical ventilation has not been well-described. DESIGN: A descriptive ethnographic study exploring critical care nurses' decision-making processes when weaning mechanically ventilated patients from ventilatory support in the real setting. METHODS: Novice and expert Scottish and Greek nurses from two tertiary intensive care units were observed in real practice of weaning mechanical ventilation and were invited to participate in reflective interviews near the end of their shift. Data were analysed thematically using concept maps based on information processing theory. Ethics approval and informed consent were obtained. RESULTS: Scottish and Greek critical care nurses acquired patient-centred objective physiological and subjective information from respiratory assessment and previous knowledge of the patient, which they clustered around seven concepts descriptive of the patient's ability to wean. Less experienced nurses required more encounters of cues to attain the concepts with certainty. Subjective criteria were intuitively derived from previous knowledge of patients' responses to changes of ventilatory support. All nurses used focusing decision-making strategies to select and group cues in order to categorise information with certainty and reduce the mental strain of the decision task. CONCLUSIONS: Nurses used patient-centred information to make a judgment about the patients' ability to wean. Decision-making strategies that involve categorisation of patient-centred information can be taught in bespoke educational programmes for mechanical ventilation and weaning. RELEVANCE TO CLINICAL PRACTICE: Advanced clinical reasoning skills and accurate detection of cues in respiratory assessment by critical care nurses will ensure optimum patient management in weaning mechanical ventilation.

Difficult to wean patients: cultural factors and their impact on weaning decision-making.

AIMS AND OBJECTIVES: To examine the elements of the intensive care environment and consider the impact on nurses' involvement in decision-making when weaning from mechanical ventilation. BACKGROUND: Optimal management of difficult to wean patients requires the dynamic collaboration of all clinicians and the contribution of their knowledge and skills. The introduction of weaning protocols has increased nurses' input in decision-making, but there are various elements of the decision environment that impact on their involvement, which have been given little consideration. DESIGN: Ethnography was used as the research design for this study. METHODS: Fieldwork took place in two tertiary hospitals in Greece and Scotland for five months each to unveil clinicians' behaviour and interactions during the weaning practice. Observation was based on the weaning process of 10 Scottish and 9 Greek long-term ventilated patients. Semi-structured interviews followed with nurses (n = 33) and doctors (n = 9) in both settings to understand nurses' perceived involvement in weaning decision-making. Thematic analysis of interviews and field notes followed using the Qualitative Data Analysis software NVivo. Clinicians' participation was voluntary. RESULTS: The main themes identified were the (1) organisation of the units (time and structure of the ward rounds, staff levels and staff allocation system), (2) the inter- professional relationships, (3) the ownership and accountability in weaning decision-making and (4) the role of the weaning protocols. These elements described the culture of the ICUs and defined nurses' role in weaning decision-making. CONCLUSIONS: Clinical decision-making is a multi-dynamic process specifically in complex clinical situations such as weaning from mechanical ventilation. This paper suggests that weaning practice should be considered in relation to the elements of the clinical environment to provide an individualised and patient-centred weaning approach. RELEVANCE TO CLINICAL PRACTICE: Methods to enhance nurses' role in teamwork and collaborative decision-making are suggested.

Alpha 2 agonists for sedation to produce better outcomes from critical illness (A2B trial): protocol for a mixed-methods process evaluation of a randomised controlled trial.

INTRODUCTION: An association between deep sedation and adverse short-term outcomes has been demonstrated although this evidence has been inconsistent. The A2B (alpha-2 agonists for sedation in critical care) sedation trial is designed to determine whether the alpha-2 agonists clonidine and dexmedetomidine, compared with usual care, are clinically and cost-effective. The A2B intervention is a complex intervention conducted in 39 intensive care units (ICUs) in the UK. Multicentre organisational factors, variable cultures, perceptions and practices and the involvement of multiple members of the healthcare team add to the complexity of the A2B trial. From our pretrial contextual exploration it was apparent that routine practices such as type and frequency of pain, agitation and delirium assessment, as well as the common sedative agents used, varied widely across the UK. Anticipated challenges in implementing A2B focused on the impact of usual practice, perceptions of risk, ICU culture, structure and the presence of equipoise. Given this complexity, a process evaluation has been embedded in the A2B trial to uncover factors that could impact successful delivery and explore their impact on intervention delivery and interpretation of outcomes. METHODS AND ANALYSIS: This is a mixed-methods process evaluation guided by the A2B intervention logic model. It includes two phases of data collection conducted during and at the end of trial. Data will be collected using a combination of questionnaires, stakeholder interviews and routinely collected trial data. A framework approach will be used to analyse qualitative data with synthesis of data within and across the phases. The nature of the relationship between delivery of the A2B intervention and the trial primary and secondary outcomes will be explored. ETHICS AND DISSEMINATION: All elements of the A2B trial, including the process evaluation, are approved by Scotland A Research Ethics Committee (Ref. 18/SS/0085). Dissemination will be via publications, presentations and media engagement. TRIAL REGISTRATION NUMBER: NCT03653832.

Cost and reimbursement analysis of end-of-life cancer inpatients. The case of the Greek public healthcare sector.

BACKGROUND: While hospital-based Palliative Care services are usually covered through the main funding healthcare framework, traditional reimbursement methods have been criticized for their appropriateness. The present study investigates for the first time the case of treating end-of-life cancer patients in a Greek public hospital in terms of cost and reimbursement. METHODS: This retrospective observational study used health administrative data of 135 deceased cancer patients who were hospitalized in the end of their lives. Following the cost estimation procedure, which indentified both the individual patient and overhead costs, we compared the relevant billing data and reimbursement requests to the estimated costs. RESULTS: The average total cost per patient per day was calculated to be 97 EUR, with equal participation of individual patient's and overhead costs. Length of stay was identified as the main cost driver. Reimbursement was performed either by per-diem fees or by Diagnosis Related Groups' (DRGs), which were correspondingly associated with under or over reimbursement risks. In the case of the combined use of the two available reimbursement alternatives a cross-subsidization phenomenon was described. CONCLUSION: Although the cost of end-of-life care proved to be quite low, the national per-diem rate fails to cover it. DRGs designed for acute care needs are rather unsuitable for such sub acute hospitalizations. POLICY SUMMARY: There is a concrete need for reconsidering the current reimbursement schemes for this group of patients as part of any national plan concerning the integration and reformation of Palliative Care services. Otherwise, there is a serious danger for public institutions' reluctance to admit them with a serious impact on access and equity of end-of-life cancer care.

Patients' experiences and perspectives of post-hospital follow-up care to improve physical recovery for intensive care survivors: A systematic review of qualitative research.

Background: Intensive care units deliver care to a heterogeneous group of patients with pre-existing co-morbid disease. Focus has shifted to improving health related quality of life with more patients surviving beyond hospital discharge. Randomised controlled trials evaluating follow-up interventions, to improve physical recovery, have not demonstrated a health-related quality of life benefit. Qualitative research may provide the context to understand the experiences of intensive care survivors during follow-up care addressing physical limitations. Objective: To synthesise qualitative studies and explore Intensive Care survivors' experiences and perspectives of physical symptoms in the context of follow-up care. Settings: A systematic search of electronic databases (MEDLINE, Cumulative Index of Nursing and Allied Health Literature, Web of Science, Applied Social Sciences Index and Abstracts, Ovid Nursing and Ovid Emcare) was conducted to identify peer-reviewed primary qualitative studies. No date parameters were applied. Inclusion/exclusion criteria guided the screening process. Participants: The data from eligible primary research studies was extracted into NVivo (v12). Methods: Critical appraisal was completed using the Joanna Briggs Critical Appraisal Tool. Thematic analysis, guided by Braun and Clarke (2022), informed the data synthesis. Results: From 2457 studies, ten relevant studies were included. Two main themes were identified: 1. Recovery as uncertain; which outlines the uncertainty experienced by intensive care unit survivors during recovery. This theme pertained to system-level factors (role of healthcare professional and information provision) which provides the context for delivering follow-up care. 2. Self-determination of recovery; outlines individual characteristics in determining recovery which is conceptualised by patient-level factors (motivation, support network and perception of health). Conclusions: For intensive care survivors, the recovery trajectory is uncertain with a gap in information provision during the acute phase following hospital discharge. Patients' self-determination of recovery is an important consideration to ensure follow-up care addresses the needs of individual patients. The impact of pre-existing co-morbid disease and subgroups of patients deriving benefit from follow-up care remains uncertain. Registration: PROSPERO Registration no. CRD42022355711. Tweetable abstract: Patients' experiences of post-hospital follow-up care to improve physical recovery for intensive care survivors: A Systematic Review of Qualitative Research.

Alpha 2 agonists for sedation to produce better outcomes from critical illness (A2B Trial): protocol for a multicentre phase 3 pragmatic clinical and cost-effectiveness randomised trial in the UK.

INTRODUCTION: Almost all patients receiving mechanical ventilation (MV) in intensive care units (ICUs) require analgesia and sedation. The most widely used sedative drug is propofol, but there is uncertainty whether alpha2-agonists are superior. The alpha 2 agonists for sedation to produce better outcomes from critical illness (A2B) trial aims to determine whether clonidine or dexmedetomidine (or both) are clinically and cost-effective in MV ICU patients compared with usual care. METHODS AND ANALYSIS: Adult ICU patients within 48 hours of starting MV, expected to require at least 24 hours further MV, are randomised in an open-label three arm trial to receive propofol (usual care) or clonidine or dexmedetomidine as primary sedative, plus analgesia according to local practice. Exclusions include patients with primary brain injury; postcardiac arrest; other neurological conditions; or bradycardia. Unless clinically contraindicated, sedation is titrated using weight-based dosing guidance to achieve a Richmond-Agitation-Sedation score of -2 or greater as early as considered safe by clinicians. The primary outcome is time to successful extubation. Secondary ICU outcomes include delirium and coma incidence/duration, sedation quality, predefined adverse events, mortality and ICU length of stay. Post-ICU outcomes include mortality, anxiety and depression, post-traumatic stress, cognitive function and health-related quality of life at 6-month follow-up. A process evaluation and health economic evaluation are embedded in the trial.The analytic framework uses a hierarchical approach to maximise efficiency and control type I error. Stage 1 tests whether each alpha2-agonist is superior to propofol. If either/both interventions are superior, stages 2 and 3 testing explores which alpha2-agonist is more effective. To detect a mean difference of 2 days in MV duration, we aim to recruit 1437 patients (479 per group) in 40-50 UK ICUs. ETHICS AND DISSEMINATION: The Scotland A REC approved the trial (18/SS/0085). We use a surrogate decision-maker or deferred consent model consistent with UK law. Dissemination will be via publications, presentations and updated guidelines. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov NCT03653832.

Decisional responsibility for mechanical ventilation and weaning: an international survey.

INTRODUCTION: Optimal management of mechanical ventilation and weaning requires dynamic and collaborative decision making to minimize complications and avoid delays in the transition to extubation. In the absence of collaboration, ventilation decision making may be fragmented, inconsistent, and delayed. Our objective was to describe the professional group with responsibility for key ventilation and weaning decisions and to examine organizational characteristics associated with nurse involvement. METHODS: A multi-center, cross-sectional, self-administered survey was sent to nurse managers of adult intensive care units (ICUs) in Denmark, Germany, Greece, Italy, Norway, Switzerland, Netherlands and United Kingdom (UK). We summarized data as proportions (95% confidence intervals (CIs)) and calculated odds ratios (OR) to examine ICU organizational variables associated with collaborative decision making. RESULTS: Response rates ranged from 39% (UK) to 92% (Switzerland), providing surveys from 586 ICUs. Interprofessional collaboration (nurses and physicians) was the most common approach to initial selection of ventilator settings (63% (95% CI 59 to 66)), determination of extubation readiness (71% (67 to 75)), weaning method (73% (69 to 76)), recognition of weaning failure (84% (81 to 87)) and weaning readiness (85% (82 to 87)), and titration of ventilator settings (88% (86 to 91)). A nurse-to-patient ratio other than 1:1 was associated with decreased interprofessional collaboration during titration of ventilator settings (OR 0.2, 95% CI 0.1 to 0.6), weaning method (0.4 (0.2 to 0.9)), determination of extubation readiness (0.5 (0.2 to 0.9)) and weaning failure (0.4 (0.1 to 1.0)). Use of a weaning protocol was associated with increased collaborative decision making for determining weaning (1.8 (1.0 to 3.3)) and extubation readiness (1.9 (1.2 to 3.0)), and weaning method (1.8 (1.1 to 3.0). Country of ICU location influenced the profile of responsibility for all decisions. Automated weaning modes were used in 55% of ICUs. CONCLUSIONS: Collaborative decision making for ventilation and weaning was employed in most ICUs in all countries although this was influenced by nurse-to-patient ratio, presence of a protocol, and varied across countries. Potential clinical implications of a lack of collaboration include delayed adaptation of ventilation to changing physiological parameters, and delayed recognition of weaning and extubation readiness resulting in unnecessary prolongation of ventilation.

Family ward rounds in intensive care: An integrative review of the literature.

BACKGROUND: The involvement of family members in the ward rounds is a novel but under-researched family-centered care intervention in adult intensive care units, with limited evidence on the impact it has on patient and family-centered outcomes. OBJECTIVES: This integrative review aimed to understand how family rounds are implemented in critical care and to appraise the evidence on outcomes for patients, family members, and healthcare professionals. DESIGN: An integrative review methodological framework permitted the inclusion of all research designs. DATA SOURCES: MEDLINE; CINAHL; PsycINFO; Cochrane Library; Web of Science Current Contents Connect; Web of Science-Core Collection; The Joanna Briggs Institute EBP Database; ProQuest Sociological Abstracts; and ProQuest Dissertation and Theses Global, Embase were systematically searched. REVIEW METHODS: We reviewed studies that referred to or used as an intervention the involvement of family members in daily critical care team rounds. We included primary research in adult intensive care units regardless of patients' length of stay. We excluded patients receiving end-of-life care. We considered any outcome related to the critically ill patient and/or their family member, outcomes related to the healthcare professionals, and outcomes related to clinical and/or nursing treatment. The Mixed Methods Appraisal Tool was used to appraise the quality of the studies. The review was registered in the Prospero database. RESULTS: From the 541 articles initially retrieved, 15 studies met the inclusion criteria and were included in the review. Studies originated from the United States of America and Canada since 2003, and a variety of designs were used. Four before and after studies and a non-randomized experimental study explored the impact of structured family rounds on family and staff satisfaction, showing limited improvement in satisfaction. Six cross-sectional survey studies explored family members' and clinicians' perceptions and demonstrated a positive attitude towards family-centered rounds, but some concerns were raised from the nursing staff. Three qualitative studies and a mixed-methods study identified structural and cultural factors influencing healthcare professionals' and families' acceptance of family rounds. Most studies were of poor to moderate quality, with limited confidence in the outcomes reported. CONCLUSIONS: Most studies reported improved family satisfaction as the main outcome. Future research should focus on longitudinal patient and family-centered outcomes, including mental health outcomes, and on qualitative data to understand the processes, barriers, and facilitators to implement family-centered rounds in intensive care units.

Understanding the complexities of antibiotic prescribing behaviour in acute hospitals: a systematic review and meta-ethnography.

BACKGROUND: Antimicrobial resistance poses a serious global public health threat. Hospital misuse of antibiotics has contributed to this problem and evidence-based interventions are urgently needed to change inappropriate prescribing practices. This paper reports the first theoretical stage of a longer-term project to improve antibiotic prescribing in hospitals through design of an effective behaviour-change intervention. METHODS: Qualitative synthesis using meta-ethnography of primary studies reporting doctors' views and experiences of antibiotic prescribing in hospitals for example, their barriers to appropriate prescribing. Twenty electronic databases were systematically searched over a 10-year period and potential studies screened against eligibility criteria. Included studies were quality-appraised. Original participant quotes and author interpretations were extracted and coded thematically into NVivo. All study processes were conducted by two reviewers working independently with findings discussed with the wider team and key stakeholders. Studies were related by findings into clusters and translated reciprocally and refutationally to develop a new line-of-argument synthesis and conceptual model. Findings are reported using eMERGe guidance. RESULTS: Fifteen papers (13 studies) conducted between 2007 and 2017 reporting the experiences of 336 doctors of varying seniority working in acute hospitals across seven countries, were synthesised. Study findings related in four ways which collectively represented multiple challenges to appropriate antibiotic medical prescribing in hospitals: loss of ownership of prescribing decisions, tension between individual care and public health concerns, evidence-based practice versus bedside medicine, and diverse priorities between different clinical teams. The resulting new line-of-argument and conceptual model reflected how these challenges operated on both micro- and macro-level, highlighting key areas for improving current prescribing practice, such as creating feedback mechanisms, normalising input from other specialties and reducing variation in responsibility for antibiotic decisions. CONCLUSIONS: This first meta-ethnography of doctors` experiences of antibiotic prescribing in acute hospital settings has enabled development of a novel conceptual model enhancing understanding of appropriate antibiotic prescribing. That is, hospital antibiotic prescribing is a complex, context-dependent and dynamic process, entailing the balancing of many tensions. To change practice, comprehensive efforts are needed to manage failures in communication and information provision, promote distribution of responsibility for antibiotic decisions, and reduce fear of consequences from not prescribing. TRIAL REGISTRATION: PROSPERO registration: CRD42017073740 .

Observing the approaches to weaning of the long-term ventilated patients.

BACKGROUND: The weaning process from mechanical ventilation is a complicated issue for patients with respiratory failure who require long-term respiratory support. Although the application of weaning protocols reduces weaning time, and enhances patient outcome, little is known about the actual approaches that clinicians use for the weaning of these patients. AIM: The purpose of this paper is to explore approaches to weaning of long-term ventilated patients in a Scottish Intensive Care Unit. The findings are part of a larger study on decision-making during the weaning of long-term ventilated patients. METHOD: Data were collected through participant observation and follow-up interviews with the nursing staff. Twenty-four-hour chart and medical notes review and informal conversation with the bedside nurse were also used to collect information on the weaning process. FINDINGS: Nine patients were recruited to the study. Two patients were extubated and three patients were extubated but then required a tracheostomy. A further four patients had a tracheostomy performed. Thematic analysis of the data showed that weaning was individualized, and physician led, regardless of the existence of the weaning protocol. Six different weaning approaches were identified. Nurses followed a conservative approach to weaning in comparison to doctors who appeared more aggressive. CONCLUSION: There are many varieties in the approaches clinicians use when weaning long-term ventilated patients, which acts on the continuity of their care. A shift of focus to identify ways of maintaining continuity of care and a combined 'wake and wean' approach needs to be considered.

Challenges and barriers to optimising sedation in intensive care: a qualitative study in eight Scottish intensive care units.

OBJECTIVES: Various strategies to promote light sedation are highly recommended in recent guidelines, as deep sedation is associated with suboptimum patient outcomes. Yet, the challenges met by clinicians in delivering high-quality analgosedation is rarely addressed. As part of the evaluation of a cluster-randomised quality improvement trial in eight Scottish intensive care units (ICUs), we aimed to understand the challenges to optimising sedation in the Scottish ICU settings prior to the trial. This article reports on the findings. DESIGN: A qualitative exploratory design: We conducted focus groups (FG) with clinicians during the preintervention period. Setting and participants: Eight Scottish ICUs. Nurses, physiotherapists and doctors working in each ICU volunteered to participate. FG were recorded and verbatim transcribed and inserted in NVivo V.10 for analysis. Qualitative thematic analysis was undertaken to develop emergent themes from the patterns identified in relation to sedation practice. Ethical approval was secured by Scotland A Research ethics committee. RESULTS: Three themes emerged from the inductive analysis: (a) a recent shift in sedation practice, (b) uncertainty in decision-making and (c) system-level factors including the ICU environment, organisational factors and educational gaps. Clinicians were challenged daily to manage agitated or difficult-to-sedate patients in the era of a progressive mantra of 'just sedate less' imposed by the pain-agitation-delirium guidelines. CONCLUSIONS: The current implementation of guidelines does not support behaviour change strategies to allow a patient-focused approach to sedation management, which obstructs optimum sedation-analgesia management. Recognition of the various challenges when mandating less sedation needs to be considered and novel sedation-analgesia strategies should allow a system-level approach to improve sedation-analgesia quality. DESIST REGISTRATION NUMBER: NCT01634451.

Patient and Family Centered Actionable Processes of Care and Performance Measures for Persistent and Chronic Critical Illness: A Systematic Review.

To identify actionable processes of care, quality indicators, or performance measures and their evidence base relevant to patients with persistent or chronic critical illness and their family members including themes relating to patient/family experience. DATA SOURCES: Two authors independently searched electronic, systemic review, and trial registration databases (inception to November 2016). STUDY SELECTION: We included studies with an ICU length of stay of greater than or equal to 7 days as an inclusion criterion and reported actionable processes of care; quality improvement indicators, measures, or tools; or patient/family experience. We excluded case series/reports of less than 10 patients. DATA EXTRACTION: Paired authors independently extracted data and performed risk of bias assessment. DATA SYNTHESIS: We screened 13,130 references identifying 114 primary studies and 102 relevant reviews. Primary studies reported data on 24,252 participants; median (interquartile range) sample size of 70 (32-182). We identified 42 distinct actionable processes of care, the most commonly investigated related to categories of 1) weaning methods (21 studies; 27 reviews); 2) rehabilitation, mobilization, and physiotherapy (20 studies; 40 reviews); and 3) provision of information, prognosis, and family communication (14 studies; 11 reviews). Processes with limited evidence were generally more patient-centered categories such as communication, promotion of sleep, symptom management, or family support. Of the 21 randomized controlled trials, only two were considered at low risk of bias across all six domains, whereas just two cohort studies and one qualitative study were considered of high quality. CONCLUSIONS: We identified 42 distinct actionable processes of care relevant to patients with persistent or chronic critical illness and their families, with most frequently studied processes relating to weaning, rehabilitation/mobilization, and family communication. Qualitative studies highlighted the need to address psychologic needs and distressing symptoms as well as enabling patient communication. Our findings are informative for clinicians and decision-makers when planning high-quality patient and family-focused care.

Rationale, design and methodology of a trial evaluating three strategies designed to improve sedation quality in intensive care units (DESIST study).

OBJECTIVES: To describe the rationale, design and methodology for a trial of three novel interventions developed to improve sedation-analgesia quality in adult intensive care units (ICUs). PARTICIPANTS AND SETTING: 8 clusters, each a Scottish ICU. All mechanically ventilated sedated patients were potentially eligible for inclusion in data analysis. DESIGN: Cluster randomised design in 8 ICUs, with ICUs randomised after 45 weeks baseline data collection to implement one of four intervention combinations: a web-based educational programme (2 ICUs); education plus regular sedation quality feedback using process control charts (2 ICUs); education plus a novel sedation monitoring technology (2 ICUs); or all three interventions. ICUs measured sedation-analgesia quality, relevant drug use and clinical outcomes, during a 45-week preintervention and 45-week postintervention period separated by an 8-week implementation period. The intended sample size was >100 patients per site per study period. MAIN OUTCOME MEASURES: The primary outcome was the proportion of 12 h care periods with optimum sedation-analgesia, defined as the absence of agitation, unnecessary deep sedation, poor relaxation and poor ventilator synchronisation. Secondary outcomes were proportions of care periods with each of these four components of optimum sedation and rates of sedation-related adverse events. Sedative and analgesic drug use, and ICU and hospital outcomes were also measured. ANALYTIC APPROACH: Multilevel generalised linear regression mixed models will explore the effects of each intervention taking clustering into account, and adjusting for age, gender and APACHE II score. Sedation-analgesia quality outcomes will be explored at ICU level and individual patient level. A process evaluation using mixed methods including quantitative description of intervention implementation, focus groups and direct observation will provide explanatory information regarding any effects observed. CONCLUSIONS: The DESIST study uses a novel design to provide system-level evaluation of three contrasting complex interventions on sedation-analgesia quality. Recruitment is complete and analysis ongoing. TRIAL REGISTRATION NUMBER: NCT01634451.

Staff education, regular sedation and analgesia quality feedback, and a sedation monitoring technology for improving sedation and analgesia quality for critically ill, mechanically ventilated patients: a cluster randomised trial.

BACKGROUND: Optimal sedation of patients in intensive care units (ICUs) requires the avoidance of pain, agitation, and unnecessary deep sedation, but these outcomes are challenging to achieve. Excessive sedation can prolong ICU stay, whereas light sedation can increase pain and frightening memories, which are commonly recalled by ICU survivors. We aimed to assess the effectiveness of three interventions to improve sedation and analgesia quality: an online education programme; regular feedback of sedation-analgesia quality data; and use of a novel sedation-monitoring technology (the Responsiveness Index [RI]). METHODS: We did a cluster randomised trial in eight ICUs, which were randomly allocated to receive education alone (two ICUs), education plus sedation-analgesia quality feedback (two ICUs), education plus RI monitoring technology (two ICUs), or all three interventions (two ICUs). Randomisation was done with computer-generated random permuted blocks, stratified according to recruitment start date. A 45 week baseline period was followed by a 45 week intervention period, separated by an 8 week implementation period in which the interventions were introduced. ICU and research staff were not masked to study group assignment during the intervention period. All mechanically ventilated patients were potentially eligible. We assessed patients' sedation-analgesia quality for each 12 h period of nursing care, and sedation-related adverse events daily. Our primary outcome was the proportion of care periods with optimal sedation-analgesia, defined as being free from excessive sedation, agitation, poor limb relaxation, and poor ventilator synchronisation. Analysis used multilevel generalised linear mixed modelling to explore intervention effects in a single model taking clustering and patient-level factors into account. A concurrent mixed-methods process evaluation was undertaken to help understand the trial findings. The trial is registered with ClinicalTrials.gov, number NCT01634451. FINDINGS: Between June 1, 2012, and Dec 31, 2014, we included 881 patients (9187 care periods) during the baseline period and 591 patients (6947 care periods) during the intervention period. During the baseline period, optimal sedation-analgesia was present for 5150 (56%) care periods. We found a significant improvement in optimal sedation-analgesia with RI monitoring (odds ratio [OR] 1·44 [95% CI 1·07-1·95]; p=0·017), which was mainly due to increased periods free from excessive sedation (OR 1·59 [1·09-2·31]) and poor ventilator synchronisation (OR 1·55 [1·05-2·30]). However, more patients experienced sedation-related adverse events (OR 1·91 [1·02-3·58]). We found no improvement in overall optimal sedation-analgesia with education (OR 1·13 [95% CI 0·86-1·48]), but fewer patients experienced sedation-related adverse events (OR 0·56 [0·32-0·99]). The sedation-analgesia quality data feedback did not improve quality (OR 0·74 [95% CI 0·54-1·00]) or sedation-related adverse events (OR 1·15 [0·61-2·15]). The process evaluation suggested many clinicians found the RI monitoring useful, but it was often not used for decision making as intended. Education was valued and considered useful by staff. By contrast, sedation-analgesia quality feedback was poorly understood and thought to lack relevance to bedside nursing practice. INTERPRETATION: Combination of RI monitoring and online education has the potential to improve sedation-analgesia quality and patient safety in mechanically ventilated ICU patients. The RI monitoring seemed to improve sedation-analgesia quality, but inconsistent adoption by bedside nurses limited its impact. The online education programme resulted in a clinically relevant improvement in patient safety and was valued by nurses, but any changes to behaviours did not seem to alter other measures of sedation-analgesia quality. Providing sedation-analgesia quality feedback to ICUs did not appear to improve any quality metrics, probably because staff did not think it relevant to bedside practice. FUNDING: Chief Scientist Office, Scotland; GE Healthcare.