"Like fighting a fire with a water pistol": A qualitative study of the work experiences of critical care nurses during the COVID-19 pandemic.

AIM: To understand the experience of critical care nurses during the COVID-19 pandemic, through the application of the Job-Demand-Resource model of occupational stress. DESIGN: Qualitative interview study. METHODS: Twenty-eight critical care nurses (CCN) working in ICU in the UK NHS during the COVID-19 pandemic took part in semi-structured interviews between May 2021 and May 2022. Interviews were guided by the constructs of the Job-Demand Resource model. Data were analysed using framework analysis. RESULTS: The most difficult job demands were the pace and amount, complexity, physical and emotional effort of their work. Prolonged high demands led to CCN experiencing emotional and physical exhaustion, burnout, post-traumatic stress symptoms and impaired sleep. Support from colleagues and supervisors was a core job resource. Sustained demands and impaired physical and psychological well-being had negative organizational consequences with CCN expressing increased intention to leave their role. CONCLUSIONS: The combination of high demands and reduced resources had negative impacts on the psychological well-being of nurses which is translating into increased consideration of leaving their profession. IMPLICATIONS FOR THE PROFESSION AND/OR PATIENT CARE: The full impacts of the pandemic on the mental health of CCN are unlikely to resolve without appropriate interventions. IMPACT: Managers of healthcare systems should use these findings to inform: (i) the structure and organization of critical care workplaces so that they support staff to be well, and (ii) supportive interventions for staff who are carrying significant psychological distress as a result of working during and after the pandemic. These changes are required to improve staff recruitment and retention. REPORTING METHOD: We used the COREQ guidelines for reporting qualitative studies. PATIENT AND PUBLIC CONTRIBUTION: Six CCN provided input to survey content and interview schedule. Two authors and members of the study team (T.S. and S.C.) worked in critical care during the pandemic.

Development of the support needs after ICU (SNAC) questionnaire.

AIMS: To develop a questionnaire to identify Intensive Care survivor needs at key transitions during the recovery process, and assess its validity and reliability in a group of ICU survivors. METHODS: Development of the Support Needs After ICU (SNAC) questionnaire was based on a systematic scoping review, and analysis of patient interviews (n = 22). Face and content validity were assessed by service users (n = 12) and an expert panel of healthcare professionals (n = 6). A pilot survey among 200 ICU survivors assessed recruitment at one of five different stages after ICU discharge [(1) in hospital, (2) < 6 weeks, (3) 7 weeks to 6 months, (4) 7 to 12 months, or (5) 12 to 24 months post-hospital discharge]; to assess reliability of the SNAC questionnaire; and to conduct exploratory data analysis. Reliability was determined using Cronbach's alpha for internal consistency; intraclass correlation coefficients for test-retest reliability. We explored correlations with sociodemographic variables using Pearson's correlation coefficient; differences between questionnaire scores and patient demographics using one-way ANOVA. RESULTS: The SNAC questionnaire consisted of 32 items that assessed five categories of support needs (informational, emotional, instrumental [e.g. practical physical help, provision of equipment or training], appraisal [e.g. clinician feedback on recovery] and spiritual needs). ICU survivors were recruited from Northern Ireland, England and Scotland. From a total of 375 questionnaires distributed, 202 (54%) were returned. The questionnaire had high internal consistency (0.97) and high test-retest reliability (r = 0.8) with subcategories ranging from 0.3 to 0.9. CONCLUSIONS: The SNAC questionnaire appears to be a comprehensive, valid, and reliable questionnaire. Further research will enable more robust examination of its properties e.g. factor analysis, and establish its utility in identifying whether patients' support needs evolve over time. RELEVANCE TO CLINICAL PRACTICE: The SNAC questionnaire has the potential to be used to identify ICU survivors' needs and inform post-hospital support services.

Intensive care survivors' experiences of ward-based care: Meleis' theory of nursing transitions and role development among critical care outreach services.

AIMS AND OBJECTIVES: To explore the psychosocial needs of patients discharged from intensive care, the extent to which they are captured using existing theory on transitions in care and the potential role development of critical care outreach, follow-up and liaison services. BACKGROUND: Intensive care patients are at an increased risk of adverse events, deterioration or death following ward transfer. Nurse-led critical care outreach, follow-up or liaison services have been adopted internationally to prevent these potentially avoidable sequelae. The need to provide patients with psychosocial support during the transition to ward-based care has also been identified, but the evidence base for role development is currently limited. DESIGN AND METHODS: Twenty participants were invited to discuss their experiences of ward-based care as part of a broader study on recovery following prolonged critical illness. Psychosocial distress was a prominent feature of their accounts, prompting secondary data analysis using Meleis et al.'s mid-range theory on experiencing transitions. RESULTS: Participants described a sense of disconnection in relation to profound debilitation and dependency and were often distressed by a perceived lack of understanding, indifference or insensitivity among ward staff to their basic care needs. Negotiating the transition between dependence and independence was identified as a significant source of distress following ward transfer. Participants varied in the extent to which they were able to express their needs and negotiate recovery within professionally mediated boundaries. CONCLUSION: These data provide new insights into the putative origins of the psychosocial distress that patients experience following ward transfer. RELEVANCE TO CLINICAL PRACTICE: Meleis et al.'s work has resonance in terms of explicating intensive care patients' experiences of psychosocial distress throughout the transition to general ward-based care, such that the future role development of critical care outreach, follow-up and liaison services may be more theoretically informed.

Virtual visiting in intensive care during the COVID-19 pandemic: a qualitative descriptive study with ICU clinicians and non-ICU family team liaison members.

OBJECTIVE: To understand the experiences and perceived benefits of virtual visiting from the perspectives of intensive care unit (ICU)-experienced clinicians and non-ICU-experienced family liaison team members. DESIGN: Qualitative descriptive study. SETTING: Adult intensive care setting across 14 hospitals within the UK National Health Service. PARTICIPANTS: ICU-experienced clinicians and non-ICU-experienced family liaison team members deployed during the first wave of the COVID-19 pandemic. METHODS: Semistructured telephone/video interviews were conducted with ICU clinicians. Analytical themes were developed inductively following a standard thematic approach, using 'family-centred care' and 'sensemaking' as sensitising concepts. RESULTS: We completed 36 interviews, with 17 ICU-experienced clinicians and 19 non-ICU-experienced family liaison team members. In the context of inperson visiting restrictions, virtual visiting offered an alternative conduit to (1) restoring the family unit, (2) facilitating family involvement, and (3) enabling sensemaking for the family. Virtual visits with multiple family members concurrently and with those living in distant geographical locations restored a sense of family unit. Family involvement in rehabilitation, communication and orientation activities, as well as presence at the end of life, highlighted how virtual visiting could contribute to family-centred care. Virtual visits were emotionally challenging for many family members, but also cathartic in helping make sense of their own emotions and experience by visualising their relatives in the ICU. Being able to see and interact with loved ones and their immediate care providers afforded important cues to enable family sensemaking of the ICU experience. CONCLUSIONS: In this UK qualitative study of clinicians using virtual ICU visiting, in the absence of inperson visiting, virtual visiting was perceived positively as an alternative that promoted family-centred care through virtual presence. We anticipate the perceived benefits of virtual visiting may extend to non-pandemic conditions through improved equity and timeliness of family access to the ICU by offering an alternative option alongside inperson visiting.

Family perspectives on facilitators and barriers to the set up and conduct of virtual visiting in intensive care during the COVID-19 pandemic: A qualitative interview study.

OBJECTIVE: To gain perspectives from family members about barriers and facilitators to virtual visit set up and conduct across intensive care unit settings in the United Kingdom to inform understanding of best practices. METHODS: We conducted a qualitative descriptive study recruiting a purposive sample of family members of adult intensive care unit patients experiencing virtual visiting during Jan to May 2021 of the COVID-19 pandemic. We used semi-structured qualitative interviews and a standard Thematic Analysis approach. RESULTS: We recruited 41 family-member participants from 16 hospitals in the United Kingdom. Facilitators to successful virtual visit set-up were preparation of the family, negotiating a preferred time, and easy-to-use technology. Facilitators to successful conduct were intensive care unit team member presence; enabling family involvement in care; inclusivity, accessibility, and flexibility; and having a sense of control. Barriers that created distress or conflict included restrictive virtual visiting practices; raising expectations then failing to meet them; lack of virtual visit pre-planning; and failing to prepare the patient. Barriers to visit conduct were incorrect camera positioning, insufficient technical and staff resources, issues with three-way connectivity, and lack of call closure. Recommendations included emotional self-preparation, increased technology availability, and preparing conversation topics. CONCLUSION: These data may guide virtual visiting practices during the ongoing pandemic but also to continue virtual visiting outside of pandemic conditions. This will benefit family members suffering from ill health, living at a distance, unable to afford travel, and those with work and care commitments, thereby reducing inequities of access and promoting family-centered care.

Increasing lay-people's intentions to initiate CPR in out of hospital cardiac arrest: Results of a mixed-methods 'before and after' pilot study of a behavioural text-message intervention (BICeP).

Background: Prompt, effective cardio-pulmonary resuscitation (CPR) increases survival in out-of-hospital cardiac arrest. However, CPR is often not provided, even by people with training. Low confidence, perceptions of risks and high emotion can prevent initiation of CPR. Behaviour-change techniques may be helpful in increasing CPR rates. Aim: To pilot a text-message behavioural intervention designed to increase intentions to initiate CPR, explore participant responses and pilot methods for future randomised controlled trial of effectiveness. Methods: A 'before and after' pilot study plus qualitative interviews was undertaken. Participants were lay-people who had undertaken CPR training in previous 2 years.Participants were sent an intervention, comprising 35 text-messages containing 14 behaviour-change techniques, to their mobile phone over 4-6 weeks.Primary outcome: intentions to initiate CPR assessed in response to 4 different scenarios.Secondary outcomes: theory-based determinants of intention (attitudes, subjective norms, perceived behavioural control and self-efficacy) and self-rated competence. Results: 20 participants (6 female, 14 male), aged 20-84 provided baseline data. 17 received the full suite of 35 text messages.15 provided follow-up data. Intentions to perform CPR in scenarios where CPR was indicated were high at baseline and increased (18.1 ± 3.2-19.5 ± 1.8/21) after the intervention, as did self-efficacy and self-rated competency. Self-efficacy, attitudes, perceived behavioural control and subjective norms were positively correlated with intentions. Qualitative data suggest the intervention was perceived as useful. Additional options for delivery format and pace were suggested. Conclusions: Pilot-testing suggests a text-message intervention delivered after CPR training is acceptable and may be helpful in increasing/maintaining intentions to perform CPR.

Physiotherapists' and Physiotherapy Assistants' Perspectives on Using Three Physical Function Measures in the Intensive Care Unit: A Mixed-Methods Study.

Purpose: We sought to understand physiotherapists' and physiotherapist assistants' perspectives on using three physical function measures in the intensive care unit (ICU) setting: the Activity Measure for Post-Acute Care Inpatient Mobility Short Form, the Johns Hopkins Highest Level of Mobility scale, and the Functional Status Score for the Intensive Care Unit. Method: A six-item questionnaire was developed and administered to physiotherapists and physiotherapist assistants working in adult ICUs at one U.S. teaching hospital. A single semi-structured focus group was conducted with seven physiotherapists, recruited using purposive sampling to include participants with a range of clinical experience. Results: Of 22 potential participants, 18 physiotherapists and 2 physiotherapist assistants completed the questionnaire. Seven physiotherapists participated in the focus group. The questionnaire found favourable perspectives on the use of the three physical function measures in clinical practice, and the focus group identified five themes related to clinicians' experience with using them: (1) ease of scoring, (2) usefulness in inter-professional communication, (3) general ease of use, (4) responsiveness to change in physical function, and (5) generalizability across patients. Conclusions: The most frequently discussed themes in this study were ease of scoring and usefulness in inter-professional communication, highlighting their importance in designing and selecting physical function measures for clinical use in the ICU setting.

Objectif : comprendre le point de vue des physiothérapeutes et des assistants-physiothérapeutes à l'égard de trois mesures de la fonction physique en soins intensifs : le questionnaire court sur la mesure de la mobilité des patients hospitalisés après des soins intensifs, l'échelle de mobilité la plus élevée de Johns Hopkins et le score de l'état fonctionnel en soins intensifs. Méthodologie : questionnaire en six questions distribué aux physiothérapeutes et assistants-physiothérapeutes travaillant dans une unité de soins intensifs pour adultes d'un hôpital universitaire américain. Les chercheurs ont formé un seul groupe de travail semi-structuré composé de sept physiothérapeutes recrutés par échantillonnage dirigé pour inclure des participants ayant diverses expériences cliniques. Résultats : sur le total de 22 participants potentiels, 18 physiothérapeutes et deux assistants-physiothérapeutes ont rempli le questionnaire. Sept physiothérapeutes ont participé au groupe de travail. Le questionnaire a fait état de points de vue favorables à l'égard de l'utilisation des trois mesures de la fonction physique en milieu clinique, et le groupe de travail a relevé cinq thèmes liés à leur utilisation : 1) facilité à établir le score, 2) utilité pour les communications interprofessionnelles, 3) facilité générale d'utilisation, 4) réactivité aux changements de la fonction physique et 5) généralisabilité entre les patients. Conclusion : la facilité à établir le score et l'utilité pour les communications interprofessionnelles étaient les thèmes les plus abordés pendant la présente étude, ce qui en souligne l'importance lors de la conception et du choix de mesures de la fonction physique en soins intensifs.

Health-related quality of life: implications for critical care interventional studies and why we need to collaborate with patients.

PURPOSE OF REVIEW: Health-related quality of life (HRQoL) is an important patient-reported outcome measure following critical illness. 'Validated' and professionally endorsed generic measures are widely used to evaluate critical care intervention and guide practice, policy and research. Although recognizing that they are 'here to stay', leading QoL researchers are beginning to question their 'fitness for purpose'. It is therefore timely to review critiques of their limitations in the wider healthcare and social science literatures and to examine the implications for critical care research including, in particular, emerging interventional studies in which HRQoL is the primary outcome of interest. RECENT FINDINGS: Generic HRQoL measures have provided important yet limited insights into HRQoL among survivors of critical illness. They are rarely developed or validated in collaboration with patients and cannot therefore be assumed to reflect their experiences and perspectives. SUMMARY: Collaboration with patients is advocated in order to improve the interpretation and utility of such data. Failure to do so may result in important study effects being overlooked and the dismissal of potentially useful interventions.

Work-related stress: the impact of COVID-19 on critical care and redeployed nurses: a mixed-methods study.

INTRODUCTION: We need to understand the impact of COVID-19 on critical care nurses (CCNs) and redeployed nurses and National Health Service (NHS) organisations. METHODS AND ANALYSIS: This is a mixed-methods study (QUANT-QUAL), underpinned by a theoretical model of occupational stress, the Job Demand-Resources Model (JD-R). Participants are critical care and redeployed nurses from Scottish and three large English units.Phase 1 is a cross-sectional survey in part replicating a pre-COVID-19 study and results will be compared with this data. Linear and logistic regression analysis will examine the relationship between antecedent, demographic and professional variables on health impairment (burnout syndrome, mental health, post-traumatic stress symptoms), motivation (work engagement, commitment) and organisational outcomes (intention to remain in critical care nursing and quality of care). We will also assess the usefulness of a range of resources provided by the NHS and professional organisations.To allow in-depth exploration of individual experiences, phase 2 will be one-to-one semistructured interviews with 25 CCNs and 10 redeployed nurses. The JD-R model will provide the initial coding framework to which the interview data will be mapped. The remaining content will be analysed inductively to identify and chart content that is not captured by the model. In this way, the adequacy of the JD-R model is examined robustly and its expression in this context will be detailed. ETHICS AND DISSEMINATION: Ethics approval was granted from the University of Aberdeen CERB2020101993. We plan to disseminate findings at stakeholder events, publish in peer-reviewed journals and at present at national and international conferences.

Communication and Virtual Visiting for Families of Patients in Intensive Care during the COVID-19 Pandemic: A UK National Survey.

Rationale: Restriction or prohibition of family visiting intensive care units (ICUs) during the coronavirus disease (COVID-19) pandemic poses substantial barriers to communication and family- and patient-centered care. Objectives: To understand how communication among families, patients, and the ICU team was enabled during the pandemic. The secondary objectives were to understand strategies used to facilitate virtual visiting and associated benefits and barriers. Methods: A multicenter, cross-sectional, and self-administered electronic survey was sent (June 2020) to all 217 UK hospitals with at least one ICU. Results: The survey response rate was 54%; 117 of 217 hospitals (182 ICUs) responded. All hospitals imposed visiting restrictions, with visits not permitted under any circumstance in 16% of hospitals (28 ICUs); 63% (112 ICUs) of hospitals permitted family presence at the end of life. The responsibility for communicating with families shifted with decreased bedside nurse involvement. A dedicated ICU family-liaison team was established in 50% (106 ICUs) of hospitals. All but three hospitals instituted virtual visiting, although there was substantial heterogeneity in the videoconferencing platform used. Unconscious or sedated ICU patients were deemed ineligible for virtual visits in 23% of ICUs. Patients at the end of life were deemed ineligible for virtual visits in 7% of ICUs. Commonly reported benefits of virtual visiting were reducing patient psychological distress (78%), improving staff morale (68%), and reorientation of patients with delirium (47%). Common barriers to virtual visiting were related to insufficient staff time, rapid implementation of videoconferencing technology, and challenges associated with family members' ability to use videoconferencing technology or access a device. Conclusions: Virtual visiting and dedicated communication teams were common COVID-19 pandemic innovations addressing the restrictions to family ICU visiting, and they resulted in valuable benefits in terms of patient recovery and staff morale. Enhancing access and developing a more consistent approach to family virtual ICU visits could improve the quality of care, both during and outside of pandemic conditions.

A qualitative study of experiences of health and social care in home mechanical ventilation.

AIM: To contribute insight into health and social care integration through an exploration of the care experiences of adults with degenerative neuromuscular conditions who use a mechanical ventilator at home. DESIGN: Descriptive qualitative research. METHODS: Seventeen semi-structured interviews were conducted with patients and family carers living in Scotland during 2015-2016 and thematically analysed. RESULTS: To achieve a satisfying life, home ventilated participants required help from a variety of health and social care services, as well as care from family. Examples of successful care were identified, but there were also serious failures and conflict with services. Identifying how care fails or succeeds for this patient population and their families requires an understanding of the interdependency of health and social care. This was achieved by examining health and social care provision from the experiential perspective of care-users to provide insights into how disconnected provision has an impact on users' lives in numerous, idiosyncratic ways.

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.

Patient- and family-centered performance measures focused on actionable processes of care for persistent and chronic critical illness: protocol for a systematic review.

BACKGROUND: Approximately 5 to 10% of critically ill patients transition from acute critical illness to a state of persistent and in some cases chronic critical illness. These patients have unique and complex needs that require a change in the clinical management plan and overall goals of care to a focus on rehabilitation, symptom relief, discharge planning, and in some cases, end-of-life care. However, existing indicators and measures of care quality, and tools such as checklists, that foster implementation of best practices, may not be sufficiently inclusive in terms of actionable processes of care relevant to these patients. Therefore, the aim of this systematic review is to identify the processes of care, performance measures, quality indicators, and outcomes including reports of patient/family experience described in the current evidence base relevant to patients with persistent or chronic critical illness and their family members. METHODS: Two authors will independently search from inception to November 2016: MEDLINE, Embase, CINAHL, Web of Science, the Cochrane Library, PROSPERO, the Joanna Briggs Institute and the International Clinical Trials Registry Platform. We will include all study designs except case series/reports of <10 patients describing their study population (aged 18 years and older) using terms such as persistent critical illness, chronic critical illness, and prolonged mechanical ventilation. Two authors will independently perform data extraction and complete risk of bias assessment. Our primary outcome is to determine actionable processes of care and interventions deemed relevant to patients experiencing persistent or chronic critical illness and their family members. Secondary outcomes include (1) performance measures and quality indicators considered relevant to our population of interest and (2) themes related to patient and family experience. DISCUSSION: We will use our systematic review findings, with data from patient, family member and clinician interviews, and a subsequent consensus building process to inform the development of quality metrics and tools to measure processes of care, outcomes and experience for patients experiencing persistent or chronic critical illness and their family members. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42016052715.

Patient and carer experience of hospital-based rehabilitation from intensive care to hospital discharge: mixed methods process evaluation of the RECOVER randomised clinical trial.

OBJECTIVES: To explore and compare patient/carer experiences of rehabilitation in the intervention and usual care arms of the RECOVER trial (ISRCTN09412438); a randomised controlled trial of a complex intervention of post-intensive care unit (ICU) acute hospital-based rehabilitation following critical illness. DESIGN: Mixed methods process evaluation including comparison of patients' and carers' experience of usual care versus the complex intervention. We integrated and compared quantitative data from a patient experience questionnaire (PEQ) with qualitative data from focus groups with patients and carers. SETTING: Two university-affiliated hospitals in Scotland. PARTICIPANTS: 240 patients discharged from ICU who required ≥48 hours of mechanical ventilation were randomised into the trial (120 per trial arm). Exclusion criteria comprised: primary neurologic diagnosis, palliative care, current/planned home ventilation and age <18 years. 182 patients completed the PEQ at 3 months postrandomisation. 22 participants (14 patients and 8 carers) took part in focus groups (2 per trial group) at >3 months postrandomisation. INTERVENTIONS: A complex intervention of post-ICU acute hospital rehabilitation, comprising enhanced physiotherapy, nutritional care and information provision, case-managed by dedicated rehabilitation assistants (RAs) working within existing ward-based clinical teams, delivered between ICU discharge and hospital discharge. Comparator was usual care. OUTCOME MEASURES: A novel PEQ capturing patient-reported aspects of quality care. RESULTS: The PEQ revealed statistically significant between-group differences across 4 key intervention components: physiotherapy (p=0.039), nutritional care (p=0.038), case management (p=0.045) and information provision (p<0.001), suggesting greater patient satisfaction in the intervention group. Focus group data strongly supported and helped explain these findings. Specifically, case management by dedicated RAs facilitated greater access to physiotherapy, nutritional care and information that cut across disciplinary boundaries and staffing constraints. Patients highly valued its individualisation according to their needs, abilities and preferences. CONCLUSIONS: Case management by dedicated RAs improves patients' experiences of post-ICU hospital-based rehabilitation and increases perceived quality of care. TRIAL REGISTRATION NUMBER: ISRCTN09412438.

A rehabilitation intervention to promote physical recovery following intensive care: a detailed description of construct development, rationale and content together with proposed taxonomy to capture processes in a randomised controlled trial.

BACKGROUND: Increasing numbers of patients are surviving critical illness, but survival may be associated with a constellation of physical and psychological sequelae that can cause ongoing disability and reduced health-related quality of life. Limited evidence currently exists to guide the optimum structure, timing, and content of rehabilitation programmes. There is a need to both develop and evaluate interventions to support and expedite recovery during the post-ICU discharge period. This paper describes the construct development for a complex rehabilitation intervention intended to promote physical recovery following critical illness. The intervention is currently being evaluated in a randomised trial (ISRCTN09412438; funder Chief Scientists Office, Scotland). METHODS: The intervention was developed using the Medical Research Council (MRC) framework for developing complex healthcare interventions. We ensured representation from a wide variety of stakeholders including content experts from multiple specialties, methodologists, and patient representation. The intervention construct was initially based on literature review, local observational and audit work, qualitative studies with ICU survivors, and brainstorming activities. Iterative refinement was aided by the publication of a National Institute for Health and Care Excellence guideline (No. 83), publicly available patient stories (Healthtalkonline), a stakeholder event in collaboration with the James Lind Alliance, and local piloting. Modelling and further work involved a feasibility trial and development of a novel generic rehabilitation assistant (GRA) role. Several rounds of external peer review during successive funding applications also contributed to development. RESULTS: The final construct for the complex intervention involved a dedicated GRA trained to pre-defined competencies across multiple rehabilitation domains (physiotherapy, dietetics, occupational therapy, and speech/language therapy), with specific training in post-critical illness issues. The intervention was from ICU discharge to 3 months post-discharge, including inpatient and post-hospital discharge elements. Clear strategies to provide information to patients/families were included. A detailed taxonomy was developed to define and describe the processes undertaken, and capture them during the trial. The detailed process measure description, together with a range of patient, health service, and economic outcomes were successfully mapped on to the modified CONSORT recommendations for reporting non-pharmacologic trial interventions. CONCLUSIONS: The MRC complex intervention framework was an effective guide to developing a novel post-ICU rehabilitation intervention. Combining a clearly defined new healthcare role with a detailed taxonomy of process and activity enabled the intervention to be clearly described for the purpose of trial delivery and reporting. These data will be useful when interpreting the results of the randomised trial, will increase internal and external trial validity, and help others implement the intervention if the intervention proves clinically and cost effective.

A longitudinal qualitative exploration of healthcare and informal support needs among survivors of critical illness: the RELINQUISH protocol.

INTRODUCTION AND BACKGROUND: Survival following critical illness is associated with a significant burden of physical, emotional and psychosocial morbidity. Recovery can be protracted and incomplete, with important and sustained effects upon everyday life, including family life, social participation and return to work. In stark contrast with other critically ill patient groups (eg, those following cardiothoracic surgery), there are comparatively few interventional studies of rehabilitation among the general intensive care unit patient population. This paper outlines the protocol for a sub study of the RECOVER study: a randomised controlled trial evaluating a complex intervention of enhanced ward-based rehabilitation for patients following discharge from intensive care. METHODS AND ANALYSIS: The RELINQUISH study is a nested longitudinal, qualitative study of family support and perceived healthcare needs among RECOVER participants at key stages of the recovery process and at up to 1 year following hospital discharge. Its central premise is that recovery is a dynamic process wherein patients' needs evolve over time. RELINQUISH is novel in that we will incorporate two parallel strategies into our data analysis: (1) a pragmatic health services-oriented approach, using an a priori analytical construct, the 'Timing it Right' framework and (2) a constructivist grounded theory approach which allows the emergence of new themes and theoretical understandings from the data. We will subsequently use Qualitative Health Needs Assessment methodology to inform the development of timely and responsive healthcare interventions throughout the recovery process. ETHICS AND DISSEMINATION: The protocol has been approved by the Lothian Research Ethics Committee (protocol number HSRU011). The study has been added to the UK Clinical Research Network Database (study ID. 9986). The authors will disseminate the findings in peer reviewed publications and to relevant critical care stakeholder groups.