Definitions, rates and associated mortality of ICU-acquired pneumonia: A multicenter cohort study.

INTRODUCTION: We aimed to analyze intensive care unit (ICU)-acquired pneumonia according to 7 definitions, estimating associated hospital mortality. METHODS: This cohort study was nested within an international randomized trial, evaluating the effect of probiotics on ICU-acquired pneumonia in 2650 mechanically ventilated adults. Each clinically suspected pneumonia was adjudicated by two physicians blinded to allocation and center. The primary outcome was ventilator-associated pneumonia (VAP) informed by ventilation for ≥2 days, new, progressive or persistent infiltrate plus 2 of: temperature > 38 °C or < 36 °C; leukopenia (<3 × 10(Fernando et al., 20206)/L) or leukocytosis (>10 × 10(Fernando et al., 20206)/L); and purulent sputum. We also used 6 other definitions estimating the risk of hospital mortality. RESULTS: The frequency of ICU-acquired pneumonia varied by definition: the trial primary outcome VAP (21.6%), Clinical Pulmonary Infection Score (CPIS) (24.9%), American College Chest Physicians (ACCP) (25.0%), International Sepsis Forum (ISF) (24.4%), Reducing Oxidative Stress Study (REDOXS) (17.6%), Centers for Disease Control (CDC) (7.8%), and invasively microbiologically confirmed (1.9%). The trial primary outcome VAP (HR 1.31 [1.08, 1.60]), ISF (HR 1.32 [1.09,1.60]), CPIS (HR 1.30 [1.08,1.58]) and ACCP definitions (HR 1.22 [1.00,1.47]) were associated with hospital mortality. CONCLUSIONS: Rates of ICU-acquired pneumonia vary by definition and are associated with differential increased risk of death.

Monitoring and auditing protocol adherence, data integrity and ethical conduct of a randomized clinical trial: A case study.

PURPOSE: To categorize, quantify and interpret findings documented in feedback letters of monitoring or auditing visits for an investigator-initiated, peer-review funded multicenter randomized trial testing probiotics for critically ill patients. MATERIALS & METHODS: In 37 Canadian centers, monitoring and auditing visits were performed by 3 trained individuals; findings were reported in feedback letters. At trial termination, we performed duplicate content analysis on letters, categorizing observations first into unique findings, followed by 10 pre-determined trial quality management domains. We further classified each observation into a) missing operational records, b) errors in process, and potential threats to c) data integrity, d) patient privacy or e) safety. RESULTS: Across 37 monitoring or auditing visits, 75 unique findings were categorized into 10 domains. Most frequently, observations were in domains of training documentation (180/566 [32%]) and the informed consent process (133/566 [23%]). Most observations were missing operational records (438/566 [77%]) rather than errors in process (128/566 [23%]). Of 75 findings, 13 (62/566 observations [11%]) posed a potential threat to data integrity, 1 (1/566 observation [0.18%]) to patient privacy, and 9 (49/566 observations [8.7%]) to patient safety. CONCLUSIONS: Monitoring and auditing findings predominantly concerned missing documentation with minimal threats to data integrity, patient privacy or safety. TRIAL REGISTRATION: PROSPECT (Probiotics: Prevention of Severe Pneumonia and Endotracheal Colonization Trial): NCT02462590.

Systemic and mucosal IgA responses are variably induced in response to SARS-CoV-2 mRNA vaccination and are associated with protection against subsequent infection.

Although SARS-CoV-2 infects the upper respiratory tract, we know little about the amount, type, and kinetics of antibodies (Ab) generated in the oral cavity in response to COVID-19 vaccination. We collected serum and saliva samples from participants receiving two doses of mRNA COVID-19 vaccines and measured the level of anti-SARS-CoV-2 Ab. We detected anti-Spike and anti-Receptor Binding Domain (RBD) IgG and IgA, as well as anti-Spike/RBD associated secretory component in the saliva of most participants after dose 1. Administration of a second dose of mRNA boosted the IgG but not the IgA response, with only 30% of participants remaining positive for IgA at this timepoint. At 6 months post-dose 2, these participants exhibited diminished anti-Spike/RBD IgG levels, although secretory component-associated anti-Spike Ab were more stable. Examining two prospective cohorts we found that participants who experienced breakthrough infections with SARS-CoV-2 variants had lower levels of vaccine-induced serum anti-Spike/RBD IgA at 2-4 weeks post-dose 2 compared to participants who did not experience an infection, whereas IgG levels were comparable between groups. These data suggest that COVID-19 vaccines that elicit a durable IgA response may have utility in preventing infection. Our study finds that a local secretory component-associated IgA response is induced by COVID-19 mRNA vaccination that persists in some, but not all participants. The serum and saliva IgA response modestly correlate at 2-4 weeks post-dose 2. Of note, levels of anti-Spike serum IgA (but not IgG) at this timepoint are lower in participants who subsequently become infected with SARS-CoV-2. As new surges of SARS-CoV-2 variants arise, developing COVID-19 booster shots that provoke high levels of IgA has the potential to reduce person-to-person transmission.

Diarrhea during critical illness: a multicenter cohort study.

PURPOSE: To study the incidence, predictors, and outcomes of diarrhea during the stay in the intensive care unit (ICU). METHODS: Prospective cohort of consecutive adults in the ICU for > 24 h during a 10-week period across 12 intensive care units (ICUs) internationally. The explored outcomes were: (1) incidence of diarrhea, (2) Clostridioides difficile-associated diarrhea (CDAD); (3) ICU and hospital length of stay (LOS) and mortality in patients with diarrhea. We fit generalized linear models to evaluate the predictors, management, morbidity and mortality associated with diarrhea. RESULTS: Among 1109 patients aged 61.4 (17.5) [mean (standard deviation)] years, 981(88.5%) were medical and 645 (58.2%) were mechanically ventilated. The incidence was 73.8% (818 patients, 73.8%, 95% confidence interval [CI] 71.1-76.6) using the definition of the World Health Organisation (WHO). Incidence varied across definitions (Bristol 53.5%, 95% CI 50.4-56.7; Bliss 37.7%, 95% CI 34.9-40.4). Of 99 patients with diarrhea undergoing CDAD testing, 23 tested positive (2.2% incidence, 95% CI 1.5-3.4). Independent predictors included enteral nutrition (RR 1.23, 95% CI 1.16-1.31, p < 0.001), antibiotic days (RR 1.02, 95% CI 1.02-1.03, p < 0.001), and suppositories (RR 1.14 95% CI 1.06-1.22, p < 0.001). Opiates decreased diarrhea risk (RR 0.76, 95% CI 0.68-0.86, p < 0.001). Diarrhea prompted management modifications (altered enteral nutrition or medications: RR 10.25, 95% CI 5.14-20.45, p < 0.001) or other consequences (fecal management device or CDAD testing: RR 6.16, 95% CI 3.4-11.17, p < 0.001). Diarrhea was associated with a longer time to discharge for ICU or hospital stay, but was not associated with hospital mortality. CONCLUSION: Diarrhea is common, has several predictors, and prompts changes in patient care, is associated with longer time to discharge but not mortality.

Retention in RCTs of physical rehabilitation for adults with frailty: a systematic review and meta-analysis.

BACKGROUND: Physical rehabilitation (PR) interventions can improve physical function for adults with frailty; however, participant retention rates in randomized controlled trials (RCTs) are unknown. Objective is to summarize participant retention rates in RCTs of PR for adults with frailty. Design is a systematic review and meta-analysis (DOI:10.17605/OSF.IO/G6XR2). Participants are adults ≥ 18 years with frailty. Setting consists of inpatient, outpatient and community-based interventions. Intervention includes any PR intervention. METHODS: We searched 7 electronic databases from inception to April 15, 2020 for published RCTs. Our primary outcome was participant retention rate to primary outcome measurement. Secondary outcomes included retention by study group, participant retention to intervention completion, reported reasons for attrition and reported strategies for maximizing retention. We completed screening, data extraction and risk of bias (ROB) assessments independently and in duplicate. We conducted a meta-analysis, calculating retention rates and 95% confidence intervals (CIs) using fixed or random-effects models, as appropriate. RESULTS: We included 21 RCTs, enrolling 1685 adults with frailty (median age 82.5 years (79.0, 82.2), 59.8% female (57.5, 69.8)). Twenty RCTs reported retention data, of which 90.0% (n = 18) had high ROB. The pooled participant retention rate to primary outcome measurement was 85.0% [95%CI (80.0, 90.0), I2 = 83.9%, p < 0.05]. There were no differences by group for retention to the primary outcome [intervention 87.0% (83.0, 91.0), p < 0.05, comparator 85.0% (79.0, 90.0), p < 0.05] or in retention to intervention completion [83.0% (95.0% CI (78.0-87.0), p < 0.05]. Of the 18 studies reporting 24 reasons for attrition, 51.3% were categorized as potentially modifiable by the research team (e.g. low motivation). Only 20.0% (n = 4) of studies reported strategies for maximizing retention. CONCLUSIONS: In this review of 21 RCTs of PR, we identified acceptable rates of retention for adults with frailty. High retention in PR interventions appears to be feasible in this population; however, our results are limited by a high ROB and heterogeneity.

Use of Video Technology in End-of-Life Care for Hospitalized Patients During the COVID-19 Pandemic.

BACKGROUND: Infection control protocols, including visitor restrictions, implemented during the COVID-19 pandemic threatened the ability to provide compassionate, family-centered care to patients dying in the hospital. In response, clinicians used videoconferencing technology to facilitate conversations between patients and their families. OBJECTIVES: To understand clinicians' perspectives on using videoconferencing technology to adapt to pandemic policies when caring for dying patients. METHODS: A qualitative descriptive study was conducted with 45 clinicians who provided end-of-life care to patients in 3 acute care units at an academically affiliated urban hospital in Canada during the first wave of the pandemic (March 2020-July 2020). A 3-step approach to conventional content analysis was used to code interview transcripts and construct overarching themes. RESULTS: Clinicians used videoconferencing technology to try to bridge gaps in end-of-life care by facilitating connections with family. Many benefits ensued, but there were also some drawbacks. Despite the opportunity for connection offered by virtual visits, participants noted concerns about equitable access to videoconferencing technology and authenticity of technology-assisted interactions. Participants also offered recommendations for future use of videoconferencing technology both during and beyond the pandemic. CONCLUSIONS: Clinician experiences can be used to inform policies and practices for using videoconferencing technology to provide high-quality end-of-life care in the future, including during public health crises.

Older Adults' Perceptions of Frailty Language: A Scoping Review.

There is growing interest in conceptualizing and diagnosing frailty. Less is understood, however, about older adults' perceptions of the term "frail", and the implications of being classified as "frail". The purpose of this scoping review was to map the breadth of primary studies; and describe the meaning, perceptions, and perceived implications of frailty language amongst community-dwelling older adults. Eight studies were included in the review and three core themes were identified: (1) understanding frailty as inevitable age-related decline in multiple domains, (2) perceiving frailty as a generalizing label, and (3) perceiving impacts of language on health and health care utilization. Clinical practice recommendations for health care professionals working with individuals with frailty include: (1) maintaining a holistic view of frailty that extends beyond physical function to include psychosocial and environmental constructs, (2) using person-first language, and (3) using a strengths-based approach to discuss aspects of frailty.

Evaluation of the SARS-CoV-2 Antibody Response to the BNT162b2 Vaccine in Patients Undergoing Hemodialysis.

Importance: Patients undergoing hemodialysis have a high mortality rate associated with COVID-19, and this patient population often has a poor response to vaccinations. Randomized clinical trials for COVID-19 vaccines included few patients with kidney disease; therefore, vaccine immunogenicity is uncertain in this population. Objective: To evaluate the SARS-CoV-2 antibody response in patients undergoing chronic hemodialysis following 1 vs 2 doses of BNT162b2 COVID-19 vaccination compared with health care workers serving as controls and convalescent serum. Design, Setting, and Participants: A prospective, single-center cohort study was conducted between February 2 and April 17, 2021, in Toronto, Ontario, Canada. Participants included 142 patients receiving in-center hemodialysis and 35 health care worker controls. Exposures: BNT162b2 (Pfizer-BioNTech) COVID-19 vaccine. Main Outcomes and Measures: SARS-CoV-2 IgG antibodies to the spike protein (anti-spike), receptor binding domain (anti-RBD), and nucleocapsid protein (anti-NP). Results: Among the 142 participants undergoing maintenance hemodialysis, 94 (66%) were men; median age was 72 (interquartile range, 62-79) years. SARS-CoV-2 IgG antibodies were measured in 66 patients receiving 1 vaccine dose following a public health policy change, 76 patients receiving 2 vaccine doses, and 35 health care workers receiving 2 vaccine doses. Detectable anti-NP suggestive of natural SARS-CoV-2 infection was detected in 15 of 142 (11%) patients at baseline, and only 3 patients had prior COVID-19 confirmed by reverse transcriptase polymerase chain reaction testing. Two additional patients contracted COVID-19 after receiving 2 doses of vaccine. In 66 patients receiving a single BNT162b2 dose, seroconversion occurred in 53 (80%) for anti-spike and 36 (55%) for anti-RBD by 28 days postdose, but a robust response, defined by reaching the median levels of antibodies in convalescent serum from COVID-19 survivors, was noted in only 15 patients (23%) for anti-spike and 4 (6%) for anti-RBD in convalescent serum from COVID-19 survivors. In patients receiving 2 doses of BNT162b2 vaccine, seroconversion occurred in 69 of 72 (96%) for anti-spike and 63 of 72 (88%) for anti-RBD by 2 weeks following the second dose and median convalescent serum levels were reached in 52 of 72 patients (72%) for anti-spike and 43 of 72 (60%) for anti-RBD. In contrast, all 35 health care workers exceeded the median level of anti-spike and anti-RBD found in convalescent serum 2 to 4 weeks after the second dose. Conclusions and Relevance: This study suggests poor immunogenicity 28 days following a single dose of BNT162b2 vaccine in the hemodialysis population, supporting adherence to recommended vaccination schedules and avoiding delay of the second dose in these at-risk individuals.

Scale-up and sustainability of a personalized end-of-life care intervention: a longitudinal mixed-methods study.

BACKGROUND: Scaling-up and sustaining healthcare interventions can be challenging. Our objective was to describe how the 3 Wishes Project (3WP), a personalized end-of-life intervention, was scaled-up and sustained in an intensive care unit (ICU). METHODS: In a longitudinal mixed-methods study from January 12,013 - December 31, 2018, dying patients and families were invited to participate if the probability of patient death was > 95% or after a decision to withdraw life support. A research team member or bedside clinician learned more about each of the patients and their family, then elicited and implemented at least 3 personalized wishes for patients and/or family members. We used a qualitative descriptive approach to analyze interviews and focus groups conducted with 25 clinicians who cared for the enrolled patients. We used descriptive statistics to summarize patient, wish, and clinician characteristics, and analyzed outcome data in quarters using Statistical Process Control charts. The primary outcome was enrollment of terminally ill patients and respective families; the secondary outcome was the number of wishes per patient; tertiary outcomes included wish features and stakeholder involvement. RESULTS: Both qualitative and quantitative analyses suggested a three-phase approach to the scale-up of this intervention during which 369 dying patients were enrolled, having 2039 terminal wishes implemented. From a research project to clinical program to an approach to practice, we documented a three-fold increase in enrolment with a five-fold increase in total wishes implemented, without a change in cost. Beginning as a study, the protocol provided structure; starting gradually enabled frontline staff to experience and recognize the value of acts of compassion for patients, families, and clinicians. The transition to a clinical program was marked by handover from the research staff to bedside staff, whereby project catalysts mentored project champions to create staff partnerships, and family engagement became more intentional. The final transition involved empowering staff to integrate the program as an approach to care, expanding it within and beyond the organization. CONCLUSIONS: The 3WP is an end-of-life intervention which was implemented as a study, scaled-up into a clinical program, and sustained by becoming integrated into practice as an approach to care.

Organ Donation at the End of Life: Experiences From the 3 Wishes Project.

PURPOSE: The 3 Wishes Project (3WP) promotes holistic end-of-life care in the intensive care unit (ICU) to honor dying patients, support families, and encourage clinician compassion. Organ donation is a wish that is sometimes made by, or on behalf of, critically ill patients. Our objective was to describe the interface between the 3WP and organ donation as experienced by families, clinicians, and organ donation coordinators. METHODS: In a multicenter evaluation of the 3WP in 4 Canadian ICUs, we conducted a thematic analysis of transcripts from interviews and focus groups with clinicians, organ donation coordinators, and families of dying or died patients for whom donation was considered. RESULTS: We analyzed transcripts from 26 interviews and 2 focus groups with 18 family members, 17 clinicians, and 6 organ donation coordinators. The central theme describes the mutual goals of the 3WP and organ donation-emphasizing personhood and agency across the temporal continuum of care. During family decision-making, conversations encouraged by the 3WP can facilitate preliminary discussions about donation. During preparation for donation, memory-making activities supported by the 3WP redirect focus toward personhood. During postmortem family care, the 3WP supports families, including when donation is unsuccessful, and highlights aspirational pursuits of donation while encouraging reflections on other fulfilled wishes. CONCLUSIONS: Organ donation and the 3WP provide complementary opportunities to engage in value-based conversations during the dying process. The shared values of these programs may help to incorporate organ donation and death into a person's life narrative and incorporate new life into a person's death narrative.

Clinician Perspectives on Caring for Dying Patients During the Pandemic : A Mixed-Methods Study.

BACKGROUND: The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic has affected the hospital experience for patients, visitors, and staff. OBJECTIVE: To understand clinician perspectives on adaptations to end-of-life care for dying patients and their families during the pandemic. DESIGN: Mixed-methods embedded study. (ClinicalTrials.gov: NCT04602520). SETTING: 3 acute care medical units in a tertiary care hospital from 16 March to 1 July 2020. PARTICIPANTS: 45 dying patients, 45 family members, and 45 clinicians. INTERVENTION: During the pandemic, clinicians continued an existing practice of collating personal information about dying patients and "what matters most," eliciting wishes, and implementing acts of compassion. MEASUREMENTS: Themes from semistructured clinician interviews that were summarized with representative quotations. RESULTS: Many barriers to end-of-life care arose because of infection control practices that mandated visiting restrictions and personal protective equipment, with attendant practical and psychological consequences. During hospitalization, family visits inside or outside the patient's room were possible for 36 patients (80.0%); 13 patients (28.9%) had virtual visits with a relative or friend. At the time of death, 20 patients (44.4%) had a family member at the bedside. Clinicians endeavored to prevent unmarked deaths by adopting advocacy roles to "fill the gap" of absent family and by initiating new and established ways to connect patients and relatives. LIMITATION: Absence of clinician symptom or wellness metrics; a single-center design. CONCLUSION: Clinicians expressed their humanity through several intentional practices to preserve personalized, compassionate end-of-life care for dying hospitalized patients during the SARS-CoV-2 pandemic. PRIMARY FUNDING SOURCE: Canadian Institutes of Health Research and Canadian Critical Care Trials Group Research Coordinator Fund.

Experiences of Bereaved Family Members Receiving Commemorative Paintings: A Qualitative Study.

Importance: Although family members of patients who die in the intensive care unit commonly experience long-term psychological distress, end-of-life bereavement support programs for such relatives are uncommon. Whether art influences the grief experience of families is largely unexplored. Objective: To explore the influence of personalized paintings created to honor deceased critically ill patients on family members' bereavement experience. Design, Setting, and Participants: A qualitative descriptive analysis was conducted of semistructured interviews of grieving relatives who received a painting after the death of their loved one. The deceased patients were from a 21-bed medical-surgical intensive care unit. Eleven families were invited to receive a painting, of whom 1 family declined. A total of 22 family members of 10 patients who died in the intensive care unit were interviewed in the study between July 11, 2017, and May 19, 2019. Interventions: Patients were enrolled in an end-of-life care program that elicits and implements wishes of patients and their families to bring peace during the dying process. Selected families of 10 decedents were invited to receive a painting to honor their loved one 1 to 10 months after the patient's death. Using details about the patient's life story, the artist created individualized paintings to commemorate each patient. Main Outcomes and Measures: The experiences of family members receiving a personalized painting and its reported influence on their grieving experience. Results: The family members of 10 decedents (mean [SD] age, 60 [14] years; 5 women [50%]; 8 White patients [80%]) were interviewed. The central theme of art to facilitate healing was illustrated through the following domains: the cocreation process, painting narratives, postmortem connections, and legacy. The process of cocreating the paintings with the artist and family members involved reminiscing, storytelling, and creativity. Family members emphasized the role of art to facilitate healing, exemplified through connections with images portrayed that deeply resonated with memories of their loved one. Participants indicated that the paintings validated that the patient was remembered, helped families feel less alone during a time of grief, honored the loved one's life, and enhanced connections between family members and clinicians. Conclusions and Relevance: This qualitative study's findings suggest that the creation of personalized paintings commemorating the lives of patients may help foster legacy and postmortem connections with clinicians and may help family members in their healing process.

Family and Clinician Experiences of Sympathy Cards in the 3 Wishes Project.

BACKGROUND: A recent randomized trial of bereaved family members of patients who died in an intensive care unit identified symptoms of depression and posttraumatic stress in recipients of semistructured condolence letters. OBJECTIVES: To explore family member and clinician experiences with receiving or sending handwritten sympathy cards upon the death of patients involved in a personalized end-of-life intervention, the 3 Wishes Project. METHODS: Interviews and focus groups were held with 171 family members and 222 clinicians at 4 centers to discuss their experiences with the 3 Wishes Project. Interview transcripts were searched to identify participants who discussed sympathy cards. Data related to sympathy cards were independently coded by 2 investigators through conventional content analysis. RESULTS: Sympathy cards were discussed during 32 interviews (by 25 family members of 21 patients and by 11 clinicians) and 2 focus groups (8 other clinicians). Family members reported that personalized sympathy cards were a welcome surprise; they experienced them as a heartfelt act of compassion. Clinicians viewed cards as an opportunity to express shared humanity with families, reminding them that they and their loved one were not forgotten. Signing cards allowed clinicians to reminisce individually and collectively with colleagues. Family members and clinicians experienced sympathy cards as a meaningful continuation of care after a patient's death. CONCLUSIONS: Inviting clinicians who cared for deceased patients to offer personalized, handwritten condolences to bereaved family members may cultivate sincere and individualized expressions of sympathy that bereaved families appreciate after the death of patients involved in the 3 Wishes Project.

Principles Guiding Nonpandemic Critical Care Research During a Pandemic.

OBJECTIVES: To describe the importance of critical care clinical research that is not pandemic-focused during pandemic times; outline principles to assist in the prioritization of nonpandemic research during pandemic times; and propose a guiding framework for decisions about whether, when and how to continue nonpandemic research while still honoring the moral and scientific imperative to launch research that is pandemic-focused. DESIGN/DATA SOURCES: Using in-person, email, and videoconference exchanges, we convened an interprofessional clinical research group, conducted a literature review of empirical studies, ethics documents and expert commentaries (2010 to present), and viewed traditional and social media posts (March 2020 to May 2020). Stakeholder consultation involved scientific, ethics, clinical, and administrative leaders. SETTING: Clinical research in the ICU. PATIENTS: Patients with and without coronavirus disease 2019. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: While clinical research should be prioritized to advantage patients with coronavirus disease 2019 in order to care for affected patients, it ideally would not unduly disadvantage patients without coronavirus disease 2019. Thus, timely, rigorous, relevant, and ethical clinical research is needed to improve the care and optimize outcomes for both patients with and without coronavirus disease 2019, acknowledging how many studies that are not exclusively focused on coronavirus disease 2019 remain relevant to patients with coronavirus disease 2019. Considerations to continue nonpandemic-focused research include the status of the pandemic, local jurisdictional guidance, capacity and safety of bedside and research personnel, disposition of patients already enrolled in nonpandemic studies, analyzing characteristics of each nonpandemic-focused study, research oversight, and final reporting requirements. CONCLUSIONS: Deliberation about continuing nonpandemic research should use objective, transparent criteria considering several aspects of the research process such as bedside and research staff safety, infection control, the informed consent model, protocol complexity, data collection, and implementation integrity. Decisions to pause or pursue nonpandemic research should be proportionate, transparent, and revisited as the pandemic abates.

Expanding the 3 Wishes Project for compassionate end-of-life care: a qualitative evaluation of local adaptations.

BACKGROUND: The 3 Wishes Project (3WP) is an end-of-life program that honors the dignity of dying patients by fostering meaningful connections among patients, families, and clinicians. Since 2013, it has become embedded in the culture of end-of-life care in over 20 ICUs across North America. The purpose of the current study is to describe the variation in implementation of 3WP across sites, in order to ascertain which factors facilitated multicenter implementation, which factors remain consistent across sites, and which may be adapted to suit local needs. METHODS: Using the methodology of qualitative description, we collected interview and focus group data from 85 clinicians who participated in the successful initiation and sustainment of 3WP in 9 ICUs. We describe the transition between different models of 3WP implementation, from core clinical program to the incorporation of various research activities. We describe various sources of financial and in-kind resources accessed to support the program. RESULTS: Beyond sharing a common goal of improving end-of-life care, sites varied considerably in organizational context, staff complement, and resources. Despite these differences, the program was successfully implemented at each site and eventually evolved from a clinical or research intervention to a general approach to end-of-life care. Key to this success was flexibility and the empowerment of frontline staff to tailor the program to address identified needs with available resources. This adaptability was fueled by cross-pollination of ideas within and outside of each site, resulting in the establishment of a network of like-minded individuals with a shared purpose. CONCLUSIONS: The successful initiation and sustainment of 3WP relied on local adaptations to suit organizational needs and resources. The semi-structured nature of the program facilitated these adaptations, encouraged creative and important ways of relating within local clinical cultures, and reinforced the main tenet of the program: meaningful human connection at the end of life. Local adaptations also encouraged a team approach to care, supplementing the typical patient-clinician dyad by explicitly empowering the healthcare team to collectively recognize and respond to the needs of dying patients, families, and each other. TRIAL REGISTRATION: NCT04147169 , retrospectively registered with clinicaltrials.gov on October 31, 2019.

The Efficacy and Safety of In-Intensive Care Unit Leg-Cycle Ergometry in Critically Ill Adults. A Systematic Review and Meta-analysis.

Background: Survivors of critical illness may experience physical-function deficits after intensive care unit (ICU) discharge. In-ICU cycle ergometry may facilitate early mobilization and decrease functional impairment.Objective: We conducted a systematic review and meta-analysis to understand the effect of in-ICU leg-cycle ergometry on patient-important and clinically relevant outcomes.Data Sources: We searched eight electronic databases from inception until July 2019.Data Extraction: We included randomized controlled trials (RCTs) and nonrandomized studies of critically ill adults admitted to the ICU for ≥24 hours, comparing cycling interventions to control arms that did not receive cycling. Main outcomes included physical function, mechanical ventilation (MV) duration, length of stay (LOS), quality of life (QoL), mortality, and safety. We conducted independent duplicate-citation screening, data abstraction, and risk-of-bias assessments. We pooled RCTs using a random-effects model and calculated the risk ratio (RR), mean difference (MD), or standardized MD with 95% confidence intervals (CIs). We assessed certainty of outcomes using the Grading of Recommendations Assessment, Development, and Evaluation approach.Results: Of 6,531 citations, we included 12 RCTs and 2 nonrandomized studies (n = 926). Between the cycling and control groups, there were no differences in physical function at hospital discharge (3 RCTs; n = 225; standardized MD, 0.07 [95% CI, -0.38 to 0.53]; very low certainty), MV duration (9 RCTs; n = 676; MD, 0.01 [-1.04 to 1.07] days; moderate certainty), ICU LOS (10 RCTs; n = 511; MD, 0.23 [-1.44 to 1.89] days; moderate certainty), hospital LOS (7 RCTs; n = 393, MD -0.07 [-3.87 to 3.73] days; moderate certainty), QoL at 6 months after hospital discharge (2 RCTs; n = 103; MD, 9.13 [13.80 to 32.05] points higher; very low certainty), or hospital mortality (7 RCTs; n = 710; RR 1.09 [0.82 to 1.46]; moderate-certainty). The adverse event rate in cycling sessions was 0.16% across studies (10 studies; 5 of 3,117 sessions; very low certainty).Conclusions: Cycling initiated in the ICU is probably safe; however, we did not find any differences in physical function, MV duration, LOS, QoL, or mortality compared with those not receiving cycling. Rigorously designed RCTs are needed to improve precision and further investigate the effect of cycling on patient-important outcomes.

Building organizational compassion among teams delivering end-of-life care in the intensive care unit: The 3 Wishes Project.

BACKGROUND: The 3 Wishes Project is a semistructured program that improves the quality of care for patients dying in the intensive care unit by eliciting and implementing wishes. This simple intervention honors the legacy of patients and eases family grief, forging human connections between family members and clinicians. AIM: To examine how the 3 Wishes Project enables collective patterns of compassion between patients, families, clinicians, and managerial leaders in the intensive care unit. DESIGN: Using a qualitative descriptive approach, interviews and focus groups were used to collect data from family members of dying patients, clinicians, and institutional leaders. Unconstrained directed qualitative content analysis was performed using Organizational Compassion as the analytic framework. SETTING/PARTICIPANTS: Four North American intensive care units, participants were 74 family members of dying patients, 72 frontline clinicians, and 20 managerial leaders. RESULTS: The policies and processes of the 3 Wishes Project exemplify organizational compassion by supporting individuals in the intensive care unit to collectively notice, feel, and respond to suffering. As an intervention that enables and empowers clinicians to engage in acts of kindness to enhance end-of-life care, the 3 Wishes Project is particularly well situated to encourage collective responses to suffering and promote compassion between patients, family members, and clinicians. CONCLUSIONS: Examining the 3 Wishes Project through the lens of organizational compassion reveals the potential of this program to cultivate the capacity for people to collectively notice, feel, and respond to suffering. Our data document multidirectional demonstrations of compassion between clinicians and family members, forging the type of human connections that may foster resilience.

Keepsakes at the End of Life.

CONTEXT: Keepsakes are a relatively unexplored form of bereavement support that is frequently provided as part of the 3 Wishes Project (3WP). The 3WP is a palliative care intervention in which individualized wishes are implemented in the adult intensive care unit for dying patients and their families. OBJECTIVES: We aimed to characterize and enumerate the keepsakes that were created as part of the 3WP and to understand their value from the perspective of bereaved family members. METHODS: We performed a secondary analysis of family interviews during a multicenter study on the 3WP and characterized all wishes that involved keepsakes. Sixty interviews with family members regarding the 3WP were reanalyzed using qualitative analysis to identify substantive themes related to keepsakes. RESULTS: Of 730 patients, 345 (47%) received keepsakes as part of their participation in 3WP. Most keepsakes were either tangible items that served as reminders of the patient's presence (thumbprints and locks of hair) or technology-assisted items (photographs and word clouds). The median cost per keepsake wish was $8.50 (interquartile range $2.00-$25.00). Qualitative analysis revealed two major themes: keepsakes are tangible items that are highly valued by family members; and the creation of the keepsake with clinical staff is valued and viewed as a gesture of compassion. CONCLUSION: Keepsakes are common wishes that clinicians in the intensive care unit are able to provide and sometimes cocreate with families when patients are dying. Both the offering to create the keepsake and receipt of the final product are perceived by family members as helpful.

Compassionate End-of-Life Care: Mixed-Methods Multisite Evaluation of the 3 Wishes Project.

Background: The 3 Wishes Project (3WP) is an end-of-life program that aims to honor the dignity of dying patients by creating meaningful patient- and family-centered memories while promoting humanistic interprofessional care. Objective: To determine whether this palliative intervention could be successfully implemented-defined as demonstrating value, transferability, affordability, and sustainability-beyond the intensive care unit in which it was created. Design: Mixed-methods formative program evaluation. (ClinicalTrials.gov: NCT04147169). Setting: 4 North American intensive care units. Participants: Dying patients, their families, clinicians, hospital managers, and administrators. Intervention: Wishes from dying patients, family members, and clinicians were elicited and implemented. Measurements: Patient characteristics and processes of care; the number, type, and cost of each wish; and semistructured interviews and focus groups with family members, clinicians, and managers. Results: A total of 730 patients were enrolled, and 3407 wishes were elicited. Qualitative data were gathered from 75 family members, 72 clinicians, and 20 managers or hospital administrators. Value included intentional comforting of families as they honored the lives and legacies of their loved ones while inspiring compassionate clinical care. Factors promoting transferability included family appreciation and a collaborative intensive care unit culture committed to dignity-conserving end-of-life care. Staff participation evolved from passive support to professional agency. Program initiation required minimal investment for reusable materials; thereafter, the mean cost was $5.19 (SD, $17.14) per wish. Sustainability was demonstrated by the continuation of 3WP at each site after study completion. Limitation: This descriptive formative evaluation describes tertiary care center-specific experiences rather than aiming for generalizability to all jurisdictions. Conclusion: The 3WP is a transferrable, affordable, and sustainable program that provides value to dying patients, their families, clinicians, and institutions. Primary Funding Source: Greenwall Foundation.

Fostering humanism: a mixed methods evaluation of the Footprints Project in critical care.

OBJECTIVES: The objectives of this mixed-methods study were to assess the uptake, sustainability and influence of the Footprints Project. SETTING: Twenty-two-bed university-affiliated ICU in Hamilton, Canada. PARTICIPANTS: ICU patients admitted and their families, as well as clinicians. INTERVENTIONS: We developed a personalised patient Footprints Form and Whiteboard to facilitate holistic, patient-centred care, to inform clinical encounters, and to create deeper connections among patients, families and clinicians. OUTCOME MEASURES: We conducted 3 audits to examine uptake and sustainability. We conducted semi-structured interviews with 10 clinicians, and held 5 focus groups with 25 clinicians; and we interviewed 5 patients and 13 family representatives of 5 patients who survived and 5 who died in the ICU. Transcripts were analysed using qualitative content analysis. RESULTS: The Footprints Project facilitated holistic, patient-centred care by setting the stage for patient and family experience, motivating the patient and humanising the patient for clinicians. Through informing clinical encounters, Footprints helped clinicians initiate more personal conversations, foster deeper connections and guide treatment. Professional practice influences included more focused attention on the patient, enhanced interdisciplinary communication and changes in community culture. Initially used in 15.8% of patients (audit A), uptake increased to 51.4% in audit B, and was sustained at 57.8% in audit C. CONCLUSIONS: By sharing valuable personal information about patients before and beyond their illness on individualised whiteboards at each bedside, the Footprints Project fosters humanism in critical care practice.