RESUMO
BACKGROUND: Whether proton-pump inhibitors are beneficial or harmful for stress ulcer prophylaxis in critically ill patients undergoing invasive ventilation is unclear. METHODS: In this international, randomized trial, we assigned critically ill adults who were undergoing invasive ventilation to receive intravenous pantoprazole (at a dose of 40 mg daily) or matching placebo. The primary efficacy outcome was clinically important upper gastrointestinal bleeding in the intensive care unit (ICU) at 90 days, and the primary safety outcome was death from any cause at 90 days. Multiplicity-adjusted secondary outcomes included ventilator-associated pneumonia, Clostridioides difficile infection, and patient-important bleeding. RESULTS: A total of 4821 patients underwent randomization in 68 ICUs. Clinically important upper gastrointestinal bleeding occurred in 25 of 2385 patients (1.0%) receiving pantoprazole and in 84 of 2377 patients (3.5%) receiving placebo (hazard ratio, 0.30; 95% confidence interval [CI], 0.19 to 0.47; P<0.001). At 90 days, death was reported in 696 of 2390 patients (29.1%) in the pantoprazole group and in 734 of 2379 patients (30.9%) in the placebo group (hazard ratio, 0.94; 95% CI, 0.85 to 1.04; P = 0.25). Patient-important bleeding was reduced with pantoprazole; all other secondary outcomes were similar in the two groups. CONCLUSIONS: Among patients undergoing invasive ventilation, pantoprazole resulted in a significantly lower risk of clinically important upper gastrointestinal bleeding than placebo, with no significant effect on mortality. (Funded by the Canadian Institutes of Health Research and others; REVISE ClinicalTrials.gov number, NCT03374800.).
Assuntos
Estado Terminal , Pantoprazol , Inibidores da Bomba de Prótons , Respiração Artificial , Humanos , Pantoprazol/uso terapêutico , Pantoprazol/efeitos adversos , Pantoprazol/administração & dosagem , Respiração Artificial/efeitos adversos , Masculino , Pessoa de Meia-Idade , Feminino , Inibidores da Bomba de Prótons/uso terapêutico , Inibidores da Bomba de Prótons/efeitos adversos , Inibidores da Bomba de Prótons/administração & dosagem , Idoso , Hemorragia Gastrointestinal/prevenção & controle , 2-Piridinilmetilsulfinilbenzimidazóis/uso terapêutico , 2-Piridinilmetilsulfinilbenzimidazóis/efeitos adversos , 2-Piridinilmetilsulfinilbenzimidazóis/administração & dosagem , Úlcera Péptica/prevenção & controle , Unidades de Terapia Intensiva , Pneumonia Associada à Ventilação Mecânica/prevenção & controle , Método Duplo-Cego , Estresse Fisiológico , AdultoRESUMO
BACKGROUND: We aimed to synthesize the qualitative evidence on the impacts of COVID-19-related restricted family presence policies from the perspective of patients, families, and healthcare professionals from neonatal (NICU), pediatric (PICU), or adult ICUs. METHODS: We searched MEDLINE, EMBASE, Cochrane Databases of Reviews and Clinical Trials, CINAHL, Scopus, PsycINFO, and Web of Science. Two researchers independently reviewed titles/abstracts and full-text articles for inclusion. Thematic analysis was completed following appraising article quality and assessing confidence in the individual review findings using standardized tools. RESULTS: We synthesized 54 findings from 184 studies, revealing the impacts of these policies in children and adults on: (1) Family integrated care and patient and family-centered care (e.g., disruption to breastfeeding/kangaroo care, dehumanizing of patients); (2) Patients, families, and healthcare professionals (e.g., negative mental health consequences, moral distress); (3) Support systems (e.g., loss of support from friends/families); and (4) Relationships (e.g., loss of essential bonding with infant, struggle to develop trust). Strategies to mitigate these impacts are reported. CONCLUSION: This review highlights the multifaceted impacts of restricted visitation policies across distinct care settings and strategies to mitigate the harmful effects of these policies and guide the creation of compassionate family presence policies in future health crises. REGISTRATION: https://www.crd.york.ac.uk/PROSPERO/display_record.php?RecordID=290263 .
Assuntos
COVID-19 , Estado Terminal , Família , Pesquisa Qualitativa , Humanos , COVID-19/epidemiologia , COVID-19/psicologia , Família/psicologia , Estado Terminal/psicologia , Cuidados Críticos/psicologia , SARS-CoV-2 , Visitas a Pacientes/psicologia , Pandemias , Pessoal de Saúde/psicologia , Adulto , Unidades de Terapia IntensivaRESUMO
OBJECTIVE: To determine if the STOP-IT randomized controlled trial changed antibiotic prescribing in patients with Complicated Intraabdominal Infection (CIAI). SUMMARY OF BACKGROUND DATA: CIAI is common and causes significant morbidity. In May 2015, the STOP-IT randomized controlled trial showed equivalent outcomes between four-day and clinically determined antibiotic duration. METHODS: This was a population-based retrospective cohort study using interrupted time series methods. The STOP-IT publication date was the exposure. Median duration of inpatient antibiotic prescription was the outcome. All adult patients admitted to four hospitals in Calgary, Canada between July 2012 and December 2018 with CIAI who survived at least four days following source control were included. Analysis was stratified by infectious source as appendix or biliary tract (group A) versus other (group B). RESULTS: Among 4384 included patients, clinical and demographic attributes were similar before vs after publication. In Group A, median inpatient antibiotic duration was 3 days and unchanged from the beginning to the end of the study period [adjusted median difference -0.00 days, 95% confidence interval (CI) -0.37 - 0.37 days]. In Group B, antibiotic duration was shorter at the end of the study period (7.87 vs 6.73 days; -1.14 days, CI-2.37 - 0.09 days), however there was no change in trend following publication (-0.03 days, CI -0.16 - 0.09). CONCLUSIONS: For appendiceal or biliary sources of CIAI, antibiotic duration was commensurate with the experimental arm of STOP-IT. For other sources, antibiotic duration was long and did not change in response to trial publication. Additional implementation science is needed to improve antibiotic stewardship.
Assuntos
Antibacterianos , Infecções Intra-Abdominais , Adulto , Humanos , Antibacterianos/uso terapêutico , Hospitalização , Análise de Séries Temporais Interrompida , Infecções Intra-Abdominais/tratamento farmacológico , Infecções Intra-Abdominais/induzido quimicamente , Estudos Retrospectivos , Ensaios Clínicos Controlados Aleatórios como AssuntoRESUMO
BACKGROUND: Antipsychotic medications do not alter the incidence or duration of delirium, but these medications are frequently prescribed and continued at transitions of care in critically ill patients when they may no longer be necessary or appropriate. OBJECTIVE: The purpose of this study was to identify and describe relevant domains and constructs that influence antipsychotic medication prescribing and deprescribing practices among physicians, nurses, and pharmacists that care for critically ill adult patients during and following critical illness. DESIGN: We conducted qualitative semi-structured interviews with critical care and ward healthcare professionals including physicians, nurses, and pharmacists to understand antipsychotic prescribing and deprescribing practices for critically ill adult patients during and following critical illness. PARTICIPANTS: Twenty-one interviews were conducted with 11 physicians, five nurses, and five pharmacists from predominantly academic centres in Alberta, Canada, between July 6 and October 29, 2021. MAIN MEASURES: We used deductive thematic analysis using the Theoretical Domains Framework (TDF) to identify and describe constructs within relevant domains. KEY RESULTS: Seven TDF domains were identified as relevant from the analysis: Social/Professional role and identity; Beliefs about capabilities; Reinforcement; Motivations and goals; Memory, attention, and decision processes; Environmental context and resources; and Beliefs about consequences. Participants reported antipsychotic prescribing for multiple indications beyond delirium and agitation including patient and staff safety, sleep management, and environmental factors such as staff availability and workload. Participants identified potential antipsychotic deprescribing strategies to reduce ongoing antipsychotic medication prescriptions for critically ill patients including direct communication tools between prescribers at transitions of care. CONCLUSIONS: Critical care and ward healthcare professionals report several factors influencing established antipsychotic medication prescribing practices. These factors aim to maintain patient and staff safety to facilitate the provision of care to patients with delirium and agitation limiting adherence to current guideline recommendations.
Assuntos
Antipsicóticos , Delírio , Desprescrições , Humanos , Adulto , Antipsicóticos/uso terapêutico , Estado Terminal/terapia , Pesquisa Qualitativa , Delírio/tratamento farmacológico , Alberta/epidemiologiaRESUMO
OBJECTIVE: To assess the effect of family presence on the prevalence and duration of delirium in adults admitted to an ICU. DESIGN: Retrospective cohort study. SETTING: Medical-surgical ICUs in Alberta, AB, Canada. PATIENTS: A population of 25,537 unique patients admitted at least once to an Alberta ICU. METHODS: We obtained electronic health records of consecutive adults (≥ 18 yr) admitted to one of 14 medical-surgical ICU in Alberta, Canada, from January 1, 2014, to December 30, 2018. Family presence was quantified using a validated algorithm and categorized as: 1) physical presence in ICU, 2) telephone call only, and 3) no presence (reference group). Delirium was measured using the Intensive Care Delirium Screening Checklist (ICDSC) and defined as an ICDSC greater than or equal to 4. Multivariable mixed-effects logistic and linear regression were used to evaluate the association between family presence and prevalence (binary) and duration (d) of delirium, respectively. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: The association between family presence and delirium prevalence differed according to admission type and admission Glasgow Coma Scale (GCS). Among medical and emergency surgical patients irrespective of admission GCS, physical presence of family was not significantly associated with the prevalence of delirium. In elective surgical patients, physical presence of family was associated with decreased prevalence of delirium in patients with intact Glasgow Coma Scale (GCS = 15; adjusted odds ratio, 0.60; 95% CI, 0.39-0.97; p = 0.02). Physical presence of family (adjusted mean difference [AMD] -1.87 d; 95% CI, -2.01 to -1.81; p < 0.001) and telephone calls (AMD -1.41 d; 95% CI, -1.52 to -1.31; p < 0.001) were associated with decreased duration of delirium in all patients. CONCLUSIONS: The effects of family presence on delirium are complex and dependent on type of visitation, reason for ICU admission, and brain function on ICU admission.
Assuntos
Estado Terminal , Delírio , Adulto , Alberta/epidemiologia , Estado Terminal/epidemiologia , Delírio/diagnóstico , Humanos , Unidades de Terapia Intensiva , Estudos RetrospectivosRESUMO
Rationale: Delirium is common in the ICU and portends worse ICU and hospital outcomes. The effect of delirium in the ICU on post-hospital discharge mortality and health resource use is less well known. Objectives: To estimate mortality and health resource use 2.5 years after hospital discharge in critically ill patients admitted to the ICU. Methods: This was a population-based, propensity score-matched, retrospective cohort study of adult patients admitted to 1 of 14 medical-surgical ICUs from January 1, 2014, to June 30, 2016. Delirium was measured by using the 8-point Intensive Care Delirium Screening Checklist. The primary outcome was mortality. The secondary outcome was a composite measure of subsequent emergency department visits, hospital readmission, or mortality. Measurements and Main Results: There were 5,936 propensity score-matched patients with and without a history of incident delirium who survived to hospital discharge. Delirium was associated with increased mortality 0-30 days after hospital discharge (hazard ratio, 1.44 [95% confidence interval, 1.08-1.92]). There was no significant difference in mortality more than 30 days after hospital discharge (delirium: 3.9%, no delirium: 2.6%). There was a persistent increased risk of emergency department visits, hospital readmissions, or mortality after hospital discharge (hazard ratio, 1.12 [95% confidence interval, 1.07-1.17]) throughout the study period. Conclusions: ICU delirium is associated with increased mortality 0-30 days after hospital discharge.
Assuntos
Delírio/mortalidade , Utilização de Instalações e Serviços/estatística & dados numéricos , Unidades de Terapia Intensiva , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Alberta/epidemiologia , Estado Terminal , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Alta do Paciente , Prognóstico , Pontuação de Propensão , Estudos Retrospectivos , Análise de Sobrevida , Adulto JovemRESUMO
PURPOSE: We sought to compare the cost-effectiveness of probiotics and usual care with usual care without probiotics in mechanically ventilated, intensive care unit patients alongside the Probiotics to Prevent Severe Pneumonia and Endotracheal Colonization Trial (PROSPECT). METHODS: We conducted a health economic evaluation alongside the PROSPECT randomized control trial (October 2013-March 2019). We adopted a public healthcare payer's perspective. Forty-four intensive care units in three countries (Canada/USA/Saudi Arabia) with adult critically ill, mechanically ventilated patients (N = 2,650) were included. Interventions were probiotics (Lactobacillus rhamnosus GG) vs placebo administered enterally twice daily. We collected healthcare resource use and estimated unit costs in 2019 United States dollars (USD) over a time horizon from randomization to hospital discharge/death. We calculated incremental cost-effectiveness ratios (ICERs) comparing probiotics vs usual care. The primary outcome was incremental cost per ventilator-associated pneumonia (VAP) event averted; secondary outcomes were costs per Clostridioides difficile-associated diarrhea (CDAD), antibiotic-associated diarrhea (AAD), and mortality averted. Uncertainty was investigated using nonparametric bootstrapping and sensitivity analyses. RESULTS: Mean (standard deviation [SD]) cost per patient was USD 66,914 (91,098) for patients randomized to probiotics, with a median [interquartile range (IQR)] of USD 42,947 [22,239 to 76,205]. By comparison, for those not receiving probiotics, mean (SD) cost per patient was USD 62,701 (78,676) (median [IQR], USD 41,102 [23,170 to 75,140]; incremental cost, USD 4,213; 95% confidence interval [CI], -2,269 to 10,708). Incremental cost-effectiveness ratios for VAP or AAD events averted, probiotics were dominated by usual care (more expensive, with similar effectiveness). The ICERs were USD 1,473,400 per CDAD event averted (95% CI, undefined) and USD 396,764 per death averted (95% CI, undefined). Cost-effectiveness acceptability curves reveal that probiotics were not cost-effective across wide ranges of plausible willingness-to-pay thresholds. Sensitivity analyses did not change the conclusions. CONCLUSIONS: Probiotics for VAP prevention among critically ill patients were not cost-effective. Study registration data www. CLINICALTRIALS: gov (NCT01782755); registered 4 February 2013.
RéSUMé: OBJECTIF: Nous avons cherché à comparer le rapport coût-efficacité d'un traitement avec probiotiques ajoutés aux soins habituels avec des soins habituels prodigués sans probiotiques chez les patients des soins intensifs sous ventilation mécanique dans le cadre de l'étude PROSPECT (Probiotics to Prevent Severe Pneumonia and Endotracheal Colonization Trial). MéTHODE: Nous avons réalisé une évaluation de l'économie de la santé parallèlement à l'étude randomisée contrôlée PROSPECT (octobre 2013-mars 2019). Nous avons adopté le point de vue d'un payeur public de services de santé. Quarante-quatre unités de soins intensifs dans trois pays (Canada/États-Unis/Arabie saoudite) prenant soin de patients adultes gravement malades sous ventilation mécanique (n = 2650) ont été inclus. Les interventions ont été les suivantes : probiotiques (Lactobacillus rhamnosus GG) vs placebo administrés par voie entérale deux fois par jour. Nous avons recueilli les données concernant l'utilisation des ressources en soins de santé et estimé les coûts unitaires en dollars américains (USD) de 2019 sur un horizon temporel allant de la randomisation au congé de l'hôpital / décès. Nous avons calculé des rapports coût-efficacité différentiels (RCED) en comparant les probiotiques vs les soins habituels. Le critère d'évaluation principal était le coût différentiel par événement évité de pneumonie associée au ventilateur (PAV); les critères d'évaluation secondaires étaient les coûts par diarrhée associée au Clostridioides difficile (DACD), diarrhée associée aux antibiotiques (DAA) et mortalité évitées. L'incertitude a été étudiée à l'aide d'analyses d'amorçage et de sensibilité non paramétriques. RéSULTATS: Le coût moyen (écart type [ÉT]) par patient était de 66 914 (91 098) USD pour les patients randomisés au groupe probiotiques, avec une médiane [écart interquartile (ÉIQ)] de 42 947 USD [22 239 à 76 205]. En comparaison, pour ceux ne recevant pas de probiotiques, le coût moyen (ÉT) par patient était de 62 701 USD (78 676) (médiane [ÉIQ], 41 102 USD [23 170 à 75 140]; coût différentiel, 4213 USD; intervalle de confiance [IC] à 95%, -2269 à 10 708). En matière de rapports coût-efficacité différentiels pour les événements de PAV ou DAA évités, les probiotiques étaient dominés par les soins habituels (plus coûteux, avec une efficacité similaire). Les RCED étaient de 1 473 400 USD par événement de DACD évitée (IC 95 %, non défini) et de 396 764 USD par décès évité (IC 95 %, non défini). Les courbes d'acceptabilité coût-efficacité révèlent que les probiotiques n'étaient pas rentables dans de larges gammes de seuils plausibles de volonté de payer. Les analyses de sensibilité n'ont pas modifié les conclusions. CONCLUSION: Les probiotiques utilisés pour prévenir la PAV chez les patients gravement malades n'étaient pas rentables. Enregistrement de l'étude : www.clinicaltrials.gov (NCT01782755); enregistrée le 4 février 2013.
Assuntos
Pneumonia Associada à Ventilação Mecânica , Probióticos , Adulto , Humanos , Análise Custo-Benefício , Estado Terminal , Probióticos/uso terapêutico , Pneumonia Associada à Ventilação Mecânica/prevenção & controle , Diarreia/prevenção & controleRESUMO
PURPOSE: Hospital policies forbidding or limiting families from visiting relatives on the intensive care unit (ICU) has affected patients, families, healthcare professionals, and patient- and family-centered care (PFCC). We sought to refine evidence-informed consensus statements to guide the creation of ICU visitation policies during the current COVID-19 pandemic and future pandemics and to identify barriers and facilitators to their implementation and sustained uptake in Canadian ICUs. METHODS: We created consensus statements from 36 evidence-informed experiences (i.e., impacts on patients, families, healthcare professionals, and PFCC) and 63 evidence-informed strategies (i.e., ways to improve restricted visitation) identified during a modified Delphi process (described elsewhere). Over two half-day virtual meetings on 7 and 8 April 2021, 45 stakeholders (patients, families, researchers, clinicians, decision-makers) discussed and refined these consensus statements. Through qualitative descriptive content analysis, we evaluated the following points for 99 consensus statements: 1) their importance for improving restricted visitation policies; 2) suggested modifications to make them more applicable; and 3) facilitators and barriers to implementing these statements when creating ICU visitation policies. RESULTS: Through discussion, participants identified three areas for improvement: 1) clarity, 2) accessibility, and 3) feasibility. Stakeholders identified several implementation facilitators (clear, flexible, succinct, and prioritized statements available in multiple modes), barriers (perceived lack of flexibility, lack of partnership between government and hospital, change fatigue), and ways to measure and monitor their use (e.g., family satisfaction, qualitative interviews). CONCLUSIONS: Existing guidance on policies that disallowed or restricted visitation in intensive care units were confusing, hard to operationalize, and often lacked supporting evidence. Prioritized, succinct, and clear consensus statements allowing for local adaptability are necessary to guide the creation of ICU visitation policies and to optimize PFCC.
RéSUMé: OBJECTIF: Les politiques hospitalières interdisant ou limitant les visites des familles à des proches à l'unité de soins intensifs (USI) ont affecté les patients, les familles, les professionnels de la santé et les soins centrés sur le patient et la famille (SCPF). Nous avons cherché à affiner les déclarations de consensus fondées sur des données probantes afin de guider la création de politiques de visite aux soins intensifs pendant la pandémie actuelle de COVID-19 et les pandémies futures, et dans le but d'identifier les obstacles et les critères facilitants à leur mise en Åuvre et à leur adoption répandue dans les unités de soins intensifs canadiennes. MéTHODE: Nous avons créé des déclarations de consensus à partir de 36 expériences fondées sur des données probantes (c.-à-d. impacts sur les patients, les familles, les professionnels de la santé et les SCPF) et 63 stratégies fondées sur des données probantes (c.-à-d. moyens d'améliorer les restrictions des visites) identifiées au cours d'un processus Delphi modifié (décrit ailleurs). Au cours de deux réunions virtuelles d'une demi-journée tenues les 7 et 8 avril 2021, 45 intervenants (patients, familles, chercheurs, cliniciens, décideurs) ont discuté et affiné ces déclarations de consensus. Grâce à une analyse descriptive qualitative du contenu, nous avons évalué les points suivants pour 99 déclarations de consensus : 1) leur importance pour l'amélioration des politiques de restriction des visites; 2) les modifications suggérées pour les rendre plus applicables; et 3) les critères facilitants et les obstacles à la mise en Åuvre de ces déclarations lors de la création de politiques de visite aux soins intensifs. RéSULTATS: En discutant, les participants ont identifié trois domaines à améliorer : 1) la clarté, 2) l'accessibilité et 3) la faisabilité. Les intervenants ont identifié plusieurs critères facilitants à la mise en Åuvre (énoncés clairs, flexibles, succincts et hiérarchisés disponibles dans plusieurs modes), des obstacles (manque perçu de flexibilité, manque de partenariat entre le gouvernement et l'hôpital, fatigue du changement) et des moyens de mesurer et de surveiller leur utilisation (p. ex., satisfaction des familles, entrevues qualitatives). CONCLUSION: Les directives existantes sur les politiques qui interdisaient ou limitaient les visites dans les unités de soins intensifs étaient déroutantes, difficiles à mettre en oeuvre et manquaient souvent de données probantes à l'appui. Des déclarations de consensus hiérarchisées, succinctes et claires permettant une adaptabilité locale sont nécessaires pour guider la création de politiques de visite en soins intensifs et pour optimiser les soins centrés sur le patient et la famille.
Assuntos
COVID-19 , Visitas a Pacientes , Canadá , Humanos , Unidades de Terapia Intensiva , Pandemias/prevenção & controle , PolíticasRESUMO
BACKGROUND: Antipsychotic medications are frequently prescribed in acute care for clinical indications other than primary psychiatric disorders such as delirium. Unfortunately, they are commonly continued at hospital discharge and at follow-ups thereafter. The objective of this scoping review was to characterize antipsychotic medication prescribing practices, to describe healthcare professional perceptions on antipsychotic prescribing and deprescribing practices, and to report on antipsychotic deprescribing strategies within acute care. METHODS: We searched MEDLINE, EMBASE, PsycINFO, CINAHL, and Web of Science databases from inception date to July 3, 2021 for published primary research studies reporting on antipsychotic medication prescribing and deprescribing practices, and perceptions on those practices within acute care. We included all study designs excluding protocols, editorials, opinion pieces, and systematic or scoping reviews. Two reviewers screened and abstracted data independently and in duplicate. The protocol was registered on Open Science Framework prior to data abstraction (10.17605/OSF.IO/W635Z). RESULTS: Of 4528 studies screened, we included 80 studies. Healthcare professionals across all acute care settings (intensive care, inpatient, emergency department) perceived prescribing haloperidol (n = 36/36, 100%) most frequently, while measured prescribing practices reported common quetiapine prescribing (n = 26/36, 76%). Indications for antipsychotic prescribing were delirium (n = 48/69, 70%) and agitation (n = 20/69, 29%). Quetiapine (n = 18/18, 100%) was most frequently prescribed at hospital discharge. Three studies reported in-hospital antipsychotic deprescribing strategies focused on pharmacist-driven deprescribing authority, handoff tools, and educational sessions. CONCLUSIONS: Perceived antipsychotic prescribing practices differed from measured prescribing practices in acute care settings. Few in-hospital deprescribing strategies were described. Ongoing evaluation of antipsychotic deprescribing strategies are needed to evaluate their efficacy and risk.
Assuntos
Antipsicóticos , Delírio , Humanos , Antipsicóticos/uso terapêutico , Haloperidol/uso terapêutico , Fumarato de Quetiapina/uso terapêutico , Cuidados Críticos , Atenção à SaúdeRESUMO
BACKGROUND: There is an urgent need to understand the determinants (i.e., barriers and facilitators) of de-implementation. The purpose of this study was to develop a comprehensive list of determinants of the de-implementation of low-value care from the published literature and to compare this list to determinants identified by a group of stakeholders with lived experience with de-implementation. METHODS: This was a two-phase multi-method study. First, a systematic review examined published barriers and facilitators to de-implementation. Articles were identified through searches within electronic databases, reference lists and the grey literature. Citations were screened independently and in duplicate and included if they were: 1) written in English; and 2) described a barrier or facilitator to de-implementation of any clinical practice in adults (age ≥ 18 years). 'Raw text' determinants cited within included articles were extracted and synthesized into a list of representative determinants using conventional content analysis. Second, semi-structured interviews were conducted with decision-makers (unit managers and medical directors) and healthcare professionals working in adult critical care medicine to explore the overlap between the determinants found in the systematic review to those experienced in critical care medicine. Thematic content analysis was used to identify key themes emerging from the interviews. RESULTS: In the systematic review, reviewers included 172 articles from 35,368 unique citations. From 437 raw text barriers and 280 raw text facilitators, content analysis produced 29 distinct barriers and 24 distinct facilitators to de-implementation. Distinct barriers commonly cited within raw text included 'lack of credible evidence to support de-implementation' (n = 90, 21%), 'entrenched norms and clinicians' resistance to change (n = 43, 21%), and 'patient demands and preferences' (n = 28, 6%). Distinct facilitators commonly cited within raw text included 'stakeholder collaboration and communication' (n = 43, 15%), and 'availability of credible evidence' (n = 33, 12%). From stakeholder interviews, 23 of 29 distinct barriers and 20 of 24 distinct facilitators from the systematic review were cited as key themes relevant to de-implementation in critical care. CONCLUSIONS: The availability and quality of evidence that identifies a clinical practice as low-value, as well as healthcare professional willingness to change, and stakeholder collaboration are common and important determinants of de-implementation and may serve as targets for future de-implementation initiatives. TRIAL REGISTRATION: The systematic review was registered in PROSPERO CRD42016050234 .
Assuntos
Atenção à Saúde , Cuidados de Baixo Valor , Adolescente , Adulto , Pessoal de Saúde , Humanos , Projetos de PesquisaRESUMO
BACKGROUND: Patients are important stakeholders in reducing low-value care, yet mechanisms for optimizing their involvement in low-value care remain unclear. To explore the role of patients in the development and implementation of Choosing Wisely recommendations to reduce low-value care and to assess the likelihood that existing patient resources will change patient health behaviour. METHODS: Three phased mixed-methods study: 1) content analysis of all publicly available Choosing Wisely clinician lists and patient resources from the United States of America and Canada. Quantitative data was summarized with frequencies and free text comments were analyzed with qualitative thematic content analysis; 2) semi-structured telephone interviews with a purposive sample of representatives of professional societies who created Choosing Wisely clinician lists and members of the public (including patients and family members). Interviews were transcribed verbatim, and two researchers conducted qualitative template analysis; 3) evaluation of Choosing Wisely patient resources. Two public partners were identified through the Calgary Critical Care Research Network and independently answered two free text questions "would this change your health behaviour" and "would you discuss this material with a healthcare provider". Free text data was analyzed by two researchers using thematic content analysis. RESULTS: From the content analysis of 136 Choosing Wisely clinician lists, six reported patient involvement in their development. From 148 patient resource documents that were mapped onto a conceptual framework (Inform, Activate, Collaborate) 64% described patient engagement at the level of Inform (educating patients). From 19 interviews stakeholder perceptions of patient involvement in reducing low-value care were captured by four themes: 1) impact of perceived power dynamics on the discussion of low-value care in the clinical interaction, 2) how to communicate about low-value care, 3) perceived barriers to patient involvement in reducing low-value care, and 4) suggested strategies to engage patients and families in Choosing Wisely initiatives. In the final phase of work in response to the question "would this change your health behaviour" two patient partners agreed 'yes' on 27% of patient resources. CONCLUSIONS: Opportunities exist to increase patient and family participation in initiatives to reduce low-value care.
Assuntos
Cuidados Críticos , Participação do Paciente , Canadá , Humanos , Estados UnidosRESUMO
BACKGROUND: Intensive care unit (ICU) patients undergoing transitions in care are at increased risk of adverse events and gaps in medical care. We evaluated existing patient- and family-centered transitions in care tools and identified facilitators, barriers, and implementation considerations for the application of a transitions in care bundle in critically ill adults (i.e., a collection of evidence-based patient- and family-centred tools to improve outcomes during and after transitions from the intensive care unit [ICU] to hospital ward or community). METHODS: We conducted a concurrent mixed methods (quan + QUAL) study, including stakeholders with experience in ICU transitions in care (i.e., patient/family partners, researchers, decision-makers, providers, and other knowledge-users). First, participants scored existing transitions in care tools using the modified Appraisal of Guidelines, Research and Evaluation (AGREE-II) framework. Transitions in care tools were discussed by stakeholders and either accepted, accepted with modifications, or rejected if consensus was achieved (≥70% agreement). We summarized quantitative results using frequencies and medians. Second, we conducted a qualitative analysis of participant discussions using grounded theory principles to elicit factors influencing AGREE-II scores, and to identify barriers, facilitators, and implementation considerations for the application of a transitions in care bundle. RESULTS: Twenty-nine stakeholders attended. Of 18 transitions in care tools evaluated, seven (39%) tools were accepted with modifications, one (6%) tool was rejected, and consensus was not reached for ten (55%) tools. Qualitative analysis found that participants' AGREE-II rankings were influenced by: 1) language (e.g., inclusive, balance of jargon and lay language); 2) if the tool was comprehensive (i.e., could stand alone); 3) if the tool could be individualized for each patient; 4) impact to clinical workflow; and 5) how the tool was presented (e.g., brochure, video). Participants discussed implementation considerations for a patient- and family-centered transitions in care bundle: 1) delivery (e.g., tool format and timing); 2) continuity (e.g., follow-up after ICU discharge); and 3) continuous evaluation and improvement (e.g., frequency of tool use). Participants discussed existing facilitators (e.g., collaboration and co-design) and barriers (e.g., health system capacity) that would impact application of a transitions in care bundle. CONCLUSIONS: Findings will inform future research to develop a transitions in care bundle for transitions from the ICU, co-designed with patients, families, providers, researchers, decision-makers, and knowledge-users.
Assuntos
Pacotes de Assistência ao Paciente , Adulto , Consenso , Cuidados Críticos , Humanos , Unidades de Terapia Intensiva , Transferência de PacientesRESUMO
Importance: The efficacy and safety of prone positioning is unclear in nonintubated patients with acute hypoxemia and COVID-19. Objective: To evaluate the efficacy and adverse events of prone positioning in nonintubated adult patients with acute hypoxemia and COVID-19. Design, Setting, and Participants: Pragmatic, unblinded randomized clinical trial conducted at 21 hospitals in Canada, Kuwait, Saudi Arabia, and the US. Eligible adult patients with COVID-19 were not intubated and required oxygen (≥40%) or noninvasive ventilation. A total of 400 patients were enrolled between May 19, 2020, and May 18, 2021, and final follow-up was completed in July 2021. Intervention: Patients were randomized to awake prone positioning (n = 205) or usual care without prone positioning (control; n = 195). Main Outcomes and Measures: The primary outcome was endotracheal intubation within 30 days of randomization. The secondary outcomes included mortality at 60 days, days free from invasive mechanical ventilation or noninvasive ventilation at 30 days, days free from the intensive care unit or hospital at 60 days, adverse events, and serious adverse events. Results: Among the 400 patients who were randomized (mean age, 57.6 years [SD, 12.83 years]; 117 [29.3%] were women), all (100%) completed the trial. In the first 4 days after randomization, the median duration of prone positioning was 4.8 h/d (IQR, 1.8 to 8.0 h/d) in the awake prone positioning group vs 0 h/d (IQR, 0 to 0 h/d) in the control group. By day 30, 70 of 205 patients (34.1%) in the prone positioning group were intubated vs 79 of 195 patients (40.5%) in the control group (hazard ratio, 0.81 [95% CI, 0.59 to 1.12], P = .20; absolute difference, -6.37% [95% CI, -15.83% to 3.10%]). Prone positioning did not significantly reduce mortality at 60 days (hazard ratio, 0.93 [95% CI, 0.62 to 1.40], P = .54; absolute difference, -1.15% [95% CI, -9.40% to 7.10%]) and had no significant effect on days free from invasive mechanical ventilation or noninvasive ventilation at 30 days or on days free from the intensive care unit or hospital at 60 days. There were no serious adverse events in either group. In the awake prone positioning group, 21 patients (10%) experienced adverse events and the most frequently reported were musculoskeletal pain or discomfort from prone positioning (13 of 205 patients [6.34%]) and desaturation (2 of 205 patients [0.98%]). There were no reported adverse events in the control group. Conclusions and Relevance: In patients with acute hypoxemic respiratory failure from COVID-19, prone positioning, compared with usual care without prone positioning, did not significantly reduce endotracheal intubation at 30 days. However, the effect size for the primary study outcome was imprecise and does not exclude a clinically important benefit. Trial Registration: ClinicalTrials.gov Identifier: NCT04350723.
Assuntos
COVID-19 , Intubação Intratraqueal , Decúbito Ventral , Insuficiência Respiratória , Vigília , Adulto , Idoso , COVID-19/complicações , COVID-19/terapia , Feminino , Humanos , Hipóxia/etiologia , Hipóxia/terapia , Intubação Intratraqueal/métodos , Masculino , Pessoa de Meia-Idade , Respiração Artificial/métodos , Síndrome do Desconforto Respiratório/etiologia , Síndrome do Desconforto Respiratório/terapia , Insuficiência Respiratória/etiologia , Insuficiência Respiratória/terapiaRESUMO
BACKGROUND: It is unclear whether vasopressors can be safely administered through a peripheral intravenous (PIV). Systematic review and meta-analysis methodology was used to examine the incidence of local anatomic adverse events associated with PIV vasopressor administration in patients of any age cared for in any acute care environment. METHODS: MEDLINE, EMBASE, CINAHL, the Cochrane Central Register of controlled trials, and the Database of Abstracts of Reviews of Effects were searched without restriction from inception to October 2019. References of included studies and related reviews, as well as relevant conference proceedings were also searched. Studies were included if they were: (1) cohort, quasi-experimental, or randomized controlled trial study design; (2) conducted in humans of any age or clinical setting; and (3) reported on local anatomic adverse events associated with PIV vasopressor administration. Risk of bias was assessed using the Revised Cochrane risk-of-bias tool for randomized trials or the Joanna Briggs Institute checklist for prevalence studies where appropriate. Incidence estimates were pooled using random effects meta-analysis. Subgroup analyses were used to explore sources of heterogeneity. RESULTS: Twenty-three studies were included in the systematic review, of which 16 and 7 described adults and children, respectively. Meta-analysis from 11 adult studies including 16,055 patients demonstrated a pooled incidence proportion of adverse events associated with PIV vasopressor administration as 1.8% (95% CI 0.1-4.8%, I2 = 93.7%). In children, meta-analysis from four studies and 388 patients demonstrated a pooled incidence proportion of adverse events as 3.3% (95% CI 0.0-10.1%, I2 = 82.4%). Subgroup analyses did not detect any statistically significant effects associated with stratification based on differences in clinical location, risk of bias or design between studies, PIV location and size, or vasopressor type or duration. Most studies had high or some concern for risk of bias. CONCLUSION: The incidence of adverse events associated with PIV vasopressor administration is low. Additional research is required to examine the effects of PIV location and size, vasopressor type and dose, and patient characteristics on the safety of PIV vasopressor administration.
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Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/etiologia , Vasoconstritores/efeitos adversos , Cateterismo Periférico/métodos , Humanos , Vasoconstritores/uso terapêuticoRESUMO
BACKGROUND: Critically ill patients require complex care and experience unique needs during and after their stay in the intensive care unit (ICU). Discharging or transferring a patient from the ICU to a hospital ward or back to community care (under the care of a general practitioner) includes several elements that may shape patient outcomes and overall experiences. The aim of this study was to answer the question: what elements facilitate a successful, high-quality discharge from the ICU? METHODS: This scoping review is an update to a review published in 2015. We searched MEDLINE, EMBASE, CINAHL, and Cochrane databases from 2013-December 3, 2020 including adult, pediatric, and neonatal populations without language restrictions. Data were abstracted using different phases of care framework models, themes, facilitators, and barriers to the ICU discharge process. RESULTS: We included 314 articles from 11,461 unique citations. Two-hundred and fifty-eight (82.2%) articles were primary research articles, mostly cohort (118/314, 37.6%) or qualitative (51/314, 16.2%) studies. Common discharge themes across all articles included adverse events, readmission, and mortality after discharge (116/314, 36.9%) and patient and family needs and experiences during discharge (112/314, 35.7%). Common discharge facilitators were discharge education for patients and families (82, 26.1%), successful provider-provider communication (77/314, 24.5%), and organizational tools to facilitate discharge (50/314, 15.9%). Barriers to a successful discharge included patient demographic and clinical characteristics (89/314, 22.3%), healthcare provider workload (21/314, 6.7%), and the impact of current discharge practices on flow and performance (49/314, 15.6%). We identified 47 discharge tools that could be used or adapted to facilitate an ICU discharge. CONCLUSIONS: Several factors contribute to a successful ICU discharge, with facilitators and barriers present at the patient and family, health care provider, and organizational level. Successful provider-patient and provider-provider communication, and educating and engaging patients and families about the discharge process were important factors in a successful ICU discharge.
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Cuidados Críticos , Alta do Paciente , Adulto , Criança , Estado Terminal , Humanos , Recém-Nascido , Unidades de Terapia Intensiva , Qualidade da Assistência à SaúdeRESUMO
BACKGROUND: Restricted visitation policies in acute care settings because of the COVID-19 pandemic have negative consequences. The objective of this scoping review is to identify impacts of restricted visitation policies in acute care settings, and describe perspectives and mitigation approaches among patients, families, and healthcare professionals. METHODS: We searched Medline, Embase, PsycINFO, Healthstar, CINAHL, Cochrane Central Register of Controlled Trials on January 01/2021, unrestricted, for published primary research records reporting any study design. We included secondary (e.g., reviews) and non-research records (e.g., commentaries), and performed manual searches in web-based resources. We excluded records that did not report primary data. Two reviewers independently abstracted data in duplicate. RESULTS: Of 7810 citations, we included 155 records. Sixty-six records (43%) were primary research; 29 (44%) case reports or case series, and 26 (39%) cohort studies; 21 (14%) were literature reviews and 8 (5%) were expert recommendations; 54 (35%) were commentary, editorial, or opinion pieces. Restricted visitation policies impacted coping and daily function (n = 31, 20%) and mental health outcomes (n = 29, 19%) of patients, families, and healthcare professionals. Participants described a need for coping and support (n = 107, 69%), connection and communication (n = 107, 69%), and awareness of state of well-being (n = 101, 65%). Eighty-seven approaches to mitigate impact of restricted visitation were identified, targeting families (n = 61, 70%), patients (n = 51, 59%), and healthcare professionals (n = 40, 46%). CONCLUSIONS: Patients, families, and healthcare professionals were impacted by restricted visitation polices in acute care settings during COVID-19. The consequences of this approach on patients and families are understudied and warrant evaluation of approaches to mitigate their impact. Future pandemic policy development should include the perspectives of patients, families, and healthcare professionals. TRIAL REGISTRATION: The review was registered on PROSPERO (CRD42020221662) and a protocol peer-reviewed prior to data extraction.
Assuntos
COVID-19/prevenção & controle , Cuidados Críticos , Família , Política de Saúde , Pacientes Internados , Distanciamento Físico , Visitas a Pacientes , COVID-19/psicologia , COVID-19/transmissão , Comunicação , Família/psicologia , Pessoal de Saúde/psicologia , Humanos , Pacientes Internados/psicologia , Serviços de Saúde Mental , Pandemias , Angústia Psicológica , SARS-CoV-2 , Telefone , Visitas a Pacientes/psicologiaRESUMO
Rationale: Guidelines for vasopressor titration suggest a universal target-mean arterial pressure (MAP) >65 mm Hg. The implications for patients with premorbid low/high blood pressure are unknown.Objectives: To investigate the relationship between premorbid blood pressure and vasopressor duration for patients with shock.Methods: We performed a retrospective cohort study of adults admitted with shock to Calgary ICUs (June 2012-December 2018). The primary exposure was premorbid blood pressure: low (systolic <100); normal (systolic 100-139 and diastolic <90); and high (systolic ≥140 or diastolic ≥90). The primary outcome was vasopressor duration; secondary outcomes included ICU/hospital length of stay and ICU/hospital mortality. We examined associations of premorbid blood pressure with vasopressor duration and length of stay using multivariable competing risk models and mortality using multivariable mixed-effects logistic regression.Measurements and Main Results: Of 3,542 admissions with shock, 177 (5.0%) had premorbid low, 2,887 (81.5%) normal, and 478 (13.5%) high blood pressure. Premorbid low admissions had lower MAPs (vs. normal or high premorbid admissions) over the duration of vasopressor use (P = 0.003) and were maintained nearest premorbid MAPs while receiving vasopressors (P < 0.001). After adjustment, premorbid low admissions had longer vasopressor use (median, 1.35 d vs. 1.04 d for normal; hazard ratio for discontinuation vs. normal, 0.78 [0.73-0.85]; P < 0.001) and premorbid high admissions had shorter use (median, 0.84 d; hazard ratio, 1.22 [1.12-1.33]; P < 0.001). Premorbid low admissions had longer adjusted length of stay and higher adjusted mortality than premorbid normal admissions.Conclusions: Premorbid blood pressure was inversely associated with vasopressor duration.
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Pressão Sanguínea/efeitos dos fármacos , Hipertensão/complicações , Hipotensão/complicações , Padrões de Prática Médica/estatística & dados numéricos , Choque/tratamento farmacológico , Vasoconstritores/administração & dosagem , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Alberta , Feminino , Humanos , Hipertensão/fisiopatologia , Hipotensão/fisiopatologia , Tempo de Internação/estatística & dados numéricos , Modelos Logísticos , Masculino , Pessoa de Meia-Idade , Análise Multivariada , Guias de Prática Clínica como Assunto , Estudos Retrospectivos , Choque/complicações , Choque/mortalidade , Choque/fisiopatologia , Resultado do Tratamento , Vasoconstritores/farmacologia , Vasoconstritores/uso terapêutico , Adulto JovemRESUMO
PURPOSE: In response to the rapid spread of SARS-CoV-2, hospitals in Canada enacted temporary visitor restrictions to limit the spread of COVID-19 and preserve personal protective equipment supplies. This study describes the extent, variation, and fluctuation of Canadian adult intensive care unit (ICU) visitation policies before and during the first wave of the COVID-19 pandemic. METHODS: We conducted an environmental scan of Canadian hospital visitation policies throughout the first wave of the pandemic. We conducted a two-phased study analyzing both quantitative and qualitative data. RESULTS: We collected 257 documents with reference to visitation policies (preCOVID, 101 [39%]; midCOVID, 71 [28%]; and lateCOVID, 85 [33%]). Of these 257 documents, 38 (15%) were ICU-specific and 70 (27%) referenced the ICU. Most policies during the midCOVID/lateCOVID pandemic period allowed no visitors with specific exceptions (e.g., end-of-life). Framework analysis revealed five overarching themes: 1) reasons for restricted visitation policies; 2) visitation policies and expectations; 3) exceptions to visitation policy; 4) patient and family-centred care; and 5) communication and transparency. CONCLUSIONS: During the first wave of the COVID-19 pandemic, most Canadian hospitals had public-facing visitor restriction policies with specific exception categories, most commonly for patients at end-of-life, patients requiring assistance, or COVID-19 positive patients (varying from not allowed to case-by-case). Further studies are needed to understand the consistency with which visitation policies were operationalized and how they may have impacted patient- and family-centred care.
RéSUMé: OBJECTIF: En réponse à la propagation rapide du SRAS-CoV-2, les hôpitaux du Canada ont adopté des restrictions temporaires pour les visites afin de limiter la propagation de la COVID-19 et de préserver les stocks d'équipements de protection individuelle. Cette étude décrit l'ampleur, les variations et fluctuations des politiques canadiennes concernant les visites aux unités de soins intensifs (USI) pour adultes avant et pendant la première vague de la pandémie de COVID-19. MéTHODE: Nous avons réalisé une étude de milieu des politiques hospitalières canadiennes concernant les visites tout au long de la première vague de la pandémie. Nous avons mené une étude en deux phases analysant des données quantitatives et qualitatives. RéSULTATS: Nous avons recueilli 257 documents faisant référence aux politiques de visites (pré-COVID, 101 [39 %]; mid-COVID, 71 [28 %]; et COVID-tardif, 85 [33 %]). Sur ces 257 documents, 38 (15 %) étaient spécifiques aux USI et 70 (27 %) faisaient référence aux USI. La plupart des politiques au cours de la période pandémique mid-COVID/COVID-tardif ne permettaient aucune visite sauf exception spécifique (p. ex., fin de vie). L'analyse du cadre a révélé cinq thèmes généraux : 1) les raisons des restrictions des politiques de visites; 2) les politiques et attentes en matière de visites; 3) les exceptions aux politiques de visites; 4) les soins aux patients et centrés sur la famille; et 5) la communication et la transparence. CONCLUSION: Au cours de la première vague de la pandémie de COVID-19, la plupart des hôpitaux canadiens avaient des politiques de restriction des visites s'appliquant au public avec des catégories d'exception spécifiques, le plus souvent pour les patients en fin de vie, les patients nécessitant de l'aide ou les patients COVID-positifs (variant d'une interdiction au cas par cas). D'autres études sont nécessaires pour comprendre l'uniformité avec laquelle les politiques de visites ont été mises en Åuvre et comment elles ont pu avoir une incidence sur les soins centrés sur le patient et la famille.
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COVID-19 , Pandemias , Adulto , Canadá , Humanos , Unidades de Terapia Intensiva , Política Organizacional , Políticas , SARS-CoV-2 , Visitas a PacientesRESUMO
BACKGROUND: Health Technology Reassessment (HTR) is a process that systematically assesses technologies that are currently used in the health care system. The process results in four outputs: increase use or decrease use, no change, or de-adoption of a technology. Implementation of these outputs remains a challenge. The Knowledge Translation (KT) field enables to transfer/translate knowledge into practice. KT could help with implementation of HTR outputs. This study sought to identify which characteristics of KT theories, models, and frameworks could be useful, specifically for decreased use or de-adoption of a technology. METHODS: A qualitative descriptive approach was used to ascertain the perspectives of international KT and HTR experts on the characteristics of KT theories, models, and frameworks for decreased use or de-adoption of a technology. One-to-one semi-structured interviews were conducted from September to December 2019. Interviews were audio recorded and transcribed verbatim. Themes and sub-themes were deduced from the data through framework analysis using five distinctive steps: familiarization, identifying an analytic framework, indexing, charting, mapping and interpretation. Themes and sub-themes were also mapped to existing KT theories, models, and frameworks. RESULTS: Thirteen experts from Canada, United States, United Kingdom, Australia, Germany, Spain, and Sweden participated in the study. Three themes emerged that illustrated the ideal traits: principles that were foundational for HTR, levers of change, and steps for knowledge to action. Principles included evidence-based, high usability, patient-centered, and ability to apply to the micro, meso, macro levels. Levers of change were characterized as positive, neutral, or negative influences for changing behaviour for HTR. Steps for knowledge to action included: build the case for HTR, adapt research knowledge, assess context, select interventions, and assess impact. Of the KT theories, models, and frameworks that were mapped, the Consolidated Framework for Implementation Research had most of the characteristics, except ability to apply to micro, meso, macro levels. CONCLUSIONS: Characteristics that need to be considered within a KT theory, model, and framework for implementing HTR outputs have been identified. Consideration of these characteristics may guide users to select relevant KT theories, models, and frameworks to apply to HTR projects.
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Tecnologia Biomédica , Pesquisa Translacional Biomédica , Austrália , Canadá , Humanos , Espanha , Suécia , Reino UnidoRESUMO
Importance: Growing interest in microbial dysbiosis during critical illness has raised questions about the therapeutic potential of microbiome modification with probiotics. Prior randomized trials in this population suggest that probiotics reduce infection, particularly ventilator-associated pneumonia (VAP), although probiotic-associated infections have also been reported. Objective: To evaluate the effect of Lactobacillus rhamnosus GG on preventing VAP, additional infections, and other clinically important outcomes in the intensive care unit (ICU). Design, Setting, and Participants: Randomized placebo-controlled trial in 44 ICUs in Canada, the United States, and Saudi Arabia enrolling adults predicted to require mechanical ventilation for at least 72 hours. A total of 2653 patients were enrolled from October 2013 to March 2019 (final follow-up, October 2020). Interventions: Enteral L rhamnosus GG (1 × 1010 colony-forming units) (n = 1321) or placebo (n = 1332) twice daily in the ICU. Main Outcomes and Measures: The primary outcome was VAP determined by duplicate blinded central adjudication. Secondary outcomes were other ICU-acquired infections including Clostridioides difficile infection, diarrhea, antimicrobial use, ICU and hospital length of stay, and mortality. Results: Among 2653 randomized patients (mean age, 59.8 years [SD], 16.5 years), 2650 (99.9%) completed the trial (mean age, 59.8 years [SD], 16.5 years; 1063 women [40.1%.] with a mean Acute Physiology and Chronic Health Evaluation II score of 22.0 (SD, 7.8) and received the study product for a median of 9 days (IQR, 5-15 days). VAP developed among 289 of 1318 patients (21.9%) receiving probiotics vs 284 of 1332 controls (21.3%; hazard ratio [HR], 1.03 (95% CI, 0.87-1.22; P = .73, absolute difference, 0.6%, 95% CI, -2.5% to 3.7%). None of the 20 prespecified secondary outcomes, including other ICU-acquired infections, diarrhea, antimicrobial use, mortality, or length of stay showed a significant difference. Fifteen patients (1.1%) receiving probiotics vs 1 (0.1%) in the control group experienced the adverse event of L rhamnosus in a sterile site or the sole or predominant organism in a nonsterile site (odds ratio, 14.02; 95% CI, 1.79-109.58; P < .001). Conclusions and Relevance: Among critically ill patients requiring mechanical ventilation, administration of the probiotic L rhamnosus GG compared with placebo, resulted in no significant difference in the development of ventilator-associated pneumonia. These findings do not support the use of L rhamnosus GG in critically ill patients. Trial Registration: ClinicalTrials.gov Identifier: NCT02462590.