[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06184945":3,"trial-entities:NCT06184945":151,"trial-summary:NCT06184945":154},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":25,"study_type":27,"primary_purpose":28,"phases":29,"enrollment_info":31,"interventions":34,"primary_outcomes":45,"secondary_outcomes":50,"sex":57,"minimum_age":58,"maximum_age":59,"healthy_volunteers":60,"eligibility_criteria":61,"std_ages":71,"locations":74,"central_contacts":136,"overall_officials":143,"references":145,"see_also_links":150},"NCT06184945","0794-23-FB","Behavioral Economic & Staffing Strategies in the ICU","Behavioral Economic and Staffing Strategies To Increase Adoption of an Evidence Based Bundle in the Intensive Care Unit (BEST ICU): A Stepped Wedge Cluster Randomized Controlled Trial","RECRUITING","2028-04","2025-09","2026-02-19","2024-07-01","University of Nebraska","OTHER",true,"The overarching goal of this study is to support the \"real world\" assessment of strategies used to foster adoption of several highly efficacious evidence-based practices in healthcare systems that provide care to critically ill adults with known health disparities. Investigators will specifically evaluate two discrete strategies grounded in behavioral economic and implementation science theory (i.e., real-time audit and feedback and registered nurse implementation facilitation) to increase adoption of the ABCDEF bundle in critically ill adults.","Millions of survivors of critical illness worldwide experience profound and frequently persistent physical, mental, and cognitive health impairments that are often preventable through the application of existing knowledge. These impairments are commonly acquired in the intensive care unit (ICU) and are often initiated and\u002For exacerbated by known racial and socioeconomic health disparities and outdated mechanical ventilation (MV) liberation and symptom management practices. Indeed, ICU-acquired pain, anxiety, delirium, and weakness are associated with numerous adverse health outcomes including prolonged MV, mortality, functional decline, new institutionalization, and severe neurocognitive dysfunction. A robust body of research demonstrates that clinical outcomes improve when integrated, interprofessional approaches to MV liberation and symptom management are applied early in the course of critical illness. One such approach is the ABCDEF bundle. When applied in everyday practice, ABCDEF bundle performance is consistently associated with meaningful improvements in important patient and healthcare system outcomes. Unfortunately, ABCDEF bundle performance remains unacceptably low as clinicians struggle with multiple barriers to bundle delivery.\n\nInvestigator's previous work demonstrates bundle-related clinical decision making is indeed complex and frequently influenced by prevailing ICU social norms, common knowledge deficits, and substantial workflow challenges. Missing from the literature are evidence-based implementation strategies that are adaptable, responsive to community needs, and account for the cultural and organizational factors necessary to increase bundle adoption particularly in traditionally under-resourced settings like safety net hospitals. Until this key gap in knowledge is filled, the excessively high morbidity, mortality, costs, and disparities associated with critical care delivery will continue and the public health benefit of the ABCDEF bundle will not be fully realized.\n\nCongruent with NIH policy, the goal of this proposal is to support the \"real world\" assessment of strategies used to foster adoption of several highly efficacious evidence-based practices in healthcare systems that provide care to critically ill adults with known health disparities. Based on strong preliminary data, the study's overall objective is to evaluate two discrete strategies grounded in behavioral economic and implementation science theory to increase adoption of the ABCDEF bundle in critically ill adults. The strategies being evaluated target a variety of ICU team members and known behavioral determinants of ABCDEF bundle performance.\n\nInvestigators will conduct a 3-arm, pragmatic, stepped-wedge, cluster-randomized, trial to evaluate both implementation (primary) and clinical (secondary) effectiveness outcomes. After creating 6 matched pairs of 12 ICUs from 3 discrete safety net hospitals (estimated total N=8,100 patients on MV), they will randomly be assigned within each matched pair to receive either real-time audit and feedback or a Registered Nurse (RN) implementation facilitator and each pair to one of six wedges. At the end of the 27-month trial, implementation and clinical outcomes will collected for an additional 3 months to evaluate the effects of removing the implementation strategies.\n\nAim 1: Primary Implementation Objective: Compare the effectiveness of real-time audit and feedback and RN implementation facilitation on proportional ABCDEF bundle performance (primary study outcome).\n\nAim 1: Secondary Implementation Objective: Compare the effectiveness of real-time audit and feedback and RN implementation facilitation on complete ABCDEF bundle performance.\n\nAim 2: Primary Clinical Objective: Compare the effectiveness of real-time audit and feedback and RN implementation facilitation on duration of invasive mechanical ventilation.\n\nAim 2: Secondary Clinical Objective: Compare the effectiveness of real-time audit and feedback and RN implementation facilitation on other patient-centered outcomes (i.e., new tracheostomy placement; advanced non-invasive respiratory therapy use and duration; ICU, hospital, and 30-day mortality; ICU and hospital length of stay; ICU days with acute brain dysfunction (i.e., ICU delirium and\u002For coma); ICU physical restraint use; daily and total opioid, benzodiazepine, sedative\u002Fhypnotic, antipsychotic, melatonin receptor agonist medication use in ICU stay and at hospital discharge; ICU days with a family visit; discharge disposition; ICU readmission; physical therapy utilization in ICU and at hospital discharge; 30-day hospital readmission; ICU days with significant pain; unplanned extubations; reintubations within 24 hours of extubation; hospital-acquired thromboembolic disease, clinically significant falls acquired during hospitalization, hospital-acquired pressure ulcers).\n\nAim 3: Identify and describe key stakeholders' experiences with, and perspectives of, real-time audit and feedback and RN implementation.\n\nAim 3.1: Compare the effects of real-time audit and feedback and RN implementation on work intensity.\n\nAim 3.2: Compare the acceptability of real-time audit and feedback and RN implementation facilitation.\n\nAim3.3: Assess the association of work intensity with acceptability and proportional bundle performance.\n\nAim 3.4: Assess provider perspectives of barriers and facilitators to adoption of real-time audit and feedback and RN implementation.\n\nBuilding on years of successful collaboration, investigator's experienced interprofessional team is ideally suited to perform the proposed work. Study results are expected to impact the field by developing equitable, efficient, effective, and replicable ways of accelerating the reliable uptake of the highly efficacious evidence-based ICU interventions contained in the ABCDEF bundle. This will dually address known healthcare disparities and ultimately improve the care and outcomes of millions of critically ill adults annually.",[19,20,21,22,23,24],"Implementation Science","Delirium","Critical Illness","Mechanical Ventilation Complication","ICU Acquired Weakness","Pain",[26],"ABCDEF bundle, delirium, intensive care, critical care, mechanical ventilation","INTERVENTIONAL","TREATMENT",[30],"NA",{"count":32,"type":33},8100,"ESTIMATED",[35,41],{"type":36,"name":37,"description":38,"armGroupLabels":39},"BEHAVIORAL","Realtime audit and feedback","ICUs randomized to this arm will receive and electronic dashboard that displays realtime ABCDEF bundle performance data",[40],"Audit and Feedback",{"type":36,"name":42,"description":43,"armGroupLabels":44},"RN Implementation Facilitator","ICUs randomized to this arm will receive a RN who will assist with ABCDEF bundle implementation",[42],[46],{"measure":47,"description":48,"timeFrame":49},"Proportional ABCDEF bundle performance","Defined as the percentage of eligible elements a patient receives on a given ICU day \\[\"bundle dose\"\\].","27 months",[51,54],{"measure":52,"description":53,"timeFrame":49},"Complete ABCDEF bundle performance","Defined as a patient day in which every eligible element of the bundle was performed (i.e., 100% of the bundle versus anything less; yes\u002Fno).",{"measure":55,"description":56,"timeFrame":49},"Duration of invasive mechanical ventilation","Days spent in ICU on invasive mechanical ventilation","ALL","19 Years",null,false,{"inclusion":62,"exclusion":67,"raw_text":70},[63,64,65,66],"Age \\>19 years at time of ICU admission","Received invasive mechanical ventilation while in the ICU","Admitted to participating cluster ICU","ICU length of stay of at least 24 hours",[68,69],"Patient who is admitted to the hospital who is already receiving chronic long-term mechanical ventilation from the home, assisted living, or long-term care setting","Prisoners","Inclusion Criteria:\n\n* Age \\>19 years at time of ICU admission\n* Received invasive mechanical ventilation while in the ICU\n* Admitted to participating cluster ICU\n* ICU length of stay of at least 24 hours\n\nExclusion Criteria:\n\n* Patient who is admitted to the hospital who is already receiving chronic long-term mechanical ventilation from the home, assisted living, or long-term care setting\n* Prisoners",[72,73],"ADULT","OLDER_ADULT",[75,94,119],{"facility":76,"status":8,"city":77,"state":78,"zip":79,"country":80,"contacts":81,"geoPoint":91},"University of Iowa Hospitals and Clinics","Iowa City","Iowa","52242","United States",[82,87],{"name":83,"role":84,"phone":85,"email":86},"James Blum, MD","CONTACT","(319) 678-7116","james-blum@uiowa.edu",{"name":88,"role":84,"phone":89,"email":90},"Anna Krupp, PhD, RN","(319) 467-1902","anna-krupp@uiowa.edu",{"lat":92,"lon":93},41.66113,-91.53017,{"facility":95,"status":8,"city":96,"state":97,"zip":98,"country":80,"contacts":99,"geoPoint":116},"University of Nebraska Medical Center","Omaha","Nebraska","68198",[100,104,107,110,112,114],{"name":101,"role":84,"phone":102,"email":103},"Michele C Balas, PhD, RN","(402) 559-9758","mibalas@unmc.edu",{"name":105,"role":106},"Breanna D Hetland, PhD","PRINCIPAL_INVESTIGATOR",{"name":108,"role":109},"Chris S Wichman, PhD","SUB_INVESTIGATOR",{"name":111,"role":109},"James R Campbell, PhD",{"name":113,"role":109},"Ronnie Horner, PHD",{"name":115,"role":109},"Jungyoon Kim, PhD",{"lat":117,"lon":118},41.25626,-95.94043,{"facility":120,"status":8,"city":121,"state":122,"zip":123,"country":80,"contacts":124,"geoPoint":133},"Ohio State University","Columbus","Ohio","43201",[125,129],{"name":126,"role":84,"phone":127,"email":128},"Matthew Exline, MD","(614) 293-4925","matthew.exline@osumc.edu",{"name":130,"role":84,"phone":131,"email":132},"Tony Gerlach, PHD","(614) 688-0234","anthony.gerlach@osumc.edu",{"lat":134,"lon":135},39.96118,-82.99879,[137,139],{"name":101,"role":84,"phone":138,"email":103},"(614) 949-5555",{"name":140,"role":84,"phone":141,"email":142},"Eduard Vasilevskis, MD","(608) 261-1571","vasilevskis@wisc.edu",[144],{"name":101,"affiliation":13,"role":106},[146],{"pmid":147,"type":148,"citation":149},"41388315","DERIVED","Vasilevskis EE, Kim J, Wichman C, Horner R, Campbell JR, Geary CR, Birge J, Hetland B, Blanchard A, Circo K, Wagner-Connolly A, Miller J, Exline MC, Gerlach AT, Krupp A, Blum J, Balas MC; BEST-ICU Team. Behavioral Economic and Staffing Strategies To Increase Adoption of the ABCDEF Bundle in the Intensive Care Unit (BEST ICU): study protocol for a multi-site stepped-wedge cluster randomized controlled trial in the USA. Trials. 2025 Dec 12;27(1):42. doi: 10.1186\u002Fs13063-025-09331-6.",[],{"nct_id":4,"conditions":152,"biomarkers":153},[21,20,23,22,24],[],{"nct_id":4,"found":15,"summary":155,"prompt_version":164},{"design":156,"status":157,"heading":6,"summary":158,"follow_up":159,"word_count":160,"commitments":161,"compensation":162,"drugs_mentioned":163},"This is an interventional study, meaning participants will receive specific strategies. It aims to enroll 8100 participants.","completed","This study is looking at ways to improve care for critically ill adults in the intensive care unit (ICU) who are on a breathing machine (mechanical ventilation). It aims to see if two different strategies can help hospitals better use the ABCDEF bundle, a set of practices known to improve patient outcomes. One strategy involves giving ICUs a real-time electronic dashboard showing how well they are using the ABCDEF bundle. The other strategy provides ICUs with a Registered Nurse (RN) who helps with implementing the bundle. The study will measure how well the ABCDEF bundle is used over 27 months. You may be able to join if you are over 19, have been on a breathing machine in the ICU for at least 24 hours, and are admitted to a participating ICU. The study plans to enroll 8100 participants, but its current status is unclear.","The primary outcome, ABCDEF bundle performance, will be measured at 27 months.",145,"Not specified in the trial record.","Not stated in the trial record.",[],"v2"]