Dataset Information

Effectiveness of the ABCDEF bundle on delirium, functional outcomes and quality of life in intensive care patients: a study protocol for a randomised controlled trial with embedded process evaluation.

ABSTRACT:

Introduction

Hospital mortality for critically ill patients has decreased significantly throughout the developed world over the past two decades, attributable to improvements in the quality of intensive care, advances in critical care medicine and technologies that provide long-term multiorgan support. However, the long-term outcomes of intensive care unit (ICU) survivors is emerging as a real issue. Cognitive and physical impairments suffered by ICU survivors are common including profound weakness, pain and delirium which are inextricably linked. This study aims to determine the effectiveness of the Assess, prevent and manage pain; Both spontaneous awakening and spontaneous breathing trials; Choice of sedation and analgesia; Delirium: assess, prevent and manage; Early mobility and exercise; Family engagement and empowerment (ABCDEF) bundle in reducing ICU-related short-term and long-term consequences of critical illness through a randomised controlled trial (RCT).

Methods and analysis

The study will be a single-centre, prospective RCT. A total of 150 participants will be recruited and randomised to either receive the ABCDEF bundle protocol or non-protocolised standard care for the duration of the participant's admission in the ICU. The primary outcome is delirium status measured using the Confusion Assessment Measure for ICU (CAM-ICU). Secondary outcomes include physical function measured by the Functional Independence Measure and quality of life measured by the European Quality of Life five dimensions, five-level questionnaire. A mixed-method process evaluation will contribute to understanding the experience of health teams who implement the ABCDEF bundle into practice.

Ethics and dissemination

Ethics approval was provided by the Metro South Health Human Research Ethics Committee (HREC) (EC00167) and the Griffith University's HREC prior to study commencement.Study results will be disseminated by presentations at conferences and via publications to peer-review journals.

Trial registration number

ACTRN12620000736943; Pre-results.

SUBMITTER: Sosnowski K

PROVIDER: S-EPMC8286762 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:The ICU Liberation (ABCDEF) Bundle can help to improve care and outcomes for ICU patients, but bundle implementation is far from universal. Understanding how ICU organizational characteristics influence bundle implementation could inform quality improvement efforts. We surveyed all hospitals in Michigan with adult ICUs to determine whether organizational characteristics were associated with bundle implementation and to determine the level of agreement between ICU physician and nurse leaders around ICU organizational characteristics and bundle implementation.DesignWe surveyed ICU physician and nurse leaders, assessing their safety culture, ICU team collaboration, and work environment. Using logistic and linear regression models, we compared these organizational characteristics to bundle element implementation, and also compared physician and nurse leaders' perceptions about organizational characteristics and bundle implementation.SettingAll (n = 72) acute care hospitals with adult ICUs in Michigan.SubjectsICU physician and nurse leader pairs from each hospital's main ICU.InterventionsWe developed, pilot-tested, and deployed an electronic survey to all subjects over a 3 month period in 2016.ResultsResults from 73 surveys (28 physicians, 45 nurses, 60% hospital response rate) demonstrated significant variation in hospital and ICU size and type, organizational characteristics, and physician/nurse perceptions of ICU organization and bundle implementation. We found that a robust safety culture and collaborative work environment that uses checklists to facilitate team communication are strongly associated with bundle implementation. There is also a significant dose-response effect between safety culture, a collaborative work environment, and overall bundle implementation.ConclusionsWe identified several specific ICU practices that can facilitate ABCDEF Bundle implementation. Our results can be used to develop effective bundle implementation strategies that leverage safety culture, interprofessional collaboration, and routine checklist use in ICUs to improve bundle implementation and performance.

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Project description:BackgroundEarly rehabilitation has been found to prevent delirium and weakness that can hamper the recovery of intensive care unit (ICU) survivors. Integrated clinical practice guidelines for managing patient pain, agitation and delirium (PAD) have been developed. The Awakening and Breathing Coordination, Delirium monitoring/management, and Early exercise/mobility (ABCDE) bundle provides a strategy to implement PAD guidelines into everyday clinical practice. However, there is limited evidence on the effectiveness of the ABCDE bundle in the literature.The purpose of this study was to evaluate the feasibility of conducting a full-scale randomised controlled trial comparing the ABCDE bundle to standard care in an ICU. Trial feasibility was defined as the successful recruitment and retention of trial participants, adherence to the intervention, identification of barriers to the intervention, and the rigorous collection of outcome data.MethodsA prospective, single-centre, randomised controlled feasibility study was conducted. Thirty adult mechanically ventilated participants were recruited from an eight-bed ICU in south east Queensland, Australia, between April 2015 and December 2015. Participants were randomised to receive either the ABCDE bundle or standard routine management. The ABCDE bundle integrated prescribed awakening and breathing trials, delirium monitoring and management, and prescribed exercise and mobility regimes. Feasibility outcomes measured included recruitment and retention rates, intervention fidelity, and the feasibility of participant outcome data collection. Outcome measurement assessors were blinded to participant assignment. It was not possible to blind the research team or the participant to group assignment.ResultsIn total, 30 (81.1%) of 37 eligible participants consented and were randomised to the intervention group (n = 15) or the control group (n = 15). Of these, 23 (76.6%) participants successfully completed the 90-day post discharge assessment. A lengthy recruitment period of 8 months was related to overly stringent inclusion and exclusion criteria. Intervention adherence exceeded defined success rates with participation in awakening and breathing trials, delirium monitoring and exercise interventions performed on 80.2, 97.4 and 90.2% of ventilated days respectively. Outcome assessments were successfully and accurately performed at ICU and hospital discharge and 90-day post hospital discharge. Intervention participants were deemed to be delirious on 39.6% of mechanically ventilated days indicating a requirement for a scripted regime to prevent delirium.ConclusionsWith minor adjustment of inclusion and exclusion criteria, the inclusion of delirium management protocols, and encouragement of family engagement and involvement, a large-scale definitive randomised controlled trial to test the impact of the ABCDEF bundle will be feasible.Trial registrationAustralian New Zealand Clinical Trials Registry 12614000763640 Date registered 17/08/2014.

Project description:ObjectivesTo investigate implementation of evidence-based and supportive cares in ICUs, such as the ABCDEF, nutrition therapy, and ICU diary, for patients with coronavirus disease 2019 infection in ICUs and their association with ICU clinical practice and setting.DesignA worldwide, 2-day point prevalence study.SettingThe study was carried out on June 3, 2020, and July 1, 2020. A total of 212 ICUs in 38 countries participated. Clinicians in each participating ICU completed web-based online surveys.PatientsThe ICU patients with coronavirus disease 2019.InterventionsNone.Measurements and main resultsThe implementation rate for the elements of the ABCDEF bundle, other supportive ICU care measures, and implementation-associated structures were investigated. Data were collected for 262 patients, of whom 47.3% underwent mechanical ventilation and 4.6% were treated with extracorporeal membrane oxygenation. Each element was implemented for the following percentages of patients: elements A (regular pain assessment), 45%; B (both spontaneous awakening and breathing trials), 28%; C (regular sedation assessment), 52%; D (regular delirium assessment), 35%; E (early mobility and exercise), 47%; and F (family engagement and empowerment), 16%. The implementation of element E was 4% for patients on mechanical ventilation and 8% for patients on extracorporeal membrane oxygenation. Supportive care, such as protein provision throughout the ICU stay (under 1.2 g/kg for more than 50% of the patients) and introduction of ICU diary (25%), was infrequent. Implementation rates of elements A and D were higher in ICUs with specific protocols and fewer ICU beds exclusively for patients with coronavirus disease 2019 infection. Element E was implemented at a higher rate in ICUs that had more ICU beds assigned for them.ConclusionsThis point prevalence study showed low implementation of the ABCDEF bundle. Specific protocols and the number of ICU beds reserved for patients with coronavirus disease 2019 infection might be key factors for delivering appropriate supportive care.