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A realist review of the effective implementation of the ICU Liberation Bundle in the paediatric intensive care unit setting

Open AccessPublished:December 27, 2022DOI:https://doi.org/10.1016/j.aucc.2022.11.007

      Abstract

      Objective

      The objective of this study was to produce an evidence base of what works, for whom, and in what context when implementing the ICU Liberation Bundle into the paediatric intensive care unit (PICU).

      Review method used

      This is a realist review (a review that considers what works, for whom, and in what context) of contemporary international literature.

      Data sources

      Data were collected via electronic searches of CINAHL, PubMed, EMBASE and MEDLINE, Google Scholar, and Web of Science for articles published before October 2020.

      Review method

      An initial scoping search identified the underpinning theory of the implementation of the ICU Liberation Bundle (a multifactor intervention aimed at improving patient outcomes) which was mapped onto the Consolidated Framework for Implementation Research (CFIR). We identified 547 unique citations; 12 full-text papers were included that reported eight studies. Data were extracted and mapped to the CFIR domains.

      Results

      Data mapped to all CFIR domains. Characteristics of individuals included involvement of key stakeholders, champions, and parents and understanding of staff attitudes and perceptions of the intervention, and all bedside staff members were involved and given training. Within the inner setting, understanding of unit culture, ensuring effective support systems in place, knowledge of the baseline, and leadership support, and buy-in were important. Culture of family-centred care and alignment of the intervention to national guidelines related to the outer setting. Intervention characteristics included the number and timings of interventions, de-escalation rounding checklists, the use of age-appropriate and validated assessment tools, and local policies for the bundle. The process included set training program, senior unit/hospital team consultation on all processes, continual audit adherence to the bundle and feedback, and celebration of successes.

      Conclusions

      This novel realist review of the literature identified that successful implementation of the ICU Liberation Bundle into PICU settings involves the following: (i) a thorough understanding of the PICU context, including baseline metrics, resources, and staff attitudes; (ii) using contextual information to adapt the intervention elements to ensure fit; and (iii) both clinical effectiveness and implementation outcomes must be measured.
      Registration of review: PROSPERO 2020 CRD42020211944.

      Keywords

      1. Introduction

      Children admitted to a paediatric intensive care unit (PICU) now have a high chance of surviving their critical illness or injury.
      PICANet
      Paediatric intensive care audit network annual report 2020.
      ,
      • Pollack M.M.
      • Holubkov R.
      • Funai T.
      • Clark A.
      • Berger J.T.
      • Meert K.
      • et al.
      Pediatric intensive care outcomes.
      However, it is also being recognised that concurrent with medical advances, the types of patients admitted to the PICU are changing.
      • Pollack M.M.
      • Banks R.
      • Holubkov R.
      • Meert K.L.
      Health atEKSNIoC, network HDCPCCR. Long-term outcome of PICU patients discharged with new, functional status morbidity.
      Over 40% of children that are admitted have at least one pre-existing chronic health condition leading to a longer length of stay, more invasive therapies, a higher risk of readmission, and a higher morbidity risk.
      • Pollack M.M.
      • Banks R.
      • Holubkov R.
      • Meert K.L.
      Health atEKSNIoC, network HDCPCCR. Long-term outcome of PICU patients discharged with new, functional status morbidity.
      • O'Brien S.
      • Nadel S.
      • Almossawi O.
      • Inwald D.P.
      The impact of chronic health conditions on length of stay and mortality in a general PICU.
      • Choong K.
      PICU-aquired complication: the new markers of the quality of care.
      • Hartman M.E.
      • Saeed M.J.
      • Bennett T.
      • Typpo K.
      • Matos R.
      • Olsen M.A.
      Readmission and late mortality after critical illness in childhood.
      As such, there has been a growing focus on PICU-acquired complications and how to reduce them and the short- and long-term impact they can have on children and their families.
      • Choong K.
      PICU-aquired complication: the new markers of the quality of care.
      PICU-acquired complications are inter-related,
      • Choong K.
      PICU-aquired complication: the new markers of the quality of care.
      often stemming from a multitude of complex factors.
      • Mikkelsen M.E.
      • Iwashyna T.
      Persistant problems and recovery after critical illness.
      One recognised factor is due to the oversedation and immobilisation of critically ill children that are perceived to be too sick to move.
      • Choong
      • Koo K.K.Y.
      • Clark H.
      • Chu R.
      • Thabane L.
      • Burns K.
      • et al.
      Early mobilization in critically ill children: a survey of Canadian practice.
      The complications can include iatrogenic infections, pain, sleep deprivation, and intensive care unit (ICU)–acquired weakness which is associated with high rates of invasive PICU therapies, high use of resources, immobility, and poor outcomes.
      • Field-Ridley A.
      • Dharmar M.
      • Steinhorn D.
      • McDonald C.
      • Marcin J.P.
      ICU-acquired weakness is associated with differences in clinical outcomes in critically ill children.
      ,
      • Khilnani P.
      • Shamim M.
      • Kukreti V.
      Intensive care unit acquired weakness in children: critical illness polyneuropathy and myopathy.
      Oversedation is also recognised as prolonging mechanical ventilation (MV) and reducing mobility and is associated with delirium and iatrogenic withdrawal syndrome.
      • Ista E.
      • van Dijk M.
      Knowing risk factors for iatrogenic withdrawal syndrome in children may still leave us empty-handed.
      Up to 57% of children experience iatrogenic withdrawal syndrome, and up to 53% of children who receive MV experience delirium.
      • Traube C.
      • Silver G.
      • Reeder R.W.
      • Doyle H.
      • Hegel E.
      • Wolfe H.
      • et al.
      Delirium in critically ill children: an international point prevalence study.
      Delirium is associated with a significantly longer length of PICU stay and increased risk of in-hospital mortality.
      • Traube C.
      • Silver G.
      • Gerber L.M.
      • Kaur S.
      • Mauer E.A.
      • Kerson A.
      Et al. Delirium and mortality in critically ill children: epidemiology and outcomes of pediatric delirium.
      Up to 61% of critically ill children develop one or more of these PICU-acquired complications.
      • Choong K.
      • Fraser D.
      • Al-Harbi S.
      • Borham A.
      • Cameron J.
      • Cameron S.
      et al. Functional recovery in critically ill children, the “WeeCover” multicenter study.
      A consequence of these complications and the critical care admission is post–intensive care syndrome (PICS). The Post Intensive Care Syndrome in paediatrics (PICS-p) framework has been developed to guide the understanding of how PICS impacts the child and family as an interdependent unit.
      • Manning J.C.
      • Pinto N.P.
      • Rennick J.E.
      • Colville G.
      • Curley M.A.Q.
      Conceptualizing post intensive care syndrome in children—the PICS-p framework.
      The PICS-p recognises that the process of surviving a critical illness and the PICU can impact physical, cognitive, emotional, and social-economic outcomes for the child and the family. There is increasing evidence demonstrating the prevalence of the PICS-p in PICU survivors,
      • Choong K.
      • Fraser D.
      • Al-Harbi S.
      • Borham A.
      • Cameron J.
      • Cameron S.
      et al. Functional recovery in critically ill children, the “WeeCover” multicenter study.
      ,
      • Herrup E.A.
      • Wieczorek B.
      • Kudchadkar S.R.
      Characteristics of postintensive care syndrome in survivors of pediatric critical illness: a systematic review.
      with up to 18% of children experiencing a deterioration in mobility a year post discharge and approximately one-third experiencing psychological morbidities such as post-traumatic stress disorder.
      • Abela K.M.
      • Wardell D.
      • Rozmus C.
      • Lobiondo-Wood G.
      Impact of pediatric critical illness and injury on families: an updated systematic review.
      In recognition of the impact of an ICU admission, the Society of Critical Care Medicine (SCCM) launched the ICU Liberation Bundle of care.
      • Ely E.W.
      The ABCDEF bundle: science and philosophy of how ICU liberation serves patients and families.
      The elements of this aim to reduce pain and delirium, minimise iatrogenic harm of critical illness, and reduce long-term consequences of an ICU admission. Research has been generated from a cohort study of the implementation of the ICU Liberation Bundle as a national quality improvement collaborative in 68 North America adult ICUs, incorporating over 15,000 patients, demonstrating that the use of the complete bundle was associated with improved survival, reduced use of MV, reduced coma and delirium rates, and reduced ICU readmission rates.

      Pun, Balas M.C., Barnes-Daly M.A., Thompson, J.L, Aldrich, J.M., Barr, J., et al. Caring for critically ill patients with the ABCDEF bundle: results of the ICU liberation collaborative in over 15,000 adults. Crit Care Med 2019;47(1):3–14. Jan 2019.

      The process of implementing the bundle involves staff education and daily interprofessional bedside rounds focusing on the bundle elements and has been shown to improve staff communication and coordination of care.
      • Stollings
      • Devlin J.W.
      • Lin J.C.
      • Pun B.T.
      • Byrum D.
      • Barr J.
      Best practices for conducting interprofessional team rounds to facilitate performance of the ICU liberation (ABCDEF) bundle.
      Whilst there is now international use of this bundle in adult ICUs, the uptake in PICUs has been slower despite clear recognition of the potential benefits,
      • Choong K.
      PICU-aquired complication: the new markers of the quality of care.
      with adoption centred to North America. There are multiple factors associated with the successful adoption of an innovation in a healthcare setting, including system readiness for innovation and alignment with the values and norms of the adopters.
      • Greenhalgh T.
      • Robert G.
      • Macfarlane F.
      • Bate P.
      • Kyriakidou O.
      Diffusion of innovations in service organizations: systematic review and recommendations.
      Furthermore, there is clear evidence in the literature detailing interventions that have been successful in North America but have not shown the same impact when replicated elsewhere.
      • Dixon-Woods M.
      • Leslie M.
      • Tarrant C.
      • Bion J.
      Explaining Matching Michigan: an ethnographic study of a patient safety program.
      Results of a recent international PICU survey of implementation of the ICU Liberation Bundle showed substantial variation in the adoption of the different elements. The researchers emphasised the need to use implementation science to understand the barriers to implementing and sustaining the bundle in different cultures and contexts.

      Ista E., Redivo J., Kananur P., Choong, K., Colleti, Jr.J. Needham, D., et al. ABCDEF bundle practices for critically ill children: an international survey of 161 PICUs in 18 countries. Crit Care Med 2022;50(1):114–125.

      We therefore conducted a realist review to produce an evidence base of ‘what works and for whom and in what context’ in terms of the implementation of the ICU Liberation Bundle into different PICU contexts.

      2. Methods

      2.1 Realist review methods

      A realist review approach was adopted. The realist review method considers that in order to suggest a causal effect between two things, such as an intervention and patient outcomes, a better understanding needs to be gained of the mechanisms that connect them and the context in which the intervention was implemented.
      • Pawson R.
      • Greenhalgh T.
      • Harvey G.
      • Walshe K.
      Realist review - a new method of systematic review designed for complex policy interventions.
      For example, the mechanism may be the implementation process and the context could include the unit structure or the healthcare system.
      • Pawson R.
      • Greenhalgh T.
      • Harvey G.
      • Walshe K.
      Realist review - a new method of systematic review designed for complex policy interventions.
      Furthermore, a realist review can be used to consider how an intervention works, for whom, and under what circumstances.
      • Pawson R.
      • Greenhalgh T.
      • Harvey G.
      • Walshe K.
      Realist review - a new method of systematic review designed for complex policy interventions.
      ,
      • McCormack B.
      • Rycroft-Malone J.
      • Decorby K.
      • et al.
      A realist review of interventions and strategies to promote evidence-informed healthcare: a focus on change agency.
      This method aligns to the aims of this review as the ICU Liberation Bundle is recognised as an effective intervention for minimising the iatrogenic harm of being in the ICU.

      Pun, Balas M.C., Barnes-Daly M.A., Thompson, J.L, Aldrich, J.M., Barr, J., et al. Caring for critically ill patients with the ABCDEF bundle: results of the ICU liberation collaborative in over 15,000 adults. Crit Care Med 2019;47(1):3–14. Jan 2019.

      To date, it has predominately been applied in North America; however, it cannot be presumed that it could be implemented in a different context and work in the same way due to workforce, resource, and system differences.
      • McCormack B.
      • Rycroft-Malone J.
      • Decorby K.
      • et al.
      A realist review of interventions and strategies to promote evidence-informed healthcare: a focus on change agency.
      Realist review methodology has two main phases: firstly, the Mid-Range Theory (MRT)—theories derived from research that can be used to generate and test hypotheses
      • Risjord M.
      Nursing science.
      —needs to be generated to propose how the intervention would be expected to work. Secondly, empirical evidence is identified or modified to populate the MRT framework, allowing the MRT to be supported or refuted and modified.
      • Pawson R.
      • Greenhalgh T.
      • Harvey G.
      • Walshe K.
      Realist review - a new method of systematic review designed for complex policy interventions.
      As such, a two-phased approach was applied to the data extraction process.
      The review protocol was registered with PROSPERO—CRD42020211944.

      2.2 Phase one: Scoping the literature and MRT generation

      In phase one, a preliminary scoping search was conducted to identify theory relating to the ICU Liberation Bundle as a complex intervention. The initial search strategy focused on papers reporting primary research of implementation in the adult ICU context as this was where the bundle was initially implemented, which yielded eight relevant papers. The same search terms as the empirical paper search (supplement 1) were then used to find editorial and opinion pieces narrating the application of the ICU Liberation Bundle in the PICU setting, or PICU guidance in a similar vein, yielding a further four papers. Each paper was read in detail, and information pertaining to the implementation process was inserted into the Consolidated Framework for Implementation Research (CFIR) (Supplement 2). The CFIR was used as it offers an organisational framework, enabling knowledge to be built and synthesised about what works, where, and why in different settings,
      • Damschroder L.J.
      • Aron D.C.
      • Keith R.E.
      • Kirsh S.R.
      • Alexander J.A.
      • Lowery J.C.
      Fostering implementation of health services research findings into practice: a consolidated framework for advancing implementation science.
      and as such is a good fit for the realist review methodology. Relevant papers were read, results/findings extracted, and mapped into the CFIR
      • Damschroder L.J.
      • Aron D.C.
      • Keith R.E.
      • Kirsh S.R.
      • Alexander J.A.
      • Lowery J.C.
      Fostering implementation of health services research findings into practice: a consolidated framework for advancing implementation science.
      using the five domains: Characteristics of individuals; inner setting; outer setting; intervention characteristics; and process of intervention. This was used to provide the Mid-Range Theory (MRT) that the empirical review in phase two could be tested against.

      2.3 Phase two: Searching processes and study selection

      In phase two, the literature was searched for empirical papers which described the ICU Liberation Bundle, or elements of it, implemented in a PICU setting. A comprehensive search of six electronic databases (CINAHL, PubMed, EMBASE, Medline, Web of Science, and Google Scholar) was carried out using a predefined search strategy (supplement 1) between 7th and 18th September 2020. It was recognised that the term ‘ICU Liberation Bundle’ is branded to the SCCM and due to this may be referred to by different names in the literature (for example, the ABCDEF bundle) where implementation was not linked to the SCCM. Therefore, a variety of terms were listed in the search strategy to ensure that papers were not missed. For continuity throughout this review, the term ‘ICU Liberation Bundle’ will be used. Searches excluded papers published prior to 2014 as this was before the SCCM had launched the ICU Liberation Collaborative/Bundle. Due to the paucity of relevant full-length papers, ‘grey literature’ was also examined and included conference submissions and posters, corresponding with specialists in the field and contacting hospitals identified as having carried out the intervention. The references of the identified papers were also searched for further relevant studies.
      Papers were selected based on predetermined criteria (Table 1) that aligned with the review aim. Title and abstracts were assessed against these criteria by the primary author (E.D.), with uncertainties of eligibility discussed and agreed with the senior author (J.C.M.).
      Table 1Inclusion and exclusion criteria for the empirical review.
      InclusionExclusion
      • All empirical research
      • Abstracts
      • Conference submissions/posters
      • Foreign language papers that have been translated.
      • Papers published after 2014
      • PICU patients aged 0-18
      • Papers looking at three or more elements of the bundle—those that only state two elements will have the full text read in recognition that not all elements used will be listed in the title or abstract.
      • Literature reviews
      • Cochrane studies
      • Neonatal ICU
      • Adult ICU
      • Studies only looking at a single element of the bundle
      ICU, intensive care unit; PICU, paediatric intensive care unit.

      2.4 Data extraction

      Each eligible paper was read in detail by the primary author (E.D.). Data pertaining to the implementation process were extracted into a predetermined data analysis matrix. This matrix allowed for details relating to the context, mechanisms, and outcomes to be documented.
      • Wong G.
      • Greenhalgh T.
      • Westhorp G.
      • Buckingham J.
      • Pawson R.
      RAMESES publication standards: realist syntheses.

      2.5 Analysis and synthesis process

      The CFIR mapped from the scoping search (the MRT) and the CFIR from the empirical papers were compared to examine the similarities and the differences.
      • Damschroder L.J.
      • Aron D.C.
      • Keith R.E.
      • Kirsh S.R.
      • Alexander J.A.
      • Lowery J.C.
      Fostering implementation of health services research findings into practice: a consolidated framework for advancing implementation science.
      We aimed to identify which aspects of the implementation process are necessary for success. A collaborative approach between the international team of co-authors was adopted where the data analysis matrix was reviewed to identify the context of each setting, the mechanism of implementation, and the outcomes observed. This process was undertaken for both the scoping search, to develop the MRT, and subsequently with the empirical papers from the comprehensive search. Once complete, the elements were mapped onto the CFIR (by E.D.) and then exposed to review and consultation with the other co-authors to enable refinement.

      2.6 Rigour and quality assurance

      To ensure the quality and rigour of the review, the set of criteria for trustworthiness proposed by Lincoln and Guba
      • Lincoln Y.S.
      • Guba E.G.
      Naturalistic inquiry.
      was followed. Credibility was enhanced by prolonged and contemporary engagement with the literature/developments in the field and extensive consultation between the co-authorship team. Their criteria for ‘transferability’ were met by the description of timing and scope of this review being clearly articulated in the methods and adopting an international team of reviewers to offer more diverse insights into the review. Dependability was met by ensuring peer review (by the co-authorship team) was part of the evidence selection, data extraction, and analysis, to ensure opportunity for scrutiny and sense checking. Their criteria of ‘confirmability’ were met using standardised approaches to extraction and transparent presentation of the data.

      3. Results

      3.1 Document flow diagram

      The PRISMA flow diagram (Fig. 1) illustrates the process of article selection for this study. An initial database search of CINAHL, PubMed, EMBASE, and MEDLINE yielded 957 results, with a secondary search of Google Scholar and Web of Science yielding 549 papers. Following removal of duplicates and those published pre 2014, a total of 837 papers had their title and abstract screened for eligibility. From these, 53 were eligible for full-text screening. After screening, 10 were identified as eligible for the realist review. A further two papers were added on recommendation from the review panel as they were experts in the field and were able to provide information on the implementation of an extra element not listed in the abstract that meant that the paper fit the eligibility criteria and from the author of one paper.
      Fig. 1
      Fig. 1PRISMA flow diagram. PICU, paediatric intensive care unit.
      Fig. 2
      Fig. 2CFIR populated with both MRT and empirical data. Black font indicates where the MRT and empirical data match, blue indicates theory only found in the MRT, and green indicates data found only in the empirical papers. AHP, allied health professional; CFIR, Consolidated Framework for Implementation Research; MRT, Mid-Range Theory; PICU, paediatric intensive care unit; MDT, Multi-disciplinary team. (For interpretation of the references to colour in this figure legend, the reader is referred to the Web version of this article.)

      3.2 Document characteristics

      Table 2 provides a summary of the 12 papers included in the review, which report eight different studies. Five of these were grey literature: four conference abstracts from the same project

      Arteaga G., Kawai Y., Rowekamp D., Rohlik, G, Matzke, N., Fryer, k. et al. The pediatric ICU liberation project impact on patient outcomes: the mayo experience. Crit Care Med 2018;46:628. Jan 2018.

      Arteaga G., Kawai Y., Rowekamp D., Rohlik, G., Matzke, N., Smith, P., et al. Bundling the bundles: can we change culture with a holistic approach to patient care in the ICU? Crit Care Med 2018;46:629. Jan 2018.

      Kawai Y., Neu L., Rohlik G., Fetterly, B., Feigal, S., Rowekamp, D. et al. PICU liberation rounding process improves satisfaction with rounds and compliance with abcdef bundle. Crit Care Med 2018;46:639. Jan 2018.

      Kawai Y., Rohlik G., Neu L., Rowekamp, D., Feigal, S., Mujic, A.et al. PICU liberation collaborative: bundle to eliminate delirium improves ICU culture and outcomes. Crit Care Med 2018;46:638. Jan 2018.

      and one poster presentation.
      • Lee L.
      • Nikitovic D.
      • Kraft T.
      • Kampman R.
      • Bissett W.
      • Doughty P.
      Contact was made with these authors to provide information on the context and methodology, normally listed in full text-papers but that was not available in abstract or poster format. All studies were conducted in North America, two of which were based in Canada
      • Lee L.
      • Nikitovic D.
      • Kraft T.
      • Kampman R.
      • Bissett W.
      • Doughty P.
      ,
      • Kongkiattikul L.
      • Dagenais M.
      • Ruo N.
      • Fontela P.
      • Di Genova T.
      • Zavalkoff S.
      The impact of a quality improvement project to standardize pain, agitation, and withdrawal assessments on the use of morphine and midazolam in the Pediatric Intensive Care Unit.
      and the rest in the USA.

      Arteaga G., Kawai Y., Rowekamp D., Rohlik, G, Matzke, N., Fryer, k. et al. The pediatric ICU liberation project impact on patient outcomes: the mayo experience. Crit Care Med 2018;46:628. Jan 2018.

      Arteaga G., Kawai Y., Rowekamp D., Rohlik, G., Matzke, N., Smith, P., et al. Bundling the bundles: can we change culture with a holistic approach to patient care in the ICU? Crit Care Med 2018;46:629. Jan 2018.

      Kawai Y., Neu L., Rohlik G., Fetterly, B., Feigal, S., Rowekamp, D. et al. PICU liberation rounding process improves satisfaction with rounds and compliance with abcdef bundle. Crit Care Med 2018;46:639. Jan 2018.

      Kawai Y., Rohlik G., Neu L., Rowekamp, D., Feigal, S., Mujic, A.et al. PICU liberation collaborative: bundle to eliminate delirium improves ICU culture and outcomes. Crit Care Med 2018;46:638. Jan 2018.

      ,

      Curley Wypij D., Watson R.S., Grant, M.J.C., Asaro, L.A., Cheifetz, I.M., Dodson, B.M.et al. Protocolized sedation vs usual care in pediatric patients mechanically ventilated for acute respiratory failure: a randomized clinical trial. JAMA 2015;313(4):379–389. Jan 2015.

      Barnes-Daly M.A., Pun B.T., Harmon L.A., Byrum, D.G., Kumar, V.K., Devlin, J.W.,et al. Improving health care for critically ill patients using an evidence-based collaborative approach to ABCDEF bundle dissemination and implementation. Worldviews Evidence-Based Nurs 2018;15(3):206–216. Jun 2018.

      Simone S., Edwards S., Lardieri A., Walker, K.L., Graciano, A.L. Kishk, O.A. et al. Implementation of an ICU bundle: an interprofessional quality improvement project to enhance delirium management and monitor delirium prevalence in a single PICU. Pediatr Crit Care Med 2017;18(6):531–540. Jun 2017.

      • Staveski S.L.
      • Wu M.
      • Tesoro T.M.
      • Roth S.J.
      • Cisco M.J.
      Interprofessional team's perception of care delivery after implementation of a pediatric pain and sedation protocol.

      Wieczorek, B., Ascenzi J., Yun K., Lenker, H., Potter, C., Shata, N., et al. PICU up!: impact of a quality improvement intervention to promote early mobilization in critically ill children. Pediatr Crit Care Med 2016;17(12). Dec 2016.

      Study designs included quality improvement/implementation projects (n = 7),

      Arteaga G., Kawai Y., Rowekamp D., Rohlik, G, Matzke, N., Fryer, k. et al. The pediatric ICU liberation project impact on patient outcomes: the mayo experience. Crit Care Med 2018;46:628. Jan 2018.

      ,
      • Lee L.
      • Nikitovic D.
      • Kraft T.
      • Kampman R.
      • Bissett W.
      • Doughty P.
      ,

      Barnes-Daly M.A., Pun B.T., Harmon L.A., Byrum, D.G., Kumar, V.K., Devlin, J.W.,et al. Improving health care for critically ill patients using an evidence-based collaborative approach to ABCDEF bundle dissemination and implementation. Worldviews Evidence-Based Nurs 2018;15(3):206–216. Jun 2018.

      ,

      Wieczorek, B., Ascenzi J., Yun K., Lenker, H., Potter, C., Shata, N., et al. PICU up!: impact of a quality improvement intervention to promote early mobilization in critically ill children. Pediatr Crit Care Med 2016;17(12). Dec 2016.

      • Anderson B.J.,M.E., Mikkelsen
      Bringing the ABCDEF bundle to life and saving lives through the process.
      with only one randomised control trial (RCT).

      Curley Wypij D., Watson R.S., Grant, M.J.C., Asaro, L.A., Cheifetz, I.M., Dodson, B.M.et al. Protocolized sedation vs usual care in pediatric patients mechanically ventilated for acute respiratory failure: a randomized clinical trial. JAMA 2015;313(4):379–389. Jan 2015.

      Five studies used a cohort design, comparing outcomes for patients pre and post implementation.

      Arteaga G., Kawai Y., Rowekamp D., Rohlik, G, Matzke, N., Fryer, k. et al. The pediatric ICU liberation project impact on patient outcomes: the mayo experience. Crit Care Med 2018;46:628. Jan 2018.

      ,
      • Lee L.
      • Nikitovic D.
      • Kraft T.
      • Kampman R.
      • Bissett W.
      • Doughty P.
      ,
      • Kongkiattikul L.
      • Dagenais M.
      • Ruo N.
      • Fontela P.
      • Di Genova T.
      • Zavalkoff S.
      The impact of a quality improvement project to standardize pain, agitation, and withdrawal assessments on the use of morphine and midazolam in the Pediatric Intensive Care Unit.
      ,
      • Staveski S.L.
      • Wu M.
      • Tesoro T.M.
      • Roth S.J.
      • Cisco M.J.
      Interprofessional team's perception of care delivery after implementation of a pediatric pain and sedation protocol.
      ,

      Wieczorek, B., Ascenzi J., Yun K., Lenker, H., Potter, C., Shata, N., et al. PICU up!: impact of a quality improvement intervention to promote early mobilization in critically ill children. Pediatr Crit Care Med 2016;17(12). Dec 2016.

      Three studies implemented the full bundle,

      Arteaga G., Kawai Y., Rowekamp D., Rohlik, G, Matzke, N., Fryer, k. et al. The pediatric ICU liberation project impact on patient outcomes: the mayo experience. Crit Care Med 2018;46:628. Jan 2018.

      ,
      • Lee L.
      • Nikitovic D.
      • Kraft T.
      • Kampman R.
      • Bissett W.
      • Doughty P.
      ,

      Barnes-Daly M.A., Pun B.T., Harmon L.A., Byrum, D.G., Kumar, V.K., Devlin, J.W.,et al. Improving health care for critically ill patients using an evidence-based collaborative approach to ABCDEF bundle dissemination and implementation. Worldviews Evidence-Based Nurs 2018;15(3):206–216. Jun 2018.

      and the others implemented between three and four elements.
      Table 2Summary of documents.
      Author and yearStudy typeSizeInterventionOutcomes measuredWas the study effective?Study limitations
      Barnes-Daly et al., 2018Implementation project69 Adult ICUs

      8 PICUs
      Full ABCDEF bundleImplementation outcomes measured including three validated surveys covering team collaboration, health work environment, and ICU care and perception. Bundle compliance and program retention was also measured.This paper was predominately discussing the implementation process rather than examining outcomes, however suggested positive outcomes.No specific PICU data documented in this study. All hospitals encouraged to implement all elements; however, not all did, unclear what the PICUs implemented. Large quantity of hospitals involved led to reduced resources.
      Curley et al. (2015)RCT31 PICUsA, B, and CPrimary: duration of mechanical ventilation (MV).

      Secondary: time of recovery from acute illness, length of PICU and hospital stay, sedation-related adverse events, sedative exposure including episodes of pain, wakefulness, and agitation and iatrogenic withdrawal syndrome (IWS).
      No significant difference between the control group and intervention group for most measured outcomes. Patients receiving the intervention had less opioid exposure and were more likely to be awake and calm, but did experience more pain.A specific patient group used so unable to ascertain if the same results would apply for different patient groups. Whilst set training program for each hospital, a large number of sites could mean potential for bias due to varied baseline practices.
      Kongkiattikul et al. (2018)Quality improvement initiativeSingle-centre PICUA, C, and FPrimary: cumulative dose of morphine and midazolam for MV patients.

      Secondary: cumulative doses of other sedatives and analgesic, pain score, and IWS.
      Significant reduction in cumulative midazolam dose, reduction in morphine dose. No difference in pain or IWS.Limited sample size means generalisability of results is difficult. Lack of delirium tool means potential that delirium was wrongly diagnosed as withdrawal.
      Simone et al. (2017)Quality improvement projectSingle-centre PICUStaged interventions over time, D, C, then EDelirium cases, adherence to delirium scoring and assessment, MV duration, and length of PICU and hospital stay. Staff delirium knowledge and attitudesPrevalence of delirium declined over time and with each intervention. Screening compliance reached 100%. Staff reported a significant increase in knowledge and confidence in delirium management.No baseline delirium data as tool introduced during intervention so unable to gauge overall impact of intervention. No secondary outcomes measured—unable to see if the intervention had positive/negative impact on pain, length of stay, etc.
      Staveski et al. (2017)Implementation projectSingle Centre PICUA, C and DStaff adherence to the intervention and staff attitudes and perceptions of comfort management.Staff were more comfortable with pain and sedation management after the intervention and utilised comfort management plans better. Staff reported an improvement in team communication.Small sample size so difficult to generalise results. Different sample population for both patients and staff so difficult to suggest direct causality.
      Wieczorek et al. (2016)Quality improvement projectSingle-centre PICUA, C, D, and EPrimary: proportion of patients with PT/OT consults by day 3 and no./type of mobilisation activity performed by day 3.

      Secondary: no. of times/reasons the activities were stopped, barriers to activities, and mobilisation-related adverse events.
      Significant increase in patients having OT consults by day 3 and in the total number of mobilisation activities. Lack of appropriate equipment and adequate staff were the biggest barrier to mobilisation.Retrospective data collection so limited by quality of documentation. No delirium monitoring pre implementation so unable to make comparison in outcomes.
      Lee et al. (2018/2019)Implementation projectSingle centre PICUFull ABCDEF bundleCompliance with pain, agitation and delirium screening, prevalence of pain and delirium, exposure to opioids and benzodiazepines and duration of MV days.An improvement was shown with all of the measured outcomes.Due to poster format, not enough information to ascertain limitations
      Kawai et al. (2018) x2

      Arteaga et al. (2018) x2
      Implementation projectSingle-centre PICUFull ABCDEF bundleStaff teamwork and collaboration, daily bundle compliance, staff confidence in delirium management and prevalence of delirium, days spent MV, and length of PICU and hospital stay.Use of the bundle led to an improvement in team partnership and coordination of care. Nurses became more confident in delirium recognition and management and prevalence decreased. Initial results show a reduction in length of ventilation and length of stay.Due to abstract format, not enough information to ascertain limitations
      ICU, intensive care unit; PICU, pediatric intensive care unit.

      3.2.1 Participants

      Across the eight studies, samples varied from 40 to 1225. The exact paediatric sample size was not recorded in one study,

      Barnes-Daly M.A., Pun B.T., Harmon L.A., Byrum, D.G., Kumar, V.K., Devlin, J.W.,et al. Improving health care for critically ill patients using an evidence-based collaborative approach to ABCDEF bundle dissemination and implementation. Worldviews Evidence-Based Nurs 2018;15(3):206–216. Jun 2018.

      so the total sample size is unknown. Likewise, patient age was not recorded in every paper; however, the broadest range documented is from 38 weeks corrected gestational age to 18 years.
      • Kongkiattikul L.
      • Dagenais M.
      • Ruo N.
      • Fontela P.
      • Di Genova T.
      • Zavalkoff S.
      The impact of a quality improvement project to standardize pain, agitation, and withdrawal assessments on the use of morphine and midazolam in the Pediatric Intensive Care Unit.
      Each study also included PICU staff as participants, including physicians, nurses, respiratory and physical therapists, and pharmacists. The number of staff members and their role differed in every study. All patients involved were admitted to the PICU for a minimum of 24 h. Curley et al.

      Curley Wypij D., Watson R.S., Grant, M.J.C., Asaro, L.A., Cheifetz, I.M., Dodson, B.M.et al. Protocolized sedation vs usual care in pediatric patients mechanically ventilated for acute respiratory failure: a randomized clinical trial. JAMA 2015;313(4):379–389. Jan 2015.

      had the strictest eligibility criteria, only including children admitted with acute respiratory failure, whereas the seven remaining studies had broader criteria for the type of illness.

      Curley Wypij D., Watson R.S., Grant, M.J.C., Asaro, L.A., Cheifetz, I.M., Dodson, B.M.et al. Protocolized sedation vs usual care in pediatric patients mechanically ventilated for acute respiratory failure: a randomized clinical trial. JAMA 2015;313(4):379–389. Jan 2015.

      3.3 Main findings

      Data were extracted from the included papers and populated into an empirical CFIR to be compared with the MRT CFIR, constructed from the phase one scoping search. This allows the findings from the empirical papers to be tested against the MRT (Fig. 2).

      3.3.1 CFIR domain 1: Characteristics of individuals

      Characteristics of individuals was the only domain where the empirical CFIR fully matched the MRT CFIR, indicating a commonality in characteristics of individuals when implementing the ICU Liberation Bundle in adult ICU and PICU. Most of the empirical papers discussed the core interprofessional team that was put in place to participate in the intervention delivery, provide support and education to others, and to be involved in data collection. Whilst there was subtle variation in the team structure between studies, teams commonly included intensivists, bedside nurses, physiotherapists, respiratory therapists, and pharmacists.
      • Kongkiattikul L.
      • Dagenais M.
      • Ruo N.
      • Fontela P.
      • Di Genova T.
      • Zavalkoff S.
      The impact of a quality improvement project to standardize pain, agitation, and withdrawal assessments on the use of morphine and midazolam in the Pediatric Intensive Care Unit.
      ,

      Barnes-Daly M.A., Pun B.T., Harmon L.A., Byrum, D.G., Kumar, V.K., Devlin, J.W.,et al. Improving health care for critically ill patients using an evidence-based collaborative approach to ABCDEF bundle dissemination and implementation. Worldviews Evidence-Based Nurs 2018;15(3):206–216. Jun 2018.

      ,
      • Staveski S.L.
      • Wu M.
      • Tesoro T.M.
      • Roth S.J.
      • Cisco M.J.
      Interprofessional team's perception of care delivery after implementation of a pediatric pain and sedation protocol.
      ,

      Wieczorek, B., Ascenzi J., Yun K., Lenker, H., Potter, C., Shata, N., et al. PICU up!: impact of a quality improvement intervention to promote early mobilization in critically ill children. Pediatr Crit Care Med 2016;17(12). Dec 2016.

      ,

      Simone S., Edwards S., Lardieri A., Walker, K.L., Graciano, A.L. Kishk, O.A. et al. Implementation of an ICU bundle: an interprofessional quality improvement project to enhance delirium management and monitor delirium prevalence in a single PICU. Pediatr Crit Care Med 2017;18(6):531–540. Jun 2017.

      Staveski et al.
      • Staveski S.L.
      • Wu M.
      • Tesoro T.M.
      • Roth S.J.
      • Cisco M.J.
      Interprofessional team's perception of care delivery after implementation of a pediatric pain and sedation protocol.
      also included a psychiatrist in this team, whilst Kongkiattikul et al.
      • Kongkiattikul L.
      • Dagenais M.
      • Ruo N.
      • Fontela P.
      • Di Genova T.
      • Zavalkoff S.
      The impact of a quality improvement project to standardize pain, agitation, and withdrawal assessments on the use of morphine and midazolam in the Pediatric Intensive Care Unit.
      incorporated a family advisor (a mother of a former patient); both this study and the study by Wieczorek et al.

      Wieczorek, B., Ascenzi J., Yun K., Lenker, H., Potter, C., Shata, N., et al. PICU up!: impact of a quality improvement intervention to promote early mobilization in critically ill children. Pediatr Crit Care Med 2016;17(12). Dec 2016.

      involved a child life specialist. Another common theme was the use of identified champions of the bundle or intervention. Staff nominated as champions acted at a unit level to provide support and encouragement to the bedside team and at a hospital level to champion the intervention to senior and board staff.
      • Lee L.
      • Nikitovic D.
      • Kraft T.
      • Kampman R.
      • Bissett W.
      • Doughty P.
      ,

      Wieczorek, B., Ascenzi J., Yun K., Lenker, H., Potter, C., Shata, N., et al. PICU up!: impact of a quality improvement intervention to promote early mobilization in critically ill children. Pediatr Crit Care Med 2016;17(12). Dec 2016.

      ,

      Simone S., Edwards S., Lardieri A., Walker, K.L., Graciano, A.L. Kishk, O.A. et al. Implementation of an ICU bundle: an interprofessional quality improvement project to enhance delirium management and monitor delirium prevalence in a single PICU. Pediatr Crit Care Med 2017;18(6):531–540. Jun 2017.

      Other aspects to this domain included gaining a baseline understanding of staff attitudes and perceptions of the intervention

      Barnes-Daly M.A., Pun B.T., Harmon L.A., Byrum, D.G., Kumar, V.K., Devlin, J.W.,et al. Improving health care for critically ill patients using an evidence-based collaborative approach to ABCDEF bundle dissemination and implementation. Worldviews Evidence-Based Nurs 2018;15(3):206–216. Jun 2018.

      ,
      • Staveski S.L.
      • Wu M.
      • Tesoro T.M.
      • Roth S.J.
      • Cisco M.J.
      Interprofessional team's perception of care delivery after implementation of a pediatric pain and sedation protocol.
      ,

      Simone S., Edwards S., Lardieri A., Walker, K.L., Graciano, A.L. Kishk, O.A. et al. Implementation of an ICU bundle: an interprofessional quality improvement project to enhance delirium management and monitor delirium prevalence in a single PICU. Pediatr Crit Care Med 2017;18(6):531–540. Jun 2017.

      and allowing staff the chance to talk about potential barriers and facilitators to the implementation of the process
      • Kongkiattikul L.
      • Dagenais M.
      • Ruo N.
      • Fontela P.
      • Di Genova T.
      • Zavalkoff S.
      The impact of a quality improvement project to standardize pain, agitation, and withdrawal assessments on the use of morphine and midazolam in the Pediatric Intensive Care Unit.
      and then using the information gathered to influence implementation. In the latter study, whilst sedation scoring was introduced, the decision was made not to use a sedation algorithm as discussion with nursing staff members indicated they valued autonomy in adjusting their patients' sedation.

      Wieczorek, B., Ascenzi J., Yun K., Lenker, H., Potter, C., Shata, N., et al. PICU up!: impact of a quality improvement intervention to promote early mobilization in critically ill children. Pediatr Crit Care Med 2016;17(12). Dec 2016.

      3.3.2 CFIR domain 2: Inner setting

      Several similarities between the MRT CFIR and the empirical CFIR exist when considering the inner setting domain. Leadership support and buy-in appeared across both CFIRs but had a greater emphasis in the empirical CFIR. A range of strategies are reported which demonstrate the leadership commitment to the intervention, which includes obtaining signed proof of commitment from the senior management team;

      Barnes-Daly M.A., Pun B.T., Harmon L.A., Byrum, D.G., Kumar, V.K., Devlin, J.W.,et al. Improving health care for critically ill patients using an evidence-based collaborative approach to ABCDEF bundle dissemination and implementation. Worldviews Evidence-Based Nurs 2018;15(3):206–216. Jun 2018.

      senior consensus that the intervention was necessary to improve patient and staff outcomes;
      • Staveski S.L.
      • Wu M.
      • Tesoro T.M.
      • Roth S.J.
      • Cisco M.J.
      Interprofessional team's perception of care delivery after implementation of a pediatric pain and sedation protocol.
      and gaining support on local, site, and provincial levels.
      • Lee L.
      • Nikitovic D.
      • Kraft T.
      • Kampman R.
      • Bissett W.
      • Doughty P.
      Senior staff and the inter-professional team having knowledge and understanding of the baseline metrics of each element to be implemented and of patient outcomes was also deemed important in the empirical papers.

      Arteaga G., Kawai Y., Rowekamp D., Rohlik, G, Matzke, N., Fryer, k. et al. The pediatric ICU liberation project impact on patient outcomes: the mayo experience. Crit Care Med 2018;46:628. Jan 2018.

      ,
      • Kongkiattikul L.
      • Dagenais M.
      • Ruo N.
      • Fontela P.
      • Di Genova T.
      • Zavalkoff S.
      The impact of a quality improvement project to standardize pain, agitation, and withdrawal assessments on the use of morphine and midazolam in the Pediatric Intensive Care Unit.
      ,
      • Staveski S.L.
      • Wu M.
      • Tesoro T.M.
      • Roth S.J.
      • Cisco M.J.
      Interprofessional team's perception of care delivery after implementation of a pediatric pain and sedation protocol.
      ,

      Wieczorek, B., Ascenzi J., Yun K., Lenker, H., Potter, C., Shata, N., et al. PICU up!: impact of a quality improvement intervention to promote early mobilization in critically ill children. Pediatr Crit Care Med 2016;17(12). Dec 2016.

      However, only one study supported the suggestion from the MRT that it was necessary to understand the culture, characteristics, and team composition of the unit prior to implementing the intervention.

      3.3.3 CFIR domain 3: Outer setting

      There were minimal references to the outer setting domain in either the MRT CFIR or the empirical CFIR. Evidence from both identified working with the ICU Liberation Collaborative which was the collaboration set up by the SCCM and used internationally as a source of support, education, and resources.

      Arteaga G., Kawai Y., Rowekamp D., Rohlik, G., Matzke, N., Smith, P., et al. Bundling the bundles: can we change culture with a holistic approach to patient care in the ICU? Crit Care Med 2018;46:629. Jan 2018.

      ,
      • Kongkiattikul L.
      • Dagenais M.
      • Ruo N.
      • Fontela P.
      • Di Genova T.
      • Zavalkoff S.
      The impact of a quality improvement project to standardize pain, agitation, and withdrawal assessments on the use of morphine and midazolam in the Pediatric Intensive Care Unit.
      ,

      Barnes-Daly M.A., Pun B.T., Harmon L.A., Byrum, D.G., Kumar, V.K., Devlin, J.W.,et al. Improving health care for critically ill patients using an evidence-based collaborative approach to ABCDEF bundle dissemination and implementation. Worldviews Evidence-Based Nurs 2018;15(3):206–216. Jun 2018.

      No further reference was made to the outer setting in the empirical studies.

      3.3.4 CFIR domain 4: Intervention characteristics

      For this domain, several similarities were evident between the MRT CFIR and empirical CFIR. The application and discussion of the core components of the ICU Liberation Bundle daily and discussing them on a structured daily IPT round was identified in several studies.

      Kawai Y., Neu L., Rohlik G., Fetterly, B., Feigal, S., Rowekamp, D. et al. PICU liberation rounding process improves satisfaction with rounds and compliance with abcdef bundle. Crit Care Med 2018;46:639. Jan 2018.

      ,

      Kawai Y., Rohlik G., Neu L., Rowekamp, D., Feigal, S., Mujic, A.et al. PICU liberation collaborative: bundle to eliminate delirium improves ICU culture and outcomes. Crit Care Med 2018;46:638. Jan 2018.

      ,

      Curley Wypij D., Watson R.S., Grant, M.J.C., Asaro, L.A., Cheifetz, I.M., Dodson, B.M.et al. Protocolized sedation vs usual care in pediatric patients mechanically ventilated for acute respiratory failure: a randomized clinical trial. JAMA 2015;313(4):379–389. Jan 2015.

      ,

      Wieczorek, B., Ascenzi J., Yun K., Lenker, H., Potter, C., Shata, N., et al. PICU up!: impact of a quality improvement intervention to promote early mobilization in critically ill children. Pediatr Crit Care Med 2016;17(12). Dec 2016.

      ,

      Simone S., Edwards S., Lardieri A., Walker, K.L., Graciano, A.L. Kishk, O.A. et al. Implementation of an ICU bundle: an interprofessional quality improvement project to enhance delirium management and monitor delirium prevalence in a single PICU. Pediatr Crit Care Med 2017;18(6):531–540. Jun 2017.

      Kawai et al.

      Kawai Y., Neu L., Rohlik G., Fetterly, B., Feigal, S., Rowekamp, D. et al. PICU liberation rounding process improves satisfaction with rounds and compliance with abcdef bundle. Crit Care Med 2018;46:639. Jan 2018.

      takes this further, implementing a daily de-escalation checklist for both nursing and medical staff to use on the ward round to improve daily compliance. Barnes-Daly et al.

      Barnes-Daly M.A., Pun B.T., Harmon L.A., Byrum, D.G., Kumar, V.K., Devlin, J.W.,et al. Improving health care for critically ill patients using an evidence-based collaborative approach to ABCDEF bundle dissemination and implementation. Worldviews Evidence-Based Nurs 2018;15(3):206–216. Jun 2018.

      also supports the MRT in stating that every element should be implemented together; however, none of the empirical papers reference the timings of the intervention which was stated as important in the MRT.
      Another commonality between the two CFIRs was the importance of using age-appropriate and validated assessment tools relating to the ICU Liberation Bundle, with each of the empirical papers referencing the use of PICU validated tools. Furthermore, each empirical paper (excluding that by Curley et al.

      Curley Wypij D., Watson R.S., Grant, M.J.C., Asaro, L.A., Cheifetz, I.M., Dodson, B.M.et al. Protocolized sedation vs usual care in pediatric patients mechanically ventilated for acute respiratory failure: a randomized clinical trial. JAMA 2015;313(4):379–389. Jan 2015.

      which had stricter eligibility criteria as it was a multicentre RCT) set their own eligibility criteria based on what was relevant to their unit. Similarly, the MRT CFIR suggested that while the core purpose of each element of the bundle should be kept the same, each ICU should have some flexibility in how each element is implemented, due to the variation that can occur between different units. This is supported by Barnes-Daly et al.

      Barnes-Daly M.A., Pun B.T., Harmon L.A., Byrum, D.G., Kumar, V.K., Devlin, J.W.,et al. Improving health care for critically ill patients using an evidence-based collaborative approach to ABCDEF bundle dissemination and implementation. Worldviews Evidence-Based Nurs 2018;15(3):206–216. Jun 2018.

      as the paper covers implementation in multiple units and states that each unit had some freedom in how they implemented the bundle. Kongkiattikul et al.
      • Kongkiattikul L.
      • Dagenais M.
      • Ruo N.
      • Fontela P.
      • Di Genova T.
      • Zavalkoff S.
      The impact of a quality improvement project to standardize pain, agitation, and withdrawal assessments on the use of morphine and midazolam in the Pediatric Intensive Care Unit.
      give a clearer example of this, stating that they chose not to implement a set sedation protocol as part of the intervention after listening to the views of bedside staff. The importance of having clear, approved policies in place for the interventions is supported by several of the empirical papers which discuss implementing either set policies or protocols for the intervention.
      • Kongkiattikul L.
      • Dagenais M.
      • Ruo N.
      • Fontela P.
      • Di Genova T.
      • Zavalkoff S.
      The impact of a quality improvement project to standardize pain, agitation, and withdrawal assessments on the use of morphine and midazolam in the Pediatric Intensive Care Unit.

      Curley Wypij D., Watson R.S., Grant, M.J.C., Asaro, L.A., Cheifetz, I.M., Dodson, B.M.et al. Protocolized sedation vs usual care in pediatric patients mechanically ventilated for acute respiratory failure: a randomized clinical trial. JAMA 2015;313(4):379–389. Jan 2015.

      Barnes-Daly M.A., Pun B.T., Harmon L.A., Byrum, D.G., Kumar, V.K., Devlin, J.W.,et al. Improving health care for critically ill patients using an evidence-based collaborative approach to ABCDEF bundle dissemination and implementation. Worldviews Evidence-Based Nurs 2018;15(3):206–216. Jun 2018.

      ,

      Wieczorek, B., Ascenzi J., Yun K., Lenker, H., Potter, C., Shata, N., et al. PICU up!: impact of a quality improvement intervention to promote early mobilization in critically ill children. Pediatr Crit Care Med 2016;17(12). Dec 2016.

      ,

      Simone S., Edwards S., Lardieri A., Walker, K.L., Graciano, A.L. Kishk, O.A. et al. Implementation of an ICU bundle: an interprofessional quality improvement project to enhance delirium management and monitor delirium prevalence in a single PICU. Pediatr Crit Care Med 2017;18(6):531–540. Jun 2017.

      Finally, the addition of a nonpharmacological pain tool for use by bedside staff and families, recommended in the MRT, is utilised in studies by both Lee et al.
      • Lee L.
      • Nikitovic D.
      • Kraft T.
      • Kampman R.
      • Bissett W.
      • Doughty P.
      and Kongkiattikul et al.
      • Kongkiattikul L.
      • Dagenais M.
      • Ruo N.
      • Fontela P.
      • Di Genova T.
      • Zavalkoff S.
      The impact of a quality improvement project to standardize pain, agitation, and withdrawal assessments on the use of morphine and midazolam in the Pediatric Intensive Care Unit.

      3.3.5 CFIR domain 5: Process of intervention

      The empirical papers provided more relevant data and greater detail in relation to process of intervention than the MRT. Whilst multimodal education was briefly referenced in the MRT, it was a key theme in the empirical papers, with most papers stating it was provided for all members of the IPT involved in any part of the intervention. However, the content differed, with mix of face-to-face and written/electronic teaching sessions, as well as resources that could be easily accessed at the bedside being utilised.
      • Lee L.
      • Nikitovic D.
      • Kraft T.
      • Kampman R.
      • Bissett W.
      • Doughty P.
      ,
      • Kongkiattikul L.
      • Dagenais M.
      • Ruo N.
      • Fontela P.
      • Di Genova T.
      • Zavalkoff S.
      The impact of a quality improvement project to standardize pain, agitation, and withdrawal assessments on the use of morphine and midazolam in the Pediatric Intensive Care Unit.
      ,

      Barnes-Daly M.A., Pun B.T., Harmon L.A., Byrum, D.G., Kumar, V.K., Devlin, J.W.,et al. Improving health care for critically ill patients using an evidence-based collaborative approach to ABCDEF bundle dissemination and implementation. Worldviews Evidence-Based Nurs 2018;15(3):206–216. Jun 2018.

      ,
      • Staveski S.L.
      • Wu M.
      • Tesoro T.M.
      • Roth S.J.
      • Cisco M.J.
      Interprofessional team's perception of care delivery after implementation of a pediatric pain and sedation protocol.
      ,

      Wieczorek, B., Ascenzi J., Yun K., Lenker, H., Potter, C., Shata, N., et al. PICU up!: impact of a quality improvement intervention to promote early mobilization in critically ill children. Pediatr Crit Care Med 2016;17(12). Dec 2016.

      Specifically, two papers offered novel approaches to empirical CFIR using discipline-specific scenario–based tests to ensure proficiency (Curley et al.

      Curley Wypij D., Watson R.S., Grant, M.J.C., Asaro, L.A., Cheifetz, I.M., Dodson, B.M.et al. Protocolized sedation vs usual care in pediatric patients mechanically ventilated for acute respiratory failure: a randomized clinical trial. JAMA 2015;313(4):379–389. Jan 2015.

      ) and simulation training on early mobilisation (Lee et al.). The empirical papers supported the MRT regarding the importance of auditing adherence to the bundle and the provision of feedback.

      Kawai Y., Neu L., Rohlik G., Fetterly, B., Feigal, S., Rowekamp, D. et al. PICU liberation rounding process improves satisfaction with rounds and compliance with abcdef bundle. Crit Care Med 2018;46:639. Jan 2018.

      ,
      • Lee L.
      • Nikitovic D.
      • Kraft T.
      • Kampman R.
      • Bissett W.
      • Doughty P.
      ,

      Curley Wypij D., Watson R.S., Grant, M.J.C., Asaro, L.A., Cheifetz, I.M., Dodson, B.M.et al. Protocolized sedation vs usual care in pediatric patients mechanically ventilated for acute respiratory failure: a randomized clinical trial. JAMA 2015;313(4):379–389. Jan 2015.

      This was expanded on by several of the empirical papers that discussed how they used Plan-Do-Study-Act (PDSA) cycles to make and assess small-scale changes throughout the implementation process.
      • Lee L.
      • Nikitovic D.
      • Kraft T.
      • Kampman R.
      • Bissett W.
      • Doughty P.
      ,
      • Kongkiattikul L.
      • Dagenais M.
      • Ruo N.
      • Fontela P.
      • Di Genova T.
      • Zavalkoff S.
      The impact of a quality improvement project to standardize pain, agitation, and withdrawal assessments on the use of morphine and midazolam in the Pediatric Intensive Care Unit.
      ,

      Simone S., Edwards S., Lardieri A., Walker, K.L., Graciano, A.L. Kishk, O.A. et al. Implementation of an ICU bundle: an interprofessional quality improvement project to enhance delirium management and monitor delirium prevalence in a single PICU. Pediatr Crit Care Med 2017;18(6):531–540. Jun 2017.

      Both Arteaga et al.

      Arteaga G., Kawai Y., Rowekamp D., Rohlik, G, Matzke, N., Fryer, k. et al. The pediatric ICU liberation project impact on patient outcomes: the mayo experience. Crit Care Med 2018;46:628. Jan 2018.

      and Barnes-Daly et al.

      Barnes-Daly M.A., Pun B.T., Harmon L.A., Byrum, D.G., Kumar, V.K., Devlin, J.W.,et al. Improving health care for critically ill patients using an evidence-based collaborative approach to ABCDEF bundle dissemination and implementation. Worldviews Evidence-Based Nurs 2018;15(3):206–216. Jun 2018.

      monitored and audited changes in ICU culture, such as improved teamwork and communication. Another theme seen in the empirical CFIR, but not in the MRT CFIR, was ensuring that any successes were celebrated and advertised within the unit and with the senior team to ensure continued motivation and support.
      • Lee L.
      • Nikitovic D.
      • Kraft T.
      • Kampman R.
      • Bissett W.
      • Doughty P.

      4. Discussion

      4.1 Summary of findings

      Each paper that was included in this review has implemented and evaluated the ICU Liberation Bundle, or elements of it, in diverse ways. As such, it is not possible to make direct comparisons. However, by analysing and comparing the CFIR and the data analysis matrix, the data could be summarised into key themes which contribute towards answers to the review question. To do this, the objectives, with their focus on the realist format of context, mechanisms, and outcomes are considered in turn, although some aspects overlap within this format.

      4.1.1 Does the intervention need to be adapted to fit different contexts?

      Analysis and comparison of the MRT and the empirical papers suggest that for a successful intervention to take place, a solid understanding of the localised context prior to implementation is vital.
      • Stollings
      • Devlin J.W.
      • Lin J.C.
      • Pun B.T.
      • Byrum D.
      • Barr J.
      Best practices for conducting interprofessional team rounds to facilitate performance of the ICU liberation (ABCDEF) bundle.
      ,

      Barnes-Daly M.A., Pun B.T., Harmon L.A., Byrum, D.G., Kumar, V.K., Devlin, J.W.,et al. Improving health care for critically ill patients using an evidence-based collaborative approach to ABCDEF bundle dissemination and implementation. Worldviews Evidence-Based Nurs 2018;15(3):206–216. Jun 2018.

      ,

      Wieczorek, B., Ascenzi J., Yun K., Lenker, H., Potter, C., Shata, N., et al. PICU up!: impact of a quality improvement intervention to promote early mobilization in critically ill children. Pediatr Crit Care Med 2016;17(12). Dec 2016.

      ,
      • Anderson B.J.,M.E., Mikkelsen
      Bringing the ABCDEF bundle to life and saving lives through the process.
      This should include a baseline understanding of what is already in place on the unit and baseline measurement for all patient outcomes that are planned to be evaluated. This baseline assessment would inform the tailoring of the ICU Liberation Bundle elements to best fit the context it is being implemented into. A recognition of the need for, and benefits of, the intervention combined with senior and frontline buy-in is the second key contextual element that has a strong impact on successful implementation of the ICU Liberation Bundle.
      • Lee L.
      • Nikitovic D.
      • Kraft T.
      • Kampman R.
      • Bissett W.
      • Doughty P.
      ,
      • Staveski S.L.
      • Wu M.
      • Tesoro T.M.
      • Roth S.J.
      • Cisco M.J.
      Interprofessional team's perception of care delivery after implementation of a pediatric pain and sedation protocol.
      ,
      • Walz A.
      • Canter M.O.
      • Betters K.
      The ICU liberation bundle and strategies for implementation in pediatrics.
      Existing literature on complex intervention supports these findings. A study providing Medical Research Council guidance on developing complex intervention states that adapting an intervention to fit local circumstances can work better than using a standardised approach, provided the process is clearly documented.
      • Craig P.
      • Dieppe P.
      • Macintyre S.
      • Michie S.
      • Nazareth I.
      • Petticrew M.
      Developing and evaluating complex interventions: the new Medical Research Council guidance.
      An analysis study on complex interventions further discusses the importance of understanding the context, not just when planning an intervention but also when assessing whether an intervention that had success in one setting would work in a different setting.
      • Campbell N.C.
      • Murray E.
      • Darbyshire J.
      • Emery J.
      • Farmer A.
      • Griffiths F.
      • et al.
      Designing and evaluating complex interventions to improve health care.
      This also may partially account for why the multicentre RCT

      Curley Wypij D., Watson R.S., Grant, M.J.C., Asaro, L.A., Cheifetz, I.M., Dodson, B.M.et al. Protocolized sedation vs usual care in pediatric patients mechanically ventilated for acute respiratory failure: a randomized clinical trial. JAMA 2015;313(4):379–389. Jan 2015.

      did not demonstrate positive results for the primary outcomes as by nature of the study design, it was not possible for each PICU involved to take an individualised approach. Furthermore, the literature on implementation science highlights the importance of this contextual understanding, providing evidence that the implementation climate (a construct representing workers perceptions on how innovation use is expected, supported, and rewarded) of an area is highly dependent on context.
      • Jacobs S.R.
      • Weiner B.J.
      • Bunger A.C.
      Context matters: measuring implementation climate among individuals and groups.
      Further literature recognises the need to consider both macro and micro factors when assessing an organisation's readiness for change.

      Gagnon M.-P., Labarthe J., Légaré F., Ouimet, M., Estabrooks, C.A., Roch., G.et al. Measuring organizational readiness for knowledge translation in chronic care. Implement Sci 2011;6(1):72.

      When considered together, the findings from these studies suggest support for the use of realist reviews as a way to gather evidence prior to considering the implementation of a complex intervention such as the ICU Liberation Bundle. Of note, all the included papers were based in North America, with most providing very minimal information about the broader context of their PICU, such as unit size, the staff structure within it, or the type of hospital. No information was given regarding the socio-economic context which is reflected in the minimal findings in the CFIR ‘outer setting’ domain and warrants further exploration.

      4.1.2 Which core mechanisms need to be in place for a successful intervention, and is there scope to adapt these?

      This review explored which mechanisms are necessary and which could be adapted in relation to the implementation of the elements of the ICU Liberation Bundle in a PICU context. This proved difficult to extrapolate at times due to overlap of the context and mechanisms seen in the CFIR. However, this difficulty does also lead to the suggestion that the adaptability of the mechanisms is dependent on having a sound understanding of the context of the PICU setting in which the bundle is to be implemented. The CFIR findings identified that the key mechanisms of the implementation process all have a core element with space for adaptation. Michie et al.
      • Michie S.
      • Fixsen D.
      • Grimshaw J.M.
      • Eccles M.P.
      Specifying and reporting complex behaviour change interventions: the need for a scientific method.
      highlight this, stating that it is essential to understand the core components of the intervention to achieve good outcomes and that in knowing these, the intervention can be more efficient and cost-effective and enable clear decisions to be made about adapting the noncore components to suit local conditions. There are several examples of this in this review. Firstly, the importance of a core interprofessional team to lead the ICU Liberation Bundle is recognised in multiple papers; however, no paper reported identical interprofessional teams, suggesting that each adapted their team to best represent their PICU.
      Secondly, findings showed that providing multifaceted education and training to all frontline team members, prior to and during the intervention, has also been shown to have a positive impact on its successful implementation. Each of the papers analysed demonstrated slightly different methods of education and training which impacts the generalisability of the results; however, at the minimum, a combination of face-to-face teaching (for example, during teaching sessions, at the bedside and during rounding) coupled with easily accessible written or electronic guidance was included. However, unit resources must be considered when selecting teaching methods. For example, simulation is recognised to have a positive impact on nursing knowledge and skill,
      • Shin S.
      • Park J.-H.
      • Kim J.-H.
      Effectiveness of patient simulation in nursing education: meta-analysis.
      but it is a resource-heavy method of teaching, requiring simulation-trained staff that not every PICU may have access to.
      • Kardong-Edgren S.
      State of the science.
      Finally, a vital mechanism for the implementation of this intervention is to ensure the process is audited throughout to ensure compliance to the bundle, identify issues and successes, and provide regular feedback to staff. PDSA cycles are suggested for this in several papers, and the use of these supported in the literature, suggesting that when used correctly, they are a beneficial way to test small-scale changes, enabling refinements to be made quickly as necessary and engaging stakeholders in the process.
      • Leis J.A.
      • Shojania K.G.
      A primer on PDSA: executing plan–do–study–act cycles in practice, not just in name.
      As such, this method can be recommended for implementing the ICU Liberation Bundle in several smaller stages, which may be beneficial for PICUs that do not have the resources to implement the full bundle directly or where further stakeholder buy-in is necessary. Furthermore, it is recognised that innovations that can be broken down to smaller parts and implemented incrementally have the potential to be more readily adopted.
      • Greenhalgh T.
      • Robert G.
      • Macfarlane F.
      • Bate P.
      • Kyriakidou O.
      Diffusion of innovations in service organizations: systematic review and recommendations.

      4.1.3 What outcomes need to be measured to establish how successful the intervention has been?

      Review findings suggest both the collection and utilisation of clinical effectiveness outcomes and implementation outcomes should be considered in the implementation of the ICU bundle in the PICU setting. A limitation with the included studies is that clinical effectiveness and implementation outcomes are not consistently measured and therefore unable to provide evidence of sustainability, moreover, impacting the generalisability of the results. Where implementation outcomes are measured, there are flaws with the study design
      • Staveski S.L.
      • Wu M.
      • Tesoro T.M.
      • Roth S.J.
      • Cisco M.J.
      Interprofessional team's perception of care delivery after implementation of a pediatric pain and sedation protocol.
      or there has not been a validated tool available to measure the required aspect (e.g., staff perceptions regarding the intervention), so a nonvalidated tool has been created to fill the gap. This reduces the reliability of the results. Other studies also implemented multiple elements but only looked at one aspect, meaning no outcome data were available that showed the impact of the elements as a bundle. This provides the potential that the positive outcome may be at the expense of something else that is not being measured, such as sedation-related adverse events or length of stay. This makes it difficult to assess the long-term impact or sustainability of the intervention. This is supported in the existing literature on complex interventions which identifies having both clearly described implementation processes plus outcomes that measure the strength and presence of the intervention better enable causal relationships.
      • Michie S.
      • Fixsen D.
      • Grimshaw J.M.
      • Eccles M.P.
      Specifying and reporting complex behaviour change interventions: the need for a scientific method.
      Furthermore, the Medical Research Council guidance states that whilst the use of a single primary outcome and minimal secondary outcomes may enable easy analysis, they may not provide adequate assessment of the impact of an intervention across a range of domains.
      • Craig P.
      • Dieppe P.
      • Macintyre S.
      • Michie S.
      • Nazareth I.
      • Petticrew M.
      Developing and evaluating complex interventions: the new Medical Research Council guidance.
      As such, the recommendation can be made that to ensure the intervention is successful, patient outcomes pertaining to each element as well as general PICU metrics such as length of stay and duration of MV should be obtained alongside outcomes considering the sustainability of the intervention such as staff attitudes, teamwork, and budgetary impact. Within implementation science literature, seminal work has been undertaken on this topic, providing a taxonomy of implementation outcomes.

      Proctor E., Silmere H., Raghavan R., Hovman, P., Aarons, G., Bunger., A.,et al. Outcomes for implementation research: conceptual distinctions, measurement challenges, and research agenda. Adm Pol Ment Health 2011;38(2):65–76.

      The measurement of implementation outcomes have the potential to advance the understanding of implementation processes, allow the effectiveness of implementation strategies to be examined, and enhance efficiency.

      Proctor E., Silmere H., Raghavan R., Hovman, P., Aarons, G., Bunger., A.,et al. Outcomes for implementation research: conceptual distinctions, measurement challenges, and research agenda. Adm Pol Ment Health 2011;38(2):65–76.

      4.1.4 Number of elements

      The literature from implementation in adult ICU clearly states that the whole ICU Liberation Bundle works best being implemented together.

      Pun, Balas M.C., Barnes-Daly M.A., Thompson, J.L, Aldrich, J.M., Barr, J., et al. Caring for critically ill patients with the ABCDEF bundle: results of the ICU liberation collaborative in over 15,000 adults. Crit Care Med 2019;47(1):3–14. Jan 2019.

      However, this review suggests that this may not be appropriate for every PICU as it is recognised that not every paper reviewed implemented every element. To ascertain how many of the elements should be implemented at one time, there are overlapping C, M, and O considerations. An understanding of the unit context is essential, with considerations to staff and resources and staff engagement appearing particularly important.

      4.1.4.1 Staff and resources

      The early mobilisation element has the potential to require more time and resources than other elements. The PICU Up! study

      Wieczorek, B., Ascenzi J., Yun K., Lenker, H., Potter, C., Shata, N., et al. PICU up!: impact of a quality improvement intervention to promote early mobilization in critically ill children. Pediatr Crit Care Med 2016;17(12). Dec 2016.

      where E (Early mobilisation) was the primary focus indicates that having adequate staffing and support from physiotherapists is needed to ensure a successful intervention and that nursing staff did not always feel that the medical team recognised the competing demands they had at the bedside. Furthermore, they cited as a limitation that the impact of the intervention on time and resources was not measured, a limitation that, whilst not reported elsewhere, was also true for most of the reviewed studies. Therefore, a PICU with fewer resources, or less access to allied health professionals such as physiotherapists or occupational therapists, may need to consider one or more of the following: reallocation of roles, adapting which elements are implemented, or to what extent they are implemented. This is supported by the literature on the CFIR, highlighting ‘available resources’ as a key construct within the inner setting domain, recognising the need to understand the level of resources dedicated to both the implementation and ongoing needs of an intervention. This includes money, training, education, time, and space.
      • Damschroder L.J.
      • Aron D.C.
      • Keith R.E.
      • Kirsh S.R.
      • Alexander J.A.
      • Lowery J.C.
      Fostering implementation of health services research findings into practice: a consolidated framework for advancing implementation science.

      4.1.4.2 Staff engagement

      The engagement of staff in the planning process can also impact which elements are implemented. This was seen in the review with papers using the information gained from staff engagement to influence implementation. Whilst this could be considered a risk in adjusting the core elements because of this, it is also likely that taking this approach will benefit staff engagement and compliance with the chosen intervention. A systematic review on implementation of care bundles in ICUs recognises the importance of staff members accepting each element of the bundle to maximise compliance.
      • Borgert M.J.
      • Goossens A.
      • Dongelmans D.A.
      What are effective strategies for the implementation of care bundles on ICUs: a systematic review.

      4.2 Strengths and limitations

      The strengths of this study lie in the use of the realist review framework as it has enabled exploration of the factors involved in effective implementation of the ICU Liberation Bundle within a PICU setting. Furthermore, the protocol was published on PROSPERO prior the study completion to provide transparency to the process. Experts in the field were consulted during the review process, including topic and clinical experts and medical librarians, this ensuring a rigorous and robust review was carried out. Clear checking and conforming mechanisms were also in place as well as an audit trail of decision-making processes. Furthermore, the findings from this study provide support to the suggestions provided by the two articles that give guidance on the implementation of the ICU Liberation Bundle into PICUs,
      • Walz A.
      • Canter M.O.
      • Betters K.
      The ICU liberation bundle and strategies for implementation in pediatrics.
      ,
      • Choong K.
      • Abu-Sultaneh S.
      both of which draw on the adult literature and research examining the individual components of the bundle. This review provides further insights into these reviews by taking a novel look at the existing research and provides extra depth when considering how the ICU Liberation Bundle may be successfully implemented into PICUs in varying contexts, such as in centres with different team cultures, in different socio-economic settings, and within different healthcare settings. This is vital as the negative impact of PICU-acquired complications on patients is well recognised, and when the potential benefits of the ICU Liberation Bundle are considered, every PICU should have the option to implement it, not just those in high-resource/high-income settings.
      This review does recognise some limitations. It cannot be ruled out that eligible papers may have been discarded as elements that were in place were not clearly discussed, and thus, the shortlist was discussed with the review panel of topic experts to prevent this happening. Time constraints prevented contact being made with every author; however, every author of grey literature was contacted to provide rigour. Finally, in the planning stages of this review, it was considered that much of the contextual findings would consider the broader healthcare setting, particularly as most of the papers were based in the USA where health care is funded, organised, and delivered differently than other nations globally which may impact the intervention, however, none of the papers mentioned this in any detail. It must be also be acknowledged that this is an emerging field of research with studies published since the search for this review ended. It could be considered that in the future, a ‘living’ realist review may be a novel way of informing implementation science.

      5. Conclusion

      This realist review has employed a novel and methodologically robust approach to examine contemporary literature in order to understand the implementation of the ICU Liberation Bundle in a PICU setting. The current evidence base is centred in North America and as such presents a potentially biased sample/perspective, with results that limit the generalisability to other contexts. However, this review has identified key recommendations for successful implementation into different PICU settings. These involve the following: (i) developing a thorough understanding of the context of the PICU (including capturing pertinent baseline metrics), available resources, and staff attitudes; (ii) using this contextual information to adapt the core elements and mechanisms of the bundle to fit the PICU, whilst retaining the core purpose of each bundle element; and (iii) both clinical effectiveness and implementation outcomes must be measured in order to ensure the intervention is providing benefit to patients and families, whilst being sustainable for those involved in the implementation. These findings are significant to providing guidance (through CFIR mapping) to the global PICU community in enhancing the effective and sustained implementation of the ICU Liberation Bundle. Further research is warranted to examine areas of the implementation (such as identifying a validated method to measure implementation outcomes) that are underexplored.

      Funding

      Elizabeth Dodds would like to acknowledge Health Education Working in the East Midlands (HEE) as a funding body for this research. This funding provided academic support and protected time to complete the research. HEE did not have any involvement with any aspect of the research.

      CRediT authorship contribution statement

      Elizabeth Dodds: Conceptualisation, Methodology, Analysis, Writing - original draft, Validation, Data curation. Sapna R Kudchadkar: Methodology, Analysis, Writing – review and editing. Karen Choong: Methodology, Analysis, Writing – review and editing. Joseph C Manning: Conceptualisation, Methodology, Analysis, Validation, Supervision, Writing – original, review and editing.

      Conflict of interest

      Dr Manning is current recipient of National Institute for Health Research/Health Education England funded ICA Clinical Lectureship. The views expressed are those of the authors and not necessarily those of the NHS, the NIHR, or the Department of Health and Social Care.

      Appendix A. Supplementary data

      The following is/are the Supplementary data to this article:

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