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Paediatric Intensive Care Unit (PICU): Every Child, Every Day, Back to Play: the PICUstars protocol

Every Child, Every Day, Back to Play: the PICUstars protocol Determining the Feasibility of Designing and Implementing a Nurse-Led Paediatric Intensive Care Unit (PICU) Liberation Program

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12621001624875
Acronym
PICUstars
Enrollment
1800
Registered
2021-11-29
Start date
2021-12-01
Completion date
2023-12-01
Last updated
2021-12-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

PICU related complications can affect up to 66% of critically ill children. They not only impact duration of hospital length of stay and cost of care (short-term impacts), but can also cause morbidity with significant ongoing negative consequences on the child’s quality of life, including psychological, behavioural and neurocognitive problems (long-term impacts). There is a lack of paediatric specific bundles to help in the recognition and prevention of PICU-related complications. It is essential to have more studies shifting from a mortality focus to quality of survivorship. The focus of the PICU Liberation study is improvement in quality of care through interdisciplinary team collaboration and best methods for sustainable quality inititative implementation. There is strong clinical evidence in the adult ICU context that the ICU Liberation program leads to significant, and dose-related, improvements in patient outcomes. This study is a single-centre prospective cohort trial evaluating the PICU Liberation program that adapts the A2F bundle in adult ICU to the PICU of a large children’s hospital in Queensland (Australia). The study aims to establish the feasibility of adapting the A2F bundle from the adult to the child context, assess the implementation success of the PICU Liberation trial through measuring the capacity to achieve A2F bundle objectives, improve patient quality of care, and optimise children’s recovery as well as reducing PICU length of stay.

Interventions

1) current practices of care in PICU will be assessed in a prospective baseline measurement to inform the adaptation of the PICU Liberation bundle and the PICU-STARS implementation 2) the implementation process will be evaluated as a longitudinal feasibility study and formative evaluation based on focus groups, interviews, questionnaires, and observations. Barriers and enablers for implementation success will be examined over time with recommendations from “lessons learned” bundle elements: A –

1) current practices of care in PICU will be assessed in a prospective baseline measurement to inform the adaptation of the PICU Liberation bundle and the PICU-STARS implementation 2) the implementation process will be evaluated as a longitudinal feasibility study and formative evaluation based on focus groups, interviews, questionnaires, and observations. Barriers and enablers for implementation success will be examined over time with recommendations from “lessons learned” bundle elements: A – Optimising analgesia: manage pain first B – Spontaneous awakening and breathing trials (SABT)/nurse-enabled extubations C – Choice of sedatives: avoid sedatives with adverse neurodevelopmental effects where possible D – Early assessment and management of delirium E – Early mobility and rehabilitation: set daily mobility goals F – Family engagement and empowerment G – Good Nutrition H – Humanism study phases: Engage (Phase 1) – 6 months • Establish the inter-professional team (nursing, medical, allied health). • Include patient and family representatives, and research team members. Clarify roles and processes. • Define problems, set goals and timelines. • Comprehensive assessment of impediments to bundle. • Assess local practice and resources. • Systematically assess enablers and barriers to implementation of the bundle using evidence-informed strategies and measures from the Knowledge Translation (KT) literature. • Develop implementation protocol. • Tailor PICU Liberation Bundle elements to the needs of the PICU. • Develop a process for reliable Bundle delivery to all patients. • Match Liberation interventions and processes to mitigate challenges identified in assessment phase. • Determine evaluation strategy. • Using these data, design the protocol. Educate (Phase 2) – 6 months • Train operational leads on all intervention activities (face to face and hybrid 1-hour workshops x 3, attendance log). • Train front line clinicians and stakeholders (face to face by clinical practice facilitators, sign off sheet; monthly 1-hour workshops, attendance sheets). • Provide self-learning modules and resources (development of 2 x self-learning online modules, example videos, mandatory training checklist). Execute (Phase 3) – 24 months • Integrate PICU Liberation into practice. • Unit wide roll-out, one to three bundle elements at every one time at every 2 - 3 months period (adherence will be monitored utilising the implementation check-list, focus groups and screening of electronic medical records). A – Instances of Face, Legs, Activity, Cry, Consolability scale (FLACC) assessments/opportunities, Appropriate stepwise use of pain medication as per pain management escalation guideline (percentage), Withdrawal assessment tool (WAT3) assessments/opportunities, Empathic questionnaire results (carer perception of child’s pain management) B – Instances of spontaneous awakening and breathing trials (SABT) screening performed/opportunities, SABT trials/opportunities, Extubation readiness assessments/opportunity, Instances of nurse-enabled extubation/opportunity, Empathic questionnaire results (carer perception of child’s spontaneous awakening and breathing trials) C – Richmond Agitation-Sedation Scale (RASS) assessments/ opportunities, Sedation goal set (RASS)/ opportunities, Sedation titration performed appropriately as per sedation guideline to target RASS goal/ opportunities, Number of patients with “deep sedation” (RASS > -2), Sedative use (by number of classes of sedatives used for example: Benzodiazepines, chloralhydrate, ketamine), Empathic questionnaire results (carers perception of child’s sedation management) D – Cornell Assessment of Pediatric Delirium (CAP-D) assessments/opportunities, Delirium identified (instances), Delirium management guideline followed/opportunities (instances of non-pharmacological interventions targeting delirium, instances of pharmacological interventions targeting delirium), sleep adjuncts utilised (e.g. day/night routine; swaddling/nesting), Empathic questionnaire results (carers perception of child’s delirium prevention management) E – Graded activity level goals set/opportunity (as daily goal during ward-round), Mobility activities administered per patient per day, Mobility levels achieved (mobility levels are named in ascending order - Lizard, Koala,Wombat, Kangoroo = activity level one to four): Lizard – immobile, routine positioning and range of motion unless contraindications; Koala – in bed activities including sitting; Wombat – in bedspace activities including mobility out of bed/standing; Kangoroo– mobility out of bedspace including ambulatory; Immobility, Deconditioning (assessment of physical function by instances of Children’s Chelsea Critical Care Physical Assessment tool (cCPAx), Empathic questionnaire results (carers perception of child’s mobility management) F – Tools used to ensure family inclusion (e.g. clear windows goals set, likes/dislikes on “getting to know you” form utilised), Instances of family participation in liberation goal setting, Family participation in liberation goals activity (education provided on PICU liberation, included in cares, neurodevelopmental and early mobility activity, rounds, plan of care including baby liberation flower, instances of therapeutic cuddles, instances of trips outside the patients room), Family communication with healthcare providers “have you been kept up to date?”, empathic questionnaire completion/opportunity G – patient weight assessed, nutritional goals set/opportunity (during daily wardround), instances of nutritional goals achieved/opportunity, institutional Nutritional assessment tool used, instances of nutrition delivered to goal (defined as 2/3 of requirements reached enterally or parentally from 48 hours post I/V), Nutrition free days, Referrals to speech pathology, Oral feeding readiness assessments, Empathic questionnaire results (carers perception of child’s feeding and nutrition management H – Family awareness of resources such as children’s book library, photo printing service (and use of same), Completion of “getting to know you” form, Empathic questionnaire results (carers perception of individualised care; use of care planning etc • Post-marketing and education (newsletter section in PICU wide weekly newsletter, feedback at monthly workshops, focus groups). Evaluate (Phase 4) – 12 months • Evaluate Impact of PICU Liberation on practice. • Regular evaluation (every 2 months in implementation period) - refine implementation and target education in response to feedback and control chart data implementation process and efficacy outcomes measurement. • Re-measure bundle fidelity over time to determine maintenance of new practices. 3) the department-level implementation team will utilise the Consolidated Framework for Implementation Research (CIFR) and process evaluation (mixed methods) to assess feasibility, implementation outcomes, and intervention effectiveness

Sponsors

Queensland Children's Hospital
Lead SponsorHospital

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Prevention
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
0 to 18 Years
Healthy volunteers
No

Inclusion criteria

Admission to study PICU less than or equal to 18 years of age on admission PICU LOS greater than or equal to 24 hours Expected survival greater than or equal to 1 year post PICU admission

Exclusion criteria

Paediatric Advanced Resuscitation Plan (PARP) actively enacted during admission Severe chronic disability precluding PICU liberation program participation Minimally consciousness state on admission

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026