TY - JOUR
T1 - The implausibility of 'usual care' in an open system
T2 - Sedation and weaning practices in Paediatric Intensive Care Units (PICUs) in the United Kingdom (UK)
AU - Blackwood, Bronagh
AU - Tume, Lyvonne
N1 - Funding Information:
Seventeen PICUs (17/23 74 %) had been involved in large multi-centre interventional paediatric trials (Control of Hyperglycaemia in Paediatric intensive care (CHIP) [28], Safety profiLe, Efficacy and Equivalence in Paediatric intensive care Sedation (SLEEPS) [7] , CATatheter infections in CHildren (CATCH) [29], Therapeutic Hypothermia After Pediatric Cardiac Arrest (THAPCA) [30]. One PICU had a dedicated research nurse funded by the hospital. In 19 (83 %) PICUs, funding to undertake screening, recruitment, consent and data collection by research nurses or data managers was obtained either from specific trial funding or from the National Institute of Health Research, Clinical Research Network. The barriers to previous trial implementation were identified as the complexity of the intervention; lack of belief in the benefit of the intervention; and inadequate training. Facilitating factors were senior staff buy-in and research nurse provision. Effective leadership and having a dedicated research nurse who could help orchestrate implementation and training were seen as crucial.
Publisher Copyright:
© 2015 Blackwood and Tume.
PY - 2015/7/31
Y1 - 2015/7/31
N2 - Background: The power of the randomised controlled trial depends upon its capacity to operate in a closed system whereby the intervention is the only causal force acting upon the experimental group and absent in the control group, permitting a valid assessment of intervention efficacy. Conversely, clinical arenas are open systems where factors relating to context, resources, interpretation and actions of individuals will affect implementation and effectiveness of interventions. Consequently, the comparator (usual care) can be difficult to define and variable in multi-centre trials. Hence outcomes cannot be understood without considering usual care and factors that may affect implementation and impact on the intervention. Methods: Using a fieldwork approach, we describe PICU context, 'usual' practice in sedation and weaning from mechanical ventilation, and factors affecting implementation prior to designing a trial involving a sedation and ventilation weaning intervention. We collected data from 23 UK PICUs between June and November 2014 using observation, individual and multi-disciplinary group interviews with staff. Results: Pain and sedation practices were broadly similar in terms of drug usage and assessment tools. Sedation protocols linking assessment to appropriate titration of sedatives and sedation holds were rarely used (9 % and 4 % of PICUs respectively). Ventilator weaning was primarily a medical-led process with 39 % of PICUs engaging senior nurses in the process: weaning protocols were rarely used (9 % of PICUs). Weaning methods were variably based on clinician preference. No formal criteria or use of spontaneous breathing trials were used to test weaning readiness. Seventeen PICUs (74 %) had prior engagement in multi-centre trials, but limited research nurse availability. Barriers to previous trial implementation were intervention complexity, lack of belief in the evidence and inadequate training. Facilitating factors were senior staff buy-in and dedicated research nurse provision. Conclusions: We examined and identified contextual and organisational factors that may impact on the implementation of our intervention. We found usual practice relating to sedation, analgesia and ventilator weaning broadly similar, yet distinctively different from our proposed intervention, providing assurance in our ability to evaluate intervention effects. The data will enable us to develop an implementation plan; considering these factors we can more fully understand their impact on study outcomes.
AB - Background: The power of the randomised controlled trial depends upon its capacity to operate in a closed system whereby the intervention is the only causal force acting upon the experimental group and absent in the control group, permitting a valid assessment of intervention efficacy. Conversely, clinical arenas are open systems where factors relating to context, resources, interpretation and actions of individuals will affect implementation and effectiveness of interventions. Consequently, the comparator (usual care) can be difficult to define and variable in multi-centre trials. Hence outcomes cannot be understood without considering usual care and factors that may affect implementation and impact on the intervention. Methods: Using a fieldwork approach, we describe PICU context, 'usual' practice in sedation and weaning from mechanical ventilation, and factors affecting implementation prior to designing a trial involving a sedation and ventilation weaning intervention. We collected data from 23 UK PICUs between June and November 2014 using observation, individual and multi-disciplinary group interviews with staff. Results: Pain and sedation practices were broadly similar in terms of drug usage and assessment tools. Sedation protocols linking assessment to appropriate titration of sedatives and sedation holds were rarely used (9 % and 4 % of PICUs respectively). Ventilator weaning was primarily a medical-led process with 39 % of PICUs engaging senior nurses in the process: weaning protocols were rarely used (9 % of PICUs). Weaning methods were variably based on clinician preference. No formal criteria or use of spontaneous breathing trials were used to test weaning readiness. Seventeen PICUs (74 %) had prior engagement in multi-centre trials, but limited research nurse availability. Barriers to previous trial implementation were intervention complexity, lack of belief in the evidence and inadequate training. Facilitating factors were senior staff buy-in and dedicated research nurse provision. Conclusions: We examined and identified contextual and organisational factors that may impact on the implementation of our intervention. We found usual practice relating to sedation, analgesia and ventilator weaning broadly similar, yet distinctively different from our proposed intervention, providing assurance in our ability to evaluate intervention effects. The data will enable us to develop an implementation plan; considering these factors we can more fully understand their impact on study outcomes.
KW - Implementation
KW - Intensive care
KW - Paediatrics
KW - Sedation
KW - Trials
KW - Ventilator weaning
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UR - http://www.scopus.com/inward/citedby.url?scp=84938079535&partnerID=8YFLogxK
U2 - 10.1186/s13063-015-0846-3
DO - 10.1186/s13063-015-0846-3
M3 - Article (journal)
C2 - 26228836
AN - SCOPUS:84938079535
SN - 1745-6215
VL - 16
JO - Trials
JF - Trials
IS - 1
M1 - 325
ER -