Acute Respiratory Distress Syndrome Clinical Trial
Official title:
Provider Perceptions of Neuromuscular Blockade in ARDS
The proposed study will use qualitative methodology to understand health care provider perceptions of neuromuscular blockade (NMB) in patients with Acute Respiratory Distress Syndrome (ARDS). To achieve this goal the investigators will conduct a prospective ancillary study at four clinical centers participating in the NHLBI PETAL network as part of the ROSE (Reevaluation of Systemic Early Neuromuscular Blockade) clinical trial (NCT02509078). Using thematic content analysis of semistructured interviews with health care providers caring for patients enrolled in the ROSE trial the investigators will determine the barriers to NMB use and develop a framework for future NMB adoption in ARDS.
Efficient translation of clinical trial results into practice is an enduring challenge in
critical care, with many critically ill patients not receiving evidence-based therapies
proven to save lives. One approach to speed the translation of clinical trial evidence into
practice is through qualitative research to better understand the barriers to evidence-based
care and help design innovative interventions to overcome those barriers.. This work need not
wait until the clinical trial is complete—an emerging literature highlights the value of
qualitative research concurrent with the conduct of a clinical trial. Such research has
several potential benefits, including facilitating implementation of the intervention in the
real world, identifying the potential mechanism of action, and identifying contextual factors
necessary for the treatments effectiveness.
The Reevaluation Of Systemic Early Neuromuscular Blockade (ROSE) study, conducted by the
NHLBI PETAL Clinical Trials Network, is an ideal trial for which to perform a concurrent
qualitative implementation study (NCT02509078). NMB has the potential to substantially reduce
mortality in ARDS. Yet NMB remains incompletely adopted for reasons that are poorly
understood but likely relate to clinical equipoise, historical concerns about safety, and the
inherent difficulties in providing complex practices in the intensive care unit (ICU). A
better understanding of provider views regarding NMB will provide essential data to aid
interpretation of study results and design an implementation study should ROSE demonstrate a
survival benefit with NMB.
To examine this issue the investigators will perform a prospective qualitative study using
semi-structured interviews health care professionals providing direct care for patients
enrolled in ROSE. A trained research coordinator will perform semi-structured interviews with
consenting participants. Interviews will be transcribed and uploaded into commercially
available qualitative data software. Trained qualitative researchers will read and code each
interview based on Consolidated Framework for Implementation Research, a widely accepted
conceptual theory of evidence-uptake.
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