About this trial
This is a non randomized pilot trial aimed to:
Test the feasibility of an intervention to support intensive care unit clinicians in conducting shared decision making conversations with families of patients with acute respiratory failure. The goal of this intervention is to mitigate racial disparities in shared decision making.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Admitted to the ICU
Being treated by a study physician currently and at least for the next 48 hours
≥ 18 years of age upon admission to hospital
Mechanically ventilated ≥ 4 days
Disqualifiers
None
Trial design
Parallel
Treatments tested in this trial
Shared decision making tip sheet
BehavioralPhysicians will view tip sheets containing best practices for shared decision making with diverse families.
Treatment groups
Trial outcomes
Primary outcomes
Intervention acceptability as measured by single Likert-scaled item completed by physicians
Likert-scaled single item, ranging from 1 (not acceptable) to 5 (completely acceptable)
Demand for the intervention measured by the proportion of physicians who viewed the intervention
Percentage of physicians who viewed intervention by email "read" receipts, range 0 to 100%
Fidelity to intervention measured by proportion of tip sheet phrases used by physicians
Proportion of tip sheet phrases used in family meeting as determined by review of audio-recorded family meeting, range 0 to 100%
Practicality as measured by proportion of screen eligible participants enrolled per month
Proportion screen eligible enrolled/month based on review of study logs, range 0 to 100%
Secondary outcomes
Decisional regret among families, measured by Decision Regret Scale
Decision Regret Scale, range 5 (low regret) to 25 (high regret)
Psychological distress among families, measured by Impact of Events Revised scale
Impact of Events revised scale, range 0 (low stress) to 88 (extreme stress)
Psychological distress among physicians, measured by moral distress scale
Moral distress scale, range 0 (low distress) to 84 (extreme distress)
Components of shared decision making, as measured by content analysis of family meeting recordings
A qualitative data analysis of transcripts from family-physician meetings using 14-item shared decision making framework from PMID 20642362, range 0 (poor shared decision making) to 14 (ideal shared decision making)
Sponsors and contacts
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Duke University
Lead sponsor
National Institutes of Health (NIH)
Collaborator
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
This trial is not recruiting at the moment. You can still explore other options: