Duke University Medical Center
Durham, North Carolina, 27710, United States
NCT Number: NCT05710744
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Durham, North Carolina, 27710, United States
The care of critically ill patients with acute respiratory failure involves life-or-death decisions. Ideally, intensive care unit (ICU) clinicians should include patients or their families in shared decision making, which promotes goal-concordant care (i.e., care aligned with patients' preferences), reduces psychological distress for both families and clinicians, and shortens ICU length of stay. However, racial disparities have been documented in shared decision making and associated outcomes. In outpatient settings, clinicians treat Black patients differently from White patients, providing fewer treatment options, less prognostic information, and less emotional support, and making assumptions about rather than eliciting patient preferences. Disparities in shared decision making are likely to be amplified in the ICU because clinicians often do not have long-standing relationships with patients or families, and decisions are complex, emotional, and time-pressured. Yet, no interventions currently exist to address racial disparities in shared decision making about acute respiratory failure. This research will directly fill this gap.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Physician inclusion criterion:
Physician exclusion criterion:
Patient inclusion criteria:
Patient exclusion criterion:
Family member inclusion criteria:
Physicians will view tip sheets containing best practices for shared decision making with diverse families.
Time frame: within 96 hours of signing study consent
Likert-scaled single item, ranging from 1 (not acceptable) to 5 (completely acceptable)
Time frame: within 96 hours of signing study consent
Percentage of physicians who viewed intervention by email "read" receipts, range 0 to 100%
Time frame: within 96 hours of signing study consent
Proportion of tip sheet phrases used in family meeting as determined by review of audio-recorded family meeting, range 0 to 100%
Time frame: through study completion, up to 1 year
Proportion screen eligible enrolled/month based on review of study logs, range 0 to 100%
Time frame: within 96 hours of signing study consent
Time to complete physician or family surveys as measured by review of study logs, range 0 to 60 minutes
Time frame: through study completion, up to 1 year
Dropout rate as ascertained by review of study logs, range 0 to 100%
Time frame: within 96 hours of signing study consent
Decision Regret Scale, range 5 (low regret) to 25 (high regret)
Time frame: within 96 hours of signing study consent
Impact of Events revised scale, range 0 (low stress) to 88 (extreme stress)
Time frame: within 96 hours of signing study consent
Moral distress scale, range 0 (low distress) to 84 (extreme distress)
Time frame: through study completion, up to 1 year
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)
Time frame: within 96 hours of signing study consent
Decisional Conflict Scale, range 0 (low conflict) to 64 (high conflict)
Time frame: through study completion, up to 1 year
ICU length of stay ascertained from electronic medical record review
Contact information is provided by the study sponsor or research team.
Duke University
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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