Mitigating Racial Disparities in Shared Decision Making in the Intensive Care Unit
- Conditions
- Health Care Disparities
- Interventions
- Behavioral: Shared decision making tip sheet
- Registration Number
- NCT05710744
- Lead Sponsor
- Duke University
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 106
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ICU Physicians Shared decision making tip sheet Physicians will view a tip sheet containing information about best practices of shared decision making with diverse individuals. Physicians will then conduct routine meetings with families of patients with acute respiratory failure.
- Primary Outcome Measures
Name Time Method Intervention acceptability as measured by single Likert-scaled item completed by physicians within 96 hours of signing study consent 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 within 96 hours of signing study consent 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 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%
Practicality as measured by proportion of screen eligible participants enrolled per month through study completion, up to 1 year Proportion screen eligible enrolled/month based on review of study logs, range 0 to 100%
Practicality as measured by dropout rate from study through study completion, up to 1 year Dropout rate as ascertained by review of study logs, range 0 to 100%
Practicality as measured by time to complete physician or family surveys 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
- Secondary Outcome Measures
Name Time Method Decisional conflict among families, measured by Decisional Conflict Scale within 96 hours of signing study consent Decisional Conflict Scale, range 0 (low conflict) to 64 (high conflict)
Psychological distress among physicians, measured by moral distress scale within 96 hours of signing study consent 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 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)
ICU utilization among patients, as measured by length of stay through study completion, up to 1 year ICU length of stay ascertained from electronic medical record review
Decisional regret among families, measured by Decision Regret Scale within 96 hours of signing study consent Decision Regret Scale, range 5 (low regret) to 25 (high regret)
Psychological distress among families, measured by Impact of Events Revised scale within 96 hours of signing study consent Impact of Events revised scale, range 0 (low stress) to 88 (extreme stress)
Trial Locations
- Locations (1)
Duke University Medical Center
🇺🇸Durham, North Carolina, United States