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Clinical Trials/NCT05710744
NCT05710744
Not Yet Recruiting
N/A

Mitigating Racial Disparities in Shared Decision Making in the Intensive Care Unit

Duke University1 site in 1 country106 target enrollmentMarch 2, 2026

Overview

Phase
N/A
Intervention
Not specified
Conditions
Health Care Disparities
Sponsor
Duke University
Enrollment
106
Locations
1
Primary Endpoint
Practicality as measured by proportion of screen eligible participants enrolled per month
Status
Not Yet Recruiting
Last Updated
6 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 2, 2026
End Date
December 31, 2027
Last Updated
6 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Practicality as measured by proportion of screen eligible participants enrolled per month

Time Frame: through study completion, up to 1 year

Proportion screen eligible enrolled/month based on review of study logs, range 0 to 100%

Intervention acceptability as measured by single Likert-scaled item completed by physicians

Time Frame: 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

Time Frame: 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

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%

Practicality as measured by dropout rate from study

Time Frame: 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

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

Secondary Outcomes

  • Decisional conflict among families, measured by Decisional Conflict Scale(within 96 hours of signing study consent)
  • Psychological distress among physicians, measured by moral distress scale(within 96 hours of signing study consent)
  • Components of shared decision making, as measured by content analysis of family meeting recordings(through study completion, up to 1 year)
  • ICU utilization among patients, as measured by length of stay(through study completion, up to 1 year)
  • Decisional regret among families, measured by Decision Regret Scale(within 96 hours of signing study consent)
  • Psychological distress among families, measured by Impact of Events Revised scale(within 96 hours of signing study consent)

Study Sites (1)

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