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NCT Number: NCT05710744

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University Medical Center

Durham, North Carolina, 27710, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Physician inclusion criterion:

  • ICU attending physician with at least 6 weeks of clinical service time in the 12 months preceding and following enrollment

Physician exclusion criterion:

  • Board certified in palliative care medicine

Patient inclusion criteria:

  • 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

Patient exclusion criterion:

  • Tracheostomy tube present or decision to pursue tracheostomy within next 7 days
  • Has decision making capacity as assessed by medical team
  • Extubation planned or death anticipated in next 24 hours
  • Patients who are prisoners or are pregnant
  • Awaiting organ transplantation during this hospitalization
  • Acute respiratory failure due to progression of chronic neuromuscular disease
  • No family decision maker available

Family member inclusion criteria:

  • Identified by medical team as person most involved in medical decision making for the patient
  • Confirmed to be patient's legally authorized representative
  • Self-identifies as non-Hispanic, Black or White
  • ≥ 18 years of age at time of consent
  • Confirms conversational fluency in English

Treatment and study plan

Shared decision making tip sheet

Behavioral

Physicians will view tip sheets containing best practices for shared decision making with diverse families.

Primary outcomes

  1. 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)

  2. 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%

  3. 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%

  4. 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%

  5. 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

  6. 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%

Secondary outcomes

  1. Decisional regret among families, measured by Decision Regret Scale

    Time frame: within 96 hours of signing study consent

    Decision Regret Scale, range 5 (low regret) to 25 (high regret)

  2. Psychological distress among families, measured by Impact of Events Revised scale

    Time frame: within 96 hours of signing study consent

    Impact of Events revised scale, range 0 (low stress) to 88 (extreme stress)

  3. Psychological distress among physicians, measured by moral distress scale

    Time frame: within 96 hours of signing study consent

    Moral distress scale, range 0 (low distress) to 84 (extreme distress)

  4. Components of shared decision making, as measured by content analysis of family meeting recordings

    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)

  5. Decisional conflict among families, measured by Decisional Conflict Scale

    Time frame: within 96 hours of signing study consent

    Decisional Conflict Scale, range 0 (low conflict) to 64 (high conflict)

  6. ICU utilization among patients, as measured by length of stay

    Time frame: through study completion, up to 1 year

    ICU length of stay ascertained from electronic medical record review

Study contacts

Contact information is provided by the study sponsor or research team.

Brittany J McDowell, BSCR

CONTACT

[email protected]

919-613-7321

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)
  • National Institutes of Health (NIH)

Registry information

Important dates

Study start
2027
Primary completion
2027
Study completion
2027
First posted
Feb 2, 2023
Registry last updated
Jun 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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