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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05710744
Enrollment
106
Registered
2023-02-02
Start date
2027-01-04
Completion date
2027-06-30
Last updated
2026-06-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Care Disparities

Keywords

Intensive Care Unit, Racial Disparities in Healthcare

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.

Interventions

BEHAVIORALShared decision making tip sheet

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

Sponsors

Duke University
Lead SponsorOTHER
National Institutes of Health (NIH)
CollaboratorNIH
National Heart, Lung, and Blood Institute (NHLBI)
CollaboratorNIH

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Intervention acceptability as measured by single Likert-scaled item completed by physicianswithin 96 hours of signing study consentLikert-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 interventionwithin 96 hours of signing study consentPercentage 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 physicianswithin 96 hours of signing study consentProportion 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 monththrough study completion, up to 1 yearProportion screen eligible enrolled/month based on review of study logs, range 0 to 100%
Practicality as measured by time to complete physician or family surveyswithin 96 hours of signing study consentTime to complete physician or family surveys as measured by review of study logs, range 0 to 60 minutes
Practicality as measured by dropout rate from studythrough study completion, up to 1 yearDropout rate as ascertained by review of study logs, range 0 to 100%

Secondary

MeasureTime frameDescription
Decisional regret among families, measured by Decision Regret Scalewithin 96 hours of signing study consentDecision Regret Scale, range 5 (low regret) to 25 (high regret)
Psychological distress among families, measured by Impact of Events Revised scalewithin 96 hours of signing study consentImpact of Events revised scale, range 0 (low stress) to 88 (extreme stress)
Psychological distress among physicians, measured by moral distress scalewithin 96 hours of signing study consentMoral distress scale, range 0 (low distress) to 84 (extreme distress)
Components of shared decision making, as measured by content analysis of family meeting recordingsthrough study completion, up to 1 yearA 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)
Decisional conflict among families, measured by Decisional Conflict Scalewithin 96 hours of signing study consentDecisional Conflict Scale, range 0 (low conflict) to 64 (high conflict)
ICU utilization among patients, as measured by length of staythrough study completion, up to 1 yearICU length of stay ascertained from electronic medical record review

Countries

United States

Contacts

CONTACTBrittany J McDowell, BSCR
brittany.mcdowell@duke.edu919-613-7321
PRINCIPAL_INVESTIGATORDeepshikha Ashana, M.D.

Duke University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 11, 2026