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

NCT ID: NCT05710744

Last Updated: 2025-10-23

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 106 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-03-02
• Study Completion Date: 2027-12-31

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.

Conditions

Health Care Disparities

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Family Members of patients in the ICU

Family members will join routine meetings with the physicians treating with their critically ill loved ones.

Group Type: NO_INTERVENTION

No interventions assigned to this group

ICU Physicians

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.

Group Type: OTHER

Shared decision making tip sheet

Intervention Type: BEHAVIORAL

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

Interventions

Shared decision making tip sheet

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

• 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

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Deepshikha Ashana, M.D.

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Duke University Medical Center

Durham, North Carolina, United States

Countries

United States

Central Contacts

Brittany J McDowell, BSCR

Role: CONTACT

brittany.mcdowell@duke.edu

919-613-7321

Other Identifiers

1K23HL164968-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Pro00111530

Identifier Type: -

Identifier Source: org_study_id