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

NCT05710744 | Not Yet Recruiting DMC

• 2 other identifiers: Pro001115301K23HL164968-01
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

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.

Conditions

Health Care Disparities

Keywords

Intensive Care Unit; Racial Disparities in Healthcare

Outcome Measures

Primary Outcomes (6)

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

  Likert-scaled single item, ranging from 1 (not acceptable) to 5 (completely acceptable)

  within 96 hours of signing study consent

• Demand for the intervention measured by the proportion of physicians who viewed the intervention

  Percentage of physicians who viewed intervention by email "read" receipts, range 0 to 100%

  within 96 hours of signing study consent

• Fidelity to intervention measured by proportion of tip sheet phrases used by physicians

  Proportion of tip sheet phrases used in family meeting as determined by review of audio-recorded family meeting, range 0 to 100%

  within 96 hours of signing study consent

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

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

  through study completion, up to 1 year

• Practicality as measured by time to complete physician or family surveys

  Time to complete physician or family surveys as measured by review of study logs, range 0 to 60 minutes

  within 96 hours of signing study consent

• Practicality as measured by dropout rate from study

  Dropout rate as ascertained by review of study logs, range 0 to 100%

  through study completion, up to 1 year

Secondary Outcomes (6)

• 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

• 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

• Decisional conflict among families, measured by Decisional Conflict Scale

  within 96 hours of signing study consent

Study Arms (2)

Family Members of patients in the ICU

NO INTERVENTION

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

ICU Physicians

OTHER

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.

Behavioral: Shared decision making tip sheet

Interventions

Shared decision making tip sheet BEHAVIORAL

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

ICU Physicians

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

Sponsors & Collaborators

• Duke University: lead
• National Institutes of Health (NIH): collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Study Officials

• Deepshikha Ashana, M.D.

  Duke University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Brittany J McDowell, BSCR

CONTACT

919-613-7321; brittany.mcdowell@duke.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2023
• First Posted: February 2, 2023
• Study Start: March 2, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: October 23, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)