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.

Study Overview

• Status: Recruiting
• Conditions: Health Care Disparities
• Intervention / Treatment: Behavioral: Shared decision making tip sheet

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.

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Brittany J McDowell, BSCR; Phone Number: 919-613-7321; Email: brittany.mcdowell@duke.edu

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Recruiting
      • Duke University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Family Members of patients in the ICU; Family members will join routine meetings with the physicians treating with their critically ill loved ones.
Other: 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.	Behavioral: Shared decision making tip sheet; Physicians will view tip sheets containing best practices for shared decision making with diverse families.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Decisional regret among families, measured by Decision Regret Scale	Decision Regret Scale, range 5 (low regret) to 25 (high regret)	within 96 hours of signing study consent
Psychological distress among families, measured by Impact of Events Revised scale	Impact of Events revised scale, range 0 (low stress) to 88 (extreme stress)	within 96 hours of signing study consent
Psychological distress among physicians, measured by moral distress scale	Moral distress scale, range 0 (low distress) to 84 (extreme distress)	within 96 hours of signing study consent
Components of shared decision making, as measured by content analysis of family meeting recordings	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)	through study completion, up to 1 year
Decisional conflict among families, measured by Decisional Conflict Scale	Decisional Conflict Scale, range 0 (low conflict) to 64 (high conflict)	within 96 hours of signing study consent
ICU utilization among patients, as measured by length of stay	ICU length of stay ascertained from electronic medical record review	through study completion, up to 1 year

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); National Institutes of Health (NIH)
• Investigators: Principal Investigator: Deepshikha Ashana, M.D., Duke University

Study record dates

Study Major Dates

• Study Start (Actual): July 7, 2023
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: January 12, 2023
• First Submitted That Met QC Criteria: January 24, 2023
• First Posted (Actual): February 2, 2023

Study Record Updates

• Last Update Posted (Estimated): March 1, 2024
• Last Update Submitted That Met QC Criteria: February 29, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Intensive Care Unit; Racial Disparities in Healthcare
• Other Study ID Numbers: Pro00111530; 1K23HL164968-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No