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

Health Care Disparities Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05710744
• Other study ID #: Pro00111530
• Secondary ID: 1K23HL164968-01
• Status: Recruiting
• Phase: N/A
• Start date: July 7, 2023
• Est. completion date: December 31, 2027

Study information

• Verified date: February 2024
• Source: Duke University
• Contact: Brittany J McDowell, BSCR
• Phone: 919-613-7321
• Email: brittany.mcdowell[@]duke.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Health Care Disparities

Intervention

Behavioral:
• Shared decision making tip sheet
Physicians will view tip sheets containing best practices for shared decision making with diverse families.

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (3)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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