Clinical trial NCT05710744: Mitigating Racial Disparities in Shared Decision Making in the Intensive Care Unit
Official title: Mitigating Racial Disparities in Shared Decision Making in the Intensive Care Unit
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Health Care Disparities
Keywords: Intensive Care Unit
Racial Disparities in Healthcare
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2023-02-02
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility 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

Primary outcomes:
measure: Intervention acceptability as measured by single Likert-scaled item completed by physicians
timeFrame: within 96 hours of signing study consent
measure: Demand for the intervention measured by the proportion of physicians who viewed the intervention
timeFrame: within 96 hours of signing study consent
measure: Fidelity to intervention measured by proportion of tip sheet phrases used by physicians
timeFrame: within 96 hours of signing study consent
measure: Practicality as measured by proportion of screen eligible participants enrolled per month
timeFrame: through study completion, up to 1 year
measure: Practicality as measured by time to complete physician or family surveys
timeFrame: within 96 hours of signing study consent
measure: Practicality as measured by dropout rate from study
timeFrame: through study completion, up to 1 year
Secondary outcomes:
measure: Decisional regret among families, measured by Decision Regret Scale
timeFrame: within 96 hours of signing study consent
measure: Psychological distress among families, measured by Impact of Events Revised scale
timeFrame: within 96 hours of signing study consent
measure: Psychological distress among physicians, measured by moral distress scale
timeFrame: within 96 hours of signing study consent
measure: Components of shared decision making, as measured by content analysis of family meeting recordings
timeFrame: through study completion, up to 1 year
measure: Decisional conflict among families, measured by Decisional Conflict Scale
timeFrame: within 96 hours of signing study consent
measure: ICU utilization among patients, as measured by length of stay
timeFrame: through study completion, up to 1 year
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Deepshikha Ashana, M.D.
role: PRINCIPAL_INVESTIGATOR
References: