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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Health Care Disparities

Intervention / Treatment
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* Behavioral: Shared decision making tip sheet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intensive Care Unit, Racial Disparities in Healthcare