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

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• Intervention acceptability as measured by single Likert-scaled item completed by physicians [Срок оценки: within 96 hours of signing study consent]
• Demand for the intervention measured by the proportion of physicians who viewed the intervention [Срок оценки: within 96 hours of signing study consent]
• Fidelity to intervention measured by proportion of tip sheet phrases used by physicians [Срок оценки: within 96 hours of signing study consent]
• Practicality as measured by proportion of screen eligible participants enrolled per month [Срок оценки: through study completion, up to 1 year]
• Practicality as measured by time to complete physician or family surveys [Срок оценки: within 96 hours of signing study consent]
• Practicality as measured by dropout rate from study [Срок оценки: through study completion, up to 1 year]

Вторичные конечные точки (6)

• Decisional regret among families, measured by Decision Regret Scale [Срок оценки: within 96 hours of signing study consent]
• Psychological distress among families, measured by Impact of Events Revised scale [Срок оценки: within 96 hours of signing study consent]
• Psychological distress among physicians, measured by moral distress scale [Срок оценки: within 96 hours of signing study consent]
• Components of shared decision making, as measured by content analysis of family meeting recordings [Срок оценки: through study completion, up to 1 year]
• Decisional conflict among families, measured by Decisional Conflict Scale [Срок оценки: within 96 hours of signing study consent]
• ICU utilization among patients, as measured by length of stay [Срок оценки: through study completion, up to 1 year]

Критерии участия

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Организация здравоохранения

Центры проведения

США · 1 центр

• Duke University Medical Center — Durham

Идентификаторы

NCT: NCT05710744 · Pro00111530 · 1K23HL164968-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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