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临床试验/NCT05710744
NCT05710744尚未招募不适用

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

Duke University1 个研究点 分布在 1 个国家目标入组 106 人开始时间: 2027年1月4日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
106
试验地点
1
主要终点
Practicality as measured by dropout rate from study

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •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

排除标准

  • 未提供

研究组 & 干预措施

Family Members of patients in the ICU

No Intervention

Family members will join routine meetings with the physicians treating with their critically ill loved ones.

ICU Physicians

Other

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.

干预措施: Shared decision making tip sheet (Behavioral)

结局指标

主要结局

Practicality as measured by dropout rate from study

时间窗: through study completion, up to 1 year

Dropout rate as ascertained by review of study logs, range 0 to 100%

Practicality as measured by time to complete physician or family surveys

时间窗: within 96 hours of signing study consent

Time to complete physician or family surveys as measured by review of study logs, range 0 to 60 minutes

Intervention acceptability as measured by single Likert-scaled item completed by physicians

时间窗: within 96 hours of signing study consent

Likert-scaled single item, ranging from 1 (not acceptable) to 5 (completely acceptable)

Demand for the intervention measured by the proportion of physicians who viewed the intervention

时间窗: within 96 hours of signing study consent

Percentage of physicians who viewed intervention by email "read" receipts, range 0 to 100%

Fidelity to intervention measured by proportion of tip sheet phrases used by physicians

时间窗: within 96 hours of signing study consent

Proportion of tip sheet phrases used in family meeting as determined by review of audio-recorded family meeting, range 0 to 100%

Practicality as measured by proportion of screen eligible participants enrolled per month

时间窗: through study completion, up to 1 year

Proportion screen eligible enrolled/month based on review of study logs, range 0 to 100%

次要结局

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

研究者

发起方
Duke University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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