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| ID | Type | Description | Link |
|---|---|---|---|
| 1K23HL164968-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Shared decision making tip sheet | Behavioral | Physicians will view tip sheets containing best practices for shared decision making with diverse families. |
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| 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 |
| 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 |
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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:
Patient exclusion criterion:
Family member inclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Brittany J McDowell, BSCR | Contact | 919-613-7321 | brittany.mcdowell@duke.edu |
| Name | Affiliation | Role |
|---|---|---|
| Deepshikha Ashana, M.D. | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
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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 |