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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorDuke University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Shared decision making tip sheet

    Behavioral

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

Treatment groups

106 Participants
are divided into 2 treatment groups
Group A: Family Members of patients in the ICUNo intervention 0 interventions
Group B: ICU PhysiciansOther 1 intervention

Trial outcomes

Primary outcomes

1

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)

Time frame
within 96 hours of signing study consent
2

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%

Time frame
within 96 hours of signing study consent
3

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%

Time frame
within 96 hours of signing study consent
4

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%

Time frame
through study completion, up to 1 year

Secondary outcomes

1

Decisional regret among families, measured by Decision Regret Scale

Decision Regret Scale, range 5 (low regret) to 25 (high regret)

Time frame
within 96 hours of signing study consent
2

Psychological distress among families, measured by Impact of Events Revised scale

Impact of Events revised scale, range 0 (low stress) to 88 (extreme stress)

Time frame
within 96 hours of signing study consent
3

Psychological distress among physicians, measured by moral distress scale

Moral distress scale, range 0 (low distress) to 84 (extreme distress)

Time frame
within 96 hours of signing study consent
4

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)

Time frame
through study completion, up to 1 year

Other outcomes

Sponsors and contacts

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Duke University

Lead sponsor

National Institutes of Health (NIH)

Collaborator

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

This trial is not recruiting at the moment. You can still explore other options: