Health Care DisparitiesNCT05710744
Mitigating Racial Disparities in Shared Decision Making in the Intensive Care Unit
A study testing Shared decision making tip sheet in people with Health Care Disparities, run by Duke University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Health Care Disparities
- What is being tested?
- Shared decision making tip sheet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jan 2027to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
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.
Read the detailed description
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.
- Conditions
- Health Care Disparities
- Being tested
- Shared decision making tip sheet
- Keywords
- Intensive Care Unit, Racial Disparities in Healthcare
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shared decision making tip sheetBehavioural
Physicians will view tip sheets containing best practices for shared decision making with diverse families.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Shared decision making tip sheet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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%
Measured: 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%
Measured: 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%
Measured: 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
Measured: 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%
Measured: through study completion, up to 1 year
Secondary outcomes (6)
Decisional regret among families, measured by Decision Regret Scale
Decision Regret Scale, range 5 (low regret) to 25 (high regret)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: through study completion, up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2023
- Study start4 Jan 2027 (estimated)
- Primary completion31 May 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health Care DisparitiesStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 106 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Deepshikha Ashana, M.D., Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05710744
- Sponsor's protocol ID
- Pro00111530
- Other IDs
- 1K23HL164968-01
- Status last verified
- Jun 2026
- First submitted
- 12 Jan 2023
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mitigating Racial Disparities in Shared Decision Making in the Intensive Care Unit
- ClinicalTrials.gov ID
- NCT05710744
- Acronym / sponsor ID
- Pro00111530
- Conditions
- Health Care Disparities
- Keywords
- Intensive Care Unit, Racial Disparities in Healthcare
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 106 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 4 Jan 2027 (estimated)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 2 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Shared decision making tip sheetPhysicians 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Shared decision making tip sheetPhysicians will view tip sheets containing best practices for shared decision making with diverse families. | Behavioural | ICU Physicians |
Primary outcome
Intervention acceptability as measured by single Likert-scaled item completed by physicians
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: through study completion, up to 1 year
Proportion screen eligible enrolled/month based on review of study logs, range 0 to 100%
Practicality as measured by time to complete physician or family surveys
Time frame: 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
Practicality as measured by dropout rate from study
Time frame: through study completion, up to 1 year
Dropout rate as ascertained by review of study logs, range 0 to 100%
6 secondary outcomes
Decisional regret among families, measured by Decision Regret Scale
Time frame: within 96 hours of signing study consent
Psychological distress among families, measured by Impact of Events Revised scale
Time frame: within 96 hours of signing study consent
Psychological distress among physicians, measured by moral distress scale
Time frame: within 96 hours of signing study consent
Components of shared decision making, as measured by content analysis of family meeting recordings
Time frame: through study completion, up to 1 year
Decisional conflict among families, measured by Decisional Conflict Scale
Time frame: within 96 hours of signing study consent
ICU utilization among patients, as measured by length of stay
Time frame: through study completion, up to 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Deepshikha Ashana, M.D. principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shared decision making tip sheet in people with Health Care Disparities, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Brittany J McDowell, BSCR (919-613-7321, brittany.mcdowell@duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intervention acceptability as measured by single Likert-scaled item completed by physicians (time frame: within 96 hours of signing study consent). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026.