Shared Decision Making Intervention for Healthcare Inequalities

Overseen By Brittany J McDowell, BSCR

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Duke University

Disqualifiers: Tracheostomy, Decision capacity, Extubation, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach to assist ICU doctors and families in making better joint care decisions. It focuses on families of patients with severe breathing problems, using a shared decision-making tip sheet to enhance communication and reduce racial inequalities. The study seeks family members deeply involved in decisions for a loved one on a ventilator for at least four days. Participants should be fluent in English and identify as non-Hispanic Black or White. As an unphased trial, it offers participants the chance to contribute to important research aimed at improving ICU care and communication.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that this intervention is safe for ICU clinicians and families?

Research has shown that shared decision-making in intensive care units is generally safe for both patients and doctors. Shared decision-making occurs when doctors and patients (or their families) collaborate on healthcare choices. Studies suggest that this approach can enhance patient safety.

No reports indicate harm or negative effects from using shared decision-making tools, such as tip sheets, in hospitals. These tip sheets assist doctors in discussing the best care options with families from diverse backgrounds. The goal is to facilitate joint decision-making between doctors and families, which is crucial for fair and equal treatment.

Overall, shared decision-making tools are well-accepted and not associated with any risks, making them a safe way to improve communication in healthcare settings. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it aims to address healthcare inequalities by enhancing communication between ICU physicians and the families of critically ill patients. Unlike standard practices that may not fully consider diverse perspectives, this approach uses a shared decision-making tip sheet to guide physicians in engaging effectively with families from varied backgrounds. By facilitating more inclusive and informed discussions, the trial hopes to improve decision-making processes and patient outcomes, potentially setting a new standard for patient and family engagement in critical care settings.

What evidence suggests that this shared decision making intervention is effective for mitigating racial disparities in healthcare?

Research shows that when doctors and families make decisions together, communication and understanding improve, especially in the ICU. In this trial, ICU physicians will use a tip sheet to involve families more in treatment discussions. Studies indicate that this method can reduce racial differences, ensuring all families feel heard and respected. This tool fosters mutual understanding among everyone involved in the care process, which is crucial for making the best decisions for patients with severe breathing problems. ^{6 7 8 9 10}

Who Is on the Research Team?

Deepshikha Ashana, MD

Principal Investigator

Duke University

Are You a Good Fit for This Trial?

This trial is for ICU physicians with recent service time and families of non-Hispanic Black or White patients over 18, who are on mechanical ventilation for at least a week. The patient's family must be involved in decision-making and fluent in English. Excluded are cases expecting extubation or death within a day, prisoners, pregnant women, those awaiting transplants, without family decision-makers, or with chronic neuromuscular disease.

Inclusion Criteria

ICU attending physician with at least 6 weeks of clinical service time in the 12 months preceding and following enrollment

Identified by medical team as person most involved in medical decision making for the patient

I have been on a mechanical ventilator for 4 or more days.

Exclusion Criteria

I am able to make my own medical decisions.

I am expected to be taken off a ventilator or pass away within the next day.

Awaiting organ transplantation during this hospitalization

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

ICU physicians view a tip sheet on best practices for shared decision making and conduct routine meetings with families

96 hours

Routine meetings with families

Follow-up

Participants are monitored for intervention acceptability, demand, fidelity, and practicality

up to 1 year

What Are the Treatments Tested in This Trial?

Interventions

• Shared decision making tip sheet

Trial Overview The study tests the effectiveness of a 'shared decision making tip sheet' designed to help ICU clinicians better involve families in treatment decisions for patients with acute respiratory failure. It aims to reduce racial disparities in these critical conversations.

How Is the Trial Designed?

Group I: ICU Physicians Experimental Treatment 1 Intervention

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.

Group II: Family Members of patients in the ICU Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Published Research Related to This Trial

The Shared Decision Making (SDM) Process scale effectively differentiates between good-quality and poor-quality SDM consultations in cancer screening and medication decisions, as evidenced by higher scores for good-quality videos in a study of 388 participants.

While the SDM Process scores correlated well with another measure of SDM (SDM-Q-9), the scale showed limited ability to accurately classify video quality, indicating that individual differences significantly influenced how participants evaluated the SDM conversations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using Standardized Videos to Examine the Validity of the Shared Decision Making Process Scale: Results of a Randomized Online Experiment. Valentine, KD., Mancini, B., Vo, H., et al.[2022]

The study involving 684 participants (324 patients and 360 disease-naïve individuals) found that communicating choice awareness positively influenced patients' perceived involvement in treatment decisions, while physician preference communication did not significantly affect this perception.

However, when physicians expressed a preference for a treatment option, it led patients to favor that option, indicating that how physicians communicate their preferences can influence patient choices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fostering Patient Choice Awareness and Presenting Treatment Options Neutrally: A Randomized Trial to Assess the Effect on Perceived Room for Involvement in Decision Making. Pieterse, AH., Brandes, K., de Graaf, J., et al.[2022]

Shared decision making during clinical encounters can enhance patient engagement in their health, potentially improving outcomes and controlling healthcare costs.

To fully realize the benefits of shared decision making, there is a need for more physician training and practice restructuring, along with further research to identify effective interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Shared decision making: examining key elements and barriers to adoption into routine clinical practice. Légaré, F., Witteman, HO.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05710744?term=Healthcare%20Disparities&aggFilters=status:not%20rec&rank=1

Mitigating Racial Disparities in Shared Decision Making ... 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 ...

2. withpower.com withpower.com/trial/phase-healthcare-disparities-7-2023-b9fed

Shared Decision Making Intervention for Healthcare ... Trial Overview The study tests the effectiveness of a 'shared decision making tip sheet' designed to help ICU clinicians better involve families in treatment ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10258434/

Association Between Shared Decision-Making During Family ... Trained study personnel abstracted patient's demographics and clinical data from the medical records. The primary outcome measure was change in surrogates' ...

4. frontiersin.org frontiersin.org/journals/medicine/articles/10.3389/fmed.2025.1639805/full

Shared decision making - a review of its evaluation ... This review aims to systematically analyze SDM models described in the literature, align them with asthma management requirements, incorporate ...

5. bmjopenrespres.bmj.com bmjopenrespres.bmj.com/content/12/1/e002637

Uncertainty and decision-making in critical care We explored influences on decision-making regarding management of COVID-19 ARDS mechanical ventilation to identify modifiable factors to improve preparedness ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4788386/

Shared Decision Making in Intensive Care Units: An American ... Shared decision-making is a collaborative process that allows patients, or their surrogates, and clinicians to make health care decisions together.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4910896/

Shared Decision-Making in Intensive Care Units. Executive ... Research suggests that nearly half of surrogates of critically ill patients prefer that physicians independently make some types of treatment decisions (10–13).

8. clinicaltrials.gov clinicaltrials.gov/study/NCT06027684

Intensive Care Decision-making, Survival and Dying Well The goal of this study is to investigate how the experiences of intensive care patients and their end-of-life wishes affect their willingness to accept ...

9. researchgate.net researchgate.net/publication/333657074_Interprofessional_Shared_Decision-Making_in_the_ICU_A_Systematic_Review_and_Recommendations_From_an_Expert_Panel

Interprofessional Shared Decision-Making in the ICU The aim of this project is to use systematic review and normative analysis by experts to examine existing evidence regarding interprofessional shared decision- ...

10. ahrq.gov ahrq.gov/sites/default/files/wysiwyg/professionals/quality-patient-safety/patient-family-engagement/pfeprimarycare/shareddec-1.pdf

Shared Decisionmaking To Improve Patient Safety, ... Shared decisionmaking involves patients and clinicians sharing information and participating in the decision-making process to agree on the ...