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

106 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Shared decision making tip sheet?

Research suggests that shared decision making, which involves patients and healthcare providers working together to make decisions, can improve patient involvement and satisfaction. However, there is limited direct evidence showing its impact on health outcomes or healthcare costs. ^{1 2 3 4 5}

Is the Shared Decision Making Intervention safe for humans?

The research articles reviewed do not provide specific safety data for the Shared Decision Making Intervention, but they focus on its implementation and effectiveness in healthcare settings. ^{6 7 8 9 10}

How is the shared decision-making treatment different from other treatments for healthcare inequalities?

This treatment is unique because it focuses on involving patients in their healthcare decisions by using tools and strategies that help them understand their options and incorporate their values and preferences. Unlike traditional treatments, it emphasizes patient engagement and aims to reduce healthcare inequalities by ensuring patients are active participants in their care. ^{1 5 6 11 12}

What is the purpose of 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.

Research Team

Deepshikha Ashana, MD

Principal Investigator

Duke University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. United States 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. [2022]

2. Ireland pubmed.ncbi.nlm.nih.gov

Does training general practitioners result in more shared decision making during consultations? [2019]

3. Ireland pubmed.ncbi.nlm.nih.gov

Measuring shared decision making in the consultation: a comparison of the OPTION and Informed Decision Making instruments. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Shared decision making and support for self-management: a rationale for change. [2020]

5. Germany pubmed.ncbi.nlm.nih.gov

Shared decision-making in the US--research & development outpaces delivery. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Patient and provider perspectives on uptake of a shared decision making intervention for asthma in primary care practices. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

A Systematic Review and Meta-Analysis of Patient Decision Aids for Socially Disadvantaged Populations: Update from the International Patient Decision Aid Standards (IDPAS). [2023]

8. United States 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. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Designing Shared Decision-Making Interventions for Dissemination and Sustainment: Can Implementation Science Help Translate Shared Decision Making Into Routine Practice? [2020]

10. United States pubmed.ncbi.nlm.nih.gov

Trends in Patient-Perceived Shared Decision Making Among Adults in the United States, 2002-2014. [2021]

11. United States pubmed.ncbi.nlm.nih.gov

Shared decision making: examining key elements and barriers to adoption into routine clinical practice. [2022]

12. Canada pubmed.ncbi.nlm.nih.gov

Adaptation and Implementation of a Shared Decision-Making Tool From One Health Context to Another: Partnership Approach Using Mixed Methods. [2023]