Digital Decision Aid + Communication Tool for Hemorrhagic Stroke

Recruiting at 3 trial locations

Overseen By Susanne Muehlschlegel, MD, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Massachusetts, Worcester

Disqualifiers: Non-English, Illiterate, Early death, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

50 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal is to pilot test a highly accessible, web-based, pragmatic, scalable intervention to overcome ongoing problems with high stakes decision-making by surrogate decision-makers of patients in ICUs with severe acute brain injury (SABI), including those with moderate-severe traumatic brain injury, large hemispheric acute ischemic stroke and intracerebral hemorrhage.

Do I need to stop my current medications for the trial?

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

What data supports the effectiveness of the Digital Decision Aid + Communication Tool for Hemorrhagic Stroke?

Research on similar digital decision aids for other conditions, like atrial fibrillation, shows they can reduce patients' uncertainty about treatment choices and help align decisions with their preferences, which suggests potential benefits for hemorrhagic stroke patients as well. ^{1 2 3 4 5}

Is the Digital Decision Aid + Communication Tool safe for use in humans?

The research on similar digital decision aids for atrial fibrillation shows they are generally safe for use, as they focus on improving communication and decision-making between patients and clinicians without causing physical harm. ^{1 2 4 6 7}

How does the Digital Decision Aid + Communication Tool for Hemorrhagic Stroke differ from other treatments?

This treatment is unique because it uses a digital decision aid to facilitate shared decision-making between patients and clinicians, helping them make informed choices about managing hemorrhagic stroke. Unlike traditional treatments that focus solely on medical interventions, this tool emphasizes patient involvement and understanding of their care options. ^{1 2 6 7 8}

Research Team

Nils Henninger, MD, PhD

Principal Investigator

University of Massachusetts Chan Medical School

Susanne Muehlschlegel, MD, MPH

Principal Investigator

Johns Hopkins University

Eligibility Criteria

This trial is for adult surrogates of critically ill patients with severe acute brain injuries (SABI) like traumatic brain injury or stroke. Surrogates must be English-speaking, literate, and officially recognized as decision-makers. The patient should have a significant risk of death or long-term impairment and not have passed away within the first 3 days after ICU admission.

Inclusion Criteria

Surrogate is age 18 years or older, no upper age limit

Patient has undergone initial stabilization but remains critically ill

Surrogate must be English speaking and literate

Exclusion Criteria

Surrogate decision-maker is non-English speaking

Surrogate decision-maker is illiterate

Unwillingness to comply with study protocol

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Surrogates use the web-based Decision Aid + Communication tool prior to clinician-family meetings

Duration of ICU stay, an expected average of 4 weeks

Continuous access to the tool

Follow-up

Participants are monitored for decision-making quality and psychological outcomes

3 months post SABI

Treatment Details

Interventions

• Web/mobile/tablet-based digital decision aid + communication (DA+C) tool

Trial Overview The study tests a digital decision aid plus communication tool designed to help surrogates make care decisions for SABI patients in ICUs. It aims to improve the quality of high-stakes medical decisions by providing accessible web-based support.

Participant Groups

Group I: Web-based Decision Aid + Communication (DA+C) tool Experimental Treatment 1 Intervention

Surrogate(s) will read/click through the DA+C tool prior to the clinician-family meeting and complete the integrated worksheet. Surrogate(s) will have unlimited access to the DA+C tool and may return to the tool and edit the worksheet at any time.

Group II: Usual Care Active Control 1 Intervention

No decision aid

Who Is Running the Clinical Trial?

University of Massachusetts, Worcester

Lead Sponsor

Trials

372

Recruited

998,000+

Johns Hopkins University

Collaborator

Trials

2,366

Recruited

15,160,000+

Worcester Polytechnic Institute

Collaborator

Trials

19

Recruited

30,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

National Institute of Nursing Research (NINR)

Collaborator

Trials

623

Recruited

10,400,000+

Findings from Research

A new decision aid (DA) tool for patients with atrial fibrillation (AF) has been developed to help them understand their specific risks for stroke and bleeding when considering oral anticoagulant (OAC) treatments, based on a comprehensive review of literature and patient feedback.

The tool integrates risk assessment modules and preference assessments to facilitate shared decision-making, aiming to empower patients to make informed choices about their treatment options, although further research is needed to test its effectiveness in real-world scenarios.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a shared decision-making tool to assist patients and clinicians with decisions on oral anticoagulant treatment for atrial fibrillation. Kaiser, K., Cheng, WY., Jensen, S., et al.[2018]

A novel digital shared decision-making toolkit significantly reduced decisional conflict in patients with atrial fibrillation (AF) compared to usual care, with a notable 7-point difference in median scores at 1 month after implementation.

The toolkit, which included various patient-centered resources, was effective in helping patients make informed choices about oral anticoagulation, although the benefits in reducing decisional conflict and regret diminished over time, indicating the need for ongoing support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized Clinical Trial to Evaluate an Atrial Fibrillation Stroke Prevention Shared Decision-Making Pathway. Wang, PJ., Lu, Y., Mahaffey, KW., et al.[2023]

In a study involving 913 patients at a General Internal Medicine Clinic, 57% of those eligible viewed at least part of the decision aids for prostate cancer screening or weight loss surgery, indicating that in-clinic distribution is feasible and effective.

The average viewing time for patients who did not complete the decision aid was 13 minutes, suggesting that shorter decision aids (under 10 minutes) could enhance patient engagement and facilitate better decision-making during medical visits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Promoting decision aid use in primary care using a staff member for delivery. Miller, KM., Brenner, A., Griffith, JM., et al.[2021]

Decision aids (DAs) significantly reduce decisional conflict regarding the use of oral anticoagulants (OACs) and enhance their uptake among patients with atrial fibrillation (AF), based on a meta-analysis of 10 studies.

DAs that incorporate key elements of shared decision-making, such as clarifying options and aligning with patient preferences, are more effective in promoting OAC uptake, although their impact on adherence and the incidence of stroke and bleeding remains unclear.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Decision aids for shared decision-making and appropriate anticoagulation therapy in patients with atrial fibrillation: a systematic review and meta-analysis. Song, D., Zhou, J., Fan, T., et al.[2022]

A decision aid (DA) prototype was developed and positively received by 12 women over 70 with Stage I breast cancer, indicating it is clear and acceptable for helping them understand treatment options.

Participants found the DA helpful for making treatment decisions and recommended its use in clinical practice, highlighting the need for better decisional support for older patients in cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Working Toward a Decision: The Development and First Impressions of a Decision Aid for Older Women with Early-stage Breast Cancer. D'Alimonte, L., Angus, J., Wong, J., et al.[2019]

A review identified 14 shared decision-making (SDM) tools for patients with atrial fibrillation (AF) considering stroke prevention, most of which provided current information but lacked practical considerations like cost.

While five of these tools showed small improvements in patient knowledge and reduced decisional conflict, their effectiveness in promoting high-quality SDM remains uncertain, highlighting the need for better user-centered development and evaluation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Shared Decision Making Tools for People Facing Stroke Prevention Strategies in Atrial Fibrillation: A Systematic Review and Environmental Scan. Torres Roldan, VD., Brand-McCarthy, SR., Ponce, OJ., et al.[2021]

The development of Anticoagulation Choice, a conversation aid for patients with atrial fibrillation, aims to enhance shared decision making (SDM) by providing comprehensive evidence on the risks of thromboembolic stroke and treatment options.

Creating effective decision aids like Anticoagulation Choice involves overcoming challenges in presenting high-quality, up-to-date evidence to ensure that treatments align with patients' individual needs and preferences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing a Conversation Aid to Support Shared Decision Making: Reflections on Designing Anticoagulation Choice. Zeballos-Palacios, CL., Hargraves, IG., Noseworthy, PA., et al.[2020]

A new goals-of-care decision aid was successfully adapted for families of critically ill patients with intracerebral hemorrhage and acute ischemic stroke, showing excellent usability and acceptability among 20 family members tested.

The decision aid incorporates validated outcome prediction models and was rated positively by over 90% of participants for its content, balance, and comprehensibility, indicating it could effectively support shared decision-making in neurologic ICUs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adapting a Traumatic Brain Injury Goals-of-Care Decision Aid for Critically Ill Patients to Intracerebral Hemorrhage and Hemispheric Acute Ischemic Stroke. Goostrey, KJ., Lee, C., Jones, K., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Development of a shared decision-making tool to assist patients and clinicians with decisions on oral anticoagulant treatment for atrial fibrillation. [2018]

2. England pubmed.ncbi.nlm.nih.gov

Randomized Clinical Trial to Evaluate an Atrial Fibrillation Stroke Prevention Shared Decision-Making Pathway. [2023]

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

Promoting decision aid use in primary care using a staff member for delivery. [2021]

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

Decision aids for shared decision-making and appropriate anticoagulation therapy in patients with atrial fibrillation: a systematic review and meta-analysis. [2022]

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

Working Toward a Decision: The Development and First Impressions of a Decision Aid for Older Women with Early-stage Breast Cancer. [2019]

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

Shared Decision Making Tools for People Facing Stroke Prevention Strategies in Atrial Fibrillation: A Systematic Review and Environmental Scan. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Developing a Conversation Aid to Support Shared Decision Making: Reflections on Designing Anticoagulation Choice. [2020]

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

Adapting a Traumatic Brain Injury Goals-of-Care Decision Aid for Critically Ill Patients to Intracerebral Hemorrhage and Hemispheric Acute Ischemic Stroke. [2022]