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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a digital tool designed to assist families in making difficult decisions when a loved one is in the ICU with severe brain injuries. It evaluates how a web-based decision aid can enhance communication between families and healthcare providers. Participants will either use the digital decision aid and communication (DA+C) tool or receive usual care without it. The trial seeks surrogate decision-makers of patients who have been critically ill for at least three days with conditions such as traumatic brain injury or severe stroke, and who are unable to swallow or require a ventilator to breathe. As an unphased study, this trial offers participants the chance to contribute to innovative research that could enhance decision-making support for families in critical care situations.

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 prior data suggests that this digital decision aid + communication tool is safe for use in surrogate decision-making for patients with severe acute brain injury?

Research shows that digital decision aid tools, like the one used in this trial, generally receive positive feedback from users. Past studies on similar tools for patients with stroke and atrial fibrillation (an irregular heartbeat) have found these aids practical and easy to use.

One study with family members of patients with severe brain injuries found the online tool simple to use, with no negative effects reported. The tool helps with decision-making by providing clear information and choices.

While this trial does not specifically look for side effects, digital tools like this one usually carry very low risk. They primarily help people better understand medical decisions and are considered safe compared to traditional medical treatments. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard care for hemorrhagic stroke, which typically involves medical management and supportive care, the Digital Decision Aid + Communication (DA+C) tool offers a unique approach. This web-based tool empowers surrogates by providing them with information and communication resources before critical meetings with clinicians. Researchers are excited about this tool because it facilitates informed decision-making, potentially improving the way families navigate complex medical choices during stressful times. Additionally, its digital format allows for easy access and updates, making it a flexible and user-friendly option for users.

What evidence suggests that this digital decision aid + communication tool is effective for surrogate decision-making in severe acute brain injury cases?

Research shows that the digital decision aid and communication (DA+C) tool, tested in this trial, helps families of very sick patients make important choices. Participants may use the DA+C tool, which studies have found improves communication between healthcare providers and surrogate decision-makers—those who make medical decisions for the patient. The tool includes features like risk and preference assessments, empowering families with clear information and guidance. Similar tools have helped previous patients make better decisions during stressful times. This method has succeeded in cases of traumatic brain injury and stroke, aiding families in understanding and choosing the best care options. ^{1 2 6 7 8}

Who Is on the Research Team?

Nils Henninger, MD, PhD

Principal Investigator

University of Massachusetts Chan Medical School

Susanne Muehlschlegel, MD, MPH

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

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

Patient has undergone initial stabilization but remains critically ill

Surrogate must be English speaking and literate

Documented surrogate decision-maker (official health care proxy, or legal next of kin) of a critically ill severe acute brain injury (SABI) patient ≥ 3 days after admission

Exclusion Criteria

Surrogate decision-maker is non-English speaking

Surrogate decision-maker is illiterate

Unwillingness to comply with study protocol

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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 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]

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]

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 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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05671874

Feasibility of a Digital Goals-of-Care Decision Aid for ... The web/mobile/tablet-based digital DA+C toll is designed to enhance communication and shared decision making between clinicians and surrogates of critically ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9576301/

Pilot Randomized Clinical Trial of a Goals-of-Care ... Adapting a traumatic brain injury goals-of-care decision aid for critically ill patients to intracerebral hemorrhage and hemispheric acute ischemic stroke.

3. withpower.com withpower.com/trial/phase-stroke-2023-d0e11

Digital Decision Aid + Communication Tool for ... The tool integrates risk assessment modules and preference assessments to facilitate shared decision-making, aiming to empower patients to make informed choices ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1878747924001909

and mobile-based shared decision-making tools in the ... This DA assists surrogate decision-makers for patients with ischemic stroke and intracerebral hemorrhage that calculates tailored prognostic information using ...

5. clinicaltrial.be clinicaltrial.be/nl/details/175289?per_page=100&only_recruiting=1&enrolling_by_invitation=1&active_not_recruiting=1&completed=0&only_eligible=0&only_active=0

Feasibility of a Digital Goals-of-Care Decision Aid for C... We have developed and refined a tailored digital, web-based decision aid (DA) for families of critically ill SABI patients, conceptually grounded in the Ottawa ...

6. clinicaltrial.be clinicaltrial.be/en/details/175289?per_page=20&recruiting=1&enrolling_by_invitation=1&active_not_recruiting=1&not_yet_recruiting=0&completed=0&only_recruiting=0&only_eligible=0

Feasibility of a Digital Goals-of-Care Decision Aid for C... This innovative tool challenges the existing paradigm for decision-making in SABI patients. This pilot study among 50 surrogates of SABI ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11840347/

Development of web- and mobile-based shared decision- ... Design and development of a digital shared decision-making tool for stroke prevention in atrial fibrillation. ... Using co-design to develop a ...

8. ctv.veeva.com ctv.veeva.com/study/feasibility-of-a-digital-goals-of-care-decision-aid-for-clinicians-and-families-of-patients-with-sab

Feasibility of a Digital Goals-of-Care Decision Aid for ... Description: Surrogate(s) will read/click through the DA+C tool prior to the clinician-family meeting and complete the integrated worksheet.