Patient Decision Aid for Acute Coronary Syndrome

(BETA-DAPT Trial)

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Overseen ByJulien Quang Le Van, BPharm, MSc, BCCP
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Montreal Heart Institute
Must be taking: Antiplatelets
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a tool designed to help patients with acute coronary syndrome make informed decisions about their antiplatelet therapy. It focuses on patients at high risk of both bleeding and blood clots after receiving heart stents. The tool, known as the Patient Decision Aid, guides these patients and their doctors in choosing the best treatment strategy by weighing the benefits and risks of different therapies. Patients hospitalized at the Montreal Heart Institute who have recently undergone heart procedures might be suitable candidates. The goal is to evaluate how well this decision-making aid performs in real-world situations. As an unphased trial, this study offers patients the opportunity to contribute to innovative research that could enhance decision-making for future heart patients.

What prior data suggests that this patient decision aid is safe for use in shared decision-making?

Research shows that using a patient decision aid (PDA) is generally safe. In other studies with different patient groups, PDAs have been well-received. For example, a study on a decision aid for people with chest pain found that it increased their knowledge without any safety issues. Another study found that using a decision aid improved how involved and satisfied patients felt.

The PDA in this trial is not a drug or medical procedure but a tool to help patients and doctors make decisions together. It does not have physical side effects like a medication might. The goal is to improve understanding and decision-making, which can lead to better health outcomes.12345

Why are researchers excited about this trial?

Researchers are excited about this trial because it introduces the Patient Decision Aid (PDA) to enhance decision-making for patients with acute coronary syndrome (ACS) undergoing complex percutaneous coronary intervention (PCI). Unlike traditional treatments that focus solely on medical procedures and medications, this approach emphasizes shared decision-making between patients and clinicians. By using the PDA, the trial aims to improve the quality of decisions by ensuring patients are fully informed and involved in their treatment choices, potentially leading to better outcomes and patient satisfaction.

What evidence suggests that this patient decision aid is effective for acute coronary syndrome?

Research shows that decision aids help patients understand their treatment options and associated risks. Studies have found that these tools enhance patient knowledge about their health condition and available treatment choices. In cases of acute coronary syndrome (ACS), understanding the balance between bleeding and clotting risks is crucial when selecting a dual antiplatelet therapy (DAPT) plan. This trial will use a Patient Decision Aid (PDA) to support shared decision-making between patients and clinicians after PCI. Previous decision aids have increased patient understanding and ensured that treatment choices align with patient values. This tool aims to achieve the same by supporting shared decision-making, which has improved decision quality.15678

Are You a Good Fit for This Trial?

This trial is for patients who have had a heart attack and received stent placement, are at high risk of bleeding, and also face a high chance of blood clots. It's designed to help them choose the best strategy for taking blood-thinning medications with their doctors.

Inclusion Criteria

High bleeding risk based on PRECISE-HBR score and high thrombotic risk, with both risks considered of comparable clinical importance by the treating medical team
I am 18 years old or older.
Clinicians working in the MHI coronary care unit (cardiologists, medical residents, nurse practitioners, or pharmacists) who use the patient decision aid with one or more study participants
See 2 more

Exclusion Criteria

Transferred from another center for reasons other than coronary angiography at MHI and expected to return to the referring center for ongoing care (i.e., 'fly-in/fly-out' patients)
I am scheduled for heart surgery during my current hospital stay.
I am on blood thinners for treatment.
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Beta Testing

Real-world testing of the Patient Decision Aid (PDA) with the target population and clinicians to evaluate usability and acceptability

During index hospitalization
1 visit (in-person)

Follow-up

Participants are monitored for decision-making preparedness and usability of the PDA

Immediately post-PDA completion
1 visit (in-person)

Post-Discharge Monitoring

Monitoring of agreement between patient-preferred antiplatelet strategy and strategy prescribed at hospital discharge

At hospital discharge

What Are the Treatments Tested in This Trial?

Interventions

  • Patient Decision Aid

Trial Overview

The study tests a patient decision aid tool that helps those at dual risk after heart procedures understand their medication options, risks, and benefits to make informed choices about their treatment together with clinicians.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: High bleeding risk patients treated with complex PCI in the context of ACSExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Montreal Heart Institute

Lead Sponsor

Trials
125
Recruited
85,400+

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/24884807/

Effectiveness of the Chest Pain Choice Decision Aid in ...

We will measure the effect of CPC on (1) patient knowledge regarding their 45-day risk for ACS and the available management options (primary ...

The Chest Pain Choice Decision Aid: A Randomized Trial

The decision aid included a 100-person pictograph depicting the pretest probability of acute coronary syndrome and available management options ...

Shared decision making in patients with low risk chest pain

The primary outcome, selected by patient and caregiver advisers, was patient knowledge of their risk for acute coronary syndrome and options for ...

DAPT Strategy in HBR Patients Undergoing Complex PCI ...

Patient decision aid to support shared decision-making between patients and clinicians by helping patients understand their risks, available ...

Testing a Decision Aid for Patients with Low-Risk Chest ...

Over the past decade, the proportion of patients diagnosed with acute coronary syndrome (ACS) in the emergency setting decreased from 26% to 13%. Despite the ...

Testing a Decision Aid for Patients with Low-Risk Chest Pain ...

We compared the effectiveness of shared decision-making facilitated by the Chest Pain Choice (CPC) decision aid with usual care (UC) in the choice of admission ...

Impact of a Shared Decision Making Intervention on Health ...

Conclusions Use of a decision aid in patients at low risk for acute coronary syndrome increased patient knowledge about their risk, increased engagement ...

Shared Decision-Making and Cardiovascular Health

Using decision aids that calculate individual risk for CVD may improve patient engagement and satisfaction and reduce decisional regret. For the best outcomes, ...