Among patients with acute coronary syndrome (ACS) treated with percutaneous coronary intervention (PCI) and stent implantation, 17.5% are both at high bleeding risk (HBR) and have undergone complex PCI, which also places them at high thrombotic risk. In this population, several dual antiplatelet therapy (DAPT) strategies may be considered: (1) de-escalation of DAPT intensity after 1 to 3 months (switch from ticagrelor/prasugrel to clopidogrel), (2) shortening DAPT duration to 1 to 3 months followed by antiplatelet monotherapy, (3) 12-month clopidogrel-based DAPT, and (4) 12-month ticagrelor/prasugrel-based DAPT. Selecting the most appropriate DAPT strategy in this dual-risk context is complex, and clinical trial evidence is limited for this specific subgroup. In the absence of clear guideline recommendations to support decision-making for patients facing both elevated bleeding and thrombotic risks, structured shared decision-making support is needed.
In this context, within research project 2025-3499 conducted with pharmacy residents, we developed a patient decision aid (PDA) designed to support shared decision-making by helping patients understand their risks, available options, and potential consequences, so they can express their preferences regarding antiplatelet therapy. The PDA aims to facilitate shared decisions by improving patients' understanding of benefits and harms and aligning choices with patient values. A preliminary version of the tool has already undergone alpha testing with a small group of internal users (physicians, pharmacists, and patient partners). The next step is beta testing, that is, real-world testing with the target population and clinicians to evaluate usability and acceptability in routine practice.
Adults aged 18 years or older
Hospitalized on the coronary care unit ward at the Montreal Heart Institute (MHI)
Acute coronary syndrome (ACS) during the current episode of care, treated with PCI and placement of one or more coronary stents
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
Receiving therapeutic anticoagulation
Planned cardiac surgery during the same episode of care
Prior history of coronary stent thrombosis
Antiphospholipid syndrome or known thrombophilia
Single group
Patient decision aid to support shared decision-making between patients and clinicians
Other interventionPatient decision aid to support shared decision-making between patients and clinicians by helping patients understand their risks, available options, and potential consequences, so they can express their preferences regarding antiplatelet therapy.
Change in Decisional Conflict (DCS-LL) After Use of the Patient Decision Aid (PDA)
Change in total score on the low-literacy Decisional Conflict Scale (DCS-LL; Ottawa Hospital Research Institute), comparing pre-PDA vs post-PDA completion. Lower scores indicate less decisional conflict.
Change in Antiplatelet Strategy Knowledge Score After PDA Use
Change in total score on an adapted OHRI knowledge questionnaire assessing understanding of bleeding and thrombotic risks and DAPT options, comparing pre-PDA vs post-PDA completion.
Preparation for Decision-Making (PrepDM) Score After PDA Use
Total score on the Preparation for Decision Making (PrepDM; OHRI) questionnaire completed after PDA use. Higher scores indicate greater perceived preparedness to make a decision with the clinician.
Patient Acceptability Score of the PDA in Routine Clinical Use
Total score on an OHRI acceptability questionnaire completed after PDA use, reflecting perceived relevance, clarity, length, and overall acceptability in the clinical setting.
Patient Refusal Rate to Use the PDA and Reasons for Refusal
Number and proportion of eligible patients who personally refuse participation/PDA use, and categorization of documented reasons for refusal (e.g., not interested, too tired, overwhelmed, language barriers, time constraints).
Exploratory Subgroup Effects on Decisional Conflict Scores Low Litteracy (DCS-LL) Questionnaire
Exploratory assessment of whether changes in DCS-LL differ by prespecified characteristics: age (\<70 vs ≥70 years), sex (male vs female), mother tongue (French vs English), education level (university vs lower) and prior percutaneous intervention with stent (yes or no). Analyses are descriptive/exploratory.
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