Dual Antiplatelet Therapy Strategy in High Bleeding Risk Patients Undergoing Complex Percutaneous Coronary Intervention Following Acute Coronary Syndrome: Second-Phase Beta Testing of a Patients Decision Aid
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Change in Decisional Conflict (DCS-LL) After Use of the Patient Decision Aid (PDA)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •Inclusion Criteria (Clinicians)
- •- 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
排除标准
- •Receiving therapeutic anticoagulation
- •Planned cardiac surgery during the same episode of care
- •Prior history of coronary stent thrombosis
- •Antiphospholipid syndrome or known thrombophilia
- •Unable to participate in shared decision-making
- •Unable to understand spoken and written French or English
- •Concurrent participation in another study (followed within another research protocol)
- •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)
研究组 & 干预措施
High bleeding risk patients treated with complex PCI in the context of ACS
The intervention is the use of the Patient Decision Aid (PDA) to support shared decision-making between patients and clinicians after PCI, assessed using questionnaires capturing multiple dimensions of decision quality.
No pharmacologic treatment is administered as part of the study; exposure consists solely of complete use of the PDA according to the protocol.
The study includes a single pre-post group, no interim analyses are planned given the limited project duration, and a single beta-testing phase will be conducted.
干预措施: Patient decision aid to support shared decision-making between patients and clinicians (Other)
结局指标
主要结局
Change in Decisional Conflict (DCS-LL) After Use of the Patient Decision Aid (PDA)
时间窗: Baseline (pre-PDA, Day 0) and immediately post-PDA completion (Day 0, index hospitalization).
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.
次要结局
- Change in Antiplatelet Strategy Knowledge Score After PDA Use(Baseline (pre-PDA, Day 0) and immediately post-PDA completion (Day 0, index hospitalization).)
- Preparation for Decision-Making (PrepDM) Score After PDA Use(Immediately post-PDA completion (Day 0, index hospitalization).)
- Patient Acceptability Score of the PDA in Routine Clinical Use(Immediately post-PDA completion (Day 0, index hospitalization).)
- Patient Refusal Rate to Use the PDA and Reasons for Refusal(Pre-intervention (at the time of the consent request, prior to PDA delivery, during the index hospitalization).)
- Agreement Between Patient-Preferred Antiplatelet Strategy and Strategy Prescribed at Hospital Discharge(At hospital discharge (index hospitalization), comparing the patient preference recorded immediately after PDA completion with the antiplatelet strategy on the discharge prescription/orders (also post-PDA completion).)
- Clinician Usability of the PDA (French System Usability Scale, F-SUS)(Day 0 (immediately after PDA use with an included patient))
- Clinician Refusal Rate to Use the PDA and Reasons for Non-Use(Pre-intervention (at the time the clinician is asked whether it is appropriate to approach the patient and offer the PDA, prior to patient approach and prior to PDA delivery, during the index hospitalization).)
研究者
Julien Quang Le Van
Pharmacist
Montreal Heart Institute