Randomised Controlled Trial of a Heart Failure Medication Decision Aid in Singapore
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Frequency of Medication cost discussion
研究概览
简要总结
A modified Zelen design randomised controlled trial over 6 months period is designed to investigate the influence of a heart failure medication decision aid prior to clinic session on shared decision making and its long term effect. Participants are randomised to either the decision aid arm or the usual care arm.
详细描述
A novel heart failure (HF) medication decision aid (DA) has been constructed, taking into account the needs of both patients and clinicians. Developed with a focus on brevity, this single-page DA is designed to offer patients a quick and concise overview of the information they desire about their medication ahead of their clinic session. It encompasses personalised cost information, considering the subsidies available in Singapore. The aim of the DA is to improve the communication between clinicians and HF patients. The conduct of this randomized controlled trial (RCT) is to study the effectiveness of the HF DA in the real-world setting.
Patients are randomized to either the DA arm or the usual care (UC) arm. In the DA group, patients will be provided with a DA featuring duration and frequency of use, benefits, side effect and cost information about angiotensin receptor neprilysin inhibitor and angiotensin-converting enzyme inhibitor medications. These patients will then be tasked to choose a preferred medication and reflect on which attribute holds the most significance for them. The preferred medication will be communicated to the clinicians during the clinic session. For the UC arm, clinicians will manage the encounter as per current usual routine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Participant)
盲法说明
Only participants are masked to the randomization allocation.
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with heart failure with reduced ejection fraction (HFrEF)
- •Singaporean nationality
排除标准
- •Patient is currently on Medifund OR have Medical Claims Pro-ration System (MCPS)
- •Age 21 years and below
- •Incapable of personally giving consent
- •Unable to speak and read English or Chinese
研究组 & 干预措施
Decision aid
Patients will be presented with a decision aid featuring personalized cost information, as well as other information about angiotensin receptor neprilysin inhibitor (ARNI) and angiotensin-converting enzyme inhibitor (ACEI) medications. These patients will then be tasked to choose a preferred medication and reflect on which attribute holds the most significance for them. The preferred medication will be communicated to the clinicians during the clinic session.
干预措施: Decision aid (Behavioral)
Usual care
Patients are managed as per usual clinical routine without the decision aid.
结局指标
主要结局
Frequency of Medication cost discussion
时间窗: Day 1 (Clinic session)
This outcome will be measured using an audio recording of the clinic session. Audio recording will be transcribed. The presence of cost discussion during the clinic session will coded based on Hunter et al. (2016) definition. Presence of cost discussion is coded as 1 and absence of cost discussion is coded as 0. Coding of cost discussion frequency will be done by 2 analysts who are blinded to the randomisation.
次要结局
- Decisional conflict(Day 1 (Immediately after clinic session) and Day 180 (Follow-up appointment))
- Decision satisfaction(Day 1 (Immediately after clinic session) and Day 180 (Follow-up appointment))
- Decision regret(Day 180 (Follow-up appointment))
- Financial toxicity(Day 1 (Immediately after clinic session) and Day 180 (Follow-up appointment))
- Prescribed medication agreement with preferred medication(Day 1 (Immediately after clinic session))
- Health-related quality of life(Day 1 (Immediately after clinic session) and Day 180 (Follow-up appointment))
- Readmission rate(Day 180 (Follow-up appointment))
- Medication Adherence(Day 180 (Follow-up appointment))
- Heart Failure symptoms and Adverse drug reactions(Day 180 (Follow-up appointment))
研究者
Shen Qianyu
Researcher
National University of Singapore