A Randomized Trial Measuring the Effect of Review of a Decision Aid Prior to the Appointment on Decisional Conflict Compared to Usual Care in the Treatment of Trapeziometacarpal (TMC) Arthritis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Decision Conflict Scale (DCS)
研究概览
简要总结
The investigators plan a prospective randomized controlled study that compares whether the use of a decision aid results in different scores on variables reflective of the decision-making process, behavior, health outcomes, communication, and healthcare system.
详细描述
Decision aids (shared decision making tools-websites, videos, or pamphlets) are interventions to prepare patients to make more informed decisions and satisfying decisions that match their preferences and values. With greater understanding of the risks and benefits of the treatment options patients may make a more informed choice.
Decision aids - delivered online, on paper, or on video - increase patient participation in the decision-making process,1 and can result in a decrease in discretionary surgery for knee osteoarthritis, herniated disk, and benign prostatic hypertrophy.2-4 They also reduce decisional conflict. Relatively few studies have investigated the influence of decision aids in orthopedic or hand surgery. Decision aids might affect decisional conflict, satisfaction, and outcomes in hand surgery where many treatments are discretionary and address quality of life.
Utilizing the Ottawa Decision Support Framework- an evidence-based, practical theory used to guide the development of decision aids - and the International Patient Decision Aid Standards criteria the investigators developed a decision aid for trapeziometacarpal arthritis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •at least 18 years of age
- •English-speaking
- •Diagnosis of trapeziometacarpal (TMC) arthritis
排除标准
- •Prior surgical intervention for trapeziometacarpal (TMC) arthritis
- •Previously accessed or used the online TMC arthritis Decision Aid (DA)
研究组 & 干预措施
Decision Aid
Cohort that will receive a decision aid.
干预措施: Decision Aid (Behavioral)
No Decision Aid (control)
One cohort will not receive the decision aid, and instead will receive only a brochure as standard treatment.
结局指标
主要结局
Decision Conflict Scale (DCS)
时间窗: Day 1
This scale measures patients' perception of uncertainty in making health-related decisions and consists of 3 subscales: (1) uncertainty choosing between different options, (2) modifiable factors contributing to this uncertainty-feeling uninformed, unclear about personal values, and feeling unsupported, and (3) perceived effectiveness of the decision-making an informed and values-based choice and expressing satisfaction with the decision. We used the validated statement format Decisional Conflict Scale, consisting of 16 items with 5 response options. Total scores range from 0 (no decisional conflict) to 100 (extremely high decisional conflict).
次要结局
- Change in Decision Regret Scale After 6 Weeks and 6 Months(6 week and 6 month follow up)
- Patient Health Questionnaire-2 (PHQ-2)(Day 1)
- Consultation and Relational Empathy (CARE) Measure(Day 1)
- 11-point Ordinal Satisfaction Scale(Day 1)
- QuickDASH (Disabilities of the Arm, Shoulder and Hand) Questionnaire(Day 1)
研究者
Neal Chung-Jen Chen
Principal Investigator
Massachusetts General Hospital