A Randomized Controlled Trial of Decision Aids for Upper and Lower Extremity Conditions.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 168
- 试验地点
- 12
- 主要终点
- Patient satisfaction on a 11-point ordinal scale
研究概览
简要总结
This study aims to assess differences in choice of treatment (and the rationale behind it), physical function, pain intensity, satisfaction, and decision regret between orthopedic patients who review a decision aid during their visit and those that do not. Decision aids for 23 different conditions are included.
详细描述
Patients visiting an orthopeadic surgeon in one of our 4 affiliated offices in a large urban area in the United States are invited to participate over a 4 month period. All English-speaking patients, between 18 and 89 years old, visiting an orthopeadic surgeon with a new problem, for which either invasive or non-invasive treatment is possible and a DA is available are asked to participate in this study. Exclusion criteria are non-English speakers or a clear preference for a treatment option by surgeon or patient. Patients will be randomly assigned to either the intervention or the control group in a 1:1 ratio using an Excel random number generator. Patients in the intervention group go over the DA during the visit, once the surgeon has identified the diagnosis. After the diagnosis is set, the surgeon steps out of the visit and steps back in when the patients has reviewed the DA. The surgeon and the patient go over the treatment options and a decision will be made. After the visit, all patients, both in the intervention and control group, are asked to fill out a survey. Two weeks after enrollment a research assistant calls all patients for a follow up questionnaire.
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 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •English-speaking, adult patients seeing an upper or lower extremity surgeon for a new visit regarding diagnoses that can be treated invasively and non-invasively:
- •Clavicle fracture in the middle
- •Clavicle fracture close to the shoulder
- •Proximal humerus fracture
- •Humerus shaft fracture
- •Distal humerus fracture
- •Lateral epicondylitis
- •Ruptured biceps at the elbow
- •Olecranon fracture
- •Radial head fracture
- •Olecranon bursitis
- •Distal radius fracture
- •Carpal tunnel syndrome
- •Scaphoid fracture
- •Thumb arthrosis
- •Trigger finger
- •Mallet fracture
- •de Quervain tendinopathy
- •Wrist ganglion
- •Dupuytren
- •Knee • Knee arthritis: cortisone injection
- •Hip arthritis: total hip arthroplasty
排除标准
- •Obvious indication for one treatment approach, either from the surgeon or the patient perspective.
- •Patients who do not want to be contacted for follow-up.
- •Non-English speaking patients, because the decision aids used in this study are not currently validated to non-English language.
结局指标
主要结局
Patient satisfaction on a 11-point ordinal scale
时间窗: From enrollment till follow-up after two weeks
On a scale of 0-10 how satisfied were you with this visit 0 being totally dissatisfied and 10 being totally satisfied.
次要结局
- Patient-Reported Outcomes Measurement Information System Physical Function Computer Adaptive Test (directly after visit)(From enrollment till two weeks after visit)
- Pain intensity on an 11-point ordinal scale(From enrollment till two weeks after visit)
- Choice of treatment (invasive/non-invasive)(Day of enrollment)
- Decision regret scale (O'Connor '96)(One time measurement, two weeks after the visit.)
研究者
David Ring
Associate Dean for Comprehensive Care and Professor, Department of Surgery and Perioperative Care
University of Texas at Austin