The Use of a Decision Aid in the Choice of Surgery for Herniated Disc
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 142
- 试验地点
- 2
- 主要终点
- Decision Quality worksheet -for herniated disc (DQW-HD v.2.0)
研究概览
简要总结
Even though surgery due to lumbar disc herniation (LDH) shows a more rapid relief of pain and recovery, the evidence of surgery being superior to conservative treatment in the long term is inconclusive. Involving patients in the decisions whether or not to have surgery is therefore essential. A small survey performed at our Spine Center however, showed that patients were often not fully involved in this treatment decision. Not being involved might lead patients to decision regret and unnecessary conflicts in the decision-making process. The purpose of this project is therefore to assess the effect of a newly developed patient decision aid (PtDA) to facilitate shared decision making (SDM), when patients choose between surgical or non-surgical treatment for LDH, on SDM, decisional conflict, decision regret and treatment outcomes in a randomized controlled trial. The project is performed at Center of Spine Surgery & Research, Middelfart. Inclusion and one month follow up is already completed and one year follow-up data currently being collected.
详细描述
Purpose of the project
The overall purpose of this study is to assess the effectiveness of a generic PtDA-template adapted to patients choosing between surgical and non-surgical treatment for LDH, on SDM, decisional conflict, decision regret and treatment outcomes in a randomized controlled trial. Development of an effective PtDA has the potential to decrease patients' decision regret and optimize treatment results and thereby in the future lead to higher patient satisfaction and fewer patient complaints. Using a generic PtDA-template, makes it feasible to adapt the used method to other spine-departments or other orthopedic-surgeries.
Background
Shared decision making (SDM) is a systematic approach aimed at improving patient involvement in preference-sensitive health care decisions. It is a process, wherein clinicians actively involve patients during the task of making decisions , based on best clinical evidence and patients' informed preferences.
Most people with lumbar disc herniation (LDH) improve with nonsurgical treatment. However, in Denmark, patients with ongoing severe pain and disability after 12 weeks of conservative care are recommended a surgical evaluation. Apart from the presence of a neurologic deficit, there are no clearly defined indications for surgery. A variety of factors, such as level of pain, walking capacity or functional limitations, can influence the judgment of the physician to advocate surgery or not. Indications for surgery are thus assessed, for each particular patient, by the individual surgeon. Even though surgical patients show a more rapid relief of pain and recovery, the evidence of surgery being superior to conservative treatment in the long term is nevertheless inconclusive. This underlines the concept that the choice of having surgical or non-surgical treatment for LHD is preference sensitive, meaning that treatment options should be offered and should matter to patients. A qualitative study by Andersen showed that the current lack of evidence for a superior treatment choice and the presence of uncertainties in risks and benefits are important to discuss with patients with LDH. Currently, there are no standard procedures used to actively involve patients in such decisions. SDM is required to accomplish the preference sensitive approach for patients with LDH.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
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
- •Patients seen by a surgeon in the Center for spine surgery and research, SLB.
- •Clinical symptoms and concordant MRI findings of a LDH from L1 to S1 with possible indication for primary discectomy surgery, assessed by an experienced spinal surgeon
- •Able to understand and read Danish
- •Informed consent
排除标准
- •General contra-indication for spine surgery
- •Diagnosis of psychiatric disorder
- •Manifest paresis disorder
- •Previous spine surgery
结局指标
主要结局
Decision Quality worksheet -for herniated disc (DQW-HD v.2.0)
时间窗: Meassured right after the surgeon-patient consultation
Decision quality is defined as the extent to which treatments reflect the considered preferences of wellinformed patients and how well it is implemented. Decision quality worksheet - HD include decision-specific items to assess: 1. knowledge, or the extent to which patients are informed 2. patients' goals, concerns and preferred treatment. These items can then be used to calculate concordance, or the extent to which patients' receive treatments that match their goals. 3. the decision making process, or the extent to which providers engage patients in decisions about their care. The three aspects are reported on separately, as a total knowledge score, a concordance (or in some cases dissonance) score, and a decisions process score. In this study only the knowledge and the process score is used. A total score is summed for each of the aspects ranging from 0-100 % with higher scores indicating a higher knowledge or a more shared decision- making process respectively.
次要结局
- Decisional conflict scale(Meassured right after the surgeon-patient consultation)
- Visual Analog Scale (VAS) leg(One month and one year after decision is made)
- Decisional Regret Scale(One month and one year after decision is made)
- Oswestry Disability Index(One year after the decision is made)
- European Quality of life - 5 Dimensions (EQ-5D)(One year after decision is made)
研究者
Stina Lykke Brogård Andersen
Ph.d. student
Spine Centre of Southern Denmark