Development, Piloting and Evaluation of an Evidence-based Informed Consent Form for Total Knee Arthroplasty
试验速览
- 阶段
- 不适用
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- Anxiety: Change from baseline anxiety after the informed consent procedure assessed by the surgical fear questionnaire and a numeric rating scale (0-10)
研究概览
简要总结
Every medical intervention requires informed consent. Informed consent may include comprehensible information about the necessity and kind of the intervention, material risks and consequences or alternative treatments. Practitioners frequently use consent forms to support the physician-patient conversation and to document informed consent. Studies show, that informed consent forms used in practice, are heterogeneous.
This study aims at investigating the effects of evidence-based informed consent forms for Total Knee Replacement and related anaesthesia procedures.
Evidence-based informed consent forms include best and latest evidence in lay language. It is hypothesized that evidence-based informed consent forms - compared to standard consent forms - improve patients' risk perception, reduce anxiety of complications and reduce the nocebo effect (unspecific negative effects caused by the way of communicating risks).
To compare evidence-based and standard informed consent forms, an Interrupted Time Series pilot study will be conducted. It is planned to include 220 patients, who are scheduled for elective total knee replacement surgery.
The accompanying qualitative analyses ensure that the (German) legal requirements for informed consent are met.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
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 are scheduled for an elective total knee arthroplasty surgery
- •Patients are at least 18 years old
- •Patients are able to understand and speak German
- •Patients are mentally competent to give consent and answer questions
排除标准
- •Patients with revision
- •Patients with posttraumatic arthrosis
结局指标
主要结局
Anxiety: Change from baseline anxiety after the informed consent procedure assessed by the surgical fear questionnaire and a numeric rating scale (0-10)
时间窗: Anxiety will be measured at the day of consultation - approximately 4 weeks before surgery - (baseline) and one day before surgery
The surgical fear questionnaire is a validated questionnaire for measuring patient reported fear of surgery. The questionnaire includes the following items: fear of operation, fear of anaesthesia, postoperative pain, side effects, health deterioration, failed operation, incomplete recovery, long duration of rehabilitation.
Nocebo-Effect: Proportion of patients with patient reported adverse events/complications and cummulaive number of adverse events/complications assessed by closed and open questions
时间窗: approximately three days after hospital discharge
The occurence of specific adverse events/complications (e.g. postoperative nausea and vomitting) will be queried. In addition it will be queried whether other adverse events/ complications not mentioned before have occurred.
次要结局
- Knowledge/risk perception: Proportion of correctly answered questions assessed by knowledge questions about benefits and risks of undergoing surgery(One day before surgery)
- Mean pain and function of the knee assessed by the Oxford Knee Score(approximately one month after hospital discharge)
- Mean satisfaction with the physician-patient-communication and informed consent form assessed by a numeric rating scale (0-10)(One day before surgery)
- Mean Quality of life (QoL) assessed by a numeric rating scale (0-10)(approximately one month after hospital discharge)