Development, Piloting and Evaluation of an Evidence-based Informed Consent Form for Total Knee Arthroplasty
- Conditions
- Consent FormsOsteoarthritis, KneeArthroplasty, Replacement, Knee
- Interventions
- Other: evidence-based informed consent form
- Registration Number
- NCT04669483
- Lead Sponsor
- University of Witten/Herdecke
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 220
- 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
- Patients with revision
- Patients with posttraumatic arthrosis
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Intervention group (post-interruption) evidence-based informed consent form Patients receive evidence-based informed consent forms for total knee arthroplasty and related anaesthesia procedures
- Primary Outcome Measures
Name Time Method Anxiety: Change from baseline anxiety after the informed consent procedure assessed by the surgical fear questionnaire and a numeric rating scale (0-10) 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 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.
- Secondary Outcome Measures
Name Time Method Knowledge/risk perception: Proportion of correctly answered questions assessed by knowledge questions about benefits and risks of undergoing surgery One day before surgery The objective knowledge questions (e.g. correct risk assessment) will be derived when developing the evidence-based informed consent forms. The development will be based on previous experiences with the measure of informed choice.
Mean pain and function of the knee assessed by the Oxford Knee Score approximately one month after hospital discharge The Oxford Knee Score (OKS) is a validated patient reported outcome measure for patients undergoing total knee arthroplasty, that consists of 12 questions about the individual's activities of daily live and how they have been affected by pain over the preceding four weeks.
Mean satisfaction with the physician-patient-communication and informed consent form assessed by a numeric rating scale (0-10) One day before surgery Patients will be queried about their overall satisfaction with the physician-patient-communication and with the informed consent form using a numeric rating scale (0-10)
Mean Quality of life (QoL) assessed by a numeric rating scale (0-10) approximately one month after hospital discharge Patients will be queried about their current overall quality of life assessed by a numeric rating scale (0-10)
Trial Locations
- Locations (1)
Cologne Merheim Medical Center
🇩🇪Cologne, NRW, Germany