Development, Piloting and Evaluation of an Evidence-based Informed Consent Form for Total Knee Arthroplasty (EvAb-Pilot)

University of Witten/Herdecke

Status: Unknown

Conditions: Arthroplasty, Replacement, Knee; Consent Forms; Osteoarthritis, Knee

Treatments: Other: evidence-based informed consent form

Study type: Observational

Funder types: Other

Identifiers

NCT04669483

EvAb-P-V1

Details and patient eligibility

About

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.

Enrollment: 220 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• Patients with revision
• Patients with posttraumatic arthrosis

Trial design

220 participants in 2 patient groups

Intervention group (post-interruption)

Description:

Patients receive evidence-based informed consent forms for total knee arthroplasty and related anaesthesia procedures

Treatment:

Other: evidence-based informed consent form

Control group (pre-interruption)

Description:

Patients receive standard consent forms (of the study centre) for total knee arthroplasty and related anaesthesia procedures