Clinical trial NCT04669483: Development, Piloting and Evaluation of an Evidence-based Informed Consent Form for Total Knee Arthroplasty
Official title: Development, Piloting and Evaluation of an Evidence-based Informed Consent Form for Total Knee Arthroplasty
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Consent Forms
Osteoarthritis, Knee
Arthroplasty, Replacement, Knee
Keywords: informed consent
consent form
risk communication
anxiety
nocebo effect
total knee arthroplasty
Lead sponsor: University of Witten/Herdecke
Sponsor class: OTHER
Collaborators: name: Martin-Luther-Universität Halle-Wittenberg
name: DLR German Aerospace Center
First posted: 2020-12-16
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We will recruit patients who are sheduled for an elective total knee arthroplasty surgery at the clinic for orthopedics, trauma surgery and sports traumatology of the Cologne-Merheim hospital (Germany).

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.


Eligibility criteria: 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

Primary outcomes:
measure: Anxiety: Change from baseline anxiety after the informed consent procedure assessed by the surgical fear questionnaire and a numeric rating scale (0-10)
timeFrame: Anxiety will be measured at the day of consultation - approximately 4 weeks before surgery - (baseline) and one day before surgery
measure: Nocebo-Effect: Proportion of patients with patient reported adverse events/complications and cummulaive number of adverse events/complications assessed by closed and open questions
timeFrame: approximately three days after hospital discharge
Secondary outcomes:
measure: Knowledge/risk perception: Proportion of correctly answered questions assessed by knowledge questions about benefits and risks of undergoing surgery
timeFrame: One day before surgery
measure: Mean satisfaction with the physician-patient-communication and informed consent form assessed by a numeric rating scale (0-10)
timeFrame: One day before surgery
measure: Mean Quality of life (QoL) assessed by a numeric rating scale (0-10)
timeFrame: approximately one month after hospital discharge
measure: Mean pain and function of the knee assessed by the Oxford Knee Score
timeFrame: approximately one month after hospital discharge
Other outcomes:
Locations:
city: Cologne
country: Germany
facility: Cologne Merheim Medical Center
state: NRW
Study officials:
affiliation: Institute for Research in Operative Medicine (IFOM), Witten/Herdecke University
name: Tim Mathes, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Weise A, Luhnen J, Buhn S, Steffen F, Zacher S, Lauberger J, Ates DM, Bohmer A, Rosenau H, Steckelberg A, Mathes T. Development, piloting, and evaluation of an evidence-based informed consent form for total knee arthroplasty (EvAb-Pilot): a protocol for a mixed methods study. Pilot Feasibility Stud. 2021 May 13;7(1):107. doi: 10.1186/s40814-021-00843-x.