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

NCT04669483 | Unknown

• 1 other identifier: EvAb-P-V1
• Study Type: observational
• Target: 220
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

informed consent; consent form; risk communication; anxiety; nocebo effect; total knee arthroplasty

Outcome Measures

Primary Outcomes (2)

• Anxiety: Change from baseline anxiety after the informed consent procedure assessed by the surgical fear questionnaire and a numeric rating scale (0-10)

  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.

  Anxiety will be measured at the day of consultation - approximately 4 weeks before surgery - (baseline) and one day before surgery

• Nocebo-Effect: Proportion of patients with patient reported adverse events/complications and cummulaive number of adverse events/complications assessed by closed and open questions

  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.

  approximately three days after hospital discharge

Secondary Outcomes (4)

• Knowledge/risk perception: Proportion of correctly answered questions assessed by knowledge questions about benefits and risks of undergoing surgery

  One day before surgery

• 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

• Mean pain and function of the knee assessed by the Oxford Knee Score

  approximately one month after hospital discharge

Study Arms (2)

Intervention group (post-interruption)

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

Other: evidence-based informed consent form

Control group (pre-interruption)

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

Interventions

evidence-based informed consent form OTHER

Evidence-based informed consent forms for total knee arthroplasty and related anesthesia procedures will be developed. The design of the evidence-based informed consent forms will be guided by an existing guideline on how to present evidence-based health information (guideline evidence-based health information) and nocebo research. The information will be presented in plain language. Benefits and harms of the procedures will be presented in absolute risk formats and in comparison with other interventions or placebo. Verbal presentations of risks lead to overestimations of risks and therefore, will not be applied exclusively. Gain and loss framing will be combined. To visualize important aspects, pictograms will be used. Information on uncertainty, missing or low quality evidence will be provided.

Intervention group (post-interruption)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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

You may not qualify if:

• Patients with revision
• Patients with posttraumatic arthrosis

Sponsors & Collaborators

• University of Witten/Herdecke: lead
• Martin-Luther-Universität Halle-Wittenberg: collaborator
• DLR German Aerospace Center: collaborator

Study Sites (1)

Cologne Merheim Medical Center

Cologne, North Rhine-Westphalia, 51109, Germany

RECRUITING

Related Publications (1)

• 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.

  PMID: 33985574 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee; Anxiety Disorders

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Mental Disorders

Study Officials

• Tim Mathes, Dr.

  Institute for Research in Operative Medicine (IFOM), Witten/Herdecke University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alina Weise, M. Sc.

CONTACT

+49 221/9895741; Alina.Weise@uni-wh.de

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2020
• First Posted: December 16, 2020
• Study Start: March 22, 2021
• Primary Completion: February 1, 2023
• Study Completion: March 1, 2023
• Last Updated: May 18, 2021

Record last verified: 2020-12

Locations

DE (1)