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

NCT04669483 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 220

Last updated 2021-05-18

No results posted yet for this study

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

Interventions

OTHER

evidence-based informed consent form

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.

Sponsors & Collaborators

  • Martin-Luther-Universität Halle-Wittenberg

    collaborator OTHER

  • DLR German Aerospace Center

    collaborator OTHER

  • University of Witten/Herdecke

    lead OTHER

Principal Investigators

  • Tim Mathes, Dr. · Institute for Research in Operative Medicine (IFOM), Witten/Herdecke University

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-22
Primary Completion
2023-02-28
Completion
2023-03-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04669483 on ClinicalTrials.gov