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

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ClinicalTrials.gov Identifier: NCT04669483
Recruitment Status : Recruiting
First Posted : December 16, 2020
Last Update Posted : May 18, 2021
Sponsor:
Collaborators:
Martin-Luther-Universität Halle-Wittenberg
DLR German Aerospace Center
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment
Consent Forms Osteoarthritis, Knee Arthroplasty, Replacement, Knee Other: evidence-based informed consent form

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Study Type : Observational
Estimated Enrollment : 220 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Development, Piloting and Evaluation of an Evidence-based Informed Consent Form for Total Knee Arthroplasty
Actual Study Start Date : March 22, 2021
Estimated Primary Completion Date : February 2023
Estimated Study Completion Date : March 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

Group/Cohort Intervention/treatment
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
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.

Control group (pre-interruption)
Patients receive standard consent forms (of the study centre) for total knee arthroplasty and related anaesthesia procedures



Primary Outcome Measures :
  1. Anxiety: Change from baseline anxiety after the informed consent procedure assessed by the surgical fear questionnaire and a numeric rating scale (0-10) [ Time Frame: 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.

  2. Nocebo-Effect: Proportion of patients with patient reported adverse events/complications and cummulaive number of adverse events/complications assessed by closed and open questions [ Time Frame: 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 :
  1. Knowledge/risk perception: Proportion of correctly answered questions assessed by knowledge questions about benefits and risks of undergoing surgery [ Time Frame: 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.

  2. Mean satisfaction with the physician-patient-communication and informed consent form assessed by a numeric rating scale (0-10) [ Time Frame: 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)

  3. Mean Quality of life (QoL) assessed by a numeric rating scale (0-10) [ Time Frame: 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)

  4. Mean pain and function of the knee assessed by the Oxford Knee Score [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04669483


Contacts
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Contact: Alina Weise, M. Sc. +49 221/9895741 Alina.Weise@uni-wh.de

Locations
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Germany
Cologne Merheim Medical Center Recruiting
Cologne, NRW, Germany, 51109
Sponsors and Collaborators
University of Witten/Herdecke
Martin-Luther-Universität Halle-Wittenberg
DLR German Aerospace Center
Investigators
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Principal Investigator: Tim Mathes, Dr. Institute for Research in Operative Medicine (IFOM), Witten/Herdecke University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Witten/Herdecke
ClinicalTrials.gov Identifier: NCT04669483    
Other Study ID Numbers: EvAb-P-V1
First Posted: December 16, 2020    Key Record Dates
Last Update Posted: May 18, 2021
Last Verified: December 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Witten/Herdecke:
informed consent
consent form
risk communication
anxiety
nocebo effect
total knee arthroplasty
Additional relevant MeSH terms:
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Osteoarthritis, Knee
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases