Consent FormsEvAb-PilotNCT04669483
Development, Piloting and Evaluation of an Evidence-based Informed Consent Form for Total Knee Arthroplasty
An observational study of Consent Forms and Osteoarthritis, Knee, run by University of Witten/Herdecke at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Consent Forms, Osteoarthritis, Knee, Arthroplasty, Replacement, Knee
- What is being tested?
- evidence-based informed consent form
- How many people
- 220 participants
- Where
- 1 siteGermany
- Study dates
- 22 Mar 2021to Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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
Who cannot join
- Patients with revision
- Patients with posttraumatic arthrosis
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Cologne Merheim Medical Center
Cologne, North Rhine-Westphalia, 51109
About this study
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.
Read more
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.
- Being tested
- evidence-based informed consent form
- Keywords
- informed consent, consent form, risk communication, anxiety, nocebo effect, total knee arthroplasty
- Medical subject headings
- Osteoarthritis, Knee, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
evidence-based informed consent formOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group (post-interruption) | Patients receive evidence-based informed consent forms for total knee arthroplasty and related anaesthesia procedures Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
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.
Measured: One day before surgery
Mean satisfaction with the physician-patient-communication and informed consent form assessed by a numeric rating scale (0-10)
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)
Measured: One day before surgery
Mean Quality of life (QoL) assessed by a numeric rating scale (0-10)
Patients will be queried about their current overall quality of life assessed by a numeric rating scale (0-10)
Measured: approximately one month after hospital discharge
Mean pain and function of the knee assessed by the Oxford Knee Score
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.
Measured: approximately one month after hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2020
- Study start22 Mar 2021
- Primary completionFeb 2023 (estimated)
- Study completionMar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Consent FormsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Witten/Herdecke
- Sponsor type
- University, hospital or other
- Collaborators
- Martin-Luther-Universität Halle-Wittenberg, DLR German Aerospace Center
- Responsible party
- Sponsor
- Investigators
- Tim Mathes, Dr., Principal investigator, Institute for Research in Operative Medicine (IFOM), Witten/Herdecke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04669483
- Sponsor's protocol ID
- EvAb-P-V1
- Acronym
- EvAb-Pilot
- Status last verified
- Dec 2020
- First submitted
- 2 Dec 2020
- Last updated
- 18 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 33985574
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development, Piloting and Evaluation of an Evidence-based Informed Consent Form for Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT04669483
- Acronym / sponsor ID
- EvAb-Pilot / EvAb-P-V1
- Keywords
- informed consent, consent form, risk communication, anxiety, nocebo effect, total knee arthroplasty
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- University of Witten/HerdeckeUniversity, hospital or other
- Collaborators
- Martin-Luther-Universität Halle-Wittenberg, DLR German Aerospace Center
- Study start
- 22 Mar 2021 (actual)
- Primary completion
- Feb 2023 (estimated)
- Study completion
- Mar 2023 (estimated)
- First posted
- 16 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group (post-interruption) | – | Other: evidence-based informed consent formPatients receive evidence-based informed consent forms for total knee arthroplasty and related anaesthesia procedures |
| Control group (pre-interruption) | – | –Patients receive standard consent forms (of the study centre) for total knee arthroplasty and related anaesthesia procedures |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Patients with revision
- Patients with posttraumatic arthrosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| evidence-based informed consent formEvidence-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. | Other | Intervention group (post-interruption) |
Primary outcome
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.
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.
4 secondary outcomes
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
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
Mean Quality of life (QoL) assessed by a numeric rating scale (0-10)
Time frame: approximately one month after hospital discharge
Mean pain and function of the knee assessed by the Oxford Knee Score
Time frame: approximately one month after hospital discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2021.
- Derived from this study: PubMed 33985574Weise 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tim Mathes, Dr. principal investigator
Institute for Research in Operative Medicine (IFOM), Witten/Herdecke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Consent Forms and Osteoarthritis, Knee, run by University of Witten/Herdecke at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alina Weise, M. Sc. (+49 221/9895741, Alina.Weise@uni-wh.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04669483, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2021.