Ignite Creation Date:
2024-05-06 @ 3:32 PM
Last Modification Date:
2024-10-26 @ 1:51 PM
Study NCT ID:
NCT04669483
Status:
UNKNOWN
Last Update Posted:
2021-05-18
First Post:
2020-12-02
Brief Title:
Development Piloting and Evaluation of an Evidence-based Informed Consent Form for Total Knee Arthroplasty
Sponsor:
University of WittenHerdecke
Organization:
University of WittenHerdecke
Study Overview
Official Title:
Development Piloting and Evaluation of an Evidence-based Informed Consent Form for Total Knee Arthroplasty
Status:
UNKNOWN
Status Verified Date:
2020-12
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EvAb-Pilot
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None