Conduct a multicenter randomized clinical trial to assess whether the use of the decision aid results in optimization of shared-decision making and improved quality of life in patients who have been accepted for aortic and/or mitral valve…
ID
Source
Brief title
Condition
- Cardiac valve disorders
Synonym
Health condition
Subjects participating in this study are men and women from the general cardio-thoracic population. The randomized study will include 120 subjects who meet all eligibility criteria and provide written informed consent. Each site must enroll a minimum of 10 subjects and may not enroll more than a maximum of 60 randomized subjects. Subjects enrolled in this study will consist of male and female subjects from the general cardio-thoracic population. The randomized study will recruit 120 subjects who meet all eligibility criteria and provide written informed consent. Each site must enroll a minimum of 10 subjects and may not enroll more than a maximum of 60 randomized subjects.
Research involving
Sponsors and support
Intervention
- Surigical procedure
Outcome measures
Primary outcome
Decisional conflict.
Secondary outcome
(1) Patient knowledge of treatment options and their consequences (2) participation in decision (3) anxiety (4) valve specific quality of life (4) quality of life and (5) regret.
Background summary
"For patients who are accepted for aortic or mitral valve replacement two options exist: mechanical and bioprosthetic valve substitutes1. The decision which valve type to choose is a delicate process, since in most patients survival is comparable with either valve substitute but the nature of prosthetic valve-related morbidity differs significantly, is hard to compare and may be value-sensitive. Therefore, patient preferences should play a major role in the decision-making2.
Consideration of informed patient preferences, the use of decision aids and the process of ‘shared decision making’3 get more and more attention in healthcare, and may improve the decision making process and hopefully lead to a better quality of life.
It is hypothesized that clinical decision making in prosthetic valve selection can be improved by the use of decision aids and the process of shared decision making.
Our research questions are:
1. Does the use of a decision aid improve decision making?
2. Does the use of a decision aid improve quality of life?
"
Study objective
Conduct a multicenter randomized clinical trial to assess whether the use of the decision aid results in optimization of shared-decision making and improved quality of life in patients who have been accepted for aortic and/or mitral valve replacement.
Study design
"Subjects will fill in two questionnaires. The first questionnaire will be conducted after the use of the decision aid for the intervention group or after the standard preoperative consultation for the control group, prior to the operation. The second questionnaire will be conducted 3 months after the operation.
Also, the patients randomized to the intervention group will visit the decision aid, fill in their study number, age and gender and receive a personalized summary of their feeling and thought regarding heart valve replacement.
"
Intervention
Use by the patient of the clinical decision aid prior to the preoperative consultation in which prosthetic valve selection is discussed. Control group receives the standard preoperative consultation.
Study burden and risks
One inconvenience of this study is that you will spend about 15 minutes completing the questionnaires twice. In addition, depending on which group you are in, you will spend about 30 minutes going through the "Heart Valve Selection Tool.
Afd. cardio-thoracale chirurgie
Kamer: BD 577
PO BOX 2040
Prof. Dr. J.J.M. Takkenberg
Dr. Molewaterplein 40
Rotterdam 3015 GD
The Netherlands
010-7032150
Research.thoraxchirurgie@erasmusmc.nl
Afd. cardio-thoracale chirurgie
Kamer: BD 577
PO BOX 2040
Prof. Dr. J.J.M. Takkenberg
Dr. Molewaterplein 40
Rotterdam 3015 GD
The Netherlands
010-7032150
Research.thoraxchirurgie@erasmusmc.nl
Age
Inclusion criteria
- 18 years or older
- Patients who have been accepted for aortic and/or mitral valve replacement (with or without additional procedures) in one of the participating centers.
"
Exclusion criteria
- Patients who are legally incapable
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL4198 |
| NTR-old | NTR4350 |
| CCMO | NL46722.078.13 |
| OMON | NL-OMON40405 |