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 valveā¦
ID
Source
Brief title
Condition
- Cardiac valve disorders
- Cardiac therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome is the decisional conflict scale
Secondary outcome
Secondary outcomes are patient knowledge, participation in decision-making,
anxiety, quality of life and regret.
Background summary
For patients who are accepted for aortic or mitral valve replacement two
options exist: mechanical and bioprosthetic valve substitutes. 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-making.
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
Randomized multicenter clinical trial.
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
For participants of this study there aren*t any direct risks or benefits,
perhaps there are benefits for future patients.
Patient's burden: 30 minutes to read the webbased decision aid. 2x 15 minutes
time to completed the questionnaires.
's Gravendijkwal 230
ROTTERDAM 3015 CE
NL
's Gravendijkwal 230
ROTTERDAM 3015 CE
NL
Listed location countries
Age
Inclusion criteria
adults > = 18 years, legally capable
heart valve replacement
Exclusion criteria
legally incapable
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
Register | ID |
---|---|
CCMO | NL46722.078.13 |
Other | NTR is aangevraagd |
OMON | NL-OMON25571 |