|- candidate number||15840|
|- NTR Number||NTR4350|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||6-dec-2013|
|- Secondary IDs||NL 46722-078-13 THCHOZ 2013-15|
|- Public Title||Zorgt een keuzehulp voor een betere besluitvorming in hartklepkeuze?|
|- Scientific Title||Does a decision aid improve decision making in prosthetic heart valve selection?|
|- hypothesis||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?
|- Healt Condition(s) or Problem(s) studied|
|- 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|
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jan-2014|
|- planned closingdate||1-jul-2015|
|- Target number of participants||120|
|- Interventions||Use by the patient of the clinical decision aid prior to the preoperative consultation in which prosthetic valve selection is discussed. |
|- 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.|
|- Timepoints||Oct-Nov 2013|
1. Writing research proposal;
2. Study relevant literature;
3. Design surveys.
Dec 2013/Jan 2014
1. METC proposal preparation;
2. Study relevant literature.
1. Perform survey.
1. Write paper.
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES|| Nelleke M. Korteland|
|- CONTACT for SCIENTIFIC QUERIES|| Nelleke M. Korteland|
|- Sponsor/Initiator ||Erasmus Medical Center, Rotterdam|
(Source(s) of Monetary or Material Support)
|Erasmus Medical Center|
|- Brief summary||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.|
|- Main changes (audit trail)|
|- RECORD||6-dec-2013 - 2-feb-2014|