No registrations found.
ID
Source
Brief title
Health condition
severe symptomatic aortic valve disease
Sponsors and support
Intervention
Outcome measures
Primary outcome
To explore among adult patients who have been accepted for aortic valve replacement, patient knowledge of the advantages and disadvantages of different valve prostheses and the information that patients received, patient view on patient participation in decision making, uncertainty in choosing options, how patients value the importance of the individual risks and benefits associated with the different therapeutic options, and patient preference for presentation of scientific evidence in relation to their numeracy.
Secondary outcome
To assess in the same patient population 3 months post-surgery patient knowledge of the advantages and disadvantages of different valve prostheses and the information that patients received, patient view on participation in decision making, uncertainty in choosing options, valve specific quality of life, and patient satisfaction with the decision that was made.
Background summary
To explore among adult patients who have been accepted for aortic valve replacement, patient knowledge of the advantages and disadvantages of different valve prostheses and the information that patients received, patient view on patient participation in decision making, uncertainty in choosing options, how patients value the importance of the individual risks and benefits associated with the different therapeutic options, and patient preference for presentation of scientific evidence in relation to their numeracy.
To assess in the same patient population 3 months post-surgery patient knowledge of the advantages and disadvantages of different valve prostheses and the information that patients received, patient view on participation in decision making, uncertainty in choosing options, valve specific quality of life, and patient satisfaction with the decision that was made.
Study objective
For patients with severe symptomatic aortic valve disease, aortic valve replacement surgery is the treatment of choice. Two options exist: Mechanical and bioprosthetic aortic valve. The decision which valve type to choose is difficult, since in most patients survival is comparable with either valve substitute but the nature of prosthetic valve-related morbidity differs significantly. While mechanical valve recipients are faced with an increased hazard of thrombo-embolic and bleeding complications, bioprosthetic valve recipients have an increased hazard of a reoperation later in life, since biological valves have a limited durability. Clinical characteristics like age, life expectancy, indication/contraindication for anticoagulation, and comorbidities play an important role in the decision-making process. However, patient preferences should also play a major role in the decision-making, since the nature of valve-related morbidity for the different prosthetic valve options is hard to compare and may be value-sensitive. Consideration of informed patient preferences, the use of decision aids and the process of ‘shared decision making’ get more and more attention in healthcare, and may improve the decision making process and hopefully lead to better patient outcomes.
One problem is that shared decision making remains undefined. First step to investigate and improve shared decision making in aortic valve replacement is to assess how patients who require aortic valve replacement experience the current decision making process.
Study design
April 2012:
1. Writing research proposal;
2. Study relevant literature;
3. Design surveys.
May 2012:
1. METC proposal preparation;
2. Study relevant literature.
June/July 2012:
1. Perform survey.
August/Sept. 2012:
1. Perform survey.
October 2012:
1. Perform survey &Data entry.
November 2012:
1. Perform survey &Data entry.
December 2012 Perform survey
January/February 2013:
1. Data-analysis NIHES.
March 2013:
1. Write paper & Defend thesis.
Intervention
Design and perform two surveys among elective adult patients who have been accepted for aortic valve replacement in Erasmus University Medical Center (Erasmus MC), University Medical Center Utrecht (UMCU) and Leiden University Medical Center (LUMC).
Survey 1 will be conducted after the decision for aortic valve replacement has been made, but before the operation.
Survey 2 will be conducted 3 months after the operation.
Afd. cardio-thoracale chirurgie<br>
Kamer: BD 577<br>
PO BOX 2040
Nelleke M. Korteland
Rotterdam 3000 CA
The Netherlands
+31 (0)10 7034377
n.korteland@erasmusmc.nl
Afd. cardio-thoracale chirurgie<br>
Kamer: BD 577<br>
PO BOX 2040
Nelleke M. Korteland
Rotterdam 3000 CA
The Netherlands
+31 (0)10 7034377
n.korteland@erasmusmc.nl
Inclusion criteria
Adult (18 years or older) patients who have been accepted for aortic valve replacement in Erasmus University Medical Center (Erasmus MC), University Medical Center Utrecht (UMCU) and Leiden University Medical Center (LUMC).
Exclusion criteria
Patients who are 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
No registrations found.
In other registers
Register | ID |
---|---|
NTR-new | NL3466 |
NTR-old | NTR3618 |
Other | MEC ErasmusMC : 2012-323 |
ISRCTN | ISRCTN wordt niet meer aangevraagd. |