Structured Shared Decision Making for Patients Undergoing SAVR or TAVR
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age70+
SponsorInsel Gruppe AG, University Hospital Bern
About this trial
Transcatheter aortic valve replacement (TAVR) is a well-established alternative to surgical aortic valve replacement (SAVR) for the treatment of patients with severe aortic stenosis regardless of surgical risk. While TAVR and SAVR share some of the benefits and risks, they importantly differ with regards to invasiveness, time to recovery, hemodynamics, as well as options for re-intervention and possibly valve durability. An early benefit of TAVR may be offset by late risks. Therefore, current guidelines of the European Society of Cardiology recommend an integration of patient values and preferences for the selection of the treatment modality.
The objective of the TOGETHER trial is to investigate the efficacy of a structured shared decision making approach (SDM) to improve patient-centered outcomes for the choice between SAVR and TAVR.
TOGETHER is an investigator-initiated, randomized, open-label, single-center clinical trial. A total of 140 patients referred for treatment of symptomatic severe aortic stenosis and deemed to undergo TAVR or SAVR according to heart team decision will be randomized in a 1:1 ratio to structured SDM or usual care.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 70 years
Symptomatic severe aortic stenosis defined by an aortic valve area ≤1.0 cm2 or an aortic valve area indexed to body surface area <0.6cm2/m2
Both SAVR and transfemoral TAVR as reasonable treatment options based on heart team decision
Disqualifiers
Life expectancy <1 year irrespective of valvular heart disease
Inability to provide informed consent
Participation in another clinical trial with an active intervention
Trial design
Design model
Parallel
Treatments tested in this trial
Structured SDM
Other interventionThe conversation between the heart team member and the patient will be structured according the adapted three-talk model for patients with symptomatic aortic stenosis and using the American College of Cardiology's decision aid for patients deciding between TAVR and SAVR
Usual Care
Other interventionUsual care will include baseline visits without a structured SDM approach. Usual care includes at least one decision making talk with a heart team member discussing information about the disease, treatment options as well as benefits and risks of each procedure.
Treatment groups
140 Participants
are divided into 2 treatment groupsGroup A: Structured SDMOther 1 intervention
Group B: Usual CareOther 1 intervention
Trial outcomes
Primary outcomes
1
Patient decisional conflict
Assessed by decisional conflict scale (ranges from 0 to 100, with higher scores indicating a worse outcome)
Time frame
3 days post baseline visit2
Patient decisional regret
Assessed by the decision regret scale (ranges from 0 to 100, with higher scores indicating a worse outcome)
Time frame
30 days post TAVR/SAVRSecondary outcomes
1
Patient-centered communication
Assessed by CollaboRATE scale (ranges from 0 to 100, with higher scores indicating a better outcome)
Time frame
3 days post baseline visit2
Patient knowledge about the treatment options and outcomes
Assessed by 6 multiple-choice items (ranges from 0 to 6, with higher scores indicating a better outcome)
Time frame
3 days post baseline visit3
Patient procedural satisfaction
Assessed by Likert Scale (ranges from 1 to 5, with higher scores indicating a better outcome)
Time frame
3 days post baseline visit4
Patient decisional satisfaction
Assessed by Likert Scale (ranges from 1 to 5, with higher scores indicating a better outcome)
Time frame
3 days post baseline visit; 30 days and 1 year post TAVR/SAVRSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov