Structured Shared Decision Making for Patients Undergoing SAVR or TAVR

Study Overview
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Brief Summary
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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.

Official Title
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Structured Shared Decision Making for Patients Undergoing Elective Surgical or Transcatheter Aortic Valve Replacement (TOGETHER): A Randomized-controlled Trial

Conditions
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Aortic Valve Stenosis, Symptomatic Aortic Stenosis

Intervention / Treatment
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* Other: Structured SDM
* Other: Usual Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Life expectancy <1 year irrespective of valvular heart disease Inability to provide informed consent Participation in another clinical trial with an active intervention

Ages Eligible for Study
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Minimum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Structured SDM<br>Structured shared decision making for the choice between SAVR and TAVR | Other: Structured SDM<br>* The 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<br>|
| Other: Usual Care<br>Usual care for the choice between SAVR and TAVR | Other: Usual Care<br>* Usual 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient decisional conflict | Assessed by decisional conflict scale (ranges from 0 to 100, with higher scores indicating a worse outcome) | 3 days post baseline visit | 
| Patient decisional regret | Assessed by the decision regret scale (ranges from 0 to 100, with higher scores indicating a worse outcome) | 30 days post TAVR/SAVR | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient-centered communication | Assessed by CollaboRATE scale (ranges from 0 to 100, with higher scores indicating a better outcome) | 3 days post baseline visit | 
| 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) | 3 days post baseline visit | 
| Patient procedural satisfaction | Assessed by Likert Scale (ranges from 1 to 5, with higher scores indicating a better outcome) | 3 days post baseline visit | 
| Patient decisional satisfaction | Assessed by Likert Scale (ranges from 1 to 5, with higher scores indicating a better outcome) | 3 days post baseline visit; 30 days and 1 year post TAVR/SAVR | 
| Incorporation of patient values | Assessed by values clarity subscore of the decisional conflict scale (ranges from 0 to 100, with higher scores indicating a worse outcome) | 3 days post baseline visit | 
| Patient feeling of not being informed | Assessed by informed subscore of the decisional conflict scale (ranges from 0 to 100, with higher scores indicating a worse outcome) | 3 days post baseline visit | 
| Quality of choice | Assessed by effective decision subscore of the decisional conflict scale (ranges from 0 to 100, with higher scores indicating a worse outcome) | 3 days post baseline visit | 
| Patient decisional regret | Assessed by the decision regret scale (ranges from 0 to 100, with higher scores indicating a worse outcome) | 1 year post TAVR/SAVR | 
| Patient health-related quality of life | Assessed by KCCQ 12 (Kansas City Cardiomyopathy Questionnaire) (ranges from 0 to 100, with higher scores indicating a better outcome) | 30 days post TAVR/SAVR | 
| The proportion of patients choosing TAVR/SAVR | Number of participants choosing valve replacement by TAVR or SAVR | Baseline | 
| The incidences of major clinical adverse events | All-cause mortality, stroke, transient ischemic attack, bleeding event, kidney injury, systemic embolism, myocardial infarction, new onset atrial fibrillation, permanent pacemaker implantation and intervention related to the device | 30 days and 1 year post TAVR/SAVR | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Symptomatic Aortic Stenosis, Aortic Valve Stenosis, SAVR (Surgical Aortic Valve Replacement), Shared Decision-Making, TAVR (Transcatheter Aortic Valve Replacement), TAVI (Transcatheter Aortic Valve Implantation), Decision Support Techniques